3[(b) if it contains a drug substance specified in Schedule H, be labeled with symbol Rx and conspicuously displayed on the left top corner of the label and shall also be labeled with the following words in legible black coloured font size in completely red rectangular box:

(c) if it contains a drug s

S.¹[Rule 97-A Modified application of Rules 96 and 97 for certain period.--

Notwithstanding anything contained in these rules, the modified or additional requirements of labelling as may be specified in the notification of the Government of India in the Ministry of Health and Family Welfare number G.S.R. 408(E), dated the 26th April, 2018, shall be on voluntary basis for a period commencing on the date of coming into force on this rule and ending on the 31st day of March, 2019, and thereafter shall be mandatory.]

S.¹[Rule 98

x x x x]

S.¹[Rule 99

x x x x]

S.¹[Rule 100

x x x x]

S.¹[Rule 101

x x x x]

S.¹[Rule 102 Non-Sterile Surgical Ligature and Suture.--

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".]

S.Rule 103

(1) ¹[x x x x]

(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.]

S.¹[Rule 104 Use of letters I.P., etc.--

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.]

S.¹[Rule 104-A Prohibition against altering inscriptions on containers, labels or wrappers of drug.--

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.]

S.¹[Rule 105 Packing of drugs.--

(1) The pack sizes of drugs meant for retail sale shall be as prescribed in Schedule P-1 to these rules.

(2) The pack sizes of drugs not covered by the Schedule P-1 shall be as given below:

Unless specified otherwise in Schedule P-1,

(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 ⁶[or 7].

(ii) The pack sizes for liquid Oral preparations shall be 30 ml (paediatric only) 60 ml/100 ml/200 ml/450 ml.

(iii) The pack sizes for Paediatric Oral Drops shall be 5 ml/10 ml/15 ml.

(iv) The pack sizes for Eye/Ear/Nasal drops shall be 3 ml/5 ml/10 ml.

(v) The pack sizes for Eye Ointment shall be 3 gm/5 gm/10 gm.

Provided that the provisions of the pack sizes covered under this rule shall

S.¹[Rule 105-A Packing of drugs specified in Schedule X.--

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 packing 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.]

S.¹[Rule 106 Diseases which a drug may not purport to prevent or cure.--

(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.

Explanation.-- ²[x x x x]]

S.Rule 106-A Manner of labelling of Homoeopathic medicines.--

(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: --

²[(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 ⁸[or the French Homoeopathic Pharmacopoeia or the European Pharmacopeia], the name specified in that Pharmacopoeia].

(b) For other drugs, the name descriptive of the real nature of the drug.

(iii) The potency of the Homoeopathic medicine-For this purpose the potency shall be expressed either in decimal, centesimal or millisimal systems.

³[(iii-A) In case of Homoeopathic medicine containing two or more ingredients the name of

S.¹[Rule 106-B Prohibition of quantity and percentage.--

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.]

S.¹[Rule 107 Name of substance.--

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 substance approved by the Licensing Authority.]

S.¹[Rule 108 Container.--

(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 withdrawn for use on different occasions, the liquid shall contain a sufficient proportion of some antiseptic to prevent the growth of an

S.¹[Rule 109 Labelling.--

(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 required by these rules, a statement of the potency in units defined in terms of relating to the standard preparation specified in Schedule F or F(1), as the case may be: Provided that this clause shall not appl

S.¹[Rule 109-A Labelling of medical devices.--

Subject to the other provisions of these rules, the following particulars shall be printed in indelible ink on the label or sticker on the shelf pack of the medical device or on the outer cover of such medical device and on every outer covering in which the medical device is packed, namely --

(a) proper name of the medical device;

(b) the details necessary for the user to identify the device and its use;

(c) the name of the manufacturer and address of the manufacturing premises where the device has been manufactured;

(d) the correct statement of the net quantity in terms of weight, measure, volume, number of units, as the case may be, and the number of the devices contained in the package shall be expressed in metric system; and

(e) the date of manufacture and date of expiry; alternately the label shall bear the shelf life of the product:

Provided that in the case of sterile devices the date of sterilisation may be given as date of the manuf

S.¹[Rule 109-B Exemption of certain labelling requirements for medical devices for export from India.--

The labels on packages or container of devices for export shall be adopted to meet specific requirements of the law of the country to which the device is to be exported, but the following particulars shall appear in conspicuous manner on the label of the shelf pack of the medical device in which the device is packed and every other outer covering in which the container is packed --

(a) name of the Device;

(b) the distinctive batch number or lot number preceded by the word "Lot No." or "Lot" or "Batch No." or "B. No.";

(c) the date of expiry, if any;

(d) the name and address of the manufacturer and address of actual premises where the device has been manufactured;

(e) the manufacturing Licence No. preceded by the letters "M.L. No" or "Manufacturing Licence No.";

(f) the internationally recognised symbols in lieu of text, wherever required:

Provided that where a device is required by the consignee not to be labelled with the name and ad

S.¹[Rule 109-C Shelf life of the medical devices.--

The shelf life of the medical devices shall not exceed sixty months from the date of manufacture:

Provided that this period may be extended by the licensing authority, in respect of any specified medical device, if satisfactory evidence is produced by the manufacturer to justify such an extension.]

S.Rule 110 Prohibition of sale of substance after prescribed date.--

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.

S.Rule 110-A

¹[x x x x]

S.Rule 111 Standards.--

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.

S.Rule 112 Tests for strength and quality.--

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) ¹[or as specified], as the case may be.

S.Rule 113 Tests for sterility.--

¹[x x x x]

S.Rule 114 Tests for presence of living aerobic or anaerobic bacteria.--

¹[x x x x]

S.Rule 115 Application of tests for sterility.--

The tests shall be applied --

¹[[(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.

S.Rule 116 Amount of samples.--

¹[x x x x]

S.Rule 117 Method of preparing and using media.--

¹[x x x x]

S.Rule 118 Method of testing.--

¹[x x x x]

S.Rule 119

(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 process 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 not sterile and the material contained 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.

S.Rule 120

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 no 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 tests 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 proportions from the containers into which the batch is filled, and after the required inoculation and incubation shall examine the tubes every day for five days;

(ii) if at any examination

S.¹[Rule 121 Test for freedom from abnormal toxicity.--

The test for freedom from abnormal toxicity shall be carried out as per the current edition of Indian Pharmacopoeia in the case 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.]

S.¹[Rule 121-A Test for pyrogens.--

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.

S.Rule 122 Substances specified in Schedule C(1).--

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.

(b) ²[ x x x x ]

(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) ⁴[or as specified], as the case may be.

(d) The test for determining the strength, quality and purity of a substance specified in Schedule F or Schedule F(1) ⁵[or as specified], as the case may be shall be applied to samples taken from the final product after each manufacturing process has been completed.

(e) The substance should be stored in a cool pl

S.Rule 122-A Application for permission to import new drug.--

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 the grant of permission to import a new drug shall be made in Form 44 to the Licensing Authority, accompanied by a fee of ³[two lakh 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 ⁵[one lakh 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 ⁴[one lakh rupees] and such information and data as required by
⁷[Appendix i or Appendix I-A or Appendix I-B] of Schedule Y, as the case may be.]

(2) The importer of a new drug when applying

S.Rule 122-B Application for approval to manufacture new drug1[x x x x].--

²[(l)(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 the 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 shall be fifteen thousand rupees:

Provided further also that any application received after one year of the grant of approval for the manufacture for

S.Rule 122-C

¹[x x x x]

S.¹[Rule 122-D Permission to import or manufacture fixed dose combination.--

(1) An application for permission to import or manufacture fixed dose combination of two or more drugs as defined in clause (c) of Rule 122-E shall be made to the Licensing Authority as defined in clause (b) of Rule 21 in Form 44, accompanied by a fee of ²[fifteen thousand in case of application for manufacture of the fixed dose combinations and one lakh rupees in case of import application of the fixed dose combinations] 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 th

S.Rule 122-DA Application for permission to conduct clinical trials for New Drug/Investigational New Drug.--

(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 trials (Phase-III) on a new drug shall be made on the basis of the data emerging from Phase-II and where necessary, data emerging from Phase-I also, and shall be accompanied by a fee of twenty-five thousand rupees:

Provided that no

S.¹[Rule 122-DAA Non-application of certain rules for new drugs and investigational new drugs for human use.--

Part XA and Schedule Y shall not be applicable in respect of new drugs and investigational new drugs for human use from the date of coming into force of the New Drugs and Clinical Trials Rules, 2019, and the references in respect of human use made in the these rules shall respectively be omitted, and the construction thereof shall be construed accordingly and shall stand amended with all cogent meaning of the grammar.]

S.¹[Rule 122-DAB Compensation in case of injury or death during clinical trial.--

²[(1) In case of an injury occurring to the subject during the clinical trial, free medical management shall be given as long as required or till such time it is established that the injury is not related to the clinical trial, whichever is earlier.]

(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[(2-A) In case, there is no permanent injury, the quantum of compensation shall be commensurate with the nature of the non-permanent injury and loss of wages 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

S.¹[Rule 122-DAC Permission to conduct clinical trial.--

(1) The Licensing Authority as defined in clause (b) of Rule 21, on being satisfied that the data submitted along with the application in support of the proposed clinical trial is adequate in all respects, issue permission for conduct of clinical trial, subject to the following conditions, namely --

(a) Clinical trial shall be conducted in compliance with the approved protocols, requirements of Schedule Y annexed to these rules, Good Clinical Practice Guidelines for conduct of clinical trials in India and other applicable regulations;

(b) Approval of the Ethics Committee shall be obtained before initiation of the study;

(c) Clinical trial shall be registered at Clinical Trials Registry of India before enrolling the first patient for the study;

(d) Annual status report of each clinical trial, as to whether it is ongoing, completed or terminated, shall be submitted to the Licensing Authority, and in case of termination of any clinical trial the detailed rea

S.Rule 122-DB Suspension or cancellation of Permission/Approval.--

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, suspend or cancel it.

S.Rule 122-DC Appeal.--

Any person aggrieved by an order passed by the Licencing 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, pass such order in relation thereto as it thinks fit.

S.¹[Rule 122-DD Registration of Ethics Committee.--

(1) No Ethics Committee shall review and accord its approval to a clinical trial protocol without prior registration with the Licensing Authority as defined in clause (b) of Rule 21:

Provided that any Ethics Committee existing on the date of commencement of the Drugs and Cosmetics (Third Amendment) Rules, 2013, who has already reviewed and accorded approval to clinical trial protocol, shall obtain registration within a period of forty-five days from the date of commencement of the Drugs and Cosmetics (Third Amendment) Rules, 2013.

(2) An application for registration of Ethics Committee shall be made to the Licensing Authority in accordance with the requirements as specified in the Appendix VIII of Schedule Y.

(3) The Licensing Authority after being satisfied that the requirements have been complied with, may grant registration to the Ethics Committee subject to such conditions as may be stated therein.

(4) The Ethics Committee shall review and accord its

S.Rule 122-E Definition of new drug.--

For the purpose of this part, new drug shall mean and include-- ¹[(a) A drug, as defined in the Act including bulk drug substance ²[or phytopharmaceutical drug] 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 administration.

(c) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first ti

S.Rule 43

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.

S.¹[Rule 43-A

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[Petrapole Road in West Bengal, Sutarkandi in Assam, Old Raghna Bazar and Agartala in Tripura: in respect of drugs imported by road from Bangladesh.]

³[Raxual: in respect of drugs imported by road and railway lines connecting Raxual in India and Birganj in Nepal.]

⁴[⁵[Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva, Kandla, Inland Container Depots at Tuglakabad and Patparganj in Delhi, ⁶[Tuticorin and Kamrajar Port] in Tamil Nadu, Marmugao port in Goa, Visakhapatnam ¹¹[, Krishnapatnam and Gangavaram ports] in Andhra Pradesh and Hazira po

S.¹[Rule 43-B

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.]

S.²[Rule 44 Qualifications of Government Analyst.--

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 ³[University established in India by 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 ⁴[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 a ⁵[University established in India by law or has an equivalent qualification recognised and notified by the Central Go

S.Rule 45 Duties of Government Analysts.--

(1) The Government Analyst shall cause to be analysed or tested such samples of drugs ¹[x x x x] as may be sent to him by Inspectors 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[within a period of sixty days of the receipt of the sample:

Provided that where it is not possible to test or analyse the sample within the specified period, the Government Analyst shall seek extension of time from the Government giving specific reasons for delay in such testing or analysis.].

(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.

S.Rule 46 Procedure on receipt of sample.--

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 pharmacopoeia are followed, references to the specific tests or analysis in the pharmacopoeias are given i

S.Rule 47 Report of result of test or analysis.--

An application from a purchaser for test or analysis of a drug under Section 26 of the Act shall be made in Form 14-A and the report of test or analysis of the drug made on such application shall be supplied to the applicant in Form 14-B.

S.Rule 48 Fee.--

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[x x x x] purchased by him shall be those specified in Schedule B.

S.¹[Rule 49 Qualifications of Inspectors.--

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 firms manufacturing any of the substances specified in Schedule C during the tenure of their services as Drugs Inspectors; shall be authorised to inspect the manufacture of the substances mentioned in Schedule C:]

²[Provided further that the requirement as to the academic qua

S.¹[Rule 49-A Qualification of a Licensing Authority.--

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.]]

S.¹[Rule 50 Controlling Authority.--

(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.]

S.¹[Rule 50-A Qualification of a Controlling Authority.--

(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.]

S.Rule 51 Duties of Inspectors of premises licensed for sale.--

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 not less than ¹[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 institute prosecutions in respect of breaches of the Act and Rules thereunder;

(6) to maintain a record of all inspections made and action taken by him in the performance of his duties, including the taking of samples and the seizure of stocks, and to submit copies o

S.Rule 52 Duties of Inspectors specially authorised to inspect the manufacture of drugs1[x x x x]. --

Subject to the instructions of the controlling authority it shall be the duty of an Inspector authorized to inspect the manufacture of drugs ²[x x x x] --

(1) to inspect not less than ³[once] a year, all premises licensed for manufacture of drugs within the area allotted to him and 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 ⁴[or cosmetics], 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 product;

(3) to send forthwith to the controlling authority after each inspection a detai

S.Rule 53 Prohibition of disclosure of information.--

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.

S.Rule 54 Form of order not to dispose of stock.--

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.

S.¹[Rule 54-A Prohibition of sale.--

No person in possession of a drug ²[x x x x] 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 ³[x x x x].]

S.¹[Rule 55 Form of receipts for seized drug,2[x x x x], record, register, documents or any other material objects.--

A receipt by an Inspector for the stock of any drug ³[x x x x] 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.]

S.¹[Rule 55-A Manner of certifying copies of seized documents.--

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 Drugs Inspector concerned and the person from whom they were seized, or, as the case may be, who produced such records.]

S.Rule 56 Form of intimation of purpose of taking samples.--

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.

S.¹[Rule 56-A Form of receipt for samples of drugs where fair price tendered is refused.--

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 17-A.]

S.Rule 57 Procedure for despatch of sample to Government Analyst.--

(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.

S.¹[Rule 58 Confiscation of drugs, implements, machinery, etc.--

(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 17-B 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 drug shall also be liable to confiscation.]

S.¹[Rule 58-A Procedure for disposal of confiscated drugs.--

(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 accordingly. ²[The Court may then order the Inspector to give the stocks of confiscated drugs to hospital or dispensary maintained o

S.Rule 59

(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 ²[x x x x] of a licence ³[to sell, stock, exhibit or offer for sale or distribute] drugs, other than those included in Schedule X, ⁴[shall be made in Form 19 accompanied by a fee of rupees one thousand and five hundred or in Form 19-A 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 19-C 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 19-A shall be accompanied by a fee of rupees ten.

(3) A fee of rupees ⁵[one hundred and fifty] shall be paid for a duplicate copy of a li

S.Rule 60

A licensing authority may with the approval of the ¹[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.

S.¹[Rule 61 Forms of licences to sell drugs.--

(1) A licence 2to 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 20-A or Form 20-B, as the case may be:

Provided that a licence in Form 20-A shall be valid for only such drugs as are specified in the licence.

(2) A licence ³[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 21-A or Form 21-B, as the case may be:

⁴[Provided that a licence in Form 21-A shall not be granted for drugs specified in Schedule C and shall be valid for only such Schedule C(l) drugs as are specified in the licence.]

(3) A licence ⁵[to sell, stock, exhibit or offer for sale or distribute] drugs specified in Schedule X by retail or by

S.Rule 62 Sale at more than one place.--

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.]

S.¹[Rule 62-A Restricted licences in Forms 20-A and 21-A.--

(a) Restricted licences in Forms 20-A and 21-A 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 for distribution of drugs are not available.

(c) The licensing authority may issue a licence in Form 21-A 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:

Provided that travelling agents of licensed manufacturers, agents of such manufacturers and of importers of drugs shall be exempted from taking

S.¹[Rule 62-B Conditions to be satisfied before a licence in Form 20-A or Form 21-A is granted.--

(1) A licence in Form 20-A or Form 21-A 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 62-A the authority empowered to grant 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:

Provided that the licensing authority may refuse to grant ²[x x x x] a licence to any applicant or licensee in respect of whom it is satisfied that by reason of his conviction of an offence under the Act or these Rules or the previous cancellation or

S.¹[Rule 62-C Application for licence to sell drugs by wholesale or to distribute the same from a motor vehicle.--

(1) Application for the grant ²[x x x x] of a licence to sell by wholesale or to distribute from a motor vehicle shall be made to the licensing authority in Form 19-AA and shall be accompanied by a fee of rupees ³[five hundred]:

⁴[x x x x]

(2) A fee of rupees ⁵[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.

S.Rule 62-D Form of licences to sell drugs by wholesale or distribute drugs from a motor vehicle.--

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 20-BB and of drugs specified in Schedule C and Schedule C(1) in Form 21-BB:

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.]

S.¹[Rule 63 Duration of licence.--

(1) A licence issued in Forms 20, 20-A, 20-B, 20-BB, 20-F, 20-G, 21, 21-A, 21-B or Form 21-BB shall remain valid, if licencee deposits a licence retention fee referred to in sub-rule (2) before the expiry of a period of every succeeding five years from the date of its issue, unless, it is suspended or cancelled by the licensing authority.

(2) The licence retention fee referred to in sub-rule (1) shall be equivalent to the respective fee required for the grant of such licence.

(3) If the licencee fails to pay licence retention fee on or before the due date as referred to in sub-rule (1), he shall be liable to pay licence retention fee along with a late fee calculated at the rate of two per cent of the licence fee for every month or part thereof up to six months, and in the event of non-payment of such fee, the licence shall be deemed to have been cancelled.]]

S.¹[Rule 63-A Certificate of renewal of a sale licence.--

²[x x x x]

S.¹[Rule 63-B Certificate of renewal of licence.--

²[x x x x]]

S.¹[Rule 64 Conditions to be satisfied before a licence in2[Forms 20, 20-B, 20-F, 20-G, 21 or 21- B] is granted3[x x x x].--

(1) A licence in ⁴[Form 20, 20-B, 20-F, 20-G, 21 or 21-B] ⁵[to sell, stock, exhibit or offer for sale or distribute] drugs shall not be granted ⁶[x x x x] 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 ⁷[x x x x] 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 ⁸[x x x x] unless the licensing authority is satisfied that the requirements prescribed for a pharmacy in Schedule N have been complied with:

⁹[Provided further that licence in Form 20-F shall be granted ¹⁰[x x x x] only

S.Rule 65 Condition of licences.--

Licences in ¹[Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B] 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 direct and personal supervision of a ³[registered Pharmacist].]

(2) The supply, otherwise than by way of wholesale dealing ⁴[x x x x] of any drug supplied on the prescription of a Registered Medical Practitioner shall be effected only by or under the personal supervision of a
⁵[registered Pharmacist].

⁶[(3) (1) The supply of any drug ⁷[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 for the purpose and the serial number of entry in this regard shall be entered on the prescription. The foll

S.¹[Rule 65-A Additional information to be furnished by an applicant for licence or a licensee to the licensing authority.--

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.]

S.¹[Rule 65-B Inspection for verification of compliance.--

The licensing authority shall cause inspection, by the Inspector appointed under the Act, of each premises licensed under this Part, to verify the compliance with the conditions of licence and the provisions of the Act and these rules, not less than once in three years or as needed as per risk based approach.]

S.Rule 66 Cancellation and suspension of licences.--

(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 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, or

(b) that he or his agent or employee had not been g

S.¹[Rule 66-A Procedure for disposal of drugs in the event of cancellation of licence.--

(1) In case a licensee, whose licence 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 sub-rule (1) and, if necessary, after inspection by an Inspector of the premises where the drugs are stocked, grant the necessary permission for their disposal.]

S.Rule 67

¹[x x x x]

S.Rule 67-A

(1) The State Government shall appoint Licensing Authorities for the purpose of this Part for such areas as may be specified.

²[(2) Application for the grant of a licence to sell, stock or exhibit or offer for sale or distribute Homoeopathic medicines shall be made in Form 19-B to the Licensing Authority and shall be accompanied by a fee of rupees two thousand.]

³[(3) If the original licence is either defaced, damaged or lost, a duplicate copy thereof may be issued on payment of a fee of ⁴[rupees fifty].]

S.Rule 67-B

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 his control.

S.¹[Rule 67C Forms of licences to sell drugs.--

(1) Subject to the conditions of rule 67F being fulfilled, a licence to sell, stock or exhibit or offer for sale or distribute Homoeopathic medicines by retail or by wholesale shall be issued in Form 20C or 20D as the case may be.

(2) The licence shall be issued within a period of two months from the date of receipt of the application or from the date of fulfillment by the applicant of any shortcomings highlighted by the licensing authority as the case may be.

(3) The application shall be processed through portal e-AUSHADHI (www.e-aushadhi.gov.in) and license in Form 20C or 20D issued online as per the format provided in the said portal:

Provided that no license shall be required for exhibiting the drugs for promotional activities in any fair.

Provided further that till the portal e-AUSHADHI (www.e-aushadhi.gov.in) shall come to effect as notified by the Central Government, till such time, either of online and offline process of license application shall

S.Rule 67-D Sale at more than one place.--

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.

S.¹[Rule 67E Duration of licences.--

(1) A licence issued in Form 20-C or 20-D shall remain valid perpetually:
Provided that the licencee shall submit a self-declaration of adherence to the conditions of license and the provisions of the Drugs and Cosmetics Act and the Rules, every five years from the date of issue of license in Form 20-C or 20-D or from the date of submission of last self-declaration as the case may be.
(2) The licensing authority shall issue two reminders to licensee for submission of self-declaration, six months and three months by Registered Post/Speed post with Acknowledgement Due and email, before the date of completion of every five years' interval from the date of issue of license or from the date of issuance of such reminder, as the case may be:
Provided further that such self-declaration should be made within three months of completion of five years from the date of issue of license in Form 20-C or 20-D or from the date of submission of last self-declaration as the case may be, and i

S.¹[Rule 67-EE

x x x x]

S.Rule 67-F Conditions to be satisfied before a licence in Form 20-C or Form 20-D is granted.--

(1) A licence in Form 20-C or Form 20-D 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 20-C the sale premises are in charge of a person who is or has been dealing in Homoeopathic medicines and
²[who is having,--

(a) degree in Homoeopathy from a recognised University; or

(b) degree in Pharmacy from a recognised University; or

(c) Bachelor's degree from a recognised University with one year experience of dealing in Homoeopathic medicines in the clinic of a registered Homoeopathic Medical Practitioner or with the holder of licence in Form 20-C or Form 20-D; or

(d) diploma in Homeopathic Pharmacy; or

(e) diploma in Homeopathy Medicine and Surgery:]

³[Provided that

S.Rule 67-G Conditions of licence.--

Licence in Form 20-C or 20-D shall be subject to the conditions stated therein and to the following further conditions, namely: --

(1) The premises where the Homoeopathic medicines are stocked for sale or sold are maintained in a clean condition.

¹[(2) In the case of licence in Form 20-C the Homeopathic medicines shall be sold,--

(i) under the supervision of a person having qualifications referred to in sub-rule (1) of Rule 67 -F; and

(ii) in manufacturer's sealed packing only except dispensing of medicines in globules, water or milk sugar or as per prescription of a Homoeopathic Medical Practitioner.]

(3) The licensee shall permit an Inspector to inspect the premises and furnish such information as he may require for ascertaining whether the provisions of the Act and the Rules made thereunder have been observed.

(4) The licensee in Form 20-D shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol

S.¹[Rule 67-GG Additional information to be furnished by an applicant for licence or a licensee to the licensing authority.--

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.]

S.Rule 67-H Cancellation and suspension of licences.--

(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, 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, or

(b) that he or his agent or employee had not been guilty of any similar act or omission within twelve months before the

S.Rule 68 Manufacture on more than one set of premises.--

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.

S.¹[Rule 68-A Grant2[x x x x] of Licences by the Central Licence Approving Authority.--

(1) Notwithstanding anything contained in this Part, on and from the commencement of the Drugs and Cosmetics (............ 3 Amendment) Rules, 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 ⁴[x x x x] by the Central Licence Approving Authority (appointed by the Central Government):

Provided that the application for the grant ⁵[x x x x] of such licence shall be made to the licensing authority.

(2) On receipt of the application for grant ⁶[x x x x] of a licence, the licensing authority shall,-

(i) verify the statement made in the application form;

(ii) cause the manufacturing and testing establishment to be inspected in accordance with the provisions of Rule 79; and

(iii) ⁷[x x x x]

(3) If the licensing authority is satisfied that the

S.¹[Rule 68-B Delegation of powers by the Central Licence Approving Authority.--

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 50-A for such areas and for such periods as may be specified.]

S.¹[Rule 69 Application for licence to manufacture drugs other than those specified in Schedules C and C(1) to the Drugs and Cosmetics Rules.--

²[(l) Application for grant ³[x x x x] of licence to manufacture for sale ⁴[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 24-B;

(b) in the case of manufacture of drugs included in Schedule X in Form 24-F;

(c) in any other case, in Form 24.

(2) ⁵[(a) Every application in Form 24-B shall be made up to ten items for each category of drugs categorised in Schedule M and shall be accompanied by a licence fee of rupees five hundred plus an inspection fee of rupees two hundred for every inspection ⁶[x x x x].

(b) Every application in Form 24-F shall be made up to ten items

S.¹[Rule 69-A Loan licences.--

²[(1) Application for the grant ³[x x x x] 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 categorised in ⁴[referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] and shall be made in Form 24-A accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred to the licensing authority:

⁵[x x x x]]

⁶[Explanation.-- For the purpose of this rule a loan licence means a licence which a licensing authority may issue to an applicant who intends to avail the manufacturing facilities owned by a licensee in Form 25.]

(2) The licensing authority shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has ad

S.¹[Rule 69-B Applications to manufacture 'new drugs' other than the drugs classifiable under Schedules C and C(1) products.--

²[x x x x]

S.¹[Rule 70 Form of licence to repack or manufacture drugs other than those specified in Schedules C and C(1).--

Licences for repacking of drugs against application in Form 24-B shall be granted in Form 25-B, licences for manufacture of drugs included in Schedule X against application in Form 24-F shall be granted in Form 25-F and licences for manufacture of drugs against application in Form 24 shall be granted in Form 25.]

S.¹[Rule 70-A Form of loan licence to manufacture for sale2[or for distribution] of drugs other than those3[specified in Schedules C, C(l) and X].--

A loan licence to manufacture for sale ⁴[or for distribution] of drugs other than those specified in ⁵[Schedules C, C(1) and X] shall be issued in Form 25-A.]

S.¹[Rule 71 Conditions for the grant2[x x x x] of a licence in Form 253[or Form 25-F].--

Before a licence in Form 25 ⁴[or Form 25-F] is granted ⁵[x x x x] 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 ⁶[a University established in India by law or has an equivalent qualification recognised and notified by the Central Government for such purpose] and has had at least ⁷[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

(b) a graduate in Science of ⁸[a University established in India by law or has an equiva

S.¹[Rule 71-A Conditions for the grant2[x x x x] of a licence in Form 25-B.--

Before a licence in Form 25-B is granted ³[x x x x] the following conditions shall be complied with by the applicant --

(1) the repacking operation shall be carried out under hygienic conditions and under the supervision of a competent person;

⁴[(2) the factory premises shall comply with the conditions prescribed in Schedule M; and]

⁵[(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;

⁶[(4) The application for grant of licence for a drug formulation containing single active ingredient shall be made only in proper name;]

⁷[(5) In case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish an undertaking in Form 51 to the licensing authority to the effect that to the best of his knowledge bas

S.¹[Rule 71-B Conditions for the grant2[x x x x] of a licence in Form 25-A.--

Before a licence in Form 25-A is granted ³[x x x x], the applicant shall, while applying for a licence to manufacture ⁴[drugs], furnish to the Licensing Authority evidence and data justifying that the ⁵[drugs] --

(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

(iv) contain such ingredients and in such quantities for which there is therapeutic justification;]

⁶[(v) In case the applicant intends to market the drug under a brand name or trade name, the applicant shall furnish

S.¹[Rule 72 Duration of licence.--

(1) A licence issued in Form 25, Form 25-B and Form 25-F shall remain valid if the licencee deposits a licence retention fee referred to in sub-rule (2) before the expiry of a period of every succeeding five years from the date of its issue, unless, it is suspended or cancelled by the licensing authority.

(2) The licence retention fee referred to in sub-rule (1) shall be equivalent to the respective fee required for the grant of such licence excluding inspection fee paid for grant of licence.

(3) If the licencee fails to pay licence retention fee on or before the due date as referred to in sub-rule (1), he shall be liable to pay licence retention fee along with a late fee calculated at the rate of two per cent of the licence fee for every month or part thereof up to six months, and in the event of non-payment of such fee, the licence shall be deemed to have been cancelled.]

S.Rule 1 Short title, extent and commencement.--

(1) These Rules may be called the Drugs ¹[x x x x] Rules, 1945.

(2) They extend to the whole of India ²[x x x x].

S.Rule 2 Definitions.--

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[(aa) "biopharmaceutical classification system" means a system used to classify drugs on the basis of solubility and permeability, classified as Category-I high solubility and high permeability, Category II low solubility and high permeability, Category III high solubility and low permeability, and Category IV low solubility and low permeability.]

²[(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;

³[(dd) "Homoeopathy medicine" includes any drug intended for internal or external us

S.Rule 3 Functions.--

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;

(ii) ¹[x x x x]

(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.

S.Rule 3-A

(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

¹[(7)] Sterilized surgical ligature and sterilized surgical suture

²[(8)] Bacteriophages:

³[Provided that the functions of the Director in respect of Oral Polio Vaccine shall be exercised by the Deputy Director and Head of the Polio Vaccine Testing Laboratory in case of Central Research Institute, Kasauli only.]

⁴[(l-A) The functions of the Laboratory in respect of Oral Polio Vaccine shall be carried out by the following Institutes and the functions of the Directo

S.Rule 4 Despatch of samples for test or analysis.--

(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.

S.Rule 5 Recording of condition of seals.--

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.

S.Rule 6 Report of result of test or analysis.--

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.

S.Rule 7 Fees.--

The fees for test and analysis shall be those specified in Schedule B.

S.Rule 8 Signature of certificates.--

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.

S.1 (Rules 9 to 20)

¹[x x x x]

S.Rule 21

In this Part--

²[(a) 'Import licence' means either a licence in Form 10 to import drugs ³[x x x x], excluding those specified in Schedule X, or a licence in Form 10-A 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 power 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;

⁴[(d) "manufacturer", includes a manufacturer of drugs, who may be a Company or a unit or a body corporate or any other establishment in a country other than India, having its drugs manufacturing facilities duly approved by the National Regulatory Authority of that country

S.Rule 22

The licensing authority may with the approval of the Central Government by an order in writing delegate the power to sign licences and ¹[Registration Certificates and] such other powers as may be specified in the order to any other person under his control.

S.¹[Rule 23 Import licences.--

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 10-A shall be required for the import of drugs specified in Schedule X.]

S.¹[Rule 24 Form and manner of application for import licence.--

(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 8-A 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 ²[ten thousand rupees for a single drug and an additional fee at the rate of one thousand 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 the same manufacturer, the fee to accompany each such application shall be

S.¹[Rule 24-A Form and manner of application for Registration Certificate.--

(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 wholesale 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 wholesale 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 which is attested by the Indian Embassy of the said country, and the original of the same shall be f

S.Rule 25 Licences for import of drugs manufactured by one manufacturer.--

(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) ⁶¹[x x x x]

S.¹[Rule 25-A Conditions to be satisfied before a licence in Form 10 or Form 10-A is granted.--

(1) A licence in Form 10 or in Form 10-A 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 10-A 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) his conviction under the Act or these rules or the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) or the rules made thereunder;]

(ii) previous suspension or cancellation of the licence granted to him; he is not a fit person to whom licence shall be granted.

(2) Any person who is agg

S.¹[Rule 25-B Registration Certificate for import of drugs manufactured by one manufacturer.--

(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.]

S.Rule 26 Conditions of import licence.--

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 licensee 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 as 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 required, furnish full protocols of the tests, if any, which have been applied;

(iv) if the licensing authority so directs the licensee shall not sell or offer for sale any batch in respect of which a s

S.Rule 27 Grant of import licence.--

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 10-A, as the case may be].

S.¹[Rule 27-A Grant of Registration Certificate.--

(1) On receipt of an application for Registration Certificate in the Form and manner specified in Rule 24-A, 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 D-I and D-II 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 period as specified in proviso to sub-rule (1), he may appeal to the Central Government and the Central Government may after such enq

S.¹[Rule 28 Duration of import licence.--

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.]

S.¹[Rule 28-A Duration of Registration Certificate.--

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.]

S.Rule 29 Suspension and cancellation of import licence.--

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.]

S.¹[Rule 29-A Suspension and cancellation of Registration Certificate.--

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.]

S.Rule 30 Prohibition of import after expiry of potency.--

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.

S.¹[Rule 30-A

²[x x x x] ]

S.¹[Rule 30-AA Import of New Homoeopathic medicines.--

(1) No New Homoeopathic medicine shall be imported except under and in accordance with the permission in writing by the Licensing Authority as defined in clause (b) of rule 21.

(2) The importer of a New Homoeopathic medicine when applying for permission under sub-rule (1) shall produce before the Licensing Authority such documentary and other evidence as may be required by the Licensing Authority for assessing the safety, therapeutic efficacy of the medicine including the minimum homoeopathic provings carried out with it.

Explanation. -- For the purpose of this rule, 'New Homoeopathic Medicine' means, --

(i) a Homoeopathic medicine which is not specified in the official Homoeopathic Pharmacopoeia of India or United States of America or of the United Kingdom or the German Homoeopathic Pharmacopoeia or the French Homoeopathic Pharmacopoeia or the European Pharmacopeia; or

(ii) which is not recognised in authoritative Homoeopathic books specified in t

S.¹[Rule 30-B Prohibition of import of certain drugs.--

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.]

S.¹[Rule 31 Standard for certain imported drugs.--

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 Schedule 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 drug having less than sixty per cent residual shelf-life period as on the date of import:

Provided also that in exceptional case

S.¹[Rule 32 Packing and labelling of imported drugs.--

No drug shall be imported unless it is packed and labelled in conformity with the rules in Parts IX and X ²[x x x x] 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).]

S.¹[Rule 32-A Packing and labelling of Homoeopathic medicine.--

No Homoeopathic medicine shall be imported unless it is packed and labelled in conformity with the rules in Part IX-A.]

S.Rule 33 Import of drugs for examination, test or analysis.--

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 inspect the premises, and investigate the manner in which the substances are being used and to take samples thereof;

(d) the licensee shall keep a record of, and shall report to the licensing a

S.¹[Rule 33-A Import of drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients.--

Small quantities of a new drug, as defined in Rule 122-E, 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 diseases 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 11-A, and the said drug has been approved for marketing in the country of origin;

(b) the licensee shall use the substances or drugs imported under the licence exclusively for the purpose of treatment of patients suffering from life-threatening diseases, or diseases causing serious permanent d

S.Rule 34 Application for licence for examination, test or analysis.--

(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[(3) Every application in Form 12 shall be accompanied by a fee of ²[five thousand rupees for a single drug and an additional fee of two thousand rupees] for each additional drug.

(4) The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi -110 001 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 be credited under the Head of Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fine".]

S.¹[Rule 34-A Application for licence to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients.--

(1) An application for an import licence for small quantities of a new drug, as defined in Rule 122-E 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 12-AA shall be accompanied by a fee of ²[six hundred rupees for a single drug and an additional fee of three hundred rupees] for each additional drug.

(4) The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi -110 001 or any

S.Rule 35 Cancellation of licence for examination, test or analysis.--

(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.

S.¹[Rule 35-A Cancellation of licence for import of small quantities of new drugs.--

(1) A licence for import of small quantities of a new drug, defined in Rule 122-E, 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 licensee 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 relation thereto, as it thinks fit.]

S.Rule 36 Imports of drugs for personal use.--

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 personal use but not forming part of bona fide personal baggage, may be allowed to be imported subject to the following conditions, namely,-

(i) the licensing authority, on an application made to it in Form 12-A is satisfied that the drug is for bona fide per

S.¹[Rule 36-A Import of drugs by charitable hospital free of cost.--

(1) Small quantity of drugs received in donation by a charitable hospital for the purpose of treatment of the patients in the said hospital may be imported provided the drugs are given or administered to the patients free of cost.

(2) The drugs shall not be prohibited for import and permitted to be marketed in the country with residual shelf life of one year or more.]

S.¹[Rule 37 Packing of patent or proprietary medicines.--

Patent or proprietary medicine shall be imported in containers intended for retail sale:

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 ²[and the imports are made within a period of twelve months from the date of issue of such permission].]

S.Rule 38 Statement to accompany imported drugs.--

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.

S.Rule 39 Documents to be supplied to the Customs Collector.--

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.

S.¹[Rule 40 Procedure for the import of drugs.--

(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 an 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 make over the consignment to the importer.

(2) If an importer who has given an undertaking

S.Rule 41

(1) If the director of the laboratory appointed for the purpose by the Central Government ¹[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 receipt of the report make a representation against the report to the Customs Collector,

S.Rule 42

¹[x x x x]

S.⁴[Rule 122-EA Definitions.--

(1) In this Part and in the Forms contained in Schedule A and in Part XII-B ⁵[, Part XII-C and Part XII-D] of Schedule F, unless there is anything repugnant in the subject or context,--

(a) "apheresis" means the process by which blood drawn from a donor, after separating plasma or platelets or leucocytes, is re-transfused simultaneously into the said donor;

(b) "autologous blood" means the blood drawn from the patient for re-transfusion into himself later on;

(c) "blood" means and includes whole human blood, drawn from a donor and mixed with an anticoagulant;

⁶[(d) "blood centre" is an authorised premises in an organization or institution as the case may be, for carrying out all or any of the operations including collection, apheresis, processing, storage and distribution of blood drawn from donors or received from another licensed Blood Centre and for preparation, storage and distribution of blood components;]

(e) "blood comp

S.Rule 122-F Form of application for licence for operation of1[Blood Centre]/processing of whole human blood for components/manufacture of blood products for sale or distribution2[, collection, processing, testing, storage, banking and release of umbilical cord blood stem cells].--

(1) Application for the grant and/or renewal of licence for the operation of a ³[Blood Centre]/processing of human blood for components/manufacture of blood products ⁴[/collection, processing, testing, storage, banking and release of umbilical cord blood stem cells] shall be made to the Licensing Authority appointed under Part VII in Form 27-C ⁵[, Form 27-E or Form 27-F], and shall be accompanied by ⁶[licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection thereof or for the purpose 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 ⁷[shall be rupees six thousand and inspection fee of rupees one thousand and five hundred plus an additional fee at rate of rupees one thousand per month or a part thereof in addition to the inspect

S.Rule 122-G 1[(1)] Form of licence for the operation of a2[Blood Centre]/processing of whole human blood for components and3[/manufacture of blood products/collection, processing, testing, storage, banking and release of umbilical cord blood stem cells] and the conditions for the grant or renewal of such licence.--

A licence for the operation of a ⁴[Blood Centre] or for processing whole human blood for components and ⁴[/manufacture of blood products/collection, processing, testing, storage, banking and release of umbilical cord blood stem cells] shall be issued in Form 28-C ⁵[or Form 28-E ⁷[Form 28-F or Form 26-G or Form 26-1 or Form 26-J, as the case may be, before a licence in Form 28-C or Form 28-E or Form 28-F or Form 26-G or Form 26-1 or Form 26-J], as the case may be,] is granted or renewed the following conditions shall be complied with by the applicant: --

⁸[(i) The operation of Blood Centre or processing or both 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) Degree in Medicine M.B.B.S. having experience of working in Blo

S.Rule 122-H Duration of licence.--

An original licence in Form 28-C ¹[or Form 28-E] ²[or Form 28-F] or a renewed licence in Form 26-G - ³[or Form 26-1] ⁴[or Form 26-J] unless sooner suspended or cancelled shall be ⁵[valid for a period of five years on and from the date on which] it is granted or renewed.

S.Rule 122-I Inspection before grant or renewal of licence for operation of1[Blood Centre], processing of whole human blood for components and manufacture of blood products.--

Before a licence in ²[Form 28-C or Form 28-E ³[or Form 28-F] is granted or a renewal of licence in Form 26- G or Form 26-I ⁴[or Form 26-J] 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 ⁵[blood Centre] is proposed to be operated/whole human blood for components is processed ⁶[/] blood products are manufactured to be inspected by one or more Inspectors, appointed under the Act and/or along with 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 along with the means to be employed or being employed for operation of ⁷[Blood Centre]/processing of whole human blood for components/manufacture of blood products together with their ⁸[testing]facili

S.Rule 122-J Report by Inspector.--

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.

S.Rule 122-K Further application after rejection.--

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 fee of rupees ¹[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 28-C or Form 28-E ³[or Form 28-F]:

 Provided that in the case of a drug notified by the Central Government under Rule 68-A, 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 the Central Licence Approving Authority, who may approve the same and return it to the Licensing Authority for issue of the licence.]

S.Rule 122-L Delegation of powers by the Central Licence Approving Authority.--

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 rules to persons under his control having same qualifications as prescribed for Controlling Authority under Rule 50-A, for such areas and for such periods as may be specified.

S.Rule 122-M Provision for appeal to the State Government by a party whose licence has not been granted or renewed.--

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.

S.Rule 122-N Additional information to be furnished by an1[applicant] for licence or by a licensee to the Licensing Authority.--

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.

S.Rule 122-O Cancellation and suspension of licences.--

(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 why 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 the order under sub-rule (1) prefer an appeal against that order to the

S.Rule 122-P Conditions of licence.--

¹[A licence in Form 28-C, Form 28-E, ²[Form 28-F, Form 26-G, Form 26-1 or Form 26-J shall be subject to the special conditions set out in Schedule F, Part XII-B and Part XII-C, Part XII-D], 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 ³[Blood Centre] 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 122-G. The licensee shall maintain necessary records and registers as specified in Schedule F, Parts XII-B and XII-C.

(c) The licensee shall test in his own laboratory whole human blood, its components and blood products and ⁴[maintain records and] registers in respect of such tests as

S.Rule 123

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.

S.¹[Rule 124 Standards of drugs.--

(1) For 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 pharmacopoeia, for the time being in force, of any country to which the drug claims to comply with.

(b) In case the standards for identity, purity and strength for drugs are not specified in the edition of such official pharmacop

S.¹[Rule 124-A Standards for veterinary drugs.--

²[x x x x]

S.¹[Rule 124-B Standards for patent or proprietary medicines.--

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.]

S.¹[Rule 124-C Standards for Surgical Dressings.--

The standards for Surgical Dressings shall be such as are laid down in Schedule F( 11).]

S.¹[Rule 124-D Standards for Sterilised Umbilical tapes.--

The standards for Sterilised Umbilical tapes shall be as laid down in Schedule F(III).]

S.¹[Rule 125 Standards for substances (other than food) intended to affect the structure or any function of human body-contraceptives.--

(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.]

S.¹[Rule 125-A Standards for Medical Devices.--

The standards for the Medical Devices shall be such as are laid down in Schedule R-1.]

S.¹[Rule 126 Standards for substances intended to be used for the destruction of vermin or insects which cause disease in human beings or animals.--]

²[x x x x]

Disinfectants.-- The standards for disinfectants shall be such as are laid down in Schedule O.]

S.¹[Rule 126-A Standards for ophthalmic preparations2[including Homeopathic ophthalmic preparations]

The standards for 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.]

S.¹[Rule 127 List of colours permitted to be used in drugs.--

(1) No drug shall contain a colour other than that specified below:

(1) Natural Colours Annatto Carotene Chlorophyll Cochineal Curcumin

Red Oxide of iron Yellow Oxide of iron ²[Titanium Oxide]

³[Black Oxide of iron]

⁴[Titanium dioxide coated mica pearlescent pigments]

(2) Artificial Colours Caramel

⁵[Riboflavin]

(3) Coal Tar Colours

S.Rule 128

The following rules are hereby repealed except as respects things done or omitted to be done under those rules, namely.--

1. Added under Government of India Notification No. F. 1-37/58-D, dt. 21/07/1958.

S.Rule 129 Registration of cosmetic products imported into the country.--

¹[x x x x]

S.Rule 129-A Form and manner of application for Registration Certificate.--

¹[x x x x]

S.Rule 129-B Registration Certificate for the import of cosmetics manufactured by one manufacturer.--

¹[x x x x]

S.Rule 129-C Grant of Registration Certificate.--

¹[x x x x]

S.Rule 129-D Duration of Registration Certificate.--

¹[x x x x]

S.Rule 129-E Suspension and cancellation of Registration Certificate.--

¹[x x x x]

S.Rule 129-F Prohibition of import of certain cosmetic.--

¹[x x x x]

S.Rule 129-G Standard for imported cosmetics.--

¹[x x x x]

S.Rule 129-H Labelling and Packing of Cosmetics.--

¹[x x x x]

S.Rule 130 Documents to be supplied to the Collector of Customs.--

¹[x x x x]

S.Rule 131 Procedure for the import of cosmetics.--

¹[x x x x]

S.Rule 132 Exemption of cosmetics.--

¹[x x x x]

S.Rule 133 Import through points of entry.--

¹[x x x x]

S.Rule 134 Cosmetic to contain Dyes, Colours and Pigments.--

¹[x x x x]

S.Rule 134-A Prohibition of import of cosmetics containing hexachlorophene.--

¹[x x x x]

S.Rule 135 Import of cosmetics containing lead or arsenic compound prohibited.--

¹[x x x x]

S.Rule 135-A Regulation of import of cosmetics containing mercury.--

¹[x x x x]

S.Rule 135-B Prohibition of import of cosmetics tested on animals.--

¹[x x x x]

S.Rule 136 Import of cosmetics for personal use.--

¹[x x x x]

S.Rule 137 Manufacture on more than one set of premises.--

¹[x x x x]

S.Rule 138 Application for licence to manufacture cosmetics for sale or for distribution.--

¹[x x x x]

S.Rule 138-A Application for loan licence to manufacture cosmetics.--

¹[x x x x]

S.Rule 139 Condition for the grant of a licence in Form 32.--

¹[x x x x]

S.Rule 139-A Form of licence to manufacture cosmetics for sale or for distribution.--

¹[x x x x]

S.Rule 139-AA Inspection before grant [x x x x] of licence.--

¹[x x x x]

S.Rule 139-AB Report by Inspector.--

¹[x x x x]

S.Rule 139-AC Grant or refusal of licence.--

¹[x x x x]

S.Rule 139-AD Further application after rejection.--

¹[x x x x]

S.Rule 139-AE Appeal to the State Government.--

¹[x x x x]

S.Rule 139-B Form of loan licence to manufacture cosmetics for sale or for distribution.--

¹[x x x x]

S.Rule 140 Duration of licence.--

¹[x x x x]

S.Rule 141 Certificate of renewal.--

¹[x x x x]

S.Rule 141-A Certificate of renewal of loan licence.--

¹[x x x x]

S.Rule 141-AA Duration of a loan licence.--

¹[x x x x]

S.Rule 142 Conditions of licence.--

¹[x x x x]

S.Rule 142-A Additional information to be furnished by an applicant for licence or a licensee to the licensing authority.--

¹[x x x x]

S.Rule 142-B Conditions of licence in Form 32-A

¹[x x x x]

S.Rule 143 Cancellation and suspension of licence.--

¹[x x x x]

S.Rule 143-A Inspection for grant of licence and verification of compliance.--

¹[x x x x]

S.Rule 144 Prohibition of manufacture of cosmetics containing colours other than those prescribed.--

¹[x x x x]

S.Rule 144-A Prohibition of manufacture of cosmetic containing hexa-chlorophene.--

¹[x x x x]

S.Rule 145 Use of Lead and Arsenic compounds for the purpose of colouring cosmetics prohibited.--

¹[x x x x]

S.Rule 145-A Form of intimation for purposes of taking samples of cosmetics.--

¹[x x x x]

S.Rule 145-AA Form of receipt of samples of cosmetics where fair price tendered is refused.--

¹[x x x x]

S.Rule 145-B Form of receipt for seized cosmetics.--

¹[x x x x]

S.Rule 145-BA Manner of certifying copies of seized documents.--

¹[x x x x]

S.Rule 145-C Form of order not to dispose of stocks of cosmetics.--

¹[x x x x]

S.Rule 145-D Regulation of use of mercury compounds in cosmetics.--

¹[x x x x]

S.Rule 146 Prohibition of sale or distribution.--

¹[x x x x]

S.Rule 147 Exemption of cosmetics not manufactured for consumption or sale in India from the provisions of this Part.--

¹[x x x x]

S.Rule 148 Manner of labelling.--

¹[x x x x]

S.Rule 148-A Prohibition against altering inscriptions on containers, labels or wrappers of cosmetics.--

¹[x x x x]

S.Rule 148-B Prohibition against false or misleading claims.--

¹[x x x x]

S.Rule 148-C Prohibition of testing of cosmetics on animals.--

¹[x x x x]

S.Rule 149 Labelling of Hair Dyes containing Dyes, Colours and Pigments.--

¹[x x x x]

S.Rule 149-A

¹[x x x x]

S.Rule 150 Report of result of test or analysis of cosmetics.--

¹[x x x x]

S.Rule 150-A Standards for cosmetics.--

¹[x x x x]

S.Rule 150-B Application for grant of approval for testingdrugs/4[x x x x].--

(1) Application for grant ⁵[x x x x] of approval for carrying out tests for identity, purity, quality and strength of drugs ⁶[x x x x] or the raw materials used in the manufacture thereof on behalf of licensees for manufacture
⁷[for sale of drugs ⁸[x x x x] or an individual or organisation or procurement agency 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 rupees ⁹[six thousand] in the case of testing of drugs specified in Schedules C and C(1) and rupees ¹⁰[one thousand and five] hundred in the case of testing of drugs other than those specified in Schedules C and C(1), homoeopathic drugs ¹¹[x x x x]:

Provided that the applicant shall furnish to the approving authority s

S.Rule 150-C Form in which approval to be granted for carrying out tests ondrugs/1[x x x x] on behalf of licensees for manufacture ofdrugs/2[x x x x]3[or for an individual or organisation or procurement agency] and conditions for grant4[x x x x] of such approval.--

(1) Approval for carrying out such tests of identity, purity, quality and strength of drugs ⁵[x x x x] required under the provisions of these rules, on behalf of licensee for manufacture of ^drugs5[x x x x] ⁷[or an individual or organisation or procurement agency] shall be granted in Form 37.

(2) Before approval in Form 37 is granted ⁸[x x x x], 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 ⁹[x x x x ] 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, microbiological tests, etc.

(2) The applicant shall provide adequate space having regard to the nature and number of sample

S.¹[Rule 150-D Duration of approval.--

(1) A licence issued under Form 37 shall remain valid if the licensee deposits a licence retention fee referred to in sub-rule (2) before the expiry of period of every succeeding five years from the date of its issue, unless, it is suspended or cancelled by the licensing authority.

(2) The licence retention fee referred to in sub-rule (1) shall be equivalent to the respective fee required for the grant of such licence.

(3) If the licence holder fails to pay licence retention fee on or before the due date as referred to in sub-rule (1), he shall be liable to pay licence retention fee along with a late fee calculated at the rate of two per cent of the licence fee for every month or part thereof up to six months, and in the event of non -payment of such fee, the licence shall be deemed to have been cancelled.]

S.Rule 150-E Conditions of approval.--

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 150-C ¹[and Schedule L-I].

(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, ²[x x x x] 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 of substances for which an expiry date is assigned for a period of two years from the expiry of such date and in the case of other substances for a period o

S.Rule 150-F Inspection before grant of approval.--

Before an approval in Form 37 is granted, the approving authority shall cause the institution at which the testing of drugs ¹[x x x x], 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 ²[x x x x] and inquire into the professional qualifications of the expert staff to be employed.

S.Rule 150-G Report of Inspection.--

The Drugs Inspector mentioned in Rule 150-F shall forward to the approving authority a detailed report of the results of the inspection.

S.Rule 150-H Procedure of approving authority.--

(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.

S.Rule 150-I Further application after rejection.--

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 rupees ¹[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.

S.Rule 150-J Renewal.--

¹[x x x x]

S.Rule 150-K Withdrawal and suspension of approvals.--

(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 therefor, 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 ^drugs1[x x x x] 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.]

S.Rule 151 Manufacture on more than one set of premises.--

If Ayurvedic ³[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.

S.Rule 152 Licensing authorities.--

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.

S.¹[Rule 153 Application for licence to manufacture Ayurvedic, Siddha or Unani drugs.--

(1) An application for the grant of licence to manufacture for sale of Ayurvedic, Siddha or Unani drug, shall be made --

(a) as defined under clause (a) of Section 3 of the Act, in Form 24-D to the licensing authority alongwith a fee of rupees two thousand; and

³[(b) as defined in sub-clause (i) of clause (h) of Section 3 of the Act, in Form 24-D to the licensing authority along with a fee of rupees two hundred per product, through the portal e-AUSHADHI (www.e-aushadhi.gov.in) as per the format provided in the said portal, pertaining to the licence for manufacture for sale of Ayurveda, Siddha or Unani drugs:]

⁴[Provided that notwithstanding the period for renewal, existing license holders under Form 25D prior to the date of commencement of the Drugs Rules, 2024 and such licence holder having a valid Good Manufacturing Practices Certificate as per Schedule T shall for the perpetuity of existing licence within a period of one year from the da

S.¹[Rule 153-A Application for loan licence to manufacture Ayurvedic, Siddha or Unani drugs.--

(1) An application for grant of a loan licence to manufacture for sale of Ayurvedic, Siddha or Unani drug, shall be made --

(a) as defined under clause (a) of Section 3 of the Act, in Form 24E to the licensing authority alongwith a fee of rupees two thousand; and

³[(b) as defined in sub-clause (i) of clause (h) of Section 3 of the Act, in Form 24-E to the licensing authority along with a fee of rupees two hundred per product, through the portal e-AUSHADHI (www.e-aushadhi.gov.in) as per the format provided in the said portal, pertaining to the loan licence for manufacture for sale of Ayurveda, Siddha or Unani drugs.]

⁴[Provided that notwithstanding the period for renewal, existing license holders under Form 25-E prior to the date of commencement of the Drugs Rules, 2024 and such licence holder having a valid Good Manufacturing Practices Certificate as per Schedule T shall seek for the perpetuity of existing licence within a period of one yea

S.Rule 153-B Application for Certificate of Good Manufacturing Practices for Ayurvedic, Siddha or Unani drugs manufacturing unit.--

(1) An application for the grant of a Certificate of Good Manufacturing Practices for Ayurvedic, Siddha or Unani drugs manufacturing unit shall be made in Form 24E-1 to the licensing authority along with a fee of rupees five thousand.

(2) Every application in Form 24E-1 shall be made for a unit having premises and other requirements as prescribed under Schedule T.

(3) The application shall be made through portal e-AUSHADHI (www.e-aushadhi.gov.in) as per the format provided in the said portal, pertaining to the Good Manufacturing Practices for Ayurvedic, Siddha or Unani drugs manufacturing units.]

S.¹[Rule 154 Form of licence to manufacture Ayurvedic, Siddha or Unani drugs.--

(1) Subject to the conditions of Rule 157 being fulfilled, a licence to manufacture for sale of any Ayurvedic, Siddha or Unani drugs shall be issued in Form 25-D within a period of two months from the date of receipt of the application or from the date of compliance by the applicant of shortcomings, if any, highlighted by the licensing authority, as the case may be.

(2) A licence under this rule shall be granted by the licensing authority after consulting such expert in Ayurvedic, Siddha or Unani Systems of medicine, as the case may be, which the State Government may approve in this behalf.

(3) The application shall be processed through portal e-AUSHADHI (www.e-aushadhi.gov.in) and the licence in Form 25-D shall be issued online as per the format provided in the said portal.]

S.¹[Rule 154-A Form of loan licence to manufacture for sale of Ayurvedic, Siddha or Unani drugs.--

(1) A loan licence to manufacture for sale of any Ayurvedic, Siddha or Unani drugs shall be issued in Form 25E within a period of two months from the date of receipt of the application or from the date of compliance of shortcomings, if any, highlighted by the licensing authority, as the case may be.

(2) A licence under this rule shall be granted by the Licensing Authority after consulting such expert in Ayurvedic, Siddha or Unani systems of medicine, as the case may be, which the State Government may approve in this behalf.

(3) The Licensing Authority after being satisfied that the manufacturing unit licenced under Form 25-D has adequate equipment, staff and capacity for manufacture and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan licence shall grant a loan licence.

(4) The application shall be processed through portal e-AUSHADHI (www.e-aushadhi.gov.in) and licence in Form 25E shall be issued online as per the format

S.Rule 155 Certificate of renewal.--

¹[x x x x]

S.Rule 155-A Certificate of renewal of a loan licence.--

¹[x x x x]

S.¹[Rule 155-B Certificate of award of G.M.P. of5[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs].--

²[(1)] The certificate of Good Manufacturing Practices to manufacturers of Ayurveda, Siddha or Unani drugs shall be issued ³[in Form 26E-1] to licensees who comply with the requirements of Good Manufacturing Practice of ⁵[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] as laid down in Schedule T.]

(2) ⁴[x x x x]

S.¹[Rule 156 Duration of licence.--

(1) A licence issued in Form 25-D shall remain valid perpetually:

Provided that the licencee shall submit a self declaration of adherence to the conditions of licence and the provisions of the Drugs and Cosmetics Act and the rules made thereunder, every year from the date of issue of licence in Form 25-D or from the date of submission of last self declaration, as the case may be:

Provided further that such self declaration shall be made within three months, of completion of one year from the date of issue of licence in Form 25-D or from the date of submission of last self declaration, as the case may be, and in the event of non submission of such self declaration, within the time mentioned in the licence of the said product shall be suspended temporarily and if the licensee fails to submit the self declaration within a further period of three months, the licence of the said product shall be deemed to have been cancelled.]

S.¹[Rule 156-A Duration of loan licence.--

A loan licence issued in Form 25-E shall remain valid perpetually:

Provided that the licencee shall submit a self declaration of adherence to the conditions of licence and the provisions of the Drugs and Cosmetics Act and the rules made thereunder, every year from the date of issue of licence in Form 25-E or from the date of submission of last self declaration, as the case may be:

Provided further that such self declaration shall be made within three months, of completion of one year from the date of issue of licence in Form 25-E or from the date of submission of last self declaration, as the case may be, and in the event of non submission of such self declaration, within the time mentioned in the licence of the said product shall be suspended temporarily and if the licensee fails to submit the self declaration within a further period of three months, the licence of the said product shall be deemed to have been cancelled.

S.¹[Rule 156-B Duration of Certificate of Good Manufacturing Practices for Ayurvedic, Siddha or Unani drugs manufacturing units.--

(1) A certificate issued in Form 26E-1 shall remain valid unless it is cancelled by the Licensing Authority subject to deposit of a certificate retention fee of rupees one thousand before the expiry of a period of every succeeding five years from the date of its issue.

(2) If the licencee fails to pay certificate retention fee on or before the due date as referred to in sub-rule (1), he shall be liable to pay certificate retention fee alongwith a late fee calculated at the rate of two per cent of the certificate retention fee for every month or part thereof up to six months, and in the event of non-payment of such fee, the certificate shall be deemed to have been cancelled.]

S.¹[Rule 156-C Inspection for grant of licence and verification of compliance.--

²[(1) Before a certificate in Form 26E-1 is granted, the licensing authority shall cause the establishment in which the manufacture of drugs is proposed to be conducted or being conducted to be inspected by one or more qualified inspectors mentioned under Rule 167 appointed by the Central or State Government under this Act, the inspector or inspectors shall examine the establishment intended to be used or being used for the manufacture of drugs.]

(2) The inspectors shall verify the self declaration of adherence to the conditions of licence and the provisions of the Drugs and Cosmetics Act and the Drugs Rules once in five years or as needed as per risk based approach:

Provided that the inspectors are allotted the inspection duty in a randomized manner ensuring that the same inspector is not assigned inspection of a particular establishment consecutively for two terms of not less than five years duration:

Provided further that if the premises is not ins

S.¹[Rule 156-D Report by Inspector.--

(1) The Inspector or Inspectors shall examine all areas 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 standardizing and testing the drugs to be manufactured or being manufactured and enquire into the professional qualifications of the technical staff to be employed and 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 Good Manufacturing Practices and Plant and Equipments as laid down in Schedule T.

(2) The Inspector after completion of his inspection shall forward a detailed report giving his findings on each aspect of inspection alongwith his recommendations, to the Licensing Authority.

S.¹[Rule 156-E Procedure of Licensing Authority.--

(1) If the Licensing Authority after such further enquiry, if any, as he may consider necessary, and after being satisfied that the requirements of the provisions referred to in the rules under the Act have been complied with and that the conditions of the licence shall be observed, shall issue a licence under this Part.

(2) If the Licensing Authority is not satisfied of the requirements under sub-rule (1), shall issue a memorandum of shortcoming, and the conditions which shall be satisfied before a licence is granted and shall supply the applicant a copy of the inspection report.

(3) The applicant within two months of issue of such memorandum under sub-rule (2) shall reply the same.

(4) On non submission of requirements under sub-rule (2), the Licensing Authority shall reject the application and shall inform the applicant, the reasons for such rejection.

(5) For this purpose, the licensing authority shall intimate the applicant and process the applicatio

S.¹[Rule 156-F Further application after rejection.--

If the applicant, within a period of six months from the rejection of an application for a licence or Certificate of Good Manufacturing Practices, as the case may be, informs the Licensing Authority that the conditions laid down have been complied with and deposit an inspection fee of rupees one thousand, the Licensing Authority may, after a further inspection, if any, is satisfied that the conditions for the grant of a licence or certificate have been complied with, issue a licence or certificate under this Part.]

S.Rule 157 Conditions for the grant1[x x x x] of a licence in Form 25-D.--

Before a licence in Form 25 -D is granted ²[x x x x] the following conditions shall be complied with by the applicant, namely: --

(1) The manufacture of Ayurvedic ³[Siddha] or Unani drugs shall be carried out in such premises and under such hygienic conditions as are specified in Schedule T.

⁴[(l-A) For issuing of the certificate of Good Manufacturing Practices, the Licensing Authority shall verify the requirements as per Schedule T and issue the Good Manufacturing Practices certificate in Form 26-E-l, simultaneously along with grant ⁵[x x x x] of Licence in Form 25-D.]

⁶[(l-B) No manufacturer shall use any prefix or suffix with the name of any Ayurvedic, Siddha or UnaniTibb drug falling under clause (a) of Section 3 of the Act, except as described in the authoritative books specified in the First Schedule to the Act:

Provided that a formulation without any specific name, described in the authoritati

S.¹[Rule 157-A Maintaining of records of raw material used by licensed manufacturing unit of3[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] in the preceding financial year.--

Each licensed manufacturing unit of Ayurveda or Siddha or Unani drugs shall keep a record of raw material used by it each licensed manufacturing unit of Ayurveda, Siddha or Unani drugs as the case may be in the pro forma given in Schedule T-A in respect of all raw materials utilized by that unit in the manufacture of Ayurveda or Siddha or Unani drugs in the preceding financial year, and shall submit the same by the 30th day of June of the succeeding financial year of the State Drug Licensing Authority of ³[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] and to the National Medicinal Plants Board or any agency nominated by the National Medicinal Plant Board for this purpose:]

²[Provided that the applicant shall submit the record online through portal e-AUSHADHI (www.e-aushadhi.gov.in) as per the format provided in the said portal and such records shall be retained by the manufacturer for a period of one year after the submission.]

S.Rule 158 Conditions of licence.--

A licence in Form 25-D 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 applicant and inspector shall submit the record online through e-AUSHADHI (www.e-aushadhi.gov.in) portal as per the format provided in the said portal.]

S.¹[Rule 158-A Conditions of loan licence.--

A licence in Form 25-E shall be subject to the following further conditions, namely:

(a) The licence in Form 25-E shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 25-D 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 IV-A 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 and of the tests, if any, carried out by him, or any other person on his behalf, of the raw materials and finished products.

(d) The licensee shall allow an Inspector appointed under the

S.¹[Rule 158-B Guidelines for issue of license with respect to Ayurveda, Siddha or Unani drugs.--

I. (A) Ayurveda, Siddha, Unani Medicines under Section 3(a)- Ayurveda, Siddha or Unani drugs includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine, as specified in the First Schedule;

(B) Patent or Proprietary medicine under Section 3(h) --

(i) In relation to Ayurvedic, Siddha and Unani Tibb system of medicine of all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb system of medicines specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a);

(ii) Balya/Poshak/Muqawi/Una

S.¹[Rule 158-C Form of Free Sale Certificate and Non-Conviction Certificate.--

The State Drug Controller or Licensing Authority shall, on request by the ³[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] manufacturer, issue, within fifteen days from the date of application, Free Sale Certificate in Form 26-E2-I for original License holder or in Form 26-E2-II for loan licensee and Non-Conviction Certificate for both original and loan license holder in Form 26-E3 or in the format as specified by the importing country or tenderer respectively, after fulfilment of all requisite formalities as required in the respective formats.]

²[Explanation.-- For the purposes of this rule, the applicant shall apply online and licensing authority shall issue such certificate online through portal e-AUSHADHI (www.e-aushadhi.gov.in) as per the format provided in the said portal.]

S.Rule 159 Cancellation and suspension of licences.--

(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 from 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.

S.Rule 160 Identification of raw materials.--

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.

S.Rule 160-A Application for grant of approval for testing2[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs].--

Application for grant or renewal of approval for carrying out tests for identity, purity, quality and strength of ²[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] or the raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of the said ²[Ayurveda, Siddha, Sowa-Rigpa 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 Ayurvedic, Siddha, Unani drugs specified in the books prescribed 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 the applicant applies for renewal

S.Rule 160-B Form in which approval to be granted for carrying out tests on3[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] on behalf of licensees for manufacture of3[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] and conditions for grant or renewal of such approval.--

(1) Approval for carrying out such tests of identity, purity, quality and strength of ³[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] as may be required under the provisions of these rules, on behalf of licensee for manufacture of ³[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] shall be granted in Form 48.

¹[(1-A) The licence shall be issued within a period of two months, from the date of receipt of the application or from the date of fulfillment of shortcomings, if any, as the case may be, communicated by the licensing authority.]

(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 ³[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] warrants otherwise. Wherever necessary, the premises shall be air-conditioned s

S.¹[Rule 160-C Duration of approval.--

An approval granted in Form 47 or renewed in Form 49 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.]

S.¹[Rule 160-D Conditions of approval.--

An approval in Form 48 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 ²[Ayurveda, Siddha, Sowa-Rigpa 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 in the case of substances for which date of expiry is assigned; for a period of two years from such date of expiry and in the case of other substances, for a period of t

S.¹[Rule 160-E Inspection before grant of approval.--

Before an approval in Form 48 is granted, the approving authority shall cause the laboratory at which the testing of ²[Ayurveda, Siddha, Sowa-Rigpa 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 verify into the professional qualifications of the expert staff who are or may be employed by the laboratory.]

S.¹[Rule 160-F Report of inspection.--

The Inspectors appointed by the Central Government as stated in Rule 160-E shall forward to the approving authority a detailed report of the results of the inspection.]

S.¹[Rule 160-G Procedure of approving authority.--

(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.]

S.¹[Rule 160-H Application after rejection.--

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.]

S.¹[Rule 160-I Renewal.--

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.]

S.¹[Rule 160-J Withdrawal and suspension of approvals.--

(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 ²[Ayurveda, Siddha, Sowa-Rigpa 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 or 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 of Medicine and Homoeopathy, Government of India in this behalf and noti

S.¹[Rule 160-K Information to be uploaded by the licencee on online portal.--

(1) The applicant or licencee under this part shall register with portal, e-AUSHADHI (www.e-aushadhi.gov.in) and upload information, as per the format provided in the said portal, pertaining to licence application, renewal, tests carried out and other such information as required and shall be updated from time to time.

(2) The information uploaded by the licencee in the portal under sub-rule (1) shall be verified by the concerned licensing authority.]

S.Rule 161 1[Labelling, packing and limit of alcohol].--

(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 ²[with the botanical names of plant based ingredients along with plant part (s) and form of ingredients, in which, these are] 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 ³[and in respect of Patent or Proprietary Ayurveda, Siddha or Unani Drugs, the true list of all the ingredients with the botanical names of plant based ingredients along with plant part(s) and form of ingredients, in which, these are used in the formulation, with their quantity:

Provided that if needed, standardized abbreviations prescribed for part(s) and form

S.¹[Rule 161-A Exemption in labelling and packing provisions for export of Ayurvedic (including Siddha) and Unani drugs.--

(1) Labels and packages or containers of Ayurvedic, Siddha and Unani drugs for export may be adapted to meet the specific requirements of the law of the country to which the said drug 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) main ingredients, if required by the importing country;

(f) For EXPORT:

Provided that where Ayurvedic, Siddha and Unani Single or compound drug not classified under the First Schedule or Schedule E-(I), is required by the consignee to be not labelled with the name and addre

S.¹[Rule 161-B Shelf life or date of expiry of medicines.--

(1) The date of expiry of Ayurvedic, Siddha or Unani medicines shall be conspicuously displayed on the label of container or package of Ayurvedic, Siddha or Unani medicine, as the case may be, and after the said date of expiry, no medicine shall be marketed, sold, distributed or consumable:

Provided that this rule shall apply to Ayurvedic, Siddha and Unani medicines seeking licence or renewal of licence for manufacturing after the date of notification of the rules:

Provided also that this rule shall not be applicable to the Ayurvedic, Siddha or Unani medicines manufactured and marketed prior to the date of this notification.

(2) Every person applying for licence or renewal of licence for the manufacturing of Ayurveda, Siddha or Unani medicines defined under clause (b) of Section 3 of the Act shall submit to the State Licensing Authority scientific data based shelf life or date of expiry of the medicine based on the ²[Real time or accelerated] stabilit

S.Rule 162 Duties of Inspectors specially authorised to inspect the manufacture of1[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs].--

Subject to the instructions of the controlling authority, it shall be the duty of an Inspector authorised to inspect the manufacture of ¹[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs]--

(i) to inspect not less than twice a year, all premises licensed for manufacture of ¹[Ayurveda, Siddha, Sowa-Rigpa and 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 send them for test or analysis in accordance with these rules;

(iv) to institute prosecutions in respect of violation of the Act and the rules made thereunder.

S.¹[Rule 162-A Qualifications for State Drug Licensing Authority for licensing of3[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs].--

²[(a) The Ayurveda or Siddha or Sowa-Rigpa or Unani qualifications as per Schedules of National Council for Indian System of Medicine (NCISM) Act, 2020 (14 of 2020)/B.Pharma (Ayurveda) of a recognised University.]

(b) At last 5 years experience in the Ayurveda/Siddha/Unani drug manufacturing or testing of ³[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] or enforcement of provisions of Chapter IV-A of the Drugs and Cosmetics Act, 1940 and rules made thereunder or teaching/research on clinical practice of Ayurveda/Siddha/Unani System.]

S.Rule 163 Procedure for despatch of sample to Government Analyst and its receipt by the Government Analyst.--

(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 18-A in an outer cover addressed to the Government Analyst.

(2) The package as well as the outer cover shall be marked with a 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 in 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 results of the test or analysis shall be supplied forthwith to the sender in Form 13-A. A copy of the result in Form 13-A shall be sent simultaneously to the controlling authority and to the Drugs Control

S.¹[Pharmacopoeia Commission for Indian Medicine and Homoeopathy and Central Drugs Laboratory of Indian Medicine and Homoeopathy to function as Central Drugs Laboratory for the purpose of testing or analysis of Ayurveda, Siddha, Unani and Homoeopathy Drugs

S.¹[Rule 163-B

The functions of the Central Drug Laboratory in respect of Ayurvedic, Siddha, Unani and Homoeopathy drugs shall be carried out at the Pharmacopoeia Commission for Indian Medicine and Homoeopathy, 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.]

S.Rule 163-BB

(1) The laboratory of Pharmacopoeia Commission for Indian Medicine and Homoeopathy shall act as the Central Appellate Drugs Laboratory under Section 6 of the Act for testing or analysis of samples of Ayurveda, Siddha , Unani and Homoeopathy Drugs as may be sent to it under sub-section (2) of Section 11 or sub-section (4) of Section 25 and 33-H of the said Act;

(2) The Central Drugs Laboratory shall maintain reference museum and herbarium of Ayurveda, Siddha, Unani and Homoeopathy drugs, conduct training programmes for analytical and drugs quality control methods and carry out such activities and duties as may be entrusted to it by the Central Government.

(3) All functions of the Central Drugs Laboratory for Ayurvedic, Siddha, Unani and Homoeopathy drugs shall be exercised by the Director or the officer appointed on his behalf of the Pharmacopoeia Commission for Indian Medicine and Homoeopathy.

S.Rule 163-C Despatch of samples for test or analysis.--

(1) Samples for testing or analysis of ⁴[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] under sub-section (2) of Section 11 or sub-section (1) of Section 25 and Section 33-H of the Act shall be sent by registered post in a sealed packet, enclosed with a memorandum in Form 1-A ¹[Form 18 or Form 18-A], specified in Schedule A, in an outer cover addressed to the Director, ²[Pharmacopoeia Commission for Indian Medicine and Homoeopathy, Ghaziabad (Uttar Pradesh)].

(2) The packet as well as the outer cover, shall be marked with a distinguish number.

(3) A copy of the memorandum in Form 1-A and a specimen impression of the seal used to seal the packet shall be sent separately by registered post to the Director, ³[pharmacopoeia Commission for Indian Medicine and Homoeopathy, Ghaziabad (Uttar Pradesh)].

S.Rule 163-D Recording of condition of seals.--

On receipt of the packet, it shall be opened by an officer authorised in writing on that behalf by the Director, ⁹⁵⁶[pharmacopoeia Commission for Indian Medicine and Homoeopathy, Ghaziabad (Uttar Pradesh)], who shall record the condition of the seal on the packet.

S.Rule 163-E Report of result of test or analysis.--

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-A ¹[or Form 13] of as specified in the said schedule.

S.Rule 163-F Fees.--

The fees for test and analysis shall be as specified in Schedule B-1.

S.Rule 163-G Signature on certificates.--

Certificates issued under these rules by the ¹[pharmacopoeia Commission for Indian Medicine and Homoeopathy, Ghaziabad (Uttar Pradesh)], shall be signed by the Director or by an officer authorised by the Central Government to sign such certificates.]

S.¹[Rule 164 Method of test or analysis to be employed in relation to Ayurvedic, Siddha, Unani or Homoeopathy drugs.--

The method of test or analysis to be employed in relation to an Ayurvedic, Siddha, Unani or Homoeopathy drugs shall be such as may be specified in the Ayurvedic, Siddha, Unani or Homoeopathy Pharmacopoeia, or if no such pharmacopoeias are available or if no test is specified in such pharmacopoeias, such test as the Government Analyst may employ, such tests being scientifically established to determine whether the drug contains the ingredients as stated on the label.]

S.Rule 165 Qualifications of Government Analyst.--

A person who is appointed a Government Analyst under Section 33-F of the Act shall be a person possessing the qualifications prescribed in Rule 44 or a degree in ¹[Ayurveda, Siddha, Unani or Homoeopathy] system, as the case may be, conferred by a University, a State Government or Statutory Faculties, Councils ²[Boards of Indian Systems of Medicine and Homoeopathy Boards] recognised by the Central or State Government, as the case may be, for this purpose and has had not less than three years' postgraduate 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.

S.Rule 166 Duties of Government Analyst.--

(1) The Government Analyst shall analyse or test or cause to be analysed or tested such samples of ¹[Ayurveda, Siddha, Unani or Homoeopathy] drugs as may be sent to him by Inspectors or any other persons or authority authorised by the Central Government or a State Government under the provisions ²[x x x x] 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 34-F 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.

S.¹[Rule 167 Qualifications of Inspector.--

A person who is appointed an Inspector under Section 33-G 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, Siddha, Unani or Homoeopathy drug, as the case may be; or

(b) has a degree in Ayurvedic, Siddha, Unani or Homoeopathy system or degree in Ayurvedic, Siddha, Unani or Homoeopathy 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 or Board of Homoeopathy recognized by the Central Government or the State Government for this purpose.]

S.Rule 168 Standards to be complied with in manufacture for sale or for distribution of2[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs].--

1. The word "Single" Omitted by GSR 422(E), dt. 11/06/2002 (w.e.f. 12/06/2002).

2. Subs. for "12 Percentage" by Drugs (Fifth Amendment) Rules, 2024, G.S.

S.¹[Rule 169 Permitted Excipients.--

Permitted excipients, along with their standards i.e. affidavits, preservatives, antioxidants, flavouring agents, chelating agents etc permitted in the Indian Pharmacopoeia (IP), Prevention of Food Adulteration Act, 1954 and Bureau of Indian Standard Act, 1986 are permitted for use in ²[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] with the following conditions, namely:

1. The above excipients shall be used in the permissible limits as prescribed in the Indian Pharmacopoeia/Prevention of Food Adulteration Act, 1954/Food Product Order/Bureau of Indian Standard Act, 1986 and they shall comply with the respective quality specifications, not exceeding any specified limits of usage therein, and except Hydrogenated vegetable oil.

2. Only natural colouring agents as permitted under Rule 26 of Prevention of Food Adulteration Rules, 1955 will be used for ²[Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs] and additionally, colours permitted under Rule 127 of D

S.¹[Rule 170

x x x x

S.SCHEDULE A

S.SCHEDULE B

S.SCHEDULE B-1