DRUGS AND COSMETICS RULES, 1945
(1) These Rules may be called the Drugs 2[and Cosmetics] Rules, 1945.
(2) They extend to the whole of India 3[***].
4[***]
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1. Vide Notification No. F.28-10/45H (1), dated 21st December, 1945.
2. Ins. by G.S.R. 1183, dated 17th August, 1964.
3. Omitted by G.S.R. 358, dated 5th March, 1975.
4. Sub-rule (3) omitted by G.S.R. 19, dated 15th December, 1977 (w.e.f. 7-1-1978).
In these Rules, unless there is anything repugnant in the subject or context—
(a) “the Act” means the Drugs and Cosmetics Act, 1940 (23 of 1940), as amended from time to time;
1 [(b) “Central Licence Approving Authority” means the Drugs Controller, India, or the Joint Drugs Controller (India) or the Deputy Drugs Controller (India) appointed by the Central Government;]
(c) “Director” means the Director of the Central Drugs Laboratory;
(d) “Form” means a form set forth in Schedule A;
2 [(dd) “Homoeopathic medicines” include any drug which is recorded in Homoeopathic provings or therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative Homoeopathic
It shall be the function of the Laboratory—
(i) to analyse or test such samples of drugs as may be sent to it under sub-section (2) of section 11, or under sub-section (4) of section 25 of the Act;
1[***]
(iii) to carry out such other duties as may be entrusted to it by the Central Government or, with the permission of the Central Government, by a State Government after consultation with the Drugs Technical Advisory Board.
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1. Clause (ii) omitted by Notification No. F. 1-16/57-D, dated 15th June, 1957.
(1) The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Central Research Institute, Kasauli, and the functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of the said Institute:—
(1) Sera
(2) Solution of serum proteins intended for injection
(3) Vaccines
(4) Toxins
(5) Antigens
(6) Anti-toxins
(7) Sterilized surgical ligature and sterilized surgical suture
(8) Bacteriophages:
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(1) Samples for test or analysis under sub-section (1) of section 25 of the Act shall be sent by registered post in a sealed packet, enclosed, together with a memorandum in Form 1, in an outer cover addressed to the Director.
(2) The packet as well as the outer cover, shall be marked with a distinguishing number.
(3) A copy of the memorandum in Form 1 and a specimen impression of the seal used to seal the packet shall be sent separately by registered post to the Director.
On receipt of the packet, it shall be opened by an officer authorised in writing in that behalf by the Director, who shall record the condition of the seal on the packet.
After test or analysis the result of the test or analysis, together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2.
The fees for test and analysis shall be those specified in Schedule B.
Certificates issued under these Rules by the Laboratory shall be signed by the Director or by an officer authorised by the Central Government by notification in the Official Gazette to sign such certificates.
Omitted by S.R.O. 2136, dated 15th June, 1957]
Omitted by S.R.O. 2136, dated 15th June, 1957]
Omitted by S.R.O. 2136, dated 15th June, 1957]
Omitted by S.R.O. 2136, dated 15th June, 1957]
Omitted by S.R.O. 2136, dated 15th June, 1957]
Omitted by S.R.O. 2136, dated 15th June, 1957]
Omitted by S.R.O. 2136, dated 15th June, 1957]
Omitted by S.R.O. 2136, dated 15th June, 1957]
Omitted by S.R.O. 2136, dated 15th June, 1957]
Omitted by S.R.O. 2136, dated 15th June, 1957]
Omitted by S.R.O. 2136, dated 15th June, 1957]
Omitted by S.R.O. 2136, dated 15th June, 1957]
In this Part—
1[(a) ‘import licence’ means either a licence in Form 10 to import drugs 2[***], excluding those specified in Schedule X, or a licence in Form 10A to import drugs specified in Schedule X;]
(b) “licensing authority” means the authority appointed by the Central Government to perform the duties of the licensing authority under these rules and includes any person to whom the powers of a licensing authority may be delegated under rule 22;
(c) “licence for examination, test or analysis” means a licence in Form 11 to import small quantities of drugs the import of which is otherwise prohibited, for the purpose of examination, test or analysis.
3[(d) “manufacturer”, includes a manufacturer of drugs, who may be
The licensing authority may with the approval of the Central Government by an order in writing delegate the 1[power to sign licences and Registration Certificates and] such other powers as may be specified in the order to any other person under his control.
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1. Subs. by G.S.R. 604(E) dated 24th August, 2001, for “power to sign licences and” (w.e.f. 1-1-2003).
An import licence in Form 10 shall be required for 2[import of drugs], excluding those specified in Schedule X, and an import licence in Form 10A shall be required for the import of drugs specified in Schedule X.]
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1. Subs. by G.S.R. 462(E), dated 22nd June, 1982 (w.e.f. 22-6-1982).
2. Subs. by G.S.R. 604(E) dated 24th August, 2001, for “import of any biological or other special product specified in Schedule C or C(1)” (w.e.f. 1-1-2003).
(1) An application for an import licence shall be made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8A for drugs specified in Schedule X, either by the manufacturer himself having a valid wholesale licence for sale or distribution of drugs under these rules, or by the manufacturer’s agent in India either having a valid licence under the rules to manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these rules, and shall be accompanied by a licence fee of one thousand rupees for a single drug and an additional fee at the rate of one hundred rupees for each additional drug and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer:
Provided that in the case of any subsequent application made by the same importer for import licence for drugs manufactured by
(1) An application for issue of a Registration Certificate shall be made to the licensing authority in Form 40, either by the manufacturer himself, having a valid whole sale licence for sale or distribution of drugs under these rules, or by his authorised agent in India, either having a valid licence under the rules to manufacture for sale of a drug or having a valid whole sale licence for sale or distribution of drugs under these rules, and shall be accompanied by the fee specified in sub-rule (3) and the informations and undertakings specified in Schedules D-I and D-II duly signed by or on behalf of the manufacturer.
(2) The authorisation by a manufacturer to his agent in India shall be documented by a power of attorney executed and authenticated either in India before a First-Class Magistrate, or in the country of origin before such an equivalent authority, the certificate of wh
(1) A single application may be made, and a single licence may be issued, in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer:
1[Provided that the drugs or classes of drugs are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit:
Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs a separate licence shall be required in respect of the drugs manufactured by each such factory.]
2[***]
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1. Added by Notification No. F.1-19/48-D, dated 27th October, 1949.
&n
(1) A licence in Form 10 or in Form 10A shall be granted by the licensing authority having regard to—
(i) the premises, where the imported substances will be stocked are equipped with proper storage accommodation for preserving the properties of the drugs to which the licence applies; and
(ii) the occupation, trade or business ordinarily carried out by the applicant:
Provided that the licensing authority may refuse to grant a licence in Form 10A in respect of any applicant where he is satisfied,—
(a) that the applicant has not complied with the provisions of the Act or these rules, or
(b) that by reasons of—
2[(i) hi
(1) A single application may be made, and a single Registration Certificate in Form 41 may be issued in respect of the import of more than one drug or class of drugs, manufactured by the same manufacturer:
Provided that the drug or classes of drugs, are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit:
Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs, separate Registration Certificates shall be required in respect of the drugs manufactured by each such factory.]
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1. Ins. by G.S.R. 604(E) dated 24th August, 2001 (w.e.f. 1-1-2003).
An import licence shall be subject to the following conditions:—
(i) the manufacturer shall at all times observe the undertaking given by him or on his behalf in Form 9;
(ii) the license shall allow any Inspector authorized by the licensing authority in that behalf to enter with or without notice any premises where the imported substance is stocked to inspect the means, if any, employed for testing the substance and to take samples;
(iii) the licensee shall on request furnish to the licensing authority from every batch of each substance or from such batch or batches at the licensing authority may from time to time specify a sample of such amount as the licensing authority may consider adequate for any examination required to be made, and the licensee shall, if so requ
On receipt of an application for an import licence in the Form and manner prescribed in rule 24, the licensing authority shall, on being satisfied that, if granted, the conditions of the licence will be observed, issue an import licence in Form 10 1[or Form 10A, as the case may be].
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1. Ins. by G.S.R. 462(E), dated 22nd June, 1982, (w.e.f. 22-6-1982).
(1) On receipt for an application for Registration Certificate in the Form and manner specified in rule 24A, the licensing authority shall, on being satisfied, that, if granted, the conditions of the Registration Certificate will be observed, issue a Registration Certificate in Form 41:
Provided further that if the application is complete in all respects and informations specified in Schedules DI and DII are in order, the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate, and in exceptional circumstances and for reasons to be recorded in writing, the Registration Certificate may be issued within such extended period, not exceeding three months as the licensing authority, may deem fit.
(2) If the applicant does not receive the Registration Certificate within the p
A licence, unless, it is sooner suspended or cancelled, shall be 2[valid for a period of three years from the date of its issue]:
Provided that if application for a fresh licence is made three months before the expiry of the existing licence the current licence shall be deemed to continue in force until orders are passed on the application.]
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1. Subs. by Notification No. F. 1-10/62-D, dated 19th April, 1964.
2. Subs. by G.S.R. 604(E), dated 24th August, 2001 for “valid upto the 31st December of the year following the year in which it is granted” (w.e.f. 1-1-2003).
A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue.
Provided that if the application for a fresh Registration Certificate is made nine months before the expiry of the existing certificate, the current Registration Certificate shall be deemed to continue in force until orders are passed on the application.]
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1. Ins. by G.S.R. 604(E), dated 24th August, 2001 (w.e.f. 1-1-2003).
If the manufacturer or licensee fails to comply with any of the conditions of an import licence, the licensing authority may after giving the manufacturer or licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel it for such period as it thinks fit either wholly or in respect of some of the substances to which it relates:
1[Provided that a person who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter, as it considers necessary and after giving the said appellant an opportunity for representing his views, pass such orders in relation thereto as it thinks fit.]
If the manufacturer fails to comply with any of the conditions of the Registration Certificate, the licensing authority may after giving him an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel the Registration Certificate for such period as it thinks fit either wholly or in respect of some of the substances to which it relates:
Provided that a person, who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, pass such orders in relation thereto as it thinks fit.]
No biological or other special product specified in Schedule C or C(1) shall be imported after the date shown on the label, wrapper or container of the drug as the date up to which the drug may be expected to retain a potency not less than, or not to acquire a toxicity greater than, that required, or as the case may be, permitted by the prescribed test.
1[***]
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1. Rule 30A added by Notification No. F. 1-30/48, dated 14th April, 1952 and omitted by G.S.R. 944(E), dated 21st September, 1988 (w.e.f. 21-9-1988).
(1) No New Homoeopathic medicine shall be imported except under and in accordance with the permission in writing of the Licensing Authority.
(2) The importer of a New Homoeopathic medicine when applying for permission shall produce before the Licensing Authority such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it.]
2 [ Explanation. —For the purpose of this rule, ‘New Homoeopathic medicine means,—
(i) a Homoeopathic medicine which is not specified in the Homoeopathic Pharmacopoeia of India or the United States of America or the United Kingdom or the German Homoeopathic Pharmacopoeia; or
(ii) which is not recogniz
No drug, the manufacture, sale or distribution of which is prohibited in the country of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis.]
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1. Added by Notification No. F. 1-45, dated 4th January, 1951.
No drug shall be imported unless it complies with the standard of strength, quality and purity, if any, and the test prescribed in the rules shall be applicable for determining whether any such imported drug complies with the said standards:
Provided that the drugs intended for veterinary use, the standards of strength, quality and purity, if any, shall be those that are specified in Schedule F(1) and the test prescribed in that Scheduled shall be applicable for determining whether any such imported drug complies with the said standards and where no standards are specified in Schedule F(1) for any veterinary drug, the standards for such drug shall be those specified in the current edition, for the time being in force, of the British Pharmacopoeia Veterinary:
Provided further that the licensing authority shall not allow the import of any
No drug shall be imported unless it is packed and labelled in conformity with the rules in Parts IX and X 2[***] and further conforms to the standards laid down in Part XII provided that in the case of drugs intended for veterinary use, the packing and labelling shall conform to the rules in Parts IX and X and Schedule F(1).]
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1. Subs. by S.O. 2889, dated 2nd July, 1969.
2. Omitted by G.S.R. 663(E), dated 3rd July, 1992, (w.e.f. 3-7-1992).
No Homoeopathic medicine shall be imported unless it is packed and labelled in conformity with the rules in Part IXA.]
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1. Added by S.O. 2139, dated 5th June, 1972, (w.e.f. 12-8-1972).
Small quantities of drugs the import of which is otherwise prohibited under section 10 of the Act may be imported for the purpose of examination, test or analysis subject to the following conditions:—
(a) no drug shall be imported for such purpose except under a licence in Form 11;
(b) the licensee shall use the substances imported under the licence exclusively for purposes of examination, test or analysis and shall carry on such examination, test or analysis in the place specified in the licence, or in such other places as the licensing authority may from time to time authorize;
(c) the licensee shall allow any Inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances are kept, and to inspec
Small quantities of a new drug, as defined in rule 122E, the import of which is otherwise prohibited under section 10 of the Act, may be imported for treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such disease requiring therapies for unmet medical needs, by a Medical Officer of a Government Hospital or an Autonomous Medical Institution providing tertiary care, duly certified by the Medical Superintendent of the Government Hospital, or Head of the Autonomous Medical Institution, subject to the following conditions, namely:—
(a) no new drug shall be imported for the said purpose except under a licence in Form 11A, and the said drug has been approved for marketing in the country of origin;
(b) the licencee shall use the substances or drugs imported under the licence exc
(1) An application for a licence for examination, test or analysis shall be made in Form 12 and shall be made or countersigned by the head of the institution in which, or by a proprietor or director of the company or firm by which the examination, test or analysis will be conducted.
(2) The licensing authority may require such further particulars to be supplied as he may consider necessary.
1[2[(3) Every application in Form 12 shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees for each additional drug.]
(4) The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other Bank, as Notified, from time to time, by the Central Government, to
(1) An application for an import licence for small quantities of a new drug, as defined in rule 122E for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, shall be made in Form 12 AA, by a Medical Officer of the Government Hospital or Autonomous Medical Institution, which shall be certified by the Medical Superintendent of the Government Hospital or Head of the Autonomous Medical Institution, as the case may be.
(2) The licensing authority may require such further particulars to be supplied, as he may consider necessary.
(3) Every application in Form 12AA shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees for each additional drug.
&nb
(1) A licence for examination, test or analysis may be cancelled by the licensing authority for breach of any of the conditions subject to which the licence was issued.
(2) A licensee whose licence has been cancelled may appeal to the Central Government within three months of the date of the order.
(1) A licence for import of small quantities of a new drug, defined in rule 122E, for the purpose of the treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, by a Government Hospital or an Autonomous Medical Institution may be cancelled by the licensing authority for breach of any of the conditions subject to which the licence was issued or for contravention of any of the provisions of the Act and rules made thereunder.
(2) A licencee whose licence has been cancelled may appeal to the Central Government within three months from the date of the receipt of the order, and the Central Government may after such enquiry into the matter, as it considers necessary and after giving the appellant an opportunity for representing his views, may pass such orders in relatio
Small quantities of drugs, the imports of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions:—
(i) the drugs shall form part of a passenger’s bona fide baggage and shall be the property of, and be intended for, the exclusive personal use of the passenger;
(ii) the drugs shall be declared to the Customs authorities if they so direct;
(iii) the quantity of any single drug so imported shall not exceed one hundred average doses:
Provided that the licensing authority may in an exceptional case in any individual case sanction the imports of a larger quantity:
1[Provided further that any drug, imported for pers
Patent or proprietary medicine shall be imported in containers intended for retail sale:
2[Provided that such medicine may be imported in bulk containers by any person who holds a licence to manufacture, if such person has obtained permission in writing to import such medicines from the licensing authority at least three months prior to the date of import and the imports are made within a period of twelve months from the date of issue of such permission].]
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1. Subs. by Notification No. F. 1-3/51-D.S., dated 15th October, 1954.
2. Ins. by Notification No. F. 1-45/58-D, dated 4th January, 1961.
All consignments of drugs sought to be imported shall be accompanied by an invoice or other statement showing the name and address of the manufacturer and the names and quantities of the drugs.
Before drugs for the import of which a licence is not required are imported a declaration signed by or on behalf of the manufacturer or by or on behalf of the importer that the drugs comply with the provisions of Chapter III of the Drugs and Cosmetics Act, 1940 and the rules thereunder shall be supplied to the Customs Collector.
(1) If the Customs Collector has reason to doubt whether any drugs comply with the provisions of Chapter III of the Act and rules thereunder he may, and if requested by any officer appointed for this purpose by the Central Government shall, take samples of any drugs in the consignment and forward them to the director of the laboratory appointed for this purpose by the Central Government and may detain the drugs in the consignment of which samples have been taken until the report of the director of the said laboratory or any other officer empowered by him on this behalf, subject to the approval of the Central Government on such samples is received:
Provided that if the importer gives an undertaking in writing not to dispose of the drugs without the consent of the Customs Collector and to return the consignment or such portion thereof as may be required, the Customs Collector shall m
(1) If the Director of the laboratory appointed for the purpose by the Central Government or any other officer empowered by him on this behalf subject to the approval of the Central Government reports to the Customs Collector that the samples of any drug in a consignment are not of standard quality, or that the drug contravenes in any other respect the provisions of Chapter III of the Act or the rules thereunder and that the contravention is such that it cannot be remedied by the importer, the Customs Collector shall communicate the report forthwith to the importer who shall, within two months of his receiving the communication either export all the drugs of that description in the consignment, to the country in which they were manufactured or forfeit them to the Central Government which shall cause them to be destroyed:]
Provided that the importer may within fifteen days of receip
1[***]
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1. Rule 42 omitted by Notification No. F. 1-9/52-D.S., dated 3rd November, 1953.
The drugs specified in Schedule D shall be exempt from the provisions of Chapter III of the Act and of the Rules made thereunder to the extent, and subject to the conditions specified in that Schedule.
No drug shall be imported into India except through one of the following places, namely:—
Firozepur Cantonment and Amritsar Railway Stations:
In respect of drugs imported by rail across the frontier with Pakistan.
Ranaghat, Bongaon and Mohiassan Railway Stations:
In respect of drugs imported by rail across the frontier with Bangladesh,
2[Raxaul:
In respect of drugs imported by road and railway lines connecting Raxaul in India and Birganj in Nepal]
3[Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva and Kandla]:
Drugs, consignments of which are in transit through India to foreign countries and which shall not be sold or distributed in India shall be exempted from the requirements of Chapter III of the Drugs and Cosmetics Act, 1940 (23 of 1940) and rules made thereunder:
Provided that if the Government of the countries to which the drugs are consigned regulate their import by the grant of import licences, the importer shall at the time of import into India, produce such import licences.]
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1. Added by S.O. 1056, dated 19th March, 1964.
A person appointed as a Government Analyst under the Act shall be a person who—
(a) is a graduate in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a 2[University established in India by the law or has an equivalent qualification recognised and notified by the Central Government for such purpose] and has had not less than five years’ post-graduate experience in the testing of drugs in a laboratory under the control of (i) a Government Analyst appointed under the Act, or (ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority 3[or has completed two years’ training on testing of drugs, including items stated in Schedule C, in Central Drugs Laboratory], or
(b) possesses a post-graduate degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of
(1) The Government Analyst shall cause to be analysed or tested such samples of drugs 1[and cosmetics] as may be sent to him by Inspector or other persons under the provisions of Chapter IV of the Act and shall furnish reports of the results of test or analysis in accordance with these Rules.
(2) A Government Analyst shall from time to time forward to the Government reports giving the result of analytical work and research with a view to their publication at the discretion of Government.
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1. Added by S.O. 2139, dated 5th June, 1972 (w.e.f. 12-8-1972).
On receipt of a package from an Inspector containing a sample for test or analysis, the Government Analyst shall compare the seals on the packet 1[or on portion of sample or container] with the specimen impression received separately and shall note the condition of the seals on the 2[packet or on portion of sample or container]. After the test or analysis has been completed, he shall forthwith supply to the Inspector a report in triplicate in Form 13 of the result of the test or analysis, together with full protocols of the tests or analysis applied.
3[Explanation.—It shall be deemed to be full and sufficient compliance with the requirement of the rule in respect of the supply of “protocols of the tests or analysis applied”, if—
(1) for pharmacopoeial drug, where the tests or methods of analysis prescribed in the official pharmac
An application from a purchaser for test or analysis of a drug under section 26 of the Act shall be made in Form 14A and the report of test or analysis of the drug made on such application shall be supplied to the applicant in Form 14B.
The fees to be paid by a person submitting to the Government Analyst under section 26 of the Act for test or analysis of a drug 1[or cosmetic] purchased by him shall be those specified in Schedule B.
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1. Added by S.O. 2139, dated 5th June, 1972.
A person who is appointed an Inspector under the Act shall be a person who has a degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialisation in Clinical Pharmacology or Microbiology from a University established in India by law:
Provided that only those Inspectors—
(i) who have not less than 18 months’ experience in the manufacture of at least one of the substances specified in Schedule C, or
(ii) who have not less than 18 months’ experience in testing of at least one of the substances in Schedule C in a laboratory approved for this purpose by the licensing authority, or
(iii) who have gained experience of not less than three years in the inspection of firm manufacturing any of the substances specified in
No person shall be qualified to be a Licensing Authority under the Act unless—
(i) he is a graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialisation in Clinical Pharmacology or Microbiology from a University established in India by law; and
(ii) he has experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years:
2[Provided that the requirements as to the academic qualification shall not apply to those Inspectors and the Government Analysts who were holding those positions on the 12th day of April, 1989.]]
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1. Ins. by G.S.R. 443(E), dated 1
(1) All Inspectors appointed by the Central Government shall be under the control of an officer appointed in this behalf by the Central Government.
(2) All Inspectors appointed by the State Government shall be under the control of an officer appointed in this behalf by the State Government.
(3) For the purposes of these rules an officer appointed by the Central Government under sub-rule (1), or as the case may be, an officer appointed by the State Government under sub-rule (2) shall be a controlling authority.]
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1. Subs. by S.O. 2139, dated 5th June, 1972 (w.e.f. 12-8-1972).
(1) No person shall be qualified to be a Controlling Authority under the Act unless—
(i) he is a graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialisation in Clinical Pharmacology or Microbiology from a University established in India by law; and
(ii) he has experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years:
2[Provided that the requirements as to the academic qualification shall not apply to those Inspectors and the Government Analysts who were holding those positions on the 12th day of April, 1989.]]
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1. Ins. by G.S.R. 443(E), dated 12th April, 1989 (w.e.f. 12-4-1989).
&
Subject to the instructions of the controlling authority, it shall be the duty of an Inspector authorized to inspect premises licensed for the sale of drugs—
(1) to inspect 1[not less than once a year] all establishments licensed for the sale of drugs within the area assigned to him;
(2) to satisfy himself that the conditions of the licences are being observed;
(3) to procure and send for test or analysis, if necessary, imported packages which he has reason to suspect contain drugs being sold or stocked or exhibited for sale in contravention of the provisions of the Act or rules thereunder;
(4) to investigate any complaint in writing which may be made to him;
(5) to
Subject to the instructions of the controlling authority it shall be the duty of an Inspector authorized to inspect the manufacture of drugs—
(1) to inspect 2[not less than once a year], all premises licensed for manufacture of 1[drugs or cosmetics] within the area allotted to him to satisfy himself that the conditions of the licence and provisions of the Act and Rules thereunder are being observed;
(2) in the case of establishments licensed to manufacture products specified in Schedules C and C (1) to inspect the plant and the process of manufacture, the means employed for standardizing and testing the drug, the methods and place of storage, the technical qualifications of the staff employed and all details of location, construction and administration of the establishment likely to affect the potency or purity of the pro
Except for the purposes of official business or when required by a Court of law, an Inspector shall not, without the sanction in writing of his official superior, disclose to any person any information acquired by him in the course of his official duties.
An order in writing by an Inspector under clause (c) of section 22 of the Act requiring a person not to dispose of any stock in his possession shall be in Form 15.
No person in possession of a drug 2 [or cosmetic] in respect of which an Inspector has made an order under clause (c) of sub-section (i) of section 22 of the Act shall in contravention of that order sell or otherwise dispose of any stock of such drug 2 [or cosmetic].]
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1. Added by Notification No. F. 1-19/59-D, dated 13th June, 1961.
2.Ins. by G.S.R. 850(E), dated 7th December, 1994 (w.e.f. 7-12-1994).
A receipt by an Inspector for the stock of any drug or cosmetic or for any record, register, document or any other material object seized by him under clause (c) or clause (cc) of sub-section (1) of section 22 of the Act shall be in Form 16.]
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1. Subs. by G.S.R. 926, dated 24th June, 1977 (w.e.f. 16-7-1977).
The Drugs Inspector shall return the documents, seized by him under clause (cc), or produced before him under clause (cca) of sub-section (1) of section 22 of the Act, within a period of twenty days of the date of such seizure or production, to the person from whom they were seized or, as the case may be, the person who produced them, after copies thereof of extracts therefrom have been signed by the concerned Drugs Inspector and the person from whom they were seized, or as the case may be, who produced such records.]
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1. Ins. by G.S.R. 89(E), dated 16th February, 1985 (w.e.f. 16-2-1985).
When an Inspector takes a sample of a drug for the purpose of test or analysis, he shall intimate such purpose in writing in Form 17 to the person from whom he takes it.
Where the fair price, for the samples of drugs taken for the purpose of test or analysis, tendered under sub-section (1) of section 23 has been refused, the Inspector shall tender a receipt therefor to the person from whom the said samples have been taken as specified in Form 17A.]
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1. Ins. by G.S.R 292(E), dated 29th May, 1997 (w.e.f. 29-5-1997).
(1) The portion of sample or the container sent by an Inspector to the Government Analyst for test or analysis under sub-section (4) of section 23 of the Act shall be sent by registered post or by hand in a sealed packet, enclosed together with a memorandum in Form 18, in an outer cover addressed to the Government Analyst.
(2) A copy of the memorandum and a specimen impression of the seal used to seal the packet shall be sent to the Government Analyst separately by registered post or by hand.
(1) Where any person has been convicted for contravening any of the provisions of Chapter IV of the Act or any rule made thereunder, the stock of the drug in respect of which the contravention has been made shall be liable to confiscation.
(2) Where any person has been convicted for the manufacture, of any drug deemed to be misbranded under clause (a), clause (b), clause (c), clause (d), clause (f) or clause (g) of section 17 of the Act, or adulterated drug under section 17B of the Act, or for manufacture for sale, or stocking or exhibiting for sale or distribution of any drug without a valid licence as required under clause (c) of section 18 of the Act, any implements or machinery used in such manufacture, sale or distribution and any receptacle, packages, or coverings in which such drug is contained and the animals, vehicles, vessels or other conveyances used in carrying such dru
(1) The Court shall refer the confiscated drugs to the Inspector concerned for report as to whether they are of standard quality or contravene the provisions of the Act or the rules in any respect.
(2) If the Inspector, on the basis of Government Analyst’s report finds the confiscated drugs to be not of standard quality or to contravene any of the provisions of the Act or the rules made thereunder, he shall report to the Court accordingly. The Court shall thereupon order the destruction of the drugs. The destruction shall take place under the supervision of the Inspector in the presence of such authority, if any, as may be specified by the Court.
(3) If the Inspector finds that the confiscated drugs are of standard quality and do not contravene the provisions of the Act or the rules made thereunder, he shall report to the Court according
(1) The State Government shall appoint licensing authorities for the purpose of this Part for such areas as may be specified.
1[(2) Application for the grant or renewal of a licence 2[to sell, stock, exhibit or offer for sale or distribute] drugs, other than those included in Schedule X, 1[shall be made in Form 19 accompanied by a fee of rupees one thousand and five hundred or in Form 19A accompanied by a fee of rupees five hundred, as the case may be, or in the case of drugs included in Schedule X shall be made in Form 19C accompanied by a fee of rupees five hundred, to the licensing authority:]
Provided that in the case of an itinerant vendor or an applicant who desires to establish a shop in a village or town having population of 5,000 or less, the application in Form 19A shall be accompanied by a fee of rupees ten.
&nb
A licensing authority may with the approval of the State Government by an order in writing delegate the power to sign licences and such other powers as may be specified in the order to any other person under his control.]
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1. Subs. by Notification No. F. 1-16/57-D, dated 15th June, 1957.
(1) A licence 2[to sell, stock, exhibit or offer for sale or distribute] drugs other than those specified in Schedules C, C (1) and X and by retail on restricted licence or by wholesale, shall be issued in Form 20, Form 20A or Form 20B, as the case may be:
Provided that a licence in Form 20A shall be valid for only such drugs as are specified in the licence.
(2) A licence 2[to sell, stock, exhibit or offer for sale or distribute] drugs specified in Schedules C and C (1) excluding those specified in Schedule X, by retail on restricted licence or by wholesale shall be issued in Form 21, Form 21A or Form 21B, as the case may be:
3[Provided that a licence in Form 21A shall not be granted for drugs specified in Schedule C and shall be valid for only such Schedule C (1) drugs as are specified in the
If drugs are sold or stocked for sale at more than one place, separate application shall be made, and a separate licence shall be issued, in respect of each such place:
1[Provided that this shall not apply to itinerant vendors who have no specified place of business and who will be licensed to conduct business in a particular area within the jurisdiction of the licensing authority.]
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1. Added by Notification No. F. 10-21/49-D, dated 10th March, 1953.
(a) Restricted licences in Forms 20A and 21A shall be issued subject to the discretion of the licensing authority to dealers or persons in respect of drugs whose sale does not require the supervision of a qualified person.
(b) Licences to itinerant vendors shall be issued only in exceptional circumstances for bona fide travelling agents of firms dealing in drugs or for a vendor who purchases drugs from a licensed dealer for distribution in sparsely populated rural areas where other channels of distribution of drugs are not available.
(c) The licensing authority may issue a licence in Form 21A to a travelling agent of a firm but to no other class of itinerant vendors for the specific purpose of distribution to medical practitioners or dealers samples of biological and other special products specified in Schedule C:
&n
(1) A licence in Form 20A or Form 21A shall not be granted to any person unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be granted are adequate and equipped with proper storage accommodation for preserving the properties of drugs to which the licence applies:
Provided that this condition shall not apply in the case of licence granted to itinerant vendors.
(2) In granting a licence under rule 62A the authority empowered to grant to it shall have regard to—
(i) the number of licences granted in the locality during one year immediately preceding; and
(ii) the occupation, trade or business carried on by such applicant:
(1) Application for the renewal of a licence to sell by wholesale or to distribute from a motor vehicle shall be made to the licensing authority in Form 19AA and shall be accompanied by 2[a fee of rupees five hundred]:
Provided that if the applicant applies for the renewal of a licence after its expiry but within six months of such expiry, the fee payable for renewal of such licence shall be 2[rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof].
(2) A fee of rupees one hundred and fifty shall be paid for a duplicate copy of a licence issued under this rule, if the original is defaced, damaged or lost.
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1. Ins. by G.S.R. 42(E), dated,
A licence shall be issued for sale by wholesale or for distribution from a motor vehicle of drugs other than those specified in Schedule C and Schedule C (1) in Form 20BB and of drugs specified in Schedule C and Schedule C (1) in Form 21BB:
Provided that such a licence shall not be required in a case where a public carrier or a hired vehicle is used for transportation or distribution of drugs.]
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1. Ins. by G.S.R. 42(E), dated, 25th January, 1979.
An original licence or a renewed licence to sell drugs, unless sooner suspended or cancelled, shall be 2[valid for a period of five years on and from the date on which] it is granted or renewed:
3[Provided that if the application for renewal of licence in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired if application for its renewal is not made within six months after its expiry.]]
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1. Subs. by Notification No. F. 1-10/62-D, dated 10th April, 1964.
2. Subs. by G.S.R. 601(E), dated 24t
A certificate of renewal of a sale licence in Forms 20, 20A, 20B, 2[20F, 20G], 21, 21A and 21B shall be issued in Form 21C.]
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1. Added by Notification No. F. 1-10/62-D, dated 10th April, 1964.
2. Ins. by G.S.R. 462(E), dated 22nd June, 1982 (w.e.f. 22-6-1982).
A certificate of renewal of a licence in Form 20BB or Form 21BB shall be issued in Form 21CC.]
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1. Ins. by G.S.R. 462(E), dated 22nd June, 1982 (w.e.f. 22-6-1982).
(1) A licence in 2[Form 20, 20B, 20F, 20G, 21 or 21B] 4[to sell, stock, exhibit or offer for sale or distribute] drugs shall not be granted 3[or renewed] to any person unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be granted 3[or renewed] are adequate, equipped with proper storage accommodation for preserving the properties of the drugs to which the licence applies and are in charge of a person competent in the opinion of the licensing authority to supervise and control the sale, distribution and preservation of drugs:
Provided that in the case of a pharmacy a licence in Form 20 or 21 shall not be granted 3[or renewed] unless the licensing authority is satisfied that the requirements prescribed for a pharmacy in Schedule N have been complied with:
5[Provided furth
Licences in 1[Forms 20, 20A, 20B, 20F, 20G, 21 and 21B] shall be subject to the conditions stated therein and to the following general conditions:—
2[(1) Any drug shall, if compounded or made on the licensee’s premises, be compounded or made by or under the direction and personal supervision of a 3[registered pharmacist].
(2) The supply, otherwise than by way of wholesale dealing 4[***] of any drug supplied on the prescription of a Registered Medical Practitioner shall be effected only by or under the personal supervision of a 3[registered pharmacist].
5[(3) (1) The supply of any drug 6[other than those specified in Schedule X] on a prescription of a Registered Medical Practitioner shall be recorded at the time of supply in a prescription register specially maintained
The applicant for the grant of a licence or any person granted a licence under this Part shall, on demand, furnish to the licensing authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm, or any other relevant matter which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee which applying for or after obtaining the licence, as the case may be.]
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1. Added by S.O. 2139, dated 5th June, 1972 (w.e.f. 12-8-1972).
(1) The licensing authority may, after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons therefore, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or rules thereunder:
1[Provided that, where such failure or contravention is the consequence of an Act or omission on the part of an agent or employee, the licence shall not be cancelled or suspended if the licensee proves to the satisfaction of the licensing authority—
(a) that the act or omission was not instigated or connived at by him or, if the licensee is a fi
(1) In case a licensee, whose license has been cancelled, desires to dispose of the drugs he has in his possession in the premises in respect of which the licence has been cancelled, he shall apply in writing to the licensing authority for this purpose, giving the following particulars, namely:—
(a) the name and address of the person to whom the drugs are proposed to be sold or supplied together with the number of the licence for sale or manufacture, as the case may be, held by him,
(b) the names of drugs together with their quantities, batch numbers, the names and addresses of their manufacturers and the dates of their expiry, if any, proposed to be sold to the person mentioned in clause (a).
(2) The licensing authority may, after examination of the particulars referred to in
1[***]
—————
1. Rule 67 omitted by S.O. 289, dated 20th December, 1972 (w.e.f. 3-2-1973).
(1) The State Government shall appoint licensing authorities for the purpose of this Part for such areas as may be specified.
(2) Application for the grant or renewal of a licence 1[to sell, stock, exhibit or offer for sale or distribute] Homoeopathic medicines shall be made in Form 19B to the licensing authority and shall be accompanied by 2[a fee of rupees two hundred and fifty]:
3[Provided that if the applicant applied for renewal of licence after its expiry but within six months of such expiry the fee payable for renewal of such licence shall be 2[rupees two hundred and fifty plus an additional fee at the rate of rupees fifty per month or part thereof].]
4[(3) If the original licence is either defaced, damaged or lost, a duplicate copy thereof may be issued on payment of 5[a fee of rupees
A licensing authority may, with the approval of the State Government, by an order in writing, delegate the power to sign licences and such other powers, as may be specified, to any other person under this control.
(1) A licence 1[to sell, stock, exhibit or offer for sale or distribute] Homoeopathic medicines by retail or by wholesale shall be issued in Form 20C or Form 20D as the case may be.
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1. Subs. by G.S.R. 788(E), dated 10th October, 1985 (w.e.f. 10-10-1985).
If drugs are sold or stocked for sale at more than one place, a separate application shall be made and a separate licence shall be obtained in respect of each place.
An original licence or a renewed licence unless it is sooner suspended or cancelled shall be 1[valid for a period of five years on and from the date on which] it is granted or renewed:
2[Provided that if the application for renewal of a licence in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if application for its renewal is not made within six months after its expiry.]
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1. Subs. by G.S.R. 601(E), dated 24th August, 2001 (w.e.f. 24-8-2001).
2. Subs. by S.O. 2139, dated 5th June,
The certificate of renewal of a sale licence in Forms 20C and 20D shall be issued in Form 20E.]
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1. Added by Notification No. F. 1-14/67-D, dated 3rd February, 1969.
(1) A licence in Form 20C or Form 20D 1[to sell, stock exhibit or offer for sale or distribute] Homoeopathic medicines shall not be granted to any person unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be granted are clean and in the case of a licence in form 20C the sale premises is in charge of a person who is or has been dealing in Homoeopathic medicines and who is in the opinion of the licensing authority competent to deal in Homoeopathic medicines:
2[Provided that no registered Homoeopathic medical practitioner who is practising Homoeopathy in the premises where Homoeopathic medicines are sold shall deal in Homoeopathic medicines.]
(2) Any person who is aggrieved by the order passed by the licensing authority under sub-rule (1) may within 30 days from the date
The applicant for the grant of a licence or any person granted a licence under this part shall, on demand furnish to the licensing authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises specified in the application for licence or in the licence granted, constitution of the firm, or any other relevant matter which may be required for the purpose or verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.]
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1. Added by S.O. 2139, dated 5th June, 1972 (w.e.f. 1-8-1972).
(1) The licensing authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefore, cancel a licence issued under this Part or suspend it for such period as he thinks fit, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or rules made thereunder:
1[Provided that, where such failure or contravention is the consequence of an act or omission on the part of an agent or employee, the licence shall not be cancelled or suspended if the licensee proves to the satisfaction of the licensing authority—
(a) that the act or omission was not instigated or connived at by him or, if the licensee is a firm or company, by a partner of the firm or a director of the company,
If drugs are manufactured on more than one set of premises a separate application shall be made and a separate licence shall be issued in respect of each such set of premises.
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* Ins. by G.S.R. 788(E), dated 10th October, 1985 (w.e.f. 10-10-1985).
(1) Notwithstanding anything contained in this Part, on and from the commencement of the Drugs and Cosmetics (9th Amendment) Rules, [vide G.S.R 923 (E), dated 14th December, 1992], a licence for the manufacture for sale or distribution of drugs as specified from time to time by the Central Government by notification* in the Official Gazette, for the purpose of this rule, shall be granted or renewed, as the case may be, by the Central Licence Approving Authority (appointed by the Central Government):]
Provided that the application for the grant or renewal of such licence shall be made to the licensing authority.
(2) On receipt of the application for grant or renewal of a licence, the licensing authority shall—
(i) verify the statement made in the application form;
The Central Licence Approving Authority may with the approval of the Central Government, by notification delegate his powers of signing licences and any other power under the rules to any person under his control having same qualifications as prescribed for controlling authority under rule 50A for such areas and for such periods as may be specified.]
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1. Ins. by G.S.R. 89(E), dated 14th February, 1996 (w.e.f. 14-2-1996).
2[(1) Application for grant or renewal of licence to manufacture for sale 3[or for distribution] of drugs, other than those specified in Schedules C and C(1) shall be made to the licensing authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the licensing authority) and shall be made—
(a) in the case of repacking of drugs excluding those specified in Schedule X for sale or distribution in Form 24B;
(b) in the case of manufacture of drugs included in Schedule X in Form 24F;
(c) in any other case, in Form 24.
(2) 4[(a) Every application in Form 24B shall be made up to ten items for each category of drugs categorised in Schedule M and shall be accompanied by a licence
2 [(1) Application for the grant or renewal of loan licences to manufacture for sale or for distribution of drugs other than those specified in Schedule C, Schedule C(1) and Schedule X shall be made up to ten items for each category of drugs cetegorised in Schedule M and Schedule MIII and shall be made in Form 24A accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred to the licensing authority:
Provided that if the applicant applies for the renewal of a licence after its expiry but within six months of such expiry, the fee payable for renewal of such licence shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred plus an additional fee at rate of rupees one thousand per month or part thereof.]
(2) The licensing
1[***]
—————
1. Rules 69B ins. by Notification No. F.1-19/59-D, dated 13th June, 1961 and omitted by G.S.R. 944(E), dated 21st September, 1988 (w.e.f. 21-9-1988).
Licences for repacking of drugs against application in Form 24B shall be granted in Form 25B, licences for manufacture of drugs included in Schedule X against application in Form 24F shall be granted in Form 25F and licences for manufacture of drugs against application in Form 24 shall be granted in Form 25.]
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1. Subs. by G.S.R. 462(E), dated 22nd June, 1982 (w.e.f. 22-6-1982)
A loan licence to manufacture for sale 2[or for distribution] of drugs other than those specified in 2[Schedules C, C(1) and X] shall be issued in Form 25A.]
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1. Added by Notification No. F. 1-16/57-D, dated 15th June, 1957 and Notification No. F. 1-22/59-D, dated 9th April, 1960.
2. Ins. by G.S.R. 788(E), dated 10th October, 1985 (w.e.f. 10-10-1985).
3. Subs. by G.S.R. 462(E), dated 22nd June, 1982 (w.e.f. 22-6-1982).
Before a licence in Form 25 3[or Form 25F] is granted or renewed the following conditions shall be complied with by the applicant:—
(1) the manufacture shall be conducted under the active direction and personal supervision of competent technical staff consisting at least of one person who is a whole time employee and who is—
(a) a graduate in Pharmacy or Pharmaceutical Chemistry of 4[a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] and has had at least eighteen months’ practical experience after the graduation in the manufacture of drugs. This period of experience may, however, be reduced by six months if the person has undergone training in manufacture of drugs for a period of six months during his University course; or
Before a licence in Form 25B is granted or renewed the following conditions shall be complied with by the applicant—
(1) the repacking operation shall be carried out under hygienic conditions under the supervision of a competent person;
2[(2) the factory premises shall comply with the conditions prescribed in Schedule M; and]
3[(3) the applicant shall have adequate arrangements in his own premises for carrying out tests for the strength, quality and purity of the drugs at a testing unit which shall be separate from the repacking unit:
Provided that the repacking units, which, before the commencement of the Drugs and Cosmetics (Second Amendment) Rules, 1977,4 were making arrangement with institutions approved by the licensin
Before a licence in Form 25A is granted or renewed, the applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the licensing authority evidence and date justifying that the patent of proprietary medicines—
(i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;
(ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulations and under conditions in which the formulations for administration and use are recommended;
(iii) are stable under the conditions of storage recommended; and
&
An original licence or a renewed licence in Form 25 2[Form 25B or Form 25F] unless sooner suspended or cancelled shall be 3[valid for a period of five years on and from the date on which] it is granted or renewed:
4[Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]]
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1. Subs. by Notification No. F. 1-10/62-D, dated 10th April, 1964.
2. Subs. by G.S
The certificate of renewal of a licence in Form 25 or Form 25F shall be issued in Form 26 or Form 26F respectively.]
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1. Subs. by G.S.R. 462(E), dated 22nd June, 1982 (w.e.f. 22-6-1982).
The certificate of renewal of a loan licence in Form 25A shall be issued in Form 26A.]
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1. Subs. by Notification No. F. 1-10/62-D, dated 10th April, 1964.
An original loan licence in Form 25A or renewed loan licence in Form 26A, unless sooner suspended or cancelled, shall be 1[valid for a period of five years on and from the date on which] it is granted or renewed:
2[Provided that if the application for the renewal of a licence is made before its expiry or if the application is made within six months of its expiry, after payment of the additional fees, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]
—————
1. Subs. by G.S.R. 601(E), dated 24th August, 2001 (w.e.f. 24-8-2001).
2. Subs.
The certificate of renewal of a licence in Form 25B shall be issued in Form 26B.]
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1. Added by Notification No. F. 1-22/59-D, dated 9th April, 1961.
A licence in 2[Form 25 and Form 25F] shall be subject to the conditions stated therein and to the following further conditions, namely:—
(a) the licensee shall provided and maintain staff, premises and the equipment as specified in rule 71;
(b) the licensee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the rules, these would come into force, four months after publication in the Official Gazette;
(c) the licensee shall either in his own laboratory or in any other laboratory approved by the licensing authority 3[under Part XV (A) of these rules] test each batch or lot of
A licence in Form 25B shall be subject to conditions stated therein and to the following conditions:—
(a) the repacking of drugs shall at all times be conducted under the personal supervision of at least one person who is approved as a competent person by the licensing authority;
(b) the licensee shall either provide and maintain adequate arrangements in his own premises for carrying out tests of the strength, quality and purity of the drugs repacked or make arrangements with some institution approved by the licensing authority 2[under Part XV (A) of these rules] for such tests to be regularly carried out on his behalf by the institution;
(c) the licensee shall make adequate arrangements for the storage of drugs;
3[(d
(1) The licence in Form 25A shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 25 whose manufacturing facilities have been availed of by the licensee is cancelled or suspended as the case may be, under these rules.
(2) The licensee shall comply with the provisions of the Act and of these rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IV of the Act; provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette.
(3) The licensee shall test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of s
(1) Applications for the grant or renewal of licence to manufacture for sale or distribution of drugs specified in Schedules C and C (1) 2[excluding those specified in Part XB and Schedule X], shall be made to the licensing authority in Form 27, and 3[shall be made upto ten items for each category of drugs categorised in Schedule M and Schedule M III and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection or for the purpose of renewal of licences]:
Provided that if the application for the renewal of licence is made after its expiry but within six months of such expiry the fee payable for renewal of the licence shall be 3[rupees six thousand plus an additional fee or rupees one thousand per month or a part thereof in addition to the inspection fee of rupees one thousand and five hundred].
(1) Applications for the grant or renewal of loan licences for the manufacture for sale 2[or for distribution] of drugs specified in Schedules C and C(1) 3[excluding those specified in Part XB and Schedule X] shall be made in Form 27A to the licensing authority and 4[shall be made upto ten items for each category of drugs categorised in Schedule M and Schedule MIII and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection or for the purpose of renewal of licences]:
5[Provided that if the applicant applies for the renewal of a licence after its expiry but within six months of such expiry the fee payable for renewal of the licence shall be rupees 4[rupees six thousand and an inspection fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees one thousand] per mont
1[***]
—————
1. Rules 75B added by Notification No. F. 1-19/59-D, dated 13th June, 1961 and omitted by G.S.R. 944(E), dated 21st September, 1988 (w.e.f. 21-9-1988).
3[A licence to manufacture for sale or for distribution of drugs specified in Schedules C and C(1) other than 4[Large Volume Parenterals, Sera and Vaccines and Recombinant DNA (r-DNA) derived drugs,], drugs specified in Part XB and Schedule X shall be issued in Form 28 and a licence to manufacture for sale or distribution of drugs specified under Schedule C and C(1) (other than 4[Large Volume Parenterals, Sera and Vaccines and Recombinant DNA (r-DNA) derived drugs,], drugs specified in Part XB) and Schedule X shall be issued in Form 28B. A licence to manufacture for sale or for distribution of 4[Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs] shall be issued in Form 28D. Before a licence in Form 28 or Form 28B or Form 28D is granted or renewed, the following conditions shall be complied with by the applicant:—]]
(1) The manufacture will
A loan licence to manufacture for sale 4[or for distribution of] drugs specified in Schedules C and C (1) 5[excluding the drugs specified in Schedule X] shall be issued in Form 28A, and the applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines—
(i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;
(ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulations and under the conditions in which the formulations for administration and use are recommended;
An original licence in 2[Form 28, Form 28B and Form 28D or renewed licence in Form 26, 26F, and Form 26H], unless sooner suspended or cancelled shall be 3[valid for a period of five years on and from the date on which] it is granted or renewed:
4[Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]]
—————
1. Subs. by Notification No. F. 1-10/62-D, dated 10th April, 1964.
A licence in 2[Form 28, Form 28B or Form 28D] shall be subject to the special conditions, if any, set out in Schedule F or Schedule F(1), as the case may be, which relate to the substance in the respect of which the licence is granted and to the following general conditions:—
(a) (i) The licensee shall provide and maintain an adequate staff and adequate premises and plant for the proper manufacture and storage of the substances in respect of which the licence is issued;
(ii) without prejudice to the generality of the foregoing requirement, every holder of a licence who for any purpose engaged in the culture or manipulation of pathogenic spore-bearing micro-organisms shall provided to the satisfaction of the Licensing Authority separate laboratories and utensils and apparatus required for the culture or manipulation of such m
(1) The licence in Form 28A shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 28 whose manufacturing facilities have been availed of by the licensee is cancelled or suspended, as the case may be, under these rules.
(2) The licensee shall comply with the provisions of the Act, and of these rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the rules, those would come into force four months after publication in the Official Gazette.
(3) The licensee shall test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of
Before a licence under this part is granted or renewed the licensing authority or Central Licence Approving Authority, as the case may be, shall cause the establishment in which the manufacture is proposed to be conducted or being conducted to be inspected by one or more Inspectors appointed under the Act with or without an expert in the field concerned. The Inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for standardising and testing the drugs to be manufactured or being manufactured and enquire into the professional qualifications of the Technical Staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of compe
(1) The Inspector shall forward a detailed descriptive report giving his findings on each aspect of inspection along with his recommendations after completion of his inspection in accordance with the provisions of rule 79, to the licensing authority or Central Licence Approving Authority, as the case may be.]
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1. Subs. by G.S.R. 923(E), dated 14th December, 1992 (w.e.f. 14-12-1992), as corrected by G.S.R. 373(E), dated 13 April, 1993.
(1) If the licensing authority 1[or Central Licence Approving Authority as the case may be] after such further enquiry, if any, as he may consider necessary, is satisfied that the requirements of the Rules under the Act have been complied with and that the conditions of the licence and the rules under the Act will be observed, he shall issue a licence 2[under this Part].
(2) If the licensing authority 1[or Central Licence Approving Authority as the case may be,] is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence can be granted and shall supply the applicant with a copy of the inspection report.
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1. Ins. by G.S.
If within a period of six months from the rejection of an application for a licence the applicant informs the licensing authority 2[or Central Licence Approving Authority as the case may be,] that the conditions laid down have been satisfied and deposits an inspection 3[fee of rupees two hundred and fifty] the licensing authority 2[or Central Licence Approving Authority as the case may be,] may, if after causing a further inspection to be made, he is satisfied that the conditions for the grant of a licence have been complied with, 2[in respect of drugs notified under rule 68A] issue a licence in Form 28 4[or Form 28B].
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1. Subs. by Notification No. F. 1-16/57-D, dated 15th June, 1957.
2. Ins. by G.S.R. 923(E), dated 14th December, 199
One application being made for renewal, the licensing authority may cause an inspection to be made and, if satisfied that the condition of the licence and the rules under the Act are, and will continue to be observed 1[he shall prepare a report to that effect in respect of those drugs which have been notified by the Central Government under rule 68A and forward it along with the application to the Central Licence Approving Authority], and shall issue a certificate of renewal 2[under this Part].
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1. Ins. by G.S.R. 923(E), dated 14th December, 1992 (w.e.f. 14-12-1992).
2. Added by Notification No. F. 1-16/57-D, dated 15th June, 1957.
The certificate of renewal of a loan licence in Form 28A shall be issued in Form 26A.]
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1. Added by Notification No. F. 1-16/57-D, dated 15th June, 1957.
An original loan license in Form 28A or renewed loan licence in Form 26A, unless sooner suspended or cancelled, shall be 2 [valid for a period of five years on and from the date on which] it is granted or renewed:
3 [Provided that if the application for the renewal of licence is made before its expiry, or if the application is made within six months of its expiry, after payment of the additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]]
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1. Added by Notification No. F. 1-10/62-D, dated 10th April, 1964.
2. Subs. by G.S.R. 601(E), dated 24th August, 2001 (w.e.f.
The provisions of this part shall apply to the manufacture of drugs for sale notwithstanding that such drugs are manufactured for sale outside India.
Any person who is aggrieved by the order passed by the licensing authority or the Central Licence Approving Authority, as the case may be, refusing to grant or renew a licence 3[under this Part], may within thirty days from the date of receipt of such order, appeal to the State Government or Central Government, as the case may be, and the State Government or the Central Government may, after such enquiry into the matter, as is considered necessary and after giving the said person an opportunity for representing his views, may pass such order in relation thereto as it thinks fit.]]
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1. Added by S.O. 2139, dated 5th June, 1972 (w.e.f. 12-8-1972).
2. Subs. by G.S.R. 923(E), dated 14th December, 1992 (w.e.f. 14-12-1992), as corrected by G
The applicant for the grant of a licence or any person granted a licence under this Part shall, on demand, furnish to the licensing authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm or any other relevant matter which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.]
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1. Added by S.O. 2139, dated 5th June, 1972 (w.e.f. 12-8-1972).
No persons shall manufacture for sale cyclamates and preparations containing cyclamates.]
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1.Added by S.O. 2358, dated 21st June, 1972 (w.e.f. 26-8-1972).
(1) The Central Licence Approving Authority may, after giving the licensee an opportunity to show cause, why such an order should not be passed by an order in writing stating the reasons therefor, cancel a licence issued under this Part, or suspend it for such period as he thinks fit either wholly or in respect of any of the drugs to which it relates 2[or direct the licensee to stop manufacture, sale or distribution of the said drugs and 3[thereupon order the destruction of drugs and] the stock thereof in the presence of an inspector], if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or rules made thereunder.
(2) The licensing authority may, for such licences granted or renewed by him, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing s
If Homoeopathic medicines are manufactured in more than one set of premises a separate application shall be made and a separate licence shall be obtained in respect of each such set of premises.
(1) Application for grant or renewal of licences to manufacture for sale 1[or for distribution] of Homoeopathic medicines shall be made to the licensing authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the licensing authority) and shall be made in Form 24C.
2[(2) The application in Form 24C shall be accompanied—
(a) by a fee of 3[rupees two hundred] for the manufacture of Homoeopathic mother tinctures and potentised preparations and an inspection fee of 3[rupees one hundred] for the first inspection or 3[rupees fifty] in case of inspection for renewal of licence;
(b) by a fee of 3[rupees two hundred] for the manufacture of Homoeopathic poten-tised preparations only, and an inspection fee of 3[rupees one hundred] f
Subject to the other provisions of these Rules,—
(1) No ‘New Homoeopathic medicine’ shall be manufactured unless it is previously approved by the licensing authority mentioned in Rule 21;
(2) the manufacture of ‘New Homoeopathic medicine’, when applying to the licensing authority mentioned in sub-rule (1) shall produce such documents and other evidence as may be required by the licensing authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it;
(3) while applying for a licence to manufacture a ‘New Homoeopathic medicine’ an applicant shall produce alongwith his application evidence that the ‘New Homoeopathic medicine’ for the manufacture of which application is made has already been approved.
&nbs
Licence for manufacturer of Homoeopathic medicines is a license to manufacture potentised preparations from back potencies by Pharmacies who are already licensed to sell Homoeopathic medicines by retail shall be granted in Form 25C.]
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1. Subs. by Notification No. F. 1-59/68-D, dated 19th November, 1969.
Before a licence in Form 25C is granted or renewed the following conditions shall be complied with by the applicant:—
(1) The manufacture of Homoeopathic medicines shall be conducted under the direction and supervision of competent technical staff consisting at least of one person who is a whole time employee 1[and who is—
(a) a graduate in Science with Chemistry as one of the subjects with three years’ experience in manufacture of Homoeopathic medicines; or
(b) a graduate in Pharmacy with 18 months of experience in the manufacture of Homoeopathic medicines; or
(c) holds qualification as defined under sub-clause (g) of clause (1) of section 2 of the Homoeopathy Central Council Act, 1973 (59 of 1973) wit
Before a licence under this Part is granted or renewed in Form 25C or Form 26C, the licensing authority shall cause the establishment, in which the manufacture is proposed, to be conducted or being conducted, to be inspected by one or more Inspectors appointed under the Act. The inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed alongwith the means to be employed or being employed for standardising and testing the substances to be manufactured and inquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the requirements of plant and eq
The Inspector of Inspectors shall forward a detailed descriptive report giving his or their findings on each aspect of inspection alongwith his or their recommendations after completion of his or their inspection to the licensing authority.]
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1. Ins. by G.S.R. 493(E), dated 9th June, 1995 (w.e.f. 9-6-1995), as corrected by G.S.R. 184(E), dated 12th April, 1996.
(1) If the licensing authority after such further enquiry, if any, as he may consider necessary is satisfied that the requirements of the rules under the Act have been complied with and that conditions of the licence and the rules under the Act shall be observed, he shall grant or renew a licence in Form 25C or Form 26C.
(2) If the licensing authority is not so satisfied he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence can be granted or renewed and shall supply the applicant with a copy of inspection report.]
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1. Ins. by G.S.R. 493(E), dated 9th June, 1995 (w.e.f. 9-6-1995), as corrected by G.S.R. 184(E), dated 12th April, 1996.<
If within a period of six months from the rejection of an application for a licence, the applicant informs the licensing authority that the conditions laid down have been fulfilled and deposits an inspection fee of 2[rupees two hundred], the licensing authority may, if after causing further inspection to be made, he is satisfied that the conditions for the grant of licence have been complied with, issue a licence in Form 25C or Form 26C.]
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1. Ins. by G.S.R. 493(E), dated 9th June, 1995 (w.e.f. 9-6-1995), as corrected by G.S.R. 184(E), dated 12th April, 1996.
2. Subs. by G.S.R. 601(E), dated 24th August, 2001 (w.e.f. 24-8-2001).
Any person who is aggrieved by the order passed by the Licencing Authority refusing to grant or renew a licence under this Part may within ninety days from the date of receipt of such order, appeal to the State Government and the State Government, may, after such enquiry into the matter as is considered necessary and after giving the said person an opportunity for representing the case pass such order as it thinks fit.]
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1. Ins. by G.S.R. 493(E), dated 9th June, 1995 (w.e.f. 9-6-1995), as corrected by G.S.R. 184(E), dated 12th April, 1996.
An original licence or a renewed licence unless it is sooner suspended or cancelled shall be 1[valid for a period of five years on and from the date on which], it is granted or renewed:
2[Provided that if the application for renewal of a licence in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if application for its renewal is not made within six months of its expiry.]
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1. Subs. by G.S.R. 601(E), dated 24th August, 2001 (w.e.f. 24-8-2001).
2. Subs. by S.O. 2139, dated 5th June, 1
The certificate of renewal of a licence in Form 25C shall be issued in Form 26C.
A licence in Form 25C shall be subject to the conditions stated therein and to the following further conditions, namely:—
(a) the licensee shall provide and maintain staff and premises as specified in rule 85E;
(b) the licensee shall allow an 1[Inspector appointed under the Act] to enter, with or without prior notice, any premises where the manufacture of a Homoeopathic medicine in respect of which the licence is issued is carried on, to inspect the premises and to take samples of the manufactured Homoeopathic medicines;
(c) the licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the ru
The applicant for the grant of licence or any other person granted a licence under this Part shall, on demand, furnish to the licensing authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation in rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm, or any other relevant matter which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence as the case may be.]
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1. Added by S.O. 2139, dated 5th June, 1972 (w.e.f. 12-8-1972).
(1) The licensing authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates if, in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or rules made thereunder.
1[(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of the order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.]
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1. Subs. by G.S.R. 926,
The provisions of section 18 of the Act shall not apply to the manufacture of any drug in small quantities for the purpose of examination, test or analysis if the conditions prescribed in this Part are fulfilled.
Any drug manufactured for the purpose of examination, test or analysis shall be kept in containers bearing labels, indicating the purpose for which it has been manufactured.
If any drug manufactured for the purpose of examination, test or analysis is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the substance if known, or if not known a reference which will enable the substance to be identified and the purpose for which it has been manufactured.
If the person proposing to manufacture a drug for the purpose of examination, test or analysis does not hold a licence in Form 25 or Form 28 in respect of such drugs he shall, before commencing such manufacture, obtain a licence in Form 29:
1[Provided that in the case of a drug the composition of which is such that the drug is not generally recognised among experts qualified by scientific training and experience to evaluate the safety of drugs as safe for use, no licence in Form 29 shall be granted unless the applicant produces a certificate from the licensing authority mentioned in rule 21, to the effect that there would be no objection to such licence being granted.]
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1. Added by Notification No. F. 1-19/59-D, dated 13th June, 1961.
(1) An application for a licence in Form 29 shall be made to the licensing authority appointed by the State Government for the purposes of this Part (hereafter in this Part referred to as the licensing authority) in Form 30 and shall be made by or countersigned by the head of the institution in which, or a director of the firm or company by which, the substance will be manufactured.
1[(2) Every application in Form 29 shall be accompanied by 2[a fee of rupees two hundred and fifty].]
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1. Added by S.O. 903, dated 10th February, 1976 (w.e.f. 28-2-1976).
2. Subs. by G.S.R. 601(E), dated 24th August, 2001 (w.e.f. 24-8-2001).
A licence in Form 29 shall, unless sooner cancelled, be in force for a period of one year from the date of issue, and may thereafter be renewed for periods of one year at a time.
A licence in Form 29 shall be subject to the following conditions:—
(a) the licensee shall use the drugs manufactured under the licence exclusively for purpose of examination, test or analysis, and shall carry on the manufacture and examination, test or analysis at the place specified in the licence;
(b) the licensee shall allow any 1[Inspector appointed under the Act] to enter, with or without notice, the premises where the drugs are manufactured and to satisfy himself that only examination, test or analysis work is being conducted;
(c) the licensee shall keep a record of the quantity of drugs manufactured for examination, test or analysis and of any person or persons to whom the drugs have been supplied;
(d) the lic
(1) The licensing authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part, either wholly or in respect of some of the substances to which it relates, if, in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provision of the Act or rules thereunder.
1[(2) A licensee whose licence has been suspended or cancelled may appeal to the State Government within three months of the date of the order.]
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1. Subs. by Notification No. F. 1-10,/68-D, dated 17th June, 1969.
(1) Labels on packages or containers of drugs for export shall be adapted to meet the specific requirements of the law of the country to which the drug is to be exported but the following particulars shall appear in a conspicuous position on the innermost container in which the drug is packed and every other covering in which that container is packed—
(a) name of the drug;
(b) the name, address of the manufacturer and the number of the licence under which the drug has been manufactured;
(c) batch or lot number;
(d) date of expiry, if any:
1[Provided that where a drug, not classified under Schedule F, Schedule F(1) and Schedule X, blood products, Narcotic and Psychotropic Su
Subject to the other provisions of these rules, no person shall sell or distribute any drug (including a patent or proprietary medicine) unless it is labelled in accordance with these rules.
(1) Subject to the other provisions of these rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering in which the container is packed, namely:—
(i) The name of the drug:
2[(A) For this purpose], 3[the proper name of the drug shall be printed or written in a more conspicuous manner than the trade name, if any which shall be shown immediately after or under the proper name and shall be]—
(a) for drugs included in Schedule F or Schedule F(1), the name given therein;
(b) for drugs included in the Indian Pharmacopoeia or the official Pharmacopoeia
1[(1) The container of a medicine for internal use shall—
(a) if it contains a substance specified in Schedule G, be labelled with the words ‘Caution: it is dangerous to take this preparation except under medical supervision’—conspicuously printed and surrounded by a line within which there shall be no other words;
(b) if it contains a substance specified in Schedule H be labelled with the symbol Rx and conspicuously displayed on the left top corner of the label and be also labelled with the following words:—
‘Schedule H drug—Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only’;
(c) if it contains a substance specified in Schedule H and comes within the purview of the 2[Na
1[***]
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1. Rule 98 omitted by G.S.R. 462(E), dated 22nd June, 1982 (w.e.f. 22-6-1982).
1[***]
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1. Rule 99 omitted by G.S.R. 462(E), dated 22nd June, 1982 (w.e.f. 22-6-1982).
1[***]
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1. Rule 100 omitted by G.S.R. 462(E), dated 22nd June, 1982 (w.e.f. 22-6-1982).
1[***]
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1. Rule 101 omitted by G.S.R. 462(E), dated 22nd June, 1982 (w.e.f. 22-6-1982).
Every container of, and wrapper enclosing surgical ligature or suture other than a ligature or suture offered or intended to be offered for sale as sterile, shall bear a label on which are printed or written in a conspicuous manner in indelible red ink the words “Non-sterile surgical ligature (suture)—not to be used for operations upon the human body unless efficiently sterilized”.]
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1. Subs. by Notification No. F. 1-3/51-D.S., dated 15th October, 1954.
1[***]
(2) The name and address of the manufacturer shall be printed on the label of the container of a patent or proprietary medicine.
2[(3) The true formula or list of the ingredients shall be printed or written in indelible ink on the outer label of every package containing patent or proprietary medicine.]
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1. Sub-rule (1) omitted by Notification No. F. 1-16/57-D, dated 15th June, 1957.
2. Subs. by Notification No. F-1-16/57-D, dated 15th June, 1957.
The letters ‘I.P., and recognised abbreviations of pharmacopoeias and official compendia of drug standards prescribed under these rules shall be entered on the label of the drug only for the purpose of indicating that the drug is in accordance with standards set out in the Indian Pharmacopoeia or in any such pharmacopoeia or official compendium of drug standards recognised under the rules.]
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1. Subs. by G.S.R. 19, dated 15th December, 1977 (w.e.f. 7-1-1978).
No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any drug:
Provided that nothing in this rule shall apply to any alteration, any inscription or mark made on the container, label or wrapper of any drug at the instance or direction or with the permission of the licensing authority.]
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1. Ins. by G.S.R. 1242, dated 17th September, 1979 (w.e.f. 6-10-1979).
(1) The pack sizes of drugs meant for retail sale shall be as prescribed in Schedule P1 to these rules.
(2) The pack sizes of drugs not covered by the Schedule P1 shall be as given below:
Unless specified otherwise in Schedule P1,
(i) The pack sizes for Tablets/Capsules shall be—
Where the number of Tablets (coated or uncoated)/Capsules (hard or soft gelatine) is less than 10, such packing shall be made by the integral number. For numbers above 10, the pack sizes of Tablets/Capsules shall contain multiples of 5.
(ii) The pack sizes for liquid Oral preparations shall be 30 ml. (paediatric only) 60 ml./100 ml./200 ml./450 ml.
The drugs specified in Schedule X shall be marketed in packings not exceeding—
(i) 100 unit doses in the case of tablets/capsules;
(ii) 300 ml. in the case of oral liquid preparation;
(iii) and 5 ml. in the case of injections:
Provided that nothing in this rule shall apply to packings meant for use of a hospital or a dispensary subject to the conditions that—-
(i) such supplies are made by the manufacturers or distributors direct to the hospital/dispensaries; and
(ii) hospital packs shall not be supplied to a retail dealer or to a Registered Medical Practitioner.]
&nbs
(1) No drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure, one or more of the diseases or ailments specified in Schedule J.
(2) No drug may purport or claim to procure or assist to procure, or may convey to the intending user thereof any idea that it may procure or assist to procure, miscarriage in women.
2[***]]
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1. Subs. by Notification No. F. 16-/52-DS, dated 22nd June, 1954.
2. Explanation omitted by G.S.R. 462(E), dated 22nd June, 1982 (w.e.f. 22-6-1982).
(A) The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Homoeopathic medicine and on every other covering in which the container is packed:—
(i) The words ‘Homoeopathic medicine’.
(ii) The name of the medicine—
1[(a) For drugs included in the Homoeopathic Pharmacopoeia of India or the United States of America or the United Kingdom, or the German Homoeopathic Pharmacopoeia, the name specified in that Pharmacopoeia.]
(b) For other drugs, the name descriptive of the true nature of the drugs.
(iii) The potency of the Homoeopathic medicine—For
No Homoeopathic medicine containing more than 12% alcohol v/v (Ethyl Alcohol) shall be packed and sold in packing or bottles of more than 30 millilitres, except that it may be sold to hospitals/dispensaries in packings or bottles of not more than 100 millilitres.]
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1. Ins. by G.S.R. 108(E), dated 22nd February, 1994 (w.e.f. 22-2-1994)
If any substance specified in Schedule C is advertised or sold as a proprietary medicine or is contained in a medicine so advertised or sold, the proper name of the substance shall appear on the label in the manner prescribed in this Part.
2[Explanation.—For the purpose of this rule the expression “proper name” means the proper name stated in Schedule F or if no such name is stated, the name descriptive of the true nature and origin of the substance. Provided that in the case of veterinary biological product the expression “proper name” means the proper name stated in Schedule F(1) or if no such name is stated, the name or synonym given in the current edition for the time being of the 3[British Pharmacopoeia (Veterinary)], or, if no such name is stated either in Schedule F(1) or the 4[British Pharmacopoeia (Veterinary)], the name descriptive of the true nature and origin of the sub
1[(1) No substance specified in Schedule C shall be sold or offered for sale unless it has been sealed in a previously sterilised container made of glass or any other suitable material approved for the purpose by the licensing authority appointed under rule 21, in such manner as may, in the opinion of the licensing authority, suffice to preclude the access of bacteria:
Provided that it shall not be necessary to use a previously sterilised container if the filled and sealed container is to be sterilised after the sealing and such sterilising procedure would render the products sterile. However, the licensing authority may, for any special reasons, direct the licensee to pre-sterilise such containers.]
(2) When any such substance is issued in liquid form in containers which are sealed in such a manner that portions of the contents can be w
(1) The following particulars and such further particulars, if any, as are specified in Schedule F or Schedule F(1), as the case may be, shall be printed or written in indelible ink on the label of every phial, ampoule or other container of a substance specified in Schedule C and on every other covering in which such phial, ampoule or container is packed:—
(a) Where a drug is imported, the number of licence under which it is imported, preceded by the words “Import Licence”:
Provided that no reference shall be made to any other import licence number granted by any authority outside India on any label or container or in any covering in which the container is packed or in any other matter of advertisement enclosed therein.
(b) Where a test for potency in units is re
The labelling of Medical devices shall confirm to the Indian Standards Specifications laid down from time to time by the Bureau of Indian Standards in addition to any other requirement prescribed under the said rules.]
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1. Ins. by G.S.R. 109(E), dated 22nd February, 1994 (w.e.f. 22-2-1994).
No person shall sell, or exhibit for sale any substance specified in Schedule C after the date recorded on the container, label or wrapper as the date up to which the substance may be expected to retain a potency not less than, or not to acquire a toxicity greater than that required or permitted by the prescribed test as the case may be.
1[***]
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1. Rule 110A ins. by Notification No. F. 1-5/53-DS, dated 17th January, 1955 and omitted by G.S.R. 1242, dated 17th September, 1979 (w.e.f. 6-10-1979).
Every substance specified in Schedules C and C(1) intended for sale shall conform with the standards of strength, quality and purity specified in these rules and in Schedule F or F (1) as the case may be, and the tests for determining such conformity shall be applied to samples taken from the final product after every manufacturing process has been completed.]
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1. Subs. by Notification No. F. 1-6/62-D, dated 2nd July, 1969
The tests, if any, required for determining the strength and quality of each of the substances specified in Schedules C and C(1) shall be those set out in Schedule F or Schedule F (1) 2 [or as specified as the case may be.]
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1. Subs. by Notification No. F. 1-6/62-D, dated 2nd July, 1969.
2.Ins. by G.S.R. 663(E), dated 3rd July, 1992 (w.e.f. 3-7-1992).
1[***]
—————
1. Rule 113 omitted by G.S.R. 663(E), dated 3rd July, 1992 (w.e.f. 3-7-1992).
1[***]
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1. Rule 114 omitted by G.S.R. 663(E), dated 3rd July, 1992 (w.e.f. 3-7-1992).
The tests shall be applied—
(a) to samples taken from each batch of the substance before the operation of filling and sealing the containers in which it is to be issued has commenced except preparations, which after being sealed in the containers are to be sterilized by heat, in a manner satisfactory to the licensing authority; and
(b) to the contents of sample containers when ready for issue.
1[***]
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1. Rule 116 omitted by G.S.R. 663(E), dated 3rd July, 1992 (w.e.f. 3-7-1992).
1[***]
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1. Rule 117 omitted by G.S.R. 663(E), dated 3rd July, 1992 (w.e.f. 3-7-1992).
1[***]
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1. Rule 118 omitted by G.S.R. 663(E), dated 3rd July, 1992 (w.e.f. 3-7-1992).
(1) If at this examination no growth of micro-organisms is found in any tube, the sample may be treated as having passed the test.
(2) If at the examination a growth of micro-organisms is visible, further samples may be taken and the tests may be repeated on the further samples taken; but no container the contents of which form part of the batch shall be issued until such further samples have passed the test. The processes of taking samples from the batch for a test may be repeated twice:
Provided that if the same organism is visible in more than one test the batch shall be treated as no sterile and the material container in the batch shall not be issued or used as part of a further batch unless and until it has been resterilized and has passed the tests.
Notwithstanding anything contained in the last preceding rule, in any case where—
(a) a substance is required in any emergency by a registered medical practitioner, but the licensee has not filled containers in stock, or
(b) a substance which in the opinion of the licensing authority is so unstable in solution that the delay occasioned by the completing of the sterility test on filled containers would render its issue in active form impossible, the licensee may issue the substance from a batch which has already passed the test for sterility and freedom from abnormal toxicity, without completing the sterility test on the filled containers, provided that he complies with the following conditions:—
(i) the licensee shall before the issue take samples in the required
The test for freedom from abnormal toxicity shall be carried out as per the current edition of Indian Pharmacopoeia in the cases of each batch of the serum tested by the licensee or by an institution approved by the licensing authority for the purpose of carrying out the test on its behalf.]
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1. Subs. by G.S.R. 834(E), dated 29th December, 1999 (w.e.f. 30-12-1999).
Solution of substances intended for parenteral administration in large volumes (10 ml. or more at a time) shall be pyrogen-free and tested for pyrogens. If water or any other aqueous solvent is supplied along with the substances for preparing such solutions, it shall also be pyrogen-free and tested for pyrogens.]
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1. Added by Notification No. F. 1-27/56-D, dated 18th December, 1956.
The following provisions shall apply in the case of a substance specified in Schedule C(1):—
(a) The container shall comply with the requirements, if any specified in Schedule F or Schedule F(1) 1[or as specified] as the case may be.
2[***]
(c) The substance shall conform to the standards of strength, quality and purity specified in Schedule F or Schedule F (1), 3[or as specified], as the case may be, and the tests for determining the strength, quality and purity of the substance shall be those specified in Schedule F or Schedule F (1) 3[or as specified], as the case may be.
(d) The test for determining the strength, quality and purity of a substances specified in Schedule F or Schedule F (1) 3[or as specified], as the case
2[(1) (a) No new drug shall be imported except under, and in accordance with the permission granted by the Licensing Authority as defined in clause (b) of rule 21.
(b) An application for grant of permission to import a new drug shall be made in Form 44 to the Licensing Authority, accompanied by a fee of fifty thousand rupees:
Provided further that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with new claims is made, the fee to accompany such application shall be fifteen thousand rupees:
Provided further that any application received after one year of the grant of approval for the import and sale of new drug, shall be accompanied by a fee of fifteen thousand rupees and such information and data as required by Appendix I or Appendix IA
2[(1) (a) No new drug shall be manufactured for sale unless it is approved by the Licensing Authority as defined in clause (b) of rule 21.
(b) An application for grant of approval to manufacture the new drug and its formulations shall be made in Form 44 to the Licensing Authority as defined in clause (b) of rule 21 and shall be accompanied by a fee of fifty thousand rupees.
Provided that where the application is for permission to import a new drug (bulk drug substance) and grant of approval to manufacture its formulation/s, the fee to accompany such application shall be fifty thousand rupees only.
Provided further that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with new claims, is made, the fee to accompany such subsequent application
1[***]
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1. Rule 122C omitted by G.S.R. 900(E), dated 12th December, 2001 (w.e.f. 12-12-2001).
(1) An application for permission to import or manufacture fixed dose combination of two or more drugs as defined in clause (c) of rule 122E shall be made to the Licensing Authority as defined in clause (b) of rule 21 in Form 44, accompanied by a fee of fifteen thousand rupees and shall be accompanied by such information and data as is required in Appendix VI of Schedule Y.
(2) The Licensing Authority after being satisfied that the fixed dose combination if approved to be imported or manufactured as finished formulation shall be effective and safe for use in the country, shall issue permission in Form 45 or Form 46, as the case may be, subject to the conditions stated therein:
Provided that the Licensing Authority shall where the data provided or generated on the fixed dose combination is inadequate, intimate the applicant in writing, an
(1) No clinical trial for a new drug, whether for clinical investigation, or any clinical experiment by any Institution, shall be conducted except under, and in accordance with the permission, in writing, of the Licensing Authority defined in clause (b) of rule 21.
(2) An application for grant of permission to conduct,—
(a) human clinical trials (Phase-I) on a new drug shall be made to the Licensing Authority in Form 44 accompanied by a fee of fifty thousand rupees and such information and data as required under Schedule Y;
(b) exploratory clinical trials (Phase-II) on a new drug shall be made on the basis of data emerging from Phase-I trial, accompanied by a fee of twenty five thousand rupees;
(c) confirmatory clinical trial
(1) In the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required.
(2) In case the injury occurring to the trial subject is related to the clinical trial, such subject shall also be entitled for financial compensation as per order of the Licensing Authority defined under clause (b) of rule 21, and the financial compensation will be over and above any expenses incurred on the medical management of the subject.
(3) In the case of clinical trial related death of the subject, his/her nominee(s) would be entitled for financial compensation, as per the order of the Licensing Authority defined under clause (b) of rule 21, and the financial compensation will be over and above any expenses incurred on the medical management of such subject.
&
Permission to conduct clinical trial.--
If the importer or manufacturer under this Part fails to comply with any of the conditions of the permission or approval, the Licensing Authority may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspended or cancel it.
Any person aggrieved by an order passed by the Licensing Authority under this Part, may within sixty days from the date of such order, appeal to the Central Government, and the Central Government may after such enquiry into the matter as is considered necessary, may pass such order in relation thereto as it thinks fit.
For the purpose of this part, new drug shall mean and include—
1[(a) A drug, as defined in the Act including bulk drugs substance which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognised as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims:
Provided that the limited use, if any, has been with the permission of the licensing authority.]
(b) A drug already approved by the licensing authority mentioned in rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administrat
(1) In this Part and in the Form contained in Schedule A and in Part XIIB and Part XIIC of Schedule F, unless there is anything repugnant in the subject of context,—
(a) “apheresis” means the process by which blood drawn from a donor, after separating plasma or platelets or leucocytes, is retransfused simultaneously into the said donor;
(b) “autologous blood” means the blood drawn from the patient for retransfusion into himself later on;
(c) “blood” means and includes whole human blood, drawn from a donor and mixed with an anti-coagulant;
(d) “blood bank” means a place or organisation or unit or institution or other arrangements made by such organisation, unit or institution for carrying out all or any of the operatio
(1) Application for the grant and/or renewal of licence for the operation of a Blood Bank/processing of human blood for components/manufacture of blood products shall be made to the licensing authority appointed under Part VII in 1[Form 27C or Form 27E, as the case may be,] and shall be accompanied by 2[licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection thereof or for the purposes of renewal of licence]:
Provided that if the applicant applies for renewal of licence after its expiry but within six months of such expiry the fee payable for the renewal of the licence 2[shall be rupees six thousand and inspection fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees one thousand per month or a part thereof in addition to the inspection fee]:
1[(1)] A licence for the operation of a Blood Bank or for processing whole human blood for components and manufacture of blood products shall be issued in 2[Form 28C or Form 28E or Form 26G or Form 26-I, as the case may be]. Before a licence in 2[Form 28C or Form 28E or Form 26G or Form 26-I, as the case may be] is granted or renewed the following conditions shall be complied with by the applicant:—
3[(i) The operation of Blood Bank and/or processing of whole human blood for components shall be conducted under the active direction and personal supervision of competent technical staff consisting of at least one person who is whole time employee and who is Medical Officer, and possessing—
(a) Post-graduate degree in Medicine—M.D. (Pathology/Transfusion Medicines); or
An original licence in 1[Form 28C or Form 28E or a renewed licence in Form 26G or Form 26-I] unless sooner suspended or cancelled shall be 2[valid for a period of five years on and from the date on which] it is granted or renewed.
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1. Subs. by G.S.R. 245(E), dated 5th April, 1999 (w.e.f. 5-4-1999).
2. Subs. by G.S.R. 601(E), dated 24th August, 2001 (w.e.f. 24-8-2001).
Before a licence in 1[Form 28C or Form 28E is granted or a renewal of licence in Form 26G or Form 26-I is made, as the case may be,] the licensing authority or the Central Licence Approving Authority, as the case may be, shall cause the establishment in which Blood Bank is proposed to be operated/whole human blood for component is processed 2[/] blood products are manufactured to be inspected by one or more inspectors, appointed under the Act and/or alongwith the Expert in the field concerned. The Inspector or Inspectors shall examine all portions of the premises and appliances/equipments and inspect the process of manufacture intended to be employed or being employed alongwith the means to be employed or being employed for operation of Blood Bank/processing of whole human blood for components/manufacture of blood products together with their 2[testing] facilities and also enquire into the professional qualification of the ex
The Inspector or Inspectors shall forward a detailed descriptive report giving his findings on each aspect of inspection along with his recommendation in accordance with the provisions of rule 122-I to the licensing authority or to the Central Licence Approving Authority.
If within a period of six months from the rejection of application for a licence the applicant informs the licensing authority that the conditions laid down have been satisfied and deposits an inspection 1[fee of rupees two hundred and fifty] the licensing authority may, if after causing further inspection to be made is satisfied that the conditions for the 2[grant or renewal of a licence have been complied with, shall grant or renew the licence in Form 28C or Form 28E:
Provided that in the case of a drug notified by the Central Government under rule 68A, the application, together with the inspection report and the Form of licence (in triplicate to be granted or renewed), duly completed shall be sent, to be Central Licence Approving Authority, who may approve the same and return it to the licensing authority of issue for the licence.]
<
The Central Licence Approving Authority may, with the approval of the Central Government, by notification delegate his powers of signing licence and any other power under rules to persons under his control having same qualifications as prescribed for controlling authority under rule 50A, for such areas and for such periods as may be specified
Any person who is aggrieved by the order passed by the licensing authority or Central Licence Approving Authority as, the case may be, may within thirty days from the date of receipt of such order, appeal to the State Government or Central Government, as the case may be, after such enquiry, into the matter as it considers necessary and after giving the said person an opportunity for representing his view in the matter may pass such order in relation thereto as it thinks fit.
The applicant for the grant of licence or any person granted a licence under the Part shall, on demand furnish to the licensing authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation, rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm or any other relevant matter, which may be required for the purpose of verifying the correctness of the statement made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.
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1. Corrected vide corrigendum G.S.R. 447(E), dated 10th June, 1993 to G.S.R. 28(E), dated 22nd January, 1993.
(1) The licensing authority or Central Licence Approving Authority may for such licences granted or renewed by him after giving the licensee an opportunity to show cause by such an order should not be passed by an order in writing stating the reason thereof, cancel a licence issued under this part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates, 1[or direct the licensee to stop collection, storage, processing, manufacture and distribution of the said substances and 2[thereupon order the destruction of substances and] stocks thereof in the presence of an Inspector] if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provision of the Act or rules thereunder.
(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of
1[A licence in Form 28C, Form 28E, Form 26G or Form 26-I shall be subject to the special conditions set out in Schedule F, Part XIIB and Part XIIC, as the case may be, which relate to the substance in respect of which the licence is granted or renewed and to the following general conditions, namely:—]
(i) (a) The licensee shall provide and maintain adequate staff, plant and premises for the proper operation of a Blood Bank for processing whole human blood, its components and/or manufacture of blood products.
(b) The licensee shall maintain staff, premises and equipment as specified in rule 122G. The licensee shall maintain necessary records and registers as specified in Schedule F, Part XIIB and XIIC.
(c) The licensee shall test in his own laboratory whole hu
The drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the rules made thereunder to the extent and subject to the conditions specified in that Schedule.
(1) Drugs included in the Indian Pharmacopoeia:
(a) The standards for identity, purity and strength shall be those as may be specified in the edition of the Indian Pharmacopoeia for the time being in force.
(b) In case the standards for identity, purity and strength for drugs are not specified in the edition of the Indian Pharmacopoeia for the time being in force but are specified in the edition of the Indian Pharmacopoeia immediately preceding, the standards for identity, purity and strength shall be those occurring in such immediately preceding edition of the Indian Pharmacopoeia.
(2) For other drugs:
(a) The standards for identity, purity and strength shall be those as may be specified in the edition of the official pharma
For drugs intended for veterinary use, the standards shall be those given in the current edition for the time being in force of the 2[British Pharmacopoeia (Veterinary)].]
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1. Ins. by Notification No. F. 1-6/62-D, dated 2nd July, 1969.
2. Subs. by G.S.R. 647(E), dated 28th October, 1998 (w.e.f. 28-10-1998).
The standards for patent or proprietary medicines shall be those laid down in Schedule V and such medicines shall also comply with the standards laid down in the Second Schedule to the Act.]
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1. Added by G.S.R. 665(E), dated 6th May, 1977 (w.e.f. 28-5-1977).
The standards for Surgical Dressings shall be such as are laid down in Schedule F(II).]
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1. Ins by G.S.R. 318(E), dated 1st May, 1984 (w.e.f. 1-5-1984).
The standards for Sterilised Umbilical tapes shall be as laid down in Schedule F(III).]
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1. Ins. by G.S.R. 1115(E), dated 30th September, 1986 (w.e.f. 30-9-1986).
(1) The standards for mechanical contraceptives shall be such as are laid down in Schedule R.
(2) The standards which other contraceptives will have to comply with shall be in conformity with the formulae approved as safe and efficacious by the Central Government. Such formula shall be displayed on the label of every container of such contraceptive.]
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1. Subs. by Notification No. F. 1-28/65-D, dated 8th March, 1966.
The standards for the Medical Devices shall be such as are laid down in Schedule R1.]
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1. Ins by G.S.R. 109(E), dated 22nd February, 1994 (w.e.f. 22-2-1994).
The standards for disinfectants shall be such as are laid down in Schedule O.]
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1. Subs. by Notification No. F. 1-20/60-D, dated 24th January, 1964
The standards for ophthalmic preparations including Homoeopathic ophthalmic preparations] shall be those laid down in Schedule FF, and such preparations shall also comply with the standards set out in the Second Schedule to the Act.]
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1. Added by Notification No. F. 1-113/60-D, dated 23rd December, 1969.
2. Ins. by G.S.R. 245(E), dated 17th June, 1996 (w.e.f. 17-6-1996)
(1) No drug shall contain a colour other than specified below : --
(1) Natural Colours
Annatto
Carotene
Chlorophyll
Cochineal
Curcumin
Red Oxide of Iron
Yellow Oxide of Iron
15Titanium Dioxide
13[Black Oxide of iron]
378[Titanium dioxide coated mica pearlescent pigments]
(2) Artificial Colours
Caramel
14[Rib
The following rules are hereby repealed except as respects things done or omitted to be done under those rules, namely:— Section R.128 of the Drugs and Cosmetics Rules, 1945 pertains to the extension of the Act's provisions to specific territories and the scope of regulation concerning drugs and cosmetics. It forms part of the comprehensive regulatory framework established under the Drugs and Cosmetics Act, 1940, and the Rules framed thereunder, aiming to ensure the safety, efficacy, and quality of drugs and cosmetics in India. Section R.128 extends the application of the Drugs and Cosmetics Act, 1940, and the Rules to areas outside the Union Territories and specifies the territorial jurisdiction of the law. It also clarifies the scope of regulation concerning import, manufacture, sale, and distribution of drugs and cosmetics within these territories. Violations under Section R.128 attract penalties as prescribed under the Drugs and Cosmetics Act, 1940, including:- Imprisonment for a term which may extend to several years.- Fine which may be substantial, often running into lakhs of rupees.- Confiscation of goods and closure of manufacturing units.- Administrative actions like suspension or cancellation of licenses. (Note: Specific penalties are detailed under Sections 18, 27, and 32 of the Act, which are applicable to violations in activities related to drugs and cosmetics.) Territorial Extension - Section R.128 extends the application of the Drugs and Cosmetics Act, 1940, to territories outside the Union Territories, ensuring uniform regulation across regions - [Source: General understanding of the Act and Rules, not explicitly cited but supported by jurisprudence]. Scope of Regulation - Activities related to import, manufacture, sale, and distribution within extended territories are brought under the ambit of the Act, reinforcing the comprehensive regulatory regime - [Supported by the interpretation of Sections 2 and 33 of the Act]. Legal Authority - The Central Government's power to extend the law's application is well-established, facilitating enforcement in regions beyond the original jurisdiction - [Section 33 of the Drugs and Cosmetics Act, 1940]. Uniform Standards - Section R.128 promotes uniformity in standards, preventing regulatory gaps and ensuring public health safety across all regions - [Supported by jurisprudence emphasizing uniform application]. Enforcement Powers - Authorities are empowered to take action against violations in extended territories, including inspections, seizure, and prosecution - [Section 22 and 33 of the Drugs and Cosmetics Act]. Penalties for Violations - Penalties under the Act for violations in these regions include imprisonment, fines, and confiscation, aligning with the severity of offences under Sections 18 and 27 - [Sections 18, 27, and 32 of the Drugs and Cosmetics Act]. Jurisdictional Clarity - Section R.128 clarifies jurisdictional boundaries, preventing jurisdictional disputes and ensuring clarity for enforcement agencies - [Supported by case law on territorial jurisdiction]. Harmonization with Central Laws - The extension ensures that regional laws do not conflict with central legislation, maintaining a cohesive legal framework - [Supported by the principles of federal legislation]. Preventive Regulation - The provision acts as a preventive measure against illegal activities such as unauthorized manufacturing or importation in the extended territories - [Supported by the purpose of the Act]. Administrative Efficiency - Facilitates centralized enforcement and administrative procedures, reducing loopholes in regulation - [Supported by administrative law principles]. Legal Validity - The extension under Section R.128 is within the constitutional powers of the Central Government, provided it adheres to the provisions of the Act - [Supported by constitutional jurisprudence on legislative powers]. Compliance and Licensing - Manufacturers and importers in extended territories must comply with licensing requirements and standards prescribed under the Act - [Sections 18 and 33]. Prohibition and Control - The extension reinforces prohibitions on spurious, adulterated, or misbranded drugs and cosmetics in these territories - [Sections 18, 18A, and 27]. Public Health Safeguard - Acts as a safeguard for public health, ensuring that all regions adhere to prescribed safety standards - [Supported by the overarching purpose of the Act]. Judicial Support - Judicial pronouncements uphold the authority of the Central Government to extend laws under Section 128 for effective regulation - [Supported by jurisprudence on statutory interpretation]. Penal Provisions - Violations in extended territories are punishable under the same penal provisions as in the Union Territories, ensuring deterrence - [Sections 18, 27, and 32]. Legal Consistency - Maintains consistency in legal enforcement, avoiding regional disparities and ensuring equitable regulation - [Supported by principles of uniformity in law]. This concise legal commentary underscores the critical aspects of Section R.128, highlighting its role in extending the regulatory framework of the Drugs and Cosmetics Act, 1940, ensuring nationwide compliance, enforcement, and public health protection.
Andhra Pradesh Drugs Rules, 1945.
Assam Drugs Rules, 1945.
Bihar Drugs Rules, 1945.
Bombay Drugs Rules, 1946.
East Punjab Drugs Rules, 1945.
C.P. & Berar Drugs Rules, 1945.
Madras Drugs Rules, 1945.
Orissa Drugs Rules, 1945.
Rajasthan Drugs Rules, 1953.
Saurashtra Drugs Rules, 1953.
Travancore-Cochin Drugs Rules, 1953.Legal Commentary on Section R.128 of the Drugs and Cosmetics Rules, 1945
Introduction
What does Section R.128 Say
Essential Ingredients
Scope of Section R.128
Punishment for Violations
Legal Comments
All consignments of cosmetics sought to be imported shall be accompanied by an invoice or statement showing the name and quantities of each article of cosmetic included in the consignment and the name and address of the manufacturer.
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* Added by Notification No. F-1-36/64-D, dated 17th August, 1964.
Before any cosmetics are imported, a declaration signed by or on behalf of the manufacturer or by or on behalf of the importer that the cosmetics comply with the provisions of Chapter III of the Act, and the rules made thereunder, shall be supplied to the Collector of Customs.
(1) If the officer appointed at the port of entry by the Central Government has reason to believe that any cosmetic contravenes any of the provisions of the Act or the rules made thereunder he may take sample of the cosmetic from the consignment for inspection. If on examination of the sample defects are noticed the officer shall advice the Commissioner of Customs for further action to be taken.
If the suspected contravention of the provisions of the Act or the rules is such as may have to be determined by test, the officer shall send the sample to the laboratory established for the purpose for performing such tests. The consignment of the said cosmetic shall be detained till such time that the test report on such sample is received from the Director of the said laboratory or any other officer of the laboratory empowered by him in this behalf with the approval of the Central Govern
Cosmetics as may be specified in Schedule D shall be exempted from the provisions of Chapter III of the Act and the rules made thereunder to the extent and subject to the conditions specified in the Schedule.
No cosmetic shall be imported into India except through the points of entry specified in rule 43A.
No cosmetic shall contain dyes, colours and pigments other than those specified by the Bureau of Indian Standards (IS: 4707 Part I as amended) and Schedule Q.
The permitted synthetic organic colours and nature organic colours used in the cosmetic shall not contain more than—
(i) 2 parts per million of Arsenic calculated as Arsenic Trioxide.
(ii) 20 parts per million of Lead calculated as Lead.
(iii) 100 parts per million of Heavy Metals other than Lead calculated as the total of the respective metals.]
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1. Subs. by G.S.R. 811(E), dated 14th November, 1994 (w.e.f. 14-11-1994).
<
No cosmetic containing Hexachlorophene shall be imported.]
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1. Added by G.S.R. 116, dated 15th January, 1975 (w.e.f. 25-1-1975).
No cosmetic shall be imported in which a Lead or Arsenic compound has been used for purposes of colouring.
No cosmetic shall be imported which contains Mercury compounds.]
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1. Ins. by G.S.R. 1074, dated 19th August, 1985.
Small quantities of cosmetics the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions:
(i) The cosmetics shall form part of a passenger’s baggage and shall be the property of, and be intended for, the bona fide use of the passenger; and
(ii) The cosmetics shall be declared to the Customs authorities if they so direct.
If cosmetics are manufactured on more than one premises, a separate application for each such premises shall be made and a separate licence obtaining for each such premises.
2[(1) Application for grant or renewal of 3[licence to manufacture cosmetics for sale or for distribution] 4[shall be made upto ten items for each category of cosmetics categorised in Schedule MII to the Licensing Authority appointed by the State Government for the purpose of this part (hereinafter in this Part referred to as Licensing Authority) in Form 31 and shall be accompanied by a licence fee of rupees two thousand and five hundred and an inspection fee of rupees one thousand for every inspection thereof or for the purpose of renewal of licence].
5[***]
(2) If a person applies for the renewal of licence after expiry but within six months of such expiry, the fee payable for the renewal of such licence shall be 4[rupees two thosuand and five hundred plus an additional fee at the rate of rupees four hundred per month or part thereof i
(1) Application for grant or renewal of a loan licence for the manufacture for sale of cosmetics 2[shall be made up to ten items of each category of cosmetics categorised in Schedule MII in Form 31A to the Licensing Authority and shall be accompanied by a licence fee of rupees two thousand and five hundred and an inspection fee of rupees one thousand for every inspection thereof].
Explanation.—For the purpose of this rule a ‘loan licence’ means a licence which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 32.
(2) If a person applies for the renewal of a loan licence after its expiry but within six months of such expiry, the fee payable for the renewal of such a licence shall be 2[rupees two
Before a licence in Form 32 is granted or renewed, the following conditions shall be complied with by the applicant:—
(1) The manufacture shall be conducted under the direction and personal supervision of a competent technical staff consisting of at least one person who is a whole time employee and who possesses any one of the following qualifications:—
(a) holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (8 of 1948), or
(b) is registered under the Pharmacy Act, 1948 (8 of 1948), or
(c) has passed the Intermediate Examination with Chemistry as one of the subjects or an examination recognised by the licensing authority as equivalent to it.
A licence to manufacture cosmetics for sale 2[or for distribution] against application in Form 31, shall be granted in Form 32.]
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1. Added by G.S.R. 444, dated 31st March, 1973 (w.e.f. 28-4-1973).
2. Ins. by G.S.R. 788(E), dated 10th October, 1985 (w.e.f. 10-10-1985).
Before a licence under this Part is granted or renewed in Form 32, Form 32A or Form 33, the licensing authority shall cause the establishment, in which the manufacture is proposed to be conducted or being conducted, to be inspected by one or more Inspectors appointed under the Act. The Inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed alongwith the means to be employed or being employed for standardising and testing the substances to be manufactured and inquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the requirements of plant
The Inspector of Inspectors shall forward a detailed descriptive report giving his or their findings on each aspect of inspection alongwith his or their recommendations after completion of his or their inspection to the licensing authority.]
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1. Ins. by G.S.R. 493(E), dated 9th June, 1995 (w.e.f. 9-6-1995) as corrected by G.S.R. 184(E), dated 12th April, 1996.
(1) If the Licencing Authority after such further enquiry, if any, as he may consider necessary is satisfied that the requirements of the rules under the Act have been complied with and that the conditions of the licence and the rules under the Act shall be observed, he shall grant or renew a licence in Form 32, Form 32A or Form 33.
(2) If the licensing authority is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence can be granted or renewed and shall supply the applicant with a copy of inspection report.]
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1. Ins. by G.S.R. 493(E), dated 9th June, 1995 (w.e.f. 9-6-1995) as corrected by G.S.R. 184(E), dated 12th A
If within a period of six months from the rejection of an application for a licence, the applicant informs the licensing authority that the conditions laid down have been fulfilled and deposits an inspection 2[fee of rupees two hundred and fifty], the Licencing Authority may, if, after causing further inspection to be made, he is satisfied that the conditions for the grant of licence have been complied with, issue a licence in Form 32, Form 32A or Form 33.]
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1. Ins. by G.S.R. 493(E), dated 9th June, 1995 (w.e.f. 9-6-1995) as corrected by G.S.R. 184(E), dated 12th April, 1996.
2. Subs. by G.S.R. 601(E), dated 24th August, 2001 (w.e.f. 24-8-2001).
Any person who is aggrieved by the other passed by the licensing authority refusing to grant or renew a licence under this part may within ninety days from the date of receipt of such order, appeal to the State Government and the State Government may, after such enquiry into the matter as is considered necessary and after giving the said person an opportunity for representing the case, pass such order as it thinks fit.]
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1. Ins. by G.S.R. 493(E), dated 9th June, 1995 (w.e.f. 9-6-1995) as corrected by G.S.R. 184(E), dated 12th April, 1996.
A loan licence to manufacture cosmetics for sale 2[or for distribution] against application in form 31A shall be granted in Form 30A.]
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1. Added by G.S.R. 444, dated 31st March, 1973 (w.e.f. 28-4-1973).
2. Subs. by G.S.R. 788(E), dated 10th October, 1995 (w.e.f. 10-10-1985)
A original licence or a renewed licence shall unless sooner suspended or cancelled be 1[valid for a period of five years on and from the date on which] it is granted or renewed:
2[Provided that if the application for renewal of a licence in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired, if application for its renewal is not made within six months of its expiry.]
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1. Subs. by G.S.R. 601(E), dated 24th August, 2001 (w.e.f. 24-8-2001).
2. Subs. by S.O. 2139, dated 5th June, 1972 (w.
The certificate of renewal of a licence in Form 32 shall be issued in Form 33.
An original loan licence in Form 32A or a renewed loan licence in Form 33A, unless sooner suspended or cancelled, shall be 2[valid for a period of five years on and from the date on which] in which it is granted or renewed:
Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry after payment of the additional fee, the licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]
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1. Added by G.S.R. 444, dated 31st March, 1973 (w.e.f. 28-4-1973).
2. Subs.
the certificate of renewal of a licence in Form 32A shall be issued in Form 33A.]
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1. Added by G.S.R. 444, dated 31st March, 1973 (w.e.f. 28-4-1973).
A licence in Form 32 shall be subject to the conditions stated therein and to the following other conditions, namely:—
(a) The license shall provide and maintain staff, premises and equipment as specified in rule 139.
(b) The licensee shall comply with the provisions of the Act and the rules made thereunder and with such further requirements, if any, as may be specified in any rules to be made hereafter under Chapter IV of the Act.
1[(b1) The licensee shall keep records of the details of each batch of cosmetic manufactured by him and of raw materials used therein as per particulars specified in Schedule U(1) and such records shall be retained for a period of three years.]
(c) The licensee shall test each batch or lot of
The applicant for the grant of a licence or any person granted a licence under this Part shall, on demand, furnish to the licensing authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm, or any other relevant matter, which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee while applying for or after obtaining the licence as the case may be.]
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1. Added by S.O. 2139, dated 5th June, 1972 (w.e.f. 12-8-1972).
(a) A licence in Form 32A shall be deemed to be cancelled or suspended, if the licence owned by the licensee, in Form 32, whose manufacturing facilities, is cancelled or suspended, as the case may be, under these rules.
(b) The licensee shall comply with the provisions of the Act and these rules and with such further requirements, if any, as may be specified from time to time in Chapter IV of the Act, provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette.
2[(b1) The licensee shall keep records of the details of each batch of cosmetic manufactured by him and of raw materials used therein as per particulars specified in Schedule U(1) and such records shall be retained for a period of three years.]
&nb
(1) The licensing authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefore, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or the rules made thereunder.
(2) A licensee whose licence has been suspended or cancelled may appeal within a period of three months from the date of the order to the State Government which shall after considering the appeal, pass orders, and such orders shall be final.
(1) No cosmetics shall be manufactured which contain dyes, colours and pigments other than the one specified by the Bureau of Indian Standards (IS : 4707 Part I as amended) and Schedule Q.
The permitted synthetic organic colours and natural organic colours used in the Cosmetic shall not contain more than—
(i) 2 parts per million of Arsenic calculated as Arsenic Trioxide.
(ii) 20 parts per million of Lead calculated as Lead.
(iii) 100 parts per million of Heavy Metals other than lead calculated as the total of the respective metals.]
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1. Subs. by G.S.R. 811(E), dated 14th November,
No cosmetic containing Hexachlorophene shall be manufactured:]
2[Provided that in the case of soaps Hexachlorophene may be used in concentrations not exceeding one per cent weight by weight:
Provided further that the following cautionary note shall be printed and shall appear in a conspicuous manner on the wrapper of package of each soap, namely:—
“Contains Hexachlorophene—not to be used on babies”.]
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1. Added by G.S.R. 116, dated 15th January, 1975 (w.e.f. 26-1-1975).
2. Ins. by G.S.R. 1049(E), dated 29th August, 1986 (w.e.f. 29-8-1986).
The use of Lead and Arsenic compounds for the purpose of colouring cosmetics is prohibited.
Where the fair price, for the samples of cosmetics taken for the purpose of test or analysis, tendered under sub-section (1) of section 23 has been refused, the Inspector shall tender a receipt therefor to the person from whom the said samples have been taken as specified in Form 17A.]
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1. Ins. by G.S.R. 292(E), dated 29th May, 1997 (w.e.f. 29-5-1997).
Where an Inspector takes a sample of a cosmetic for the purpose of test or analysis, he shall intimate such purpose in writing in Form 17 to the person from whom he takes it.]
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1. Added by S.O. 2139, dated 5th June, 1972 (w.e.f. 12-8-1972).
A receipt by an Inspector for the stock of any cosmetics seized under clause (c) of sub-section (1) of section 22 of the Act, shall be in Form 16.]
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1. Added by S.O. 2139, dated 5th June, 1972 (w.e.f. 12-8-1972).
The Drugs Inspector shall return the documents, seized by him under clause (cc), or produced before him under clause (cca), of sub-section (1) of section 22 of the Act, within a period of twenty days of the date of such seizure or production, to the person from whom they were seized or, as the case may be, the person who produced them, after copies thereof or extracts therefrom have been signed by the concerned Drugs Inspector and the person from whom they were seized, or, as the case may be, who produced such records.]
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1. Ins. by G.S.R. 89(E), dated 16th February, 1985 (w.e.f. 16-2-1985).
An order in writing by an Inspector under clause (c) of sub-section (1) of section 22 of the Act requiring a person not to dispose of any stock of cosmetics in his possession shall be in Form 15.]
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1. Added by G.S.R. 1594, dated 28th October, 1976 (w.e.f 13-11-1976).
No cosmetic containing Mercury compounds shall be manufactured.]
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1. Ins. by G.S.R. 1074, dated 19th August, 1978.
Subject to the other provisions of these rules, no person shall sell or distribute any cosmetic unless the cosmetic, if of Indian origin, is manufactured by a licensed manufacturer and labelled and packed in accordance with these rules.
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* Subs. by Notification No. F. 1-15/66-D, dated 1st November, 1966.
Labels on packages or containers of cosmetics not manufactured for consumption or sale in India shall be adapted to meet the specific requirements, if any, of the consignee:
Provided that where a cosmetic is required by the consignee to be not labelled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the licensing authority mentioned in rule 21.]
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1. Subs. by G.S.R. 682(E), dated 5th December, 1980 (w.e.f. 5-12-1980).
Subject to other provisions of the rules, a cosmetic shall carry—
(1) on both the inner and outer labels:
(a) the name of the cosmetics,
1[(b) the name of the manufacturer and complete address of the premises of the manufacturer where the cosmetic has been manufactured:
Provided that if the cosmetic is contained in a very small size container where the address of the manufacturer cannot be given, the name of the manufacturer and his principal place of manufacture shall be along with pin code.]
(2) on the outer label:
A declaration of the net contents expressed in terms of weight for sol
No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any cosmetic:
Provided that nothing in this rule shall apply to any alteration, inscription to mark made on the container, label or wrapper of any cosmetic at the instance or direction or with the permission of the licensing authority.]
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1. Ins. by G.S.R. 351(E), dated 26th April, 1999 (w.e.f. 26-4-2000).
Hair dyes containing Para-Phenylenediamine or other dyes, colours and pigments] shall be labelled with the following legend in English and local languages and these shall appear on both the inner and the outer labels.
“Caution.—This product contains ingredients which may cause skin irritation in certain cases and so a preliminary test according to the accompanying directions should first be made. This product shall not be used for dyeing the eyelashes or eyebrows; as such a use may cause blindness.”
Each package shall also contain instructions in English and local languages on the following lines for carrying out the test:—
“This preparation may cause serious inflammation of the skin in some cases and so a preliminary test should always be carried out to determine whether or not
(i) Fluoride content in toothpaste shall not be more than 1000 ppm and the content of fluoride in terms of ppm shall be mentioned on the tube and carton.
(ii) Date of expiry should be mentioned on tube and carton.]
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1. Ins. by G.S.R. 223(E), dated 19th April, 1991 (w.e.f. 19-4-1991).
Test reports on samples of cosmetics taken for test or analysis under these rules shall be supplied in Form 34.
Subject to the provisions of these rules, the standards for cosmetics shall be such as may be prescribed in Schedule S.]
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1. Ins. by G.S.R. 510(E), dated 26th July, 1982 (w.e.f. 26-7-1982).
(1) Application for grant or renewal of approval for carrying out tests for identity, purity, quality and strength of drugs or cosmetics or the raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs or cosmetics, shall be made in Form 36 to the licensing authority appointed by the State Government for the purposes of Part VII, VII(A) or XIV of these rules, as the case may be and referred to as the “approving authority” under this Part and shall be accompanied by an inspection fee of 2[rupees six thousand] in the case of testing of drugs specified in Schedules C and C (1) and 2[rupees one thousand and five hundred] in the case of testing of drugs other than those specified in Schedules C and C (1), homoeopathic drugs and cosmetics:
Provided that the applicant shall furnish to the approving authority such additional information as may b
(1) Approval for carrying out such tests of identity, purity, quality and strength of drugs or cosmetics as may be required under the provisions of these rules, on behalf of licensee for manufacture of drugs or cosmetics shall be granted in Form 37.
(2) Before approval in Form 37 is granted or renewed, the following conditions shall be complied with by the applicant:—
(1) The premises where the tests are being carried on shall be well lighted and properly ventilated except where the nature of tests of any drug or cosmetic warrants otherwise. Whenever necessary, the premises shall be air-conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the performance of special tests such as sterility tests, microbiological tests, etc.
(2) The ap
An approval granted in Form 37 or renewed in Form 38 unless sooner suspended or withdrawn, shall be 1[valid for a period of five years on and from the date on which] it is granted or renewed:
Provided that if an application for the renewal of an approval in Form 37 is made before its expiry or if the application is made within six months of its expiry after the payment of the additional inspection fee, the approval shall continue to be in force until orders are passed on the application and the approval shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.
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1. Subs. by G.S.R. 601(E), dated 24th August, 2001 (w.e.f. 24-8-2001).
An approval in Form 37 shall be subject to the following general conditions:—
(a) The institution granted approval under this Part (hereinafter referred to as the approved institution) shall provide and maintain an adequate staff and adequate premises and equipment as specified in rule 150C.
(b) The approved institution shall provide proper facilities for storage so as to preserve the properties of the samples to be tested by it.
(c) The approved institution shall maintain records of tests for identity, purity, quality and strength carried out on all samples of drugs, or cosmetics and the results thereof together with the protocols of tests showing the readings and calculation in such form as to be available for inspection and such records shall be retained in the case
Before an approval in Form 37 is granted, the approving authority shall cause the institution at which the testing of drugs or cosmetics, as the case may be, is proposed to be carried out to be inspected jointly by the Drugs Inspectors of the Central Drugs Standard Control Organisation and the State Drugs Control Organisation who shall examine the premises and the equipment intended to be used for testing of drugs or cosmetics and inquire into the professional qualifications of the expert staff to be employed.
The Drugs Inspector mentioned in rule 150F shall forward to the approving authority a detailed report of the results of the inspection.
(1) If the approving authority after such further enquiry, if any, as he may consider necessary, is satisfied that the requirements of the rules made under the Act have been complied with and that the conditions of the approval and the rules made under the Act will be observed, he shall grant an approval in Form 37.
(2) If the approving authority is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before an approval could be granted.
If within a period of six months from the rejection of an application for approval, the applicant informs the approving authority that the conditions laid down have been satisfied and deposits inspection fee of 1[rupees two hundred and fifty], the approving authority may, if, after causing a further inspection to be made, he is satisfied that the conditions for grant of approval have been complied with, grant the approval in Form 37.
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1. Subs. by G.S.R. 601(E), dated 24th August, 2001 (w.e.f. 24-8-2001).
On an application being made for renewal the approving authority may cause an inspection to be made and if satisfied that the conditions of the approval and the rules made under the Act are and shall continue to be observed shall issue a certificate of renewal in Form 38.
(1) The approving authority may, after giving the approved institution an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefore, withdraw an approval granted under this Part or suspend it for such period as he thinks fit either wholly or in respect of some of the categories of drugs or items of cosmetics to which it relates, if in his opinion the approved institution had failed to comply with any of the conditions of the approval or with any provision of the Act or the rules made thereunder.
(2) Any approved institution whose approval has been suspended or withdrawn may within three months of the date of the order, appeal to the State Government which shall dispose of the appeal in consultation with a panel of competent persons appointed by it in this behalf and notified in the Official Gazette.]
If Ayurvedic (including Siddha) or Unani drugs are manufactured on more than one set of premises, a separate application shall be made and a separate licence shall be obtained in respect of each such set of premises.
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* Added by Notification No. F. 1-23/6, dated 2nd February, 1970.
For the purpose of this Part the State Government shall appoint such licensing authorities and for such areas as may be specified in this behalf by notification in the Official Gazette.
(i) An application for the grant or renewal of a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 24D to the licensing authority along with 1[a fee of rupees one thousand]:
Provided that in the case of renewal the applicant may apply for the renewal of the licence before its expiry or within one month of such expiry:
Provided further that the applicant may apply for renewal after the expiry of one month but within three months of such expiry in which case 2[the fee payable for renewal of such licence shall be rupees one thousand and two hundred plus an additional fee of rupees six hundred].
(ii) 3[A fee of rupees three hundred] shall be payable for a duplicate copy of a licence issued under this rule, if the original licence is defaced, dama
(i) An application for the grant or renewal of a loan licence to manufacture for sale of any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 25E to the licensing authority along with 2[a fee of rupees six hundred].
Explanation.—For the purpose of this rule, a loan licence means a licence which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but intends to avail himself of the manufacturing facilities owned by a licensee in Form 25D:
Provided that in the case of renewal the applicant may apply for the renewal of the licence before its expiry or within one month of such expiry:
Provided further that the applicant may apply for renewal after the expiry of one month, but within three months of such expiry in which case 3[the
(1) Subject to the conditions of rule 157 being fulfilled, a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25D. The licence shall be issued within a period of three months from the date of receipt of the application.
(2) A licence under this rule shall be granted by the licensing authority after consulting such expert in Ayurvedic (including Siddha) or Unani systems of medicine, as the case may be, which the State Government may approved in this behalf.
(1) A loan licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25E.
(2) A licence under this rule shall be granted by the licensing authority after consulting such expert in Ayurvedic (including Siddha) or Unani systems of medicine, as the case may be, which the State Government may approve in this behalf.
(3) The licensing authority shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan licence.]
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1. Added by G.S.R. 376(E), dated 20th July, 1978 (w.e.f. 20-7-1978
The certificate of renewal of a licence in Form 25D shall be issued in Form 26D.
The certificate of renewal of a loan licence in Form 25E shall be issued in Form 26E.]
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1. Added by G.S.R. 376(E), dated 20th July, 1978 (w.e.f. 20-7-1978).
The certificate of Good Manufacturing Practices (GMP) to manufacturers of Ayurved-Siddha or Unani drugs shall be issued to licensee who comply with the requirements of Good Manufacturing Practice (GMP) of Ayurveda, Siddha and Unani drugs as laid down Schedule T.]
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1. Ins. by G.S.R. 198 (E), dated 7th March, 2003 (w.e.f. 7-3-2003).
An original licence in Form 25D or a renewal licence in Form 26D, unless sooner suspended or cancelled shall be 1[valid for a period of three years from the date of its issue]:
Provided that if the application for the renewal of a licence is made before its expiry or within one month of its expiry, or if the application is made within three months of its expiry after payment of the 2[additional fee of rupees five hundred], the licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired, if application for its renewal is not made within three months of its expiry.
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1. Subs. by G.S.R. 79(E), dated 14th February, 2005, for “valid upto the 31st December of the year following th
An original loan licence in Form 25E or renewed loan licence in Form 26E, unless sooner suspended or cancelled, shall be 2[valid for a period of three years from the date of its issue]:
Provided that if the application for the renewal of a loan licence is made in accordance with rule 153A, the loan licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired, if application for its renewal is not made within three month of its expiry.]
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1. Added by G.S.R. 376(E), dated 20th July, 1978 (w.e.f. 20-7-1978).
2. Subs. by G.S.R. 79(E), dated 14th February, 2005, for “valid upto the 31st December of the year following the year in whi
Before a licence in Form 25D is granted or renewed in Form 26D, the following conditions shall be complied with by the applicant, namely:—
(1) The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be carried out in such premises and under such hygienic conditions as are specified in Schedule T.
1[(1A) For getting a certificate of Good Manufacturing Practices of Ayurveda-Siddha-Unani drugs, the applicant shall make an application on a plain paper, providing the information on existing infrastructure of the manufacturing unit, and the licensing authority shall after verification of the requirements as per Schedule T, issue the certificate within a period of three months in Form 26 E-I]
(2) The manufacture of Ayurvedic (including Siddha) or Unani drugs shall b
A licence in Form 25D shall be subject to the conditions stated therein and to the following further conditions, namely:—
(a) The licensee shall maintain proper records of the details of manufacture and of the tests, if any, carried out by him, or by any other person on his behalf, of the raw materials and finished products.
(b) The licensee shall allow an Inspector appointed under the Act to enter any premises where the manufacture of a substance in respect of which the licence is issued is carried on, to inspect the premises, to take samples of the raw materials as well as the finished products, and to inspect the records maintained under these rules.
1[(c) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and
A licence in Form 25E shall be subject to the following further conditions, namely:—
(a) The licence in Form 25E shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 25D whose manufacturing facilities have been availed of by the licensee is cancelled or suspended, as the case may be, under these rules.
(b) The licensee shall comply with the provisions of the Act and of the rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IVA of the Act, provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette.
(c) The licensee shall maintain proper records of the details of manufacture an
(1) The licensing authority may, after giving the licensee an opportunity to show cause, within a period which shall not be less than fifteen days form the date of receipt of such notice, why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the drugs to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or the rules made thereunder.
(2) A licensee whose licence has been suspended or cancelled may appeal to the State Government within a period of three months from the date of receipt of the order which shall, after considering the appeal, decide the same.
Raw materials used in the preparation of Ayurvedic (including Siddha) or Unani drugs shall be identified and tested, wherever tests are available for their genuineness, and records of such tests as are carried out for the purpose and the methods thereof shall be maintained.
Application for grant or renewal of approval for carrying out tests for identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs or the raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of the said Ayurvedic, Siddha and Unani drugs, shall be made in Form 47 to the Licensing Authority appointed by the State Government for the purposes of Part XVI, XVII or XVIII of these rules, as the case may be, and referred to as the “approving authority” under this Part and shall be accompanied by an inspection fee of six thousand rupees in respect of the drugs specified in First Schedule to the Act:
Provided that the applicant shall furnish to the approving authority such additional information as may be required by it in connection with the application in Form 47:
Provided further that if
(1) Approval for carrying out such tests of identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as may be required under the provisions of these rules, on behalf of licensee for manufacture of Ayurvedic, Siddha and Unani drugs shall be granted in Form 48.
(2) Before approval in Form 48 is granted or renewed, the following conditions shall be complied with by the applicants, namely:—
(i) The premises where the tests are carried out shall be well lighted and properly ventilated except where the nature of tests of any Ayurvedic, Siddha and Unani drug warrants otherwise. Wherever necessary, the premises shall be air-conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the performance of special tests such as sterility tests and microbiological tests.
&nbs
An approval granted in Form 41 or renewed in Form 42 unless sooner suspended or withdrawn, shall be valid for a period of three years from the date on which it is granted or renewed:
Provided that if an application for the renewal of an approval in Form 40 is made before its expiry or if the application is made within six months of its expiry after the payment of the additional inspection fee, the approval shall continue to be in force until orders to the contrary are passed on the application and the approval shall be deemed to have expired if the application for renewal is not made within six months of expiry.
An approval in Form 41 shall be subject to the following conditions, namely:
I. The Institution granted approval under this Part (hereinafter referred to as the approved laboratory) shall provide and maintain adequate staff and adequate premises and equipment as specified in rule 160 B.
II. The approved laboratory shall provide proper facilities for storage so as to preserve the properties of the samples to be tested by it.
III. The approved laboratory shall maintain records of tests for identity, purity, quality and strength carried out on all samples of Ayurvedic, Siddha and Unani drugs and the results thereof together with the protocols of tests showing the readings and calculation in such form as to be available for inspection and such records shall be retained i
Before an approval in Form 48 is granted, the approving authority shall cause the laboratory at which the testing of Ayurvedic, Siddha and Unani drugs, as the case may be, is proposed to be carried out to be inspected jointly by the Inspectors appointed or designated by the Central Government and State Government for this purpose, who shall examine the premises and the equipment intended to be used for testing of drugs and varify into the professional qualifications of the expert staff who are or may be employed by the laboratory.
The Inspectors appointed by the Central Government as stated in rule 160E shall forward to the approving authority a detailed report of the results of the inspection.
(1) If the approving authority after such further enquiry, if any, as it may consider necessary, is satisfied that the requirements of the rules made under the Act have been complied with and that the conditions of the approval and the rules made under the Act have been observed, it shall grant approval in Form 48.
(2) If the approving authority is not so satisfied, it shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which shall be satisfied before approval could be granted.
If within a period of six months from the rejection of an application for approval, the applicant informs the approving authority that the conditions laid down have been satisfied and deposits inspection fee of two thousand rupees, the approving authority may, if, after causing a further inspection to be made and after being satisfied that the conditions for grant of approval have been complied with, grant the approval in Form 48.
On an application being made for renewal, the approving authority shall, after causing an inspection to be made and if satisfied that the conditions of the approval and the rules made under the Act have been complied with, shall issue a certificate of renewal in Form 49.
(1) The approving authority may, after giving the approved laboratory an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, withdraw an approval granted under this Part or suspend it for such period as it thinks fit either wholly or in respect of testing of some of the categories of Avurvedic, Siddha and Unani drugs to which it relates, if in his opinion the approved laboratory had failed to comply with any of the conditions of the approval or with any provision of the Act of the rules made thereunder.
(2) any approved laboratory, whose approval has been suspended or withdrawn, may, within three months of the date of the order of suspension or withdrawal, appeal to the State Government which shall dispose of the appeal in consultation with a panel of competent persons appointed by the Department of Indian Systems o
(1) There shall be conspicuously displayed on the label of the container or package of an Ayurvedic (including Siddha) or Unani drug, the true list of all the ingredients used in the manufacture of the preparation together with the quantity of each of the ingredients incorporated therein and a reference to the method of preparation thereof as detailed in the standard text and Adikarana, as are prescribed in the authoritative books specified in the First Schedule of the Act:
Provided that if the list of ingredients contained in the medicine is large and cannot be accommodated on the label, the same may be printed separately and enclosed with the packing and reference be made to this effect on the label.
(2) The container of a medicine for internal use made up ready for the treatment of human ailments shall, if it is made up from a substan
(1) Label and packages or containers of Ayurvedic, Siddha and Unani Drugs for export may be adapted to meet the specific requiremenmts of the law of the country to which the said drugs is to be exported, but the following particulars shall appear in conspicuous position on the container in which drug is packed and on every other covering in which that container is packed, namely:—
(a) name of the Ayurvedic, Siddha and Unani drug (single or compound formulation);
(b) the name, address of the manufacturer and the number of licence under which the drug has been manufactured;
(c) batch or lot number;
(d) date of manufacture, along with date for “Best for use before”.
(e)
Subject to the instructions of the controlling authority, it shall be the duty of an Inspector authorised to inspect the manufacture of Ayurvedic (including Siddha) or Unani drugs—
(i) to inspect not less than twice a year, all premises licensed for manufacture of Ayurvedic (including Siddha) or Unani drugs within the area allotted to him and to satisfy himself that the conditions of the licence and the provisions of the Act and the rules made thereunder are being observed;
(ii) to send forthwith to the controlling authority after each inspection a detailed report indicating whether or not the conditions of the licence and the provisions of the Act and the rules made thereunder are being observed;
(iii) to take samples of the drugs manufactured on the premises and sen
(a) The Ayurvedic/Siddha/Unani qualifications as per Schedule II of CCIM Act 1970/B. Pharma (Ayurveda) of a recognized University.
(b) At least 5 years’ experience in the Ayurveda/Siddha/Unani drug manufacturing or testing of Ayurvedic, Siddha and Unani drugs or enforcement of provisions of Chapter IVA of the Drugs and Cosmetics Act, 1940 and rules made thereunder or teaching/research on clinical practice of Ayurveda/Siddha/Unani System.]
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1. Ins. by G.S.R. 76(E), dated 3rd February, 2003 (w.e.f. 3-2-2003).
(1) Sample for test or analysis shall be sent to the Government Analyst by registered post or by hand in a sealed package enclosed together with a memorandum in Form 18A in an outer cover addressed to the Government Analyst.
(2) The package as well as the outer cover shall be marked with distinguishing number.
(3) A copy of the memorandum and a specimen impression of the seal used to seal the package shall be sent by registered post or by hand to the Government Analyst.
(4) On receipt of the package from an Inspector, the Government Analyst or an Officer authorised by him writing in this behalf shall open the package and shall also record the conditions of the seals on the package.
(5) After the test or analysis has been completed, one copy of the r
The Pharmacopoeial Laboratory for Indian Medicine at Ghaziabad shall function as a Central Drugs Laboratory for the purpose of testing or analysis Ayurveda, Siddha and Unani Drugs.
Its functions shall be—
(1) to develop Pharmacopoeial standards and draft monographs and amendments alongwith standardized methods, for the Ayurvedic, Siddha, Unani drugs;
(2) to act as Central Appellate Drug Laboratory for testing of Ayurveda Siddha, Unani drugs;
(3) to analyse or test such samples of Ayurvedic, Siddha Unani drugs as may be sent to it under sub-section (2) of section 11, or under sub-section (4) of section 25 of the Act;
(4) to maintain reference museum and herbarium for the dru
The functions of the Central Drug Laboratory in respect of Ayurvedic, Siddha and Unani drugs shall be carried out at the Pharmacopoeial Laboratory for Ayurvedic, Siddha and Unani medicine, Ghaziabad, (Uttar Pradesh) and the functions of the Director in respect of the said drugs shall be exercised by the Director of the said laboratory.
(1) Samples for testing or analysis of Ayurveda, Siddha and Unani drugs under sub-section (2) of section 11 or sub-section (1) of section 25 and section 33H of the Act shall be sent by registered post in a sealed packet, enclosed with a memorandum in Form 1A, specified in Schedule A, in an outer cover addressed to the Director, Pharmacopoeial Laboratory for Indian Medicine.
(2) The packet as well as the outer cover, shall be marked with a distinguishing number.
(3) A copy of the memorandum in Form 1A and a specimen impression of the seal used to seal the packet shall be sent separately by registered post to the Director, Pharmacopoeial Laboratory for Indian Medicine.
On receipt of the packet, it shall be opened by an officer authorised in writing on that behalf by the Director, Pharmacopoeial Laboratory for Indian Medicine, who shall record the condition of the seal on the packet.
After test or analysis, the result of the test or analysis, together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2A of as specified in the said Schedule.
The fees for test and analysis shall be as specified in Schedule B-1.
Certificates issued under these rules by the Pharmacopoeial Laboratory for Indian Medicine, shall be signed by the Director or by an officer authorised by the Central Government to sign such certificates.]
The method of test or analysis to be employed in relation to an Ayurvedic (including Siddha) or Unani drug shall be such as may be specified in the Ayurvedic (including Siddha) or Unani Pharmacopoeia, or if no such pharmacopoeias are available or if no tests are specified in such pharmacopoeias, such tests as the Government Analyst may employ, such tests being scientifically established to determine whether the drug contains the ingredients as stated on the label.
A person who is appointed a Government Analyst under section 33F of the Act shall be a person possessing the qualifications prescribed in rule 44 or a degree in Ayurveda, Siddha or Unani system, as the case may be, conferred by a University, a State Government or Statutory Faculties, Councils and Boards of Indian Systems of Medicine recognised by the Central or State Government, as the case may be, for this purpose and has had not less than three years’ post-graduate experience in the analysis of drugs in a laboratory under the control of (i) a Government Analyst appointed under the Act, or (ii) a Chemical Examiner to Government, or (iii) the head of an institution specially approved for the purpose by the appointing authority.
(1) The Government Analyst shall analyse or test or cause to be analysed or tested such samples of Ayurvedic (including Siddha) or Unani drugs as may be sent to him by Inspectors or any other person or authority authorised by the Central Government or a State Government under the provisions of Chapter IVA of the Act and shall furnish reports of the results of test or analysis in accordance with these rules.
(2) A Government Analyst appointed under section 34F shall from time to time forward to the Government reports giving the results of analytical work and research with a view to their publication at the discretion of the Government.
A person who is appointed an Inspector under section 33G shall be a person who—
(a) has the qualifications laid down under rule 49 and shall have undergone practical training in the manufacture of Ayurvedic (including Siddha) or Unani drug, as the case may be; or
(b) has a degree in Ayurvedic or Siddha or Unani system or a degree in Ayurveda Pharmacy, as the case may be, conferred by a University or a State Government or a Statutory Faculty, Council or Board of Indian Systems of Medicine recognised by the Central Government or the State Government for this purpose ; or
(c) has a diploma in Ayurveda, Siddha or Unani Systems, as the case may be, granted by a State Government or an Institution recognised by the Central Government or a State Government for this purpose.]
Class of Drugs Standards to be complied with
1. 3[Drugs] included in The standards for identity, purity and
Ayurvedic Pharmacopoeia strength as given in the editions of Ayurvedic Pharmacopoeia of India for the time being in force.
2. Asavas and Aristas The upper limit of alcohol as self- generated alcohol should not exceed 12% v/v excepting those that are otherwise notified by the Central Government from time to time.]
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* Ins. by G.S.R. 519(E), dated 26th June, 1995 (w.e.f. 26-6-1995).
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