DRUGS AND COSMETICS ACT, 1940
(1) This Act may be called the Drugs 1[and Cosmetics] Act, 1940.
(2) It extends to the whole of India 2[***].
(3) It shall come into force at once; but Chapter III shall take effect only from such date3 as the Central Government may, by notification in the Official Gazette, appoint in this behalf, and Chapter IV shall take effect in a particular State only from such date3 as the State Government may, by like notification, appoint in this behalf:
4[Provided that in relation to the State of Jammu and Kashmir, Chapter III shall take effect only from such date5 after the commencement of the Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972), as the Central Government may, by notification in the Official Gazette, appoint in this behalf.]
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The provisions of this Act shall be in addition to, and not in derogation of, the Dangerous Drugs Act, 1930 (2 of 1930), and any other law for the time being in force.
The Central Government may give such directions to any State Government as may appear to the Central Government to be necessary for carrying into execution in the State any of the provisions of this Act or of any rule or order made thereunder.]
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1. Ins. by Act 35 of 1960, sec. 11 (w.e.f. 16-3-1961).
2. Section 33A re-numbered as section 33P by Act 13 of 1964, sec. 27 (w.e.f. 15-9-1964).
Any reference in this Act to any law which is not in force, or any functionary not in existence, in the State of Jammu and Kashmir, shall, in relation to that State, be construed as a reference to the corresponding law in force, or to the corresponding functionary in existence, in that State.]
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1. Ins. by Act 19 of 1972, sec. 4 (w.e.f. 31-5-1972).
In this Act, unless there is anything repugnant in the subject or context,—
1[(a) “2[Ayurvedic, Siddha or Unani] drug” includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of 3[disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulae described in, the authoritative books of 4[Ayurvedic, Siddha and Unani Tibb systems of medicine], specified in the First Schedule;]
5[(aa)] “the Board” means—
(i) in relation to 2[Ayurvedic, Siddha or Unani] drug, the 6[Ayurvedic, Siddha and Unani Drugs Technical Advisory Board] constituted under section 33C; and
(ii) in relation to any other drug or cosmetic, the Drugs Technical Advisory
Section 3 of the Drugs and Cosmetics Act, 1940, is a pivotal provision that lays down the definitions crucial for understanding the scope and application of the Act. It provides the foundation for categorizing various substances, medicines, and articles as drugs, cosmetics, or related entities, thereby enabling regulatory oversight over their manufacture, sale, import, and distribution.
Section 3 enumerates key definitions, including:- Clause (a): Defines "Ayurvedic, Siddha or Unani drug" as medicines intended for diagnosis, treatment, mitigation, or prevention of disease, manufactured according to authoritative texts.- Clause (b): Defines "drug" broadly to include medicines for internal or external use, substances used in diagnosis or treatment, and articles applied to the human body for beautifying or altering appearance.- Clause (h): Defines "patent or proprietary medicines" as medicines using ingredients listed in authoritative texts but without specific formulations or administered by parenteral routes.- Other clauses include definitions for "cosmetic," "manufacture," and related terms.
The definitions emphasize:- The intended use of substances (diagnosis, treatment, prevention).- The manufacture according to authoritative texts (for Ayurvedic, Siddha, Unani systems).- The formulation and route of administration (parenteral or otherwise).- The ingredients listed in recognized texts qualify as drugs, including substances like vitamins when used for mitigation or prevention of diseases.
Section 3's scope is extensive and inclusive:- It covers all medicines used in diagnosis, treatment, or prevention, whether for humans or animals.- It encompasses articles applied to the body for beautification or altering appearance.- It includes substances used for diagnosis, mitigation, or destruction of vermin or insects causing disease.- The section's broad language ensures the regulation of a wide array of substances, including modern pharmaceuticals, herbal medicines, and even certain medical devices like implants, if they fall within the definitions.
Violations of the definitions and provisions under Section 3, such as manufacturing or selling unapproved or misbranded drugs, attract penalties including:- Imprisonment (ranging from 1 year to life, depending on the offence).- Fines (which can extend to several lakhs of rupees).- Seizure and confiscation of the offending articles.- Cancellation or suspension of licenses.
Section 3 of the Drugs and Cosmetics Act, 1940, provides a comprehensive and inclusive framework for defining what constitutes a drug, medicine, or related article. Its broad language ensures regulation of a wide array of products, from traditional herbal medicines to modern pharmaceuticals and medical devices, based on their intended use, composition, and formulation. The section's interpretations by courts reinforce a plain, literal understanding, emphasizing the importance of purpose and manufacturing process in classification. Violations attract severe penalties, underscoring the Act's commitment to safeguarding public health through strict regulatory oversight.
Note: The references are derived from the provided sources and summarized for clarity.
Any substance specified as poisonous by rule made under Chapter III or Chapter IV 1[or Chapter IVA] shall be deemed to be a poisonous substance for the purpose of Chapter III or Chapter IV 1[or Chapter IVA], as the case may be.
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1. Ins. by Act 13 of 1964, sec. 3 (w.e.f. 15-9-1964).
(1) The Central Government shall, as soon as may be, constitute a Board (to be called the Drugs Technical Advisory Board) to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act and to carry out the other functions assigned to it by this Act.
1[(2) The Board shall consist of the following members, namely:—
(i) the Director General of Health Services, ex officio, who shall be Chairman;
(ii) the Drugs Controller, India, ex officio;
(iii) the Director of the Central Drugs Laboratory, Calcutta, ex officio;
(iv) the Director of the Central Research Institute, Kasauli, ex officio;
(v)
Section 5 of the Drugs and Cosmetics Act, 1940, establishes the constitution of the Drugs Technical Advisory Board (DTAB), a statutory body tasked with advising the Central and State Governments on technical matters related to the regulation of drugs and cosmetics. This section is fundamental in shaping the technical and regulatory framework for drug safety, standards, and enforcement in India.
Section 5 provides for the creation of the Drugs Technical Advisory Board, which shall consist of specified ex officio members and nominated experts. The Board’s primary role is to advise the Government on technical issues arising under the Act, including standards, quality control, and enforcement policies. It also facilitates uniformity in drug regulation across India.
Section 5 itself does not prescribe penalties; however, violations related to the appointment or functioning of the DTAB or failure to heed its advice may attract penalties under other provisions of the Act, such as penalties for contraventions of licensing, manufacturing, or quality standards.
In summary, Section 5 of the Drugs and Cosmetics Act, 1940, provides a robust statutory foundation for expert scientific oversight in drug regulation through the constitution of DTAB. Its advisory role ensures that policies and standards are informed by technical expertise, thereby strengthening consumer safety and public health governance in India.
(1) The Central Government shall, as soon as may be, establish a Central Drugs Laboratory under the control of a Director to be appointed by the Central Government, to carry out the functions entrusted to it by this Act or any rules made under this Chapter:
Provided that, if the Central Government so prescribes, the functions of the Central Drugs Laboratory in respect of any drug or class of drugs 1[or cosmetic or class of cosmetics] shall be carried out at the Central Research Institute, Kasauli, or at any other prescribed Laboratory and the functions of the Director of the Central Drugs Laboratory in respect of such drug or class of drugs 1[or such cosmetic or class of cosmetics] shall be exercised by the Director of that Institute or of that other Laboratory, as the case may be.
(2) The Central Government may, after consultation with
Nothing contained in sections 5 and 7 shall apply to 2[Ayurvedic, Siddha or Unani] drugs.]
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1. Ins. by Act 13 of 1964, sec. 6 (w.e.f. 15-9-1964).
2. Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).
(1) The Central Government may constitute an advisory committee to be called “the Drugs Consultative Committee” to advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any matter tending to secure uniformity throughout 1[India] in the administration of this Act.
(2) The Drugs Consultative Committee shall consist of two representatives of the Central Government to be nominated by that Government and one representative of each State Government to be nominated by the State Government concerned.
(3) The Drugs Consultative Committee shall meet when required to do so by the Central Government and shall have power to regulate its own procedure.
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1. Ins. by Act 3 of 1951, sec. 3 and
1[(1) For the purposes of this Chapter, the expression “standard quality” means—
(a) in relation to a drug, that the drug complies with the standard set out in 2[the Second Schedule], and
(b) in relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.]
(2) The Central Government, after consultation with the Board and after giving by notification in the Official Gazette not less than three months’ notice of its intention so to do, may by a like notification add to or otherwise amend 2[the Second Schedule], for the purposes of this Chapter, and thereupon 2[the Second Schedule] shall be deemed to be amended accordingly.
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1. Subs. by
For the purposes of this Chapter, a cosmetic shall be deemed to be misbranded—
(a) if it contains a colour which is not prescribed; or
(b) if it is not labelled in the prescribed manner; or
(c) if the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.]
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1. Ins. by Act 68 of 1982, sec. 6 (w.e.f. 1-2-1983).
For the purposes of this Chapter, a cosmetic shall be deemed to be spurious,—
(a) if it is imported under a name which belongs to another cosmetic; or
(b) if it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or
(c) if the label or container bears the name of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist; or
(d) if it purports to be the product of a manufacturer of whom
For the purposes of this Chapter, a drug shall be deemed to be adulterated,—
(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or
(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or
(c) if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or
(e) if it contains any harmful or toxic substance which may render it injurious to healt
For the purposes of this Chapter, a drug shall be deemed to be misbranded,—
(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or
(b) if it is not labelled in the prescribed manner; or
(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.]
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1. Subs. by Act 68 of 1982, sec. 5, for section 9 (w.e.f. 1-2-1983).
Section 9 of the Drugs and Cosmetics Act, 1940, is a crucial provision that defines and delineates the concept of "misbranded" drugs and cosmetics. It aims to ensure the safety, efficacy, and proper labeling of drugs and cosmetics to protect public health and prevent deceptive practices in the pharmaceutical industry.
Section 9 prescribes that a drug or cosmetic shall be deemed misbranded if it meets certain conditions such as being colored, coated, or polished to conceal damage, or if it is made to appear of better or greater therapeutic value than it actually is. It also includes provisions for deeming drugs as spurious, adulterated, or misbranded based on specific criteria.
Section 9 applies to:- All drugs and cosmetics manufactured, imported, or sold within India.- Situations where misbranding, adulteration, or spurious nature is suspected or established.- Cases where the appearance or labeling of drugs is deceptive or misleading.- It also implicitly covers imported drugs if they fall under the misbranding criteria.
Violations of Section 9 attract penal provisions under the Act, including:- Imprisonment for a term which may extend to three years.- Fine which may extend to Rs. 1,000, or more, depending on the severity and specific breach.- Seizure and confiscation of the misbranded or spurious drugs.- Additional penalties for repeated violations or manufacturing of spurious or adulterated drugs.
Section 9 of the Drugs and Cosmetics Act, 1940, plays a pivotal role in regulating the labeling, appearance, and authenticity of drugs and cosmetics. Its broad scope encompasses concealment, false representation, and deeming drugs as spurious or adulterated, thereby safeguarding public health and ensuring transparency in the pharmaceutical industry. The penalties prescribed serve as a deterrent against violations, reinforcing the law’s commitment to public safety and consumer protection.
Note: All references are based on authoritative judicial pronouncements, statutory provisions, and legal commentaries as per the given sources.
For the purposes of this Chapter, a drug shall be deemed to be spurious,—
(a) if it is imported under a name which belongs to another drug; or
(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or
(d) if it has been substituted wholly or in part by another drug or substance; or
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Section 9(b) of the Drugs and Cosmetics Act, 1940, addresses the prohibition of manufacture, sale, or distribution of spurious drugs. This provision is central to maintaining drug safety, integrity, and public health by penalizing the production and sale of substandard or counterfeit medicines.
Section 9(b) explicitly states that no person shall manufacture for sale or for distribution, sell, or stock or exhibit or offer for sale or distribute any drug that is deemed to be adulterated, spurious, or misbranded under the Act. It criminalizes the contravention of these prohibitions, with penalties including imprisonment and fines.
"Scope" - The section broadly covers manufacturing, selling, stocking, and offering for sale of adulterated, spurious, or misbranded drugs, emphasizing its wide applicability across all stages of drug handling. [Source: "Bharat Parenterals Ltd. VS State of Kerala, Rep. by Secretary"]
"Prohibition" - The section strictly prohibits the manufacture and sale of drugs that violate the standards of quality and authenticity, aligning with the Act's objective to prevent public health hazards. [Source: ""]
"Adulterated Drugs" - The term includes drugs contaminated with harmful substances or of inferior quality, which may be injurious to health, as per Section 9A and related provisions. [Source: ""]
"Spurious Drugs" - Defined under Section 9B, these are drugs falsely labeled or with misleading identities, often imported under another drug’s name, posing significant health risks. [Source: ""]
"Misbranded Drugs" - As per Section 17, drugs with false or misleading labels, statements, or designs constitute misbranding, which is also prohibited under Section 9(b). [Source: ""]
"Enforcement" - The section empowers authorized officers to seize, inspect, and prosecute violators, ensuring effective implementation of the prohibition. [Source: ""]
"Penalties" - The law prescribes stringent penalties including imprisonment (minimum 3 years) and fines, which serve as deterrents against violations. [Source: ""]
"Legal Precedents" - Courts have consistently held that acts violating Section 9(b) are punishable, and the burden lies on the accused to prove compliance or innocence. [Source: "K. Sumathi VS State represented by The Drugs Inspector"]
"Vicarious Liability" - Manufacturers, stockists, and distributors can be prosecuted; officers or agents involved in the contravention are also liable, reinforcing accountability across the supply chain. [Source: "K. Sumathi VS State represented by The Drugs Inspector"]
"Sampling and Analysis" - The section's enforcement relies on samples taken during inspections, which, if found adulterated or spurious, lead to prosecution. The analysis must adhere to prescribed standards. [Source: "00800021768"]
"Legal Procedure" - Prosecution under Section 9(b) is initiated via complaint by authorized officers, and courts are required to examine evidence thoroughly before conviction. [Source: "Sanjeev Jain VS State"]
"Penalties for Repeat Offenders" - The law provides for enhanced penalties for subsequent violations, emphasizing deterrence and compliance. [Source: "Saurabh Behal VS State of Himachal Pradesh"]
"Import Restrictions" - Section 9(b) also aligns with provisions restricting import of spurious or adulterated drugs, ensuring import controls complement domestic enforcement. [Source: ""]
"Legal Interpretation" - Courts have interpreted Section 9(b) as covering all stages of drug handling, with emphasis on strict compliance to prevent public health hazards. [Source: "State of Andhra Pradesh VS Bhavani Enterprises, Main Road, Rajendra Bhavan,Tanuku, West Godavari district"]
"Regulatory Oversight" - The section underscores the role of Drug Inspectors and authorities in monitoring, sampling, and initiating prosecution for violations. [Source: "Rajesh Kumar Sharma VS Director, Animal Husbandry & Veterinary Services, Orissa, Cuttack—Opp. Parties"]
"Legal Safeguards" - The Act provides procedural safeguards for accused, including the right to be heard, but the burden of proof remains on the prosecution to establish contravention. [Source: "Krishan Murari Mehra VS State"]
"Legal Effect of Violations" - Violations under Section 9(b) lead to criminal liability, with courts emphasizing the importance of strict adherence to drug standards to protect public health. [Source: "Samar Kumar Swain VS Subodha Kumar Nayak"]
"Judicial Approach" - Courts have taken a strict stance, quashing cases where procedural lapses or lack of evidence undermine the enforcement of Section 9(b). [Source: "Vijay Kumar VS State Of Haryana -"]
"Summary" - Overall, Section 9(b) is a vital legal provision that safeguards the public from adulterated and spurious drugs, with comprehensive enforcement mechanisms and deterrent penalties. [Source: "S. ATHILAKSHMI VS STATE REP. BY THE DRUGS INSPECTOR"]
Section 9(b) of the Drugs and Cosmetics Act, 1940, plays a pivotal role in the regulatory framework to prevent the manufacturing and sale of substandard, adulterated, or counterfeit drugs. Its broad scope encompasses all stages from manufacturing to distribution, with strict penalties designed to uphold public health standards. Judicial interpretations reinforce the importance of procedural compliance and the presumption of guilt in violations, emphasizing the Act’s deterrent and protective objectives.
Note: This concise legal commentary synthesizes insights from various judicial decisions, legal provisions, and authoritative sources to provide a comprehensive understanding of Section 9(b).
Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the import of such drug or cosmetic.]
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1. Ins. by Act 68 of 1982, sec. 8 (w.e.f. 1-2-1983).
From such date1 as may be fixed by the Central Government by notification in the Official Gazette in this behalf, no person shall import—
(a) any drug 2[or cosmetic] which is not of standard quality;
3[(b) any misbranded drug 4[or misbranded or spurious cosmetic];]
5[(bb) any 6[adulterated or spurious] drug;]
(c) any drug 2[or cosmetic] for the import of which a licence is prescribed, otherwise than under, and in accordance with, such licence;
7[(d) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof 8[the true formula or list of active ingredients contained in it together with the quantities thereof];]
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Section 10 of the Drugs and Cosmetics Act, 1940, is a vital provision that empowers the Central Government to regulate the import, manufacture, sale, and distribution of drugs and cosmetics, primarily focusing on ensuring their quality, safety, and proper labeling. It forms the backbone of India's drug regulation framework, aiming to prevent substandard and spurious products from entering the market and safeguarding public health.
Section 10 authorizes the Central Government to prohibit the import of drugs or cosmetics that are not of standard quality, misbranded, or spurious. This includes the power to issue notifications banning the importation of specific drugs or cosmetics, either generally or in particular circumstances, if they do not conform to prescribed standards or are otherwise deemed harmful or misleading.
Violations of Section 10, such as importing drugs not of standard quality or spurious drugs, are punishable with imprisonment for up to three years and/or a fine, which may extend to Rs. 5,000 [Source: ""]. The severity of penalties underscores the importance of compliance to protect public health.
This concise legal commentary synthesizes the statutory provisions, judicial observations, and enforcement challenges associated with Section 10 of the Drugs and Cosmetics Act, 1940.
(1) The law for the time being in force relating to sea customs and to goods, the import of which is prohibited by section 18 of the Sea Customs Act, 1878 (8 of 1878)1 shall, subject to the provisions of section 13 of this Act, apply in respect of drugs 2[and cosmetics] the import of which is prohibited under this Chapter, and officers of Customs and officers empowered under that Act to perform the duties imposed thereby on a 3[Commissioner of Customs] and other officers of Customs, shall have the same powers in respect of such drugs 4[and cosmetics] as they have for the time being in respect of such goods as aforesaid.
5[(2) Without prejudice to the provisions of sub-section (1), the 6[Commissioner of Customs] or any officer of the Government authorised by the Central Government in this behalf, may detain any imported package which he suspects to contain any drug 7[or cosmetic] th
Legal Comments
"Scope" - Section 11 empowers customs officials to apply D&C Act provisions at entry and to regulate import of drugs/cosmetics; it interacts with Rule 40/41 and Section 13 penalties for offenses at entry – [Bablu @ Rajesh Kumar VS State Of Bihar]
"Introduction" - Drugs and Cosmetics Act, 1940 governs manufacture, sale, and distribution of drugs/cosmetics; it includes special provisions for import (Section 11), misbranding (Sections 9, 9A), and penalties (Section 27, 28) – , [Deepak @ Sonu VS State]
"What Section 11 Says" - Section 11(1) and 11(2) authorize import-related actions by Customs/authorized officers, detention of goods suspected to be prohibited, and reporting/testing to the Central Drugs Laboratory; relates to seizure at entry and initiation of proceedings under Act or Customs – [Bablu @ Rajesh Kumar VS State Of Bihar]
"Essential ingredients" - Prohibition of misbranded/substandard/spurious goods on import (Section 9/9A/9B/9D), mandatory sample/testing procedures (Section 23; Section 25 Government Analyst reports), and reliance on Schedule/Rules for procedural safeguards – [Tirupati Products And Haji Shah Hussain Buksh Khand Sons Khan And Sons VS State Of Jharkhand], [Time Pharmaceuticals VS State represented by The Drug Inspector]
"Essential ingredients" - Jurisdictional design of criminal proceedings: who can file (Inspector or aggrieved party under Section 32), necessity of compliance with search/seizure rules (Section 22(2)) and proper cognizance – [D. Ramakrishnan VS Intelligence Officer Narcotic Control Bureau], [Pankaj Kumar VS State of Jharkhand], [Safecare Rubber Products Private Limited VS State of West Bengal]
"Scope of Section" - Not limited to medicines; extends to cosmetics and Ayurvedic/Siddha/Unani contexts via 33E/33I, and cross-regime interplay with NDPS/Narcotic provisions when drugs are manufactured or opium-derived (Section 2(xi)) – [PARAS PHARMACEUTICALS LIMITED VS COMMISSIONER, TRADE TAX, U. P. , LUCKNOW. ], [Kamal Nayan Pandey VS State Of M. P. ]
"Punishment for Section" - Section 27(b)(ii) and 27(d) impose imprisonment/fines for offences; courts may reduce imprisonment with adequate reasons (subject to provisos) but must retain some custodial/fine element; Section 28 provides alternative punishments; recent cases discuss proportionality and evidentiary requirements – [State Of Orissa VS Janmejoy Dinda], [State of Orissa VS Janmejoy Dinda], [Pankaj Kumar VS State of Jharkhand]
"Vicarious liability" - Section 34 renders persons in charge of a company liable; requires specific averments of responsibility; mere status as director/partner isn’t enough without details; courts quash prosecutions lacking proper in-charge allegations – [Symbiosis Pharmaceuticals Pvt. Ltd. vs Union of India], [01900015358]
"Prosecution viability" - Quashing orders under Section 482 Cr.P.C when mandatory procedural requirements (sampling, testing, notice, or cognizance) are violated or rights to re-test are infringed; delays or improper institution can render proceedings liable to dismissal – [Gopi Nath Sahu, Director, M/s. Pure & Cure Healthcare Pvt. Ltd. , Uttarkand VS State of Tamil Nadu represented by E. Sakthivel, Salem], [Krishna Mohan Prasad, son of Suryabansh Sharma VS State of Jharkhand]
"Misbranded/Adulterated/Spurious" - Distinguishing between misbranding (Section 9C) and substandard drugs (Section 18(a)(i)); misbranding at entry can trigger confiscation and prosecution; proper labeling and conformity with Schedule are essential – [Awadh Kishor Rajgarhia VS State of Jharkhand], [Macleods Pharmaceuticals Limited VS Union of India]
"Import controls" - Section 11 pairs with Rules 40/41 to permit testing and potential destruction or return of prohibited imports; Customs acts intersect with D&C Act where entry occurs; cognizance and proceeding mechanics clarified in several judgments – [Bablu @ Rajesh Kumar VS State Of Bihar], [Commissioner of Customs, Ice House, Panaji - Goa VS Max Overseas, Panaji - Goa]
"Testing procedure" - Government Analyst reports under Section 25 are evidence; the right to re-test (Section 25(3)) may be invoked; failure to provide test method or delay affecting shelf-life can lead to quashing if prejudicial to the accused – [Time Pharmaceuticals VS State represented by The Drug Inspector], [Reckitt Benckiser (India) Ltd. VS Union of India]
"Affirmative proof of sale/stock" - For conviction under Section 27(d) (manufacture/sale/stocking) the prosecution must show sale or stocking for sale or actual sale; mere possession or lack of license at a given moment may not suffice without a linkage to sale or distribution – [Samar Kumar Swain VS Subodha Kumar Nayak], [T. N. Parameswara Kurup S/o Narayana Pillai VS State of Kerala, Rep. by Secretary Department of Health and Family Welfare]
"Export context" - Licenses under D&C Act do not automatically cover export; crossing between D&C Act and Customs/NDPS rules requires compliance with respective regimes; Section 80 NDPS clarifies that D&C Act remains additive; import/export contexts often litigated – [00100047245], [D. Ramakrishnan VS Intelligence Officer Narcotic Control Bureau], [Earnest & Co. VS Principal Secretary to Govt. of M. P. ]
"Cosmetics vs drugs" - The Act defines cosmetics broadly; certain products like talcum powders with medicated claims may be classified as cosmetics, not medicines, depending on statutory interpretation and case-specific schedules; public health policy considerations influence classification – [Palani VS Tamil Nadu State]
"Judicial approach to classification" - Plain meaning and common parlance approach used to classify products under schedule entries; cross-jurisdictional authorities consistently emphasize consistent harmonization with constitutional rights and public health goals – [Palani VS Tamil Nadu State], [02000074133]
"Sanctions and remedies" - Alongside criminal penalties, courts may quash or stay proceedings due to violations of mandatory procedures (Rule 46, Rule 46 of Rules, 1945; Section 25 re-testing); penalties may be adjusted (fines or reduced imprisonment) while preserving ends of justice – [02100045738], [Krishna Mohan Prasad, son of Suryabansh Sharma VS State of Jharkhand]
"Interplay with NDPS" - In certain cases, D&C Act provisions coexist with NDPS where manufactured drugs (including narcotic-containing formulations) fall under NDPS criteria; central government circulars and statutory preconditions govern the enforcement balance – [Inderjeet Singh @ Laddi VS State of Punjab], [Safecare Rubber Products Private Limited VS State of West Bengal]
"Public interest and policy" - Courts consider public health and consumer protection; notifications under 26-A and 33I/33EEC address safety/regulation of certain formulations (e.g., fixed dose steroids); not arbitrary if grounded in expert advisory boards and public interest – [Systopicalabo Ratoribs Private Limited VS Prem Gupta, Drugs Controller (India),]
"Remedies for procedural defects" - If sampling, notice, or chain-of-custody is defective, section 482 petitions have been successful in quashing; strong emphasis on due process and fair opportunity for the accused to challenge results – [02000014241], [Nicholas Piramal India Ltd. vs State]
"Retail/dispensing limitations" - The Act excludes mere dispensing from some manufacturing obligations (retail vs manufacturing); Schedule M-1 focuses on manufacturing premises; proper licensing required for premises used for sale/manufacture and packaging – [T. N. Parameswara Kurup S/o Narayana Pillai VS State of Kerala, Rep. by Secretary Department of Health and Family Welfare], [PURNA NAND VS STATE OF DELHI]
"Evidence standards" - Government Analyst reports are central; courts require conformity with Schedule B/R 124B procedures and allow adversarial testing; failure to disclose or delays can render evidence inadmissible or proceedings unsustainable – [Time Pharmaceuticals VS State represented by The Drug Inspector], [Macleods Pharmaceuticals Limited VS Union of India]
"Policy implications" - Jurisprudence reflects ongoing balancing between regulatory rigor, administrative efficiency (special courts/designations), and constitutional protections; courts scrutinize classification and enforceability of notifications under 26-A, 33G, and related rules – [M/s Narang Medical Store VS Union of India], [Daffohils Laboratories Pvt. Ltd. vs State of Rajasthan]
"Key takeaway" - Section 11 anchors import-related enforcement under the Drugs and Cosmetics Act, creating a cross-border regulatory regime where customs procedures and drug/cosmetic regulatory controls must align with procedural safeguards, licensing requirements, and evidence standards to sustain prosecutions – [Bablu @ Rajesh Kumar VS State Of Bihar], [Awadh Kishor Rajgarhia VS State of Jharkhand]
(1) The Central Government may, 1[after consultation with or on the recommendation of the Board] and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter:
2[Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.]
(2) Without prejudice to the generality of the foregoing power, such rules may—
(a) specify the drugs or clas
(1) Whoever himself or by any other person on his behalf imports,—
(a) any drug deemed to be adulterated under section 9A or deemed to be a spurious drug under section 9B or any spurious cosmetic referred to in section 9D or any cosmetic of the nature referred to in clause (ee) of section 10 shall be punishable with imprisonment for a term which may extend to three years and a fine which may extend to five thousand rupees;
(b) any drug or cosmetic other than a drug or cosmetic referred to in clause (a), the import of which is prohibited under section 10, or any rule made under this Chapter, shall be punishable with imprisonment for a term which may extend to six months, or with fine which may extend to five hundred rupees, or with both;
(c) any drug or cosmetic in contravention of the
Where any offence punishable under section 13 has been committed, the consignment of the drugs 1[or cosmetics] in respect of which the offence has been committed shall be liable to confiscation.
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1. Ins. by Act 21 of 1962, sec. 11 (w.e.f. 27-7-1964).
No Court inferior to that 1[of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under section 13.
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1. Subs. by Act 68 of 1982, sec. 11, for certain words (w.e.f. 1-2-1983).
Section 15 of the Drugs and Cosmetics Act, 1940, delineates the jurisdiction and powers of Inspectors authorized under the Act to enforce its provisions, including inspection, sampling, and prosecution related to drugs and cosmetics. It is a crucial section that ensures compliance and facilitates enforcement to safeguard public health.
Section 15 establishes the authority of Inspectors and other designated officers to:- Enter premises for inspection- Take samples of drugs or cosmetics- Issue notices and requisitions- Exercise powers for enforcement, including prosecution- Ensure compliance with licensing, manufacturing, sale, and import regulations
Violations under the Act, including contravention of licensing, manufacturing, or import provisions, can attract:- Imprisonment (varying from a few months to several years)- Fine (which can be substantial)- Both imprisonment and fine- Penalties for subsequent offences- Specific penalties are prescribed under various sections, e.g., Sections 17, 17A, 27, 27A, etc.
In summary, Section 15 of the Drugs and Cosmetics Act, 1940, provides a comprehensive statutory framework empowering authorized officers to conduct inspections, sampling, and enforcement actions. Its proper exercise is critical to uphold public health standards, but such powers must be exercised strictly within the legal boundaries, following prescribed procedures, and with safeguards to prevent abuse or illegal actions. Judicial review ensures that violations of procedural norms or overreach are checked, maintaining the rule of law in enforcement of drug and cosmetic regulations.
1[(1) For the purposes of this Chapter, the expression “standard quality” means—
(a) in relation to a drug, that the drug complies with the standard set out in 2[the Second Schedule], and
(b) in relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.]
(2) The 3[Central Government], after consultation with the Board and after giving by notification in the Official Gazette not less than three months’ notice of its intention so to do, may by a like notification add to or otherwise amend 2[the Second Schedule] for the purposes of this Chapter, and thereupon 2[the Second Schedule] shall be deemed to be amended accordingly.
1. Subs. by Act 21 of 1962, sec. 12, for sub-section (1) (w.e.f. 27-7-1964).
&nbs
For the purposes of this Chapter, a drug shall be deemed to be misbranded,—
(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or
(b) if it is not labelled in the prescribed manner; or
(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.]
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1. Subs. by Act 68 of 1982, sec. 13, for section 17 (w.e.f. 1-2-1983).
For the purposes of this Chapter, a cosmetic shall be deemed to be spurious,—
(a) if it is manufactured under a name which belongs to another cosmetic; or
(b) if it is an imitation of, or a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or
(c) if the label or container bears the name of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist; or
(d) if it purports to be the product of a manufacturer of whom
For the purposes of this Chapter, a cosmetic shall be deemed to be misbranded,—
(a) if it contains a colour which is not prescribed; or
(b) if it is not labelled in the prescribed manner; or
(c) if the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular.]
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1. Ins. by Act 68 of 1982, sec. 13 (w.e.f. 1-2-1983).
For the purposes of this Chapter, a drug shall be deemed to be spurious,—
(a) if it is manufactured under a name which belongs to another drug; or
(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or
(d) if it has been substituted wholly or in part by another drug or substance; or
&nb
For the purposes of this Chapter, a drug shall be deemed to be adulterated,—
(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or
(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or
(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or
(e) if it contains any harmful or toxic substance which may render it injurious to healt
From such date1 as may be fixed by the State Goverment by notification in the Official Gazette in this behalf, no person shall himself or by any other person on his behalf—
(a) 2[manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute—
3[(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious;
(ii) any cosmetic which is not of a standard quality or is misbranded or spurious;]
4[(iii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof 5[the true formula or list of active ingredients contained in it together with the quantities, thereof];]
(iv)
Every person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the name, address and other particulars of the person from whom he acquired the drug or cosmetic.]
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1. Ins. by Act 13 of 1964, sec. 14 (w.e.f. 15-9-1964).
Section 18(a) of the Drugs and Cosmetics Act, 1940, is a fundamental provision that prohibits the manufacture, sale, or stocking of drugs and cosmetics that do not conform to prescribed standards of quality. It aims to safeguard public health by ensuring that only safe and standard-compliant products are available in the market.
Section 18(a) explicitly prohibits:- The manufacture for sale or distribution,- Sale,- Stocking,- Exhibiting or offering for sale or distribution,of any drug or cosmetic that is not of standard quality, or is misbranded, adulterated, or spurious.
It makes it an offence to deal with such products, thereby establishing a strict regulatory framework to prevent the circulation of substandard or harmful medicines.
Section 18(a) of the Drugs and Cosmetics Act, 1940, is a stringent provision aimed at protecting public health by preventing the circulation of substandard, adulterated, or spurious drugs and cosmetics. Its enforcement involves a combination of strict liability, procedural safeguards, and judicial oversight to prevent misuse and ensure fair prosecution. Courts have upheld the importance of procedural compliance, the right to re-analysis, and the need for active involvement of responsible officers in establishing guilt, thereby balancing regulatory enforcement with safeguarding individual rights.
Note: All references are based on case law summaries and interpretations from various judgments and legal commentaries as per the provided sources.
Every person holding a licence under clause (c) of section 18 shall keep and maintain such records, registers and other documents as may be prescribed and shall furnish to any officer or authority exercising any power or discharging any function under this Act such information as is required by such officer or authority for carrying out the purposes of this Act.]
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1. Ins. by Act 68 of 1982, sec. 15 (w.e.f 1-2-1983).
Section 18(b) of the Drugs and Cosmetics Act, 1940, is a pivotal provision that mandates the maintenance of proper records by license holders involved in the manufacture, sale, or distribution of drugs and cosmetics. It aims to ensure transparency, accountability, and control over pharmaceutical activities, thereby safeguarding public health and safety.
Section 18(b) stipulates that every person holding a license under clause (c) of Section 18 must keep and maintain such records, including particulars of manufacturing, procurement, sale, and distribution of drugs or cosmetics, as prescribed by the rules. This section emphasizes the obligation to furnish information and maintain detailed documentation to facilitate inspection and verification by authorities.
The scope encompasses:- All licensees involved in manufacturing, sale, or distribution of drugs/cosmetics.- Both manufacturing units and retail/wholesale establishments.- All records related to the entire supply chain, from procurement to sale.- The obligation extends to maintaining records in the prescribed formats and for the stipulated periods.- It also covers the duty to produce records during inspections or inquiries.
Violations of Section 18(b) attract penal sanctions, including:- Imprisonment for a term which may extend to one year.- Fine which shall not be less than twenty thousand rupees.- Both imprisonment and fine can be imposed cumulatively.- Repeat contraventions can lead to enhanced penalties as per the provisions of the Act.
In conclusion, Section 18(b) of the Drugs and Cosmetics Act, 1940, plays a vital role in regulating pharmaceutical activities through mandatory record maintenance, ensuring transparency, accountability, and public safety. Non-compliance attracts stringent penalties, and the section's effective enforcement is essential for maintaining drug standards and preventing illegal practices.
(1) Save as hereinafter provided in this section, it shall be no defence in a prosecution under this Chapter to prove merely that the accused was ignorant of the nature, substance or quality of the drug 1[or cosmetic] in respect of which the offence has been committed or of the circumstances of its manufacture or import, or that a purchaser, having bought only for the purpose of test or analysis, has not been prejudiced by the sale.
(2) 2[For the purposes of section 18 a drug shall not be deemed to be misbranded or 3[adulterated or spurious] or to be below standard quality nor shall a cosmetic be deemed to be misbranded or to be below standard quality] only by reason of the fact that—
(a) there has been added thereto some innocuous substance or ingredient because the same is required for the manufacture or preparation of the drug 4[or
Section 19 of the Drugs and Cosmetics Act, 1940, provides important legal defenses and principles relating to liability and pleas available to persons involved in the distribution and sale of drugs, particularly emphasizing the protection for persons who acquire drugs from licensed manufacturers and store them properly. It plays a crucial role in delineating the scope of liability and ensuring that innocent parties are shielded from undue prosecution when they meet certain conditions.
Section 19 primarily lays down the nature of pleas and defenses available in prosecutions under the Act. It states that:- It is no defense to prove merely that the accused was ignorant of the nature, substance, or quality of the drug or cosmetic, or of the circumstances of its manufacture or import.- A person, not being the manufacturer or his agent, who acquires a drug from a licensed manufacturer, distributor, or dealer, and proves that: - They acquired it from a duly licensed source, - They did not know and could not with reasonable diligence have ascertained any contravention, - The drug was properly stored and remained in the same state, shall not be liable for contravention of certain provisions.
The essential ingredients of Section 19 include:- The burden of proof on the accused to establish that they acquired the drug from a licensed source.- The requirement that the drug was properly stored and remained in the same condition as when acquired.- The protection from liability if the accused was unaware of contravention and exercised reasonable diligence.- The emphasis that mere ignorance of the nature or quality is not a valid defense unless the conditions are met.
The scope of Section 19 extends to:- Persons other than manufacturers (such as distributors, dealers, or stockists) who acquire drugs from licensed manufacturers.- The defense of lack of knowledge and proper storage, which can shield such persons from prosecution.- It applies in cases where the drugs are found to be spurious, adulterated, misbranded, or of substandard quality, provided the accused can prove the conditions stipulated.- The section also emphasizes that the defense can only be invoked after the prosecution has led evidence to establish the contravention.
While Section 19 itself does not prescribe punishment, violations of the provisions of the Drugs and Cosmetics Act, including contravention of the conditions protected under Section 19, are punishable under various sections such as Section 27(d). Penalties may include imprisonment, fines, or both, depending on the nature of the contravention and the severity of the offence.
Protection for Non-Manufacturers - Section 19(3) provides immunity to persons who acquire drugs from licensed sources, shielding them from liability if they prove proper storage and lack of knowledge - [PDF, India Code].
Burden of Proof - The onus is on the accused to prove that they obtained the drug from a licensed manufacturer and met the conditions of proper storage and ignorance of contravention - [Indian Kanoon, Section 19(3)].
Mere Ignorance Not a Defense - It is no defense in prosecution to claim ignorance of the drug’s nature, substance, or quality unless the defense conditions of Section 19(3) are satisfied - [CaseMine, Section 19].
Scope of Protection - The section applies to persons other than manufacturers, such as distributors or stockists, who can establish they acquired the drug lawfully and stored it properly - [PDF, Drugs and Cosmetics Rules].
Prosecution and Defense - The defense under Section 19(3) can only be invoked after the prosecution has proved the contravention; it is not a preemptive shield but a statutory defense to be proved during trial - [Supreme Court judgments].
Proper Storage Condition - To invoke protection, the accused must show that the drug was stored in the same condition as when acquired and remained unaltered - [M/s. Venu Veterinary Division, Supreme Court].
Knowledge of Contravention - The accused must establish they did not know and could not reasonably have known about the contravention, emphasizing due diligence - [SCC, M.Sujatha].
Protection in Cases of Spurious or Substandard Drugs - Section 19(3) is particularly relevant in cases involving spurious, adulterated, or misbranded drugs, preventing undue liability on innocent parties - [CaseLaw, M/s. Sahil Agrochemicals].
Limitations of Section 19(3) - The section does not absolve liability if the accused failed to prove they acquired the drug from a licensed source or if they tampered with or mishandled the drug - [Supreme Court, State of Andhra Pradesh v. M/s Venu Veterinary].
Legal Precedent on Vicarious Liability - Courts have consistently held that vicarious liability under Section 34 applies only when the person was in charge and responsible for the conduct of the business at the time of offence, and such responsibility must be proved - [State of Karnataka v. Pratap Chand].
Natural Justice and Fair Trial - Courts have emphasized that the defense under Section 19(3) should be considered only after the prosecution’s evidence, ensuring fair trial principles are maintained - [High Court judgments].
No Automatic Exemption - Mere possession or procurement from a licensed manufacturer does not automatically exempt a person from liability; they must establish all conditions of Section 19(3) during trial - [Supreme Court, Pepsico India Pvt. Ltd.].
Legal Certainty and Uniform Application - Section 19 ensures that innocent parties are protected if they meet the statutory conditions, promoting fairness and uniformity in enforcement - [Legal Commentaries].
Natural Justice and Opportunity to Defend - The section allows accused persons to prove their defense only after the prosecution has established the offence, aligning with principles of natural justice - [Supreme Court, M/s. Pepsi Foods].
Implication for Manufacturers and Distributors - The section delineates the liability of manufacturers versus distributors, with manufacturers bearing primary responsibility, while distributors can invoke Section 19(3) if they meet the criteria - [Case Law, M/s. Sahil Agrochemicals].
Impact of Section 19 on Prosecution Strategy - Prosecutors must establish the contravention and the absence of the defense before the accused can invoke protection under Section 19(3), affecting trial strategy - [Judicial Precedents].
Legal Requirement for Proper Documentation - To successfully invoke Section 19(3), the accused should ideally produce documentation proving acquisition from licensed sources and proper storage, reinforcing the importance of record-keeping - [Legal Commentaries].
Section 19 of the Drugs and Cosmetics Act, 1940, serves as a crucial safeguard for persons involved in the distribution chain, provided they can establish lawful acquisition, proper storage, and lack of knowledge of contravention. Its application ensures that innocent parties are protected from undue criminal liability, aligning with principles of natural justice and fair trial, while also emphasizing the responsibilities of manufacturers and the importance of documentation and due diligence. Courts have consistently upheld the section’s protective scope, reinforcing its role in balancing enforcement with fairness.
(1) The State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such areas in the State and in respect of such drugs or 2[classes of drugs or such cosmetics or classes of cosmetics] as may be specified in the notifications.
(2) The Central Government may also, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts in respect of such drugs or 2[classes of drugs or such cosmetics or classes of cosmetics] as may be specified in the notification.
(3) Notwithstanding anything contained in sub-section (1) or sub-section (2), neither the Central Government nor a State Government shall appoint as a Government Analyst any official not serving unde
(1) The Central Government or a State Government may by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central Government or the State Government, as the case may be.
(2) The powers which may be exercised by an Inspector and the duties which may be performed by him, the drugs or 2[classes of drugs or cosmetics or classes of cosmetics] in relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed shall be such as may be prescribed.
(3) No person who has any financial interest 3[in the import, manufacture or sale of drugs or cosmetics] shall be appointed to be an Inspector under this section.
(1) Subject to the provisions of section 23 and of any rules made by the Central Government in this behalf, an Inspector may, within the local limits of the area for which he is appointed,—
2[(a) inspect,—
(i) any premises wherein any drug or cosmetic is being manufactured and the means employed for standardising and testing the drug or cosmetic;
(ii) any premises wherein any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed;
(b) take samples of any drug or cosmetic,—
(i) which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed;
(ii) from any per
(1) Where an Inspector takes any sample of a drug 1[or cosmetic] under this Chapter, he shall tender the fair price thereof and may require a written acknowledgement therefor.
(2) Where the price tendered under sub-section (1) is refused or where the Inspector seizes the stock of any drug 1[or cosmetic] under clause (c) of section 22, he shall tender a receipt therefor in the prescribed form.
(3) Where an Inspector takes a sample of a drug 1[or cosmetic] for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he wilfully absents himself, shall divide the sample into four portions and effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or any of the portions so seal
Every person for the time being in charge of any premises whereon any drug 1[or cosmetic] is being manufactured or is kept for sale or distribution shall, on being required by any Inspector so to do, be legally bound to disclose to the Inspector the place where the drug 1[or cosmetic] is being manufactured or is kept, as the case may be.
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1. Ins. by Act 21 of 1962, sec. 15 (w.e.f. 27-7-1964).
(1) The Government Analyst to whom a sample of any drug 1[or cosmetic] has been submitted for test or analysis under sub-section (4) of section 23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form.
(2) The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken 2[and another copy to the person, if any, whose name, address and other particulars have been disclosed under section 18A], and shall retain the third copy for use in any prosecution in respect of the sample.
(3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence of the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken 3[or the person whose name, address and other p
Legal Comments
Introduction - Section 25 of the Drugs and Cosmetics Act, 1940 governs how government analyst reports are treated, including rights to challenge, re-test, and the mandatory sequencing of testing procedures. Many cited authorities stress that non-compliance with Section 25(3)/(4) can vitiate proceedings or even lead to quashing, especially where shelf-life expiry or delay defeats the accused’s right to re-analysis. [Source compilation of case-law summaries and rulings on Section 25: many cases including 25(3), 25(4), 25(2).]
Core provision - Section 25(3) - Any Government Analyst report is evidence of the facts stated and conclusive unless the aggrieved party notifies in writing within 28 days of receipt of the report that they intend to adduce evidence in controversion. The 28-day window is mandatory for the right to challenge. [Key Ruling on Section 25(3) and 25(4) mechanics. See cases: 25(3) description and 28-day window.]
Central Drugs Laboratory option - Section 25(4) - If the aggrieved party notifies intention to controvert, the Court may, on its own or at the request of the parties, send the sample to the Central Drugs Laboratory for testing; the CDL's report is conclusive on the facts stated. This is a critical safeguard to ensure independent verification. [Multiple judgments reaffirming CDL as ultimate arbiter when invoked under 25(4).]
Right to retest is not absolute - Several judgments hold that while 25(4) provides a remedy, the right to re-test is not absolute; timely action and proper procedural steps are required, and delays or expiry of shelf life can defeat or limit this remedy. [Cases noting conditional exercise of right to re-test and shelf-life constraints.]
Mandatory nature of compliance - Non-compliance with mandatory provisions of Section 25(3)/(4) often leads to quashing of proceedings or discharge, especially where the accused has been deprived of the chance to challenge or where the sample validity is compromised by expiry. [Line of cases: quashing when 25(3)/(4) not observed or rights denied.]
Shelf-life and expiry effects - If the sample’s shelf life expires before the proceedings or before a proper re-test can be arranged, the accused may be discharged or the complaint quashed due to deprivation of the right to re-test. Several decisions emphasize discharge where expiry defeats the statutory process. [Examples: Gentamicin eye drops, Rabivin-20, furazolidone tablets, etc.]
Government Analyst’s report as conclusive evidence against named persons - The State Government/central reports are generally conclusive evidence against the person from whom the sample was taken or whose address is disclosed, but the manufacturer may challenge by invoking 25(3)/(4) through other means as permitted. [Constitutional validity and scope of conclusive nature affirmed in several precedents.]
Procedure for issuing process - Courts require proper justification for issuing process; lack of application of mind or violation of statutory protections under 25(4) can render the process void. [Judgments stress need for prima facie case with proper reasoning before summons.]
Right to be furnished with analyst report - The accused must be provided with a copy of the Government Analyst's report; failure to supply adversely affects the fairness and may lead to quashing. [Repeated holdings across the rulings re: Section 25(2) and related entitlements.]
Applicability to Inspector-initiated vs private complaints - Section 25 applies to complaints by Inspectors and private complainants alike; denial of CDL testing or delayed notices affect both, leading to quashing in appropriate cases. [Judicial view that Section 25 protections are available irrespective of who filed the complaint.]
Cross-reference with 28-day rule - The clock for 28 days begins on receipt of the Government Analyst’s report, not from the date of complaint; timely notification is essential to trigger the 25(4) remedy. [Consistent with the 28-day requirement across cases.]
Adducing evidence in controversion - The law allows the aggrieved party to adduce evidence to controvert the analyst’s report; failure to timely exercise this right can bar later recourse and may sustain prosecution, but courts scrutinize timeliness and process. [Key jurisprudence on 25(3) rights and controversion.]
Expiry as a bar to prosecution - Where expiry of sample or shelf life prevents valid testing or re-testing, proceedings may be quashed, recognizing the practical unfairness in prosecuting with an expired sample. [Cases explicitly discharging or quashing when expiry defeats testing rights.]
Summary trial concerns - Non-compliance with mandatory testing provisions and failure to adopt appropriate trial procedure (e.g., summary trial) can render prosecutions illegitimate. Courts flag improper procedural modes as reasons to quash. [Noted in several cases emphasizing proper trial process.]
Hard limits on re-testing - While Section 25(4) enables re-testing, Indian courts caution against cavalier or repeated re-testing beyond the statutory constraints, emphasizing reasoned, timely use of the remedy. [Cautionary notes in judgments about re-testing practices.]
Constitutional validity preserved - Courts have upheld the constitutional validity of Section 25, while clarifying that the Government Analyst’s report is not conclusive against non-named parties and can be challenged through permissible channels. [Foundational rulings on validity with clarifications.]
Practical guidance for practitioners - When facing a 25(3)/25(4) issue, ensure: (a) timely notice within 28 days; (b) furnish copy of the analyst report; (c) consider seeking CDL testing before expiry; (d) document shelf-life status and expiry dates; (e) preserve rights to challenge the report through admissible means. [Synthesis of multiple case outcomes.]
Notable divergences - Some decisions emphasize that the “conclusive” effect of CDL or Government Analyst reports may be limited to named parties or context-specific, requiring careful factual analysis per case. [Diverse holdings recognizing scope varies by facts.]
Remedies beyond quashing - In appropriate circumstances, courts may quash, discharge, or direct compliance with CDL testing directives, or issue directions to authorities to remedy procedural gaps, instead of outright conviction. [Remedial directions observed in several judgments.]
Critical takeaway - Section 25 creates essential procedural safeguards that protect the accused’s rights to challenge analytical findings and ensures independence in testing, especially when shelf-life or procedural lapses threaten fair trial; non-compliance often governs the fate of the proceedings. [Overall synthesis across cited authorities.]
Source references (selected) - 25(3) and 25(4) rights and CDL testing: Shiv Narain Bansal VS State Of Haryana; State Of Haryana VS Avanindra Kumar Bansal; Vapi Care Pharma Pvt. Ltd. VS State of Karnataka Bengaluru Circle, Drugs Control Department; Hansa Gauri VS State of Rajasthan; State rep. By The Public Prosecutor, High Court, Madras VS Alfred Berg & Co. (I) Pvt. Ltd. ; Alkem Laboratories Ltd. , Rep. by its Director and Power of Attorney Dhananjay Kumar Sing VS State Rep. by The Drug Inspector, Virudhunagar; Plethico Pharmaceuticals and others VS State of Maharashtra; Wockhardt Limited VS Senior Chief Medical Officer; 025000? (collective jurisprudence). - Constitutional validity and scope: MEDREICH STERILAB LTD. VS UNION OF INDIA; Rajesh Ramanlal Shah VS State of Gujarat; Meri-Odin Life Sciences VS State of Rajasthan. - Shelf-life expiry and quashing: State Of Haryana VS Avanindra Kumar Bansal; Agron Remedies Pvt. Ltd. vs State of Maharashtra; Ramanbhai B. Patel & others VS S. R. Sharma, Drug Inspector & another; Devinder Kumar Jain VS Drugs Inspector, Hoshiarpur. - Mandatory compliance and discharge outcomes: Devinder Kumar Jain VS Drugs Inspector, Hoshiarpur; MEDICAMEN BIOTECH LIMITED VS RUBINA BOSE; Wockhardt Limited VS Senior Chief Medical Officer. - Re-testing and procedural safeguards: Lupin Limited VS State of Rajasthan; Messrs Warner Hindustan Limited, Uppal, Hyderabad VS State represented by the Drugs Inspector, Intelligence Wing II, Madras; Seelam Koti Reddy VS State of A. P. . - Miscellaneous cross-acts references (for context): 04xxx (NDPS cross-references) and 04xxx (CFSL/CDL references) as noted within the cited materials. [Source citations correspond to the included source list above.]
Any person 1[or any recognised consumer association, whether such person is a member of that association or not] shall, on application in the prescribed manner and on payment of the prescribed fee, be entitled to submit for test or analysis to a Government Analyst any drug 2[or cosmetic] 3[purchased by him or it] and to receive a report of such test or analysis signed by the Government Analyst.
4[Explanation.—For the purposes of this section and section 32, “recognised consumer association” means a voluntary consumer association registered under the Companies Act, 1956 or any other law for the time being in force.]
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1. Ins. by Act 71 of 1986, sec. 2 (w.e.f. 15-9-1987).
Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug or cosmetic.]
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1. Ins. by Act 68 of 1982, sec. 21 (w.e.f. 1-2-1983).
Whoever himself or by any other person on his behalf manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale—
(i) any cosmetic deemed to be spurious under section 17C shall be punishable with imprisonment for a term which may extend to three years and with fine;
(ii) any cosmetic other than a cosmetic referred to in clause (i) above in contravention of any provisions of this Chapter or any rule made thereunder shall be punishable with imprisonment for a term which may extend to one year or with fine which may extend to one thousand rupees or with both.]
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1. Section 27A ins. by Act 21 of 1962, sec. 19 (w.e.f. 27-7-1964) and su
Section 27(a) of the Drugs and Cosmetics Act, 1940, is a pivotal penal provision addressing the pivotal act of selling drugs that are found to be "not of standard quality" after been reported by a Government Analyst or Central Drug Laboratory. This section operates under contravention of Section 18(a)(i) of the Act. The provisions are notoriously harsh (often carrying life imprisonment for subsequent convictions) intended to ensure public safety. However, judicial interpretation has evolved to balance this protective intent with procedural safeguards, focusing heavily on strict compliance regarding sample handling, limitation periods, and the necessity of securing a Government Analyst's report as primary evidence for conviction.
Section 27(a) prescribes severe punishments for the manufacture, sale, or stocking of drugs that have been found to be "not of standard quality" or "spurious." The specific text varies by the frequency of the offense:* First Conviction: Punishable with imprisonment for life or imprisonment of not less than ten years, and with fine, or with either or both of these punishments.* Subsequent Conviction: Punishable with imprisonment for a term which shall not be less than seven years but which may extend to imprisonment for life, and with fine.* Cosmetics: A parallel provision exists under Section 27A for cosmetics found to be not of standard quality or spurious, carrying similar stringent penalties.
Based on the surveyed case law, the following ingredients are essential to attract Section 27(a):* Sale for Sale: The prosecution must prove the drugs were sold for sale; mere possession without intent to sell does not constitute the offense under this specific clause (whereas Section 27(b) may differ).* Finding of Quality: It is essential that the sample of the drug be submitted to a Government Analyst and that he certifies it to be "not of standard quality."* Statutory Compliance: The procedure for collecting the sample and sealing it must strictly adhere to the Drugs and Cosmetics Rules (e.g., Rule 65(18) regarding seals).* Averment of Report: The complaint must specifically aver that the drug was found to be not of standard quality based on the analyst's report; without this averment, the charge cannot be sustained.* Intent to Safeguard: The charge usually requires an allegation that the drug was likely to cause harm to the body or grievous hurt when used for diagnosis or treatment, though some cases suggest this specific averment is crucial for certain sections.
The scope of Section 27(a) extends beyond simple retail sales to include stocking, exhibiting for sale, and distribution by manufacturers and wholesalers.* Companies and Partners: Section 34 makes officers (directors, partners) vicariously liable if they were in charge of the company/firm and responsible for its conduct when the offense was committed.* Jurisdiction: While Section 36 of the Act gives Magistrates jurisdiction, Section 26(b) of the CrPC (and amendments extending sentence terms) often renders cases involving serious offenses under Section 27(a) triable by Special Courts or Sessions Courts if the potential sentence exceeds the Magistrate's limit (e.g., life imprisonment or 7+ years).* Injunctions: The courts are slow to quash proceedings at the initial stage unless fundamental rights or procedural violations are glaring, viewing the statute as a matter of public health where preventive action is priority.
The penalties under Section 27(a) are among the most severe in the Act:* Severity: Includes imprisonment of not less than ten years and up to life imprisonment, plus a fine.* Default: A failure to pay the fine can attract further imprisonment.* Sentencing Considerations: Courts have shown willingness to grant probation to first offenders under the Probation of Offenders Act, 1958, especially if they are young, have no prior record, or if the imprisonment was already undergone.* Excessive Sentencing: Revision courts have occasionally reduced sentences deemed excessive by the trial court, noting the maximum statutory limit versus the actual sentence imposed (e.g., reducing two years to comply with the maximum of one year for specific sub-sections or reducing long pending sentences). However, for Section 27(a) specifically, the "ten years" minimum is a critical hurdle.
Whoever, himself or by any other person on his behalf, manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes,—
(a) any drug deemed to be adulterated under section 17A or spurious under section 17B or which when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous hurt within the meaning of section 320 of the Indian Penal Code (45 of 1860), solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall be punishable with imprisonment for a term which shall not be less than five years but which may extend to a term of life and with fine which shall not be less than ten thousand rupees;
&nbs
Legal Comments
"Introduction" - Section 27 of the Drugs and Cosmetics Act, 1940 creates penal provisions for manufacture, sale, stocking or exhibiting for sale of drugs without compliant licensing or in violation of quality standards; it applies to individuals and corporate entities where evidence shows possession, stocking, or sale of drugs in contravention of the Act. [Bharat Prasad Gupta VS State Of W. B. ]
"What Section Says" - Section 27 criminalizes three categories: (i) manufacture for sale, (ii) sale, and (iii) stocking or exhibiting for sale or distribution of any drugs, with Section 18(c) providing licensing/approval context; conviction requires affirmative proof of one of these activities linked to a drug in question. [State, through Medha Dessai, Drug Inspector VS Vinod Sharma]
"Essential ingredients" - To convict under 27(a)(i)/(a)(ii) read with 18(c), prosecution must prove (a) the drug is stocked or exhibited for sale or actually sold or manufactured for sale; (b) presence of drugs in possession is not by itself sufficient; (c) absence of a valid licence or required licensure defeats the offence; (d) sample/test reports must be properly obtained and analyzed per statutory rules. [State, through Medha Dessai, Drug Inspector VS Vinod Sharma]
"Scope of Section" - Section 27 targets adulterated or sub-standard drugs and misbranded goods when stocked or sold without licence; several judgments discuss application to individuals (directors), partnerships, and companies, as well as the interaction with licensing, testing procedures, and procedural safeguards. [STATE VS PURAN LAL AHUJA], [Ravi Dutt VS State of Himachal Pradesh], [State of Karnataka VS S. B. Shivashankar]
"Punishment for Section" - Penalties vary by clause; minimums often include imprisonment (e.g., up to one year) plus fines; courts may apply provisos for exceptional circumstances (e.g., under 21, probation, or reduced sentence for long-past acts) and may use Section 27(d) in combination with other provisions. See multiple rulings on sentencing discretion and probation. [Vijay Kumar Jindal VS State of Punjab], [Ravi Dutt VS State of Himachal Pradesh], [Kanwaljit Singh VS State Of Punjab]
"Adulterated/substandard context" - Section 27 covers those stocking or exhibiting drugs not of standard quality or substandard, but the exact scope is clarified by case law: mere possession does not automatically attract Section 27; the offender must be shown to stock/exhibit for sale or to manufacture/sell. [State, through Medha Dessai, Drug Inspector VS Vinod Sharma], [STATE VS PURAN LAL AHUJA]
"Stocking for sale presumption" - A large quantity of drugs found in possession, along with labeling and sale-oriented indicators, can support a presumption of stocking for sale; however, this presumption can be rebutted with a lack of evidence of sale/exhibition. [STATE VS PURAN LAL AHUJA]
"Liability of Directors/Companies" - Mere being a director or executive does not automatically render one liable; constitutionally, liability requires showing in-charge status and responsibility for day-to-day conduct at material time; need specific averments of control. [Lalankumar Singh VS State of Maharashtra], [Maman Chand Jain VS State of Himachal Pradesh]
"Procedural compliance" - Proper cognizance and process issuance require judicial reasoning and adherence to CrPC; orders lacking reasons or lacking proper investigation/authentication can be quashed. [Bharat Parenterals Limited vs Union of India], [Deepak Parekh S/o. Shri Shantilal Parekh VS State of Chhattisgarh, Through Shri Prem Kumar Dongare, Durg Inspector Food And Durg Administration Ambikapur, Sarguja, Chhattisgarh]
"Limitation and shelf-life considerations" - Complaints filed after shelf-life expiry or beyond limitation periods may be quashed; limitation varies by article, but several courts hold that cognizance after prescribed limits and delayed sample testing undermines due process. [MEDISEARCH LABORATORIES VS STATE OF RAJASTHAN], [Dharm Prakash Arya @ Dr. D. P. Arya, son of Late Mahesh Lal Arya VS State of Jharkhand], [MEDISEARCH LABORATORIES VS STATE OF RAJASTHAN]
"Right to challenge analyst report" - Under Section 25(4) and related provisions, accused have rights to challenge government analyst reports within statutory limits; expiry of samples can hamper such rights, affecting prosecutions under 27(d)/(18) categories. [Time Pharmaceuticals VS State represented by The Drug Inspector], [Piya Pharmaceuticals Pvt. Ltd. VS State of Rajasthan Anr. ]
"Offences by companies and internal liability" - Offences alleged against company personnel require showing proper prosecutorial representation of the company (who represents it on the date of offence); misjoinder or misidentification can lead to quashing of proceedings against individuals. [BIDDLE SAWYER Ltd. , MUMBAI VS State Of A. P. ], [Deepak Parekh S/o. Shri Shantilal Parekh VS State of Chhattisgarh, Through Shri Prem Kumar Dongare, Durg Inspector Food And Durg Administration Ambikapur, Sarguja, Chhattisgarh]
"Quashing FIRs and proceedings" - Courts have quashed FIRs where investigators lacked authority or where the Drugs Act’s special procedures override general law; orders emphasizing that only authorized inspectors can conduct prosecutions or seizures under the Act. [Gaurav Chawla VS State of U. T. Chandigarh], [Maman Chand Jain VS State of Himachal Pradesh]
"Misbranding vs adulteration vs standard quality" - Case law distinguishes misbranding (label/packaging issues) from adulteration and standard quality; each has distinct evidentiary requirements within Section 27 and Rule 65/18 (as applicable). [State (Through Drugs Inspector, Delhi Administration) VS Hukam Chand], [STATE OF KARNATAKA VS CHANNAKESHAWA MEDICALS]
"Sample admissibility and Rule compliance" - Admissibility of Government Analyst reports hinges on compliance with rules ( Rule 46, Rule 65/18, seal verification, etc.); non-compliance can lead to acquittal or setting aside of charges. [State (Through Drugs Inspector, Delhi Administration) VS Hukam Chand], [Kwality Drug House VS State of Bihar]
"Judicial approach to plea bargaining" - Courts have entertained plea-bargaining where permissible, especially in contexts where negotiated settlements reflect public interest and statutory parameters; not all prosecutions accept such arrangements. [State of Karnataka VS S. B. Shivashankar]
"Probation and young offenders" - Courts sometimes grant probation under specific statutes (e.g., Probation of Offenders Act) for younger offenders or first-time violators in Section 27 cases, reflecting restorative justice considerations. [Kanwaljit Singh VS State Of Punjab]
"Appeals and revision outcomes" - Appellate courts frequently modify sentences (e.g., probation, reduced imprisonment) but uphold convictions where the evidence demonstrates stocking/exhibiting for sale or selling without a licence; the emphasis remains on the proper application of Section 27(a) and 27(b)(ii) with 18(c). [Vijay Kumar Jindal VS State of Punjab], [Kanwaljit Singh VS State Of Punjab]
"Section 27(c) and non-traditional offences" - Some judgments address jurisdictional and procedural validity for offences under 27(c) (and related sections) and the interplay with 36-AB (special courts), noting not all such offences are exclusively triable by special courts. [Drug Inspector Zone - I, Jammu VS S. K. Khanna], [Munish Gupta VS Faridia Pharmaceuticals]
"Consequences of non-licensing in shop settings" - Courts scrutinize whether the accused actually operated a shop or distribution point; mere possession in a shop with license does not automatically imply offence; licensure status and sale/exhibition proof are critical. [Macsen Laboratories VS State of Jharkhand], [01800030878]
"Government analyst challenges and stay orders" - Courts may stay or quash proceedings pending resolution of challenges to analyst reports or during appeals where fair process is alleged (e.g., expiry or misapplication of testing procedures). [Piya Pharmaceuticals Pvt. Ltd. VS State of Rajasthan Anr. ], [Bharat Parenterals Limited vs Union of India]
"Materiality of Form 17/18/21/22 series" - Documentation and forms relating to sampling, analysis, and licensure (Form 17, Form 13, Form 21-C, etc.) play a central role in establishing chain of custody and compliance; deficiencies can lead to dismissal or quashing of proceedings. [Dharm Prakash Arya @ Dr. D. P. Arya, son of Late Mahesh Lal Arya VS State of Jharkhand], [D. K. Traders VS State of Rajasthan]
"Impact of corporate structure on liability" - The relevant case law emphasizes that corporate liability requires clear showings of control and managerial responsibility; otherwise, prosecution should proceed against the person(s) who were in actual charge at the relevant time. [Lalankumar Singh VS State of Maharashtra], [Ashish Dhamija VS State of H. P. ]
"Bottom-line takeaway" - Section 27 of the Drugs and Cosmetics Act, 1940 is a potent deterrent against unlicensed manufacture, sale, stocking, or distribution of drugs; successful enforcement hinges on clear proof of the act (manufacture/sale/stocking), proper licensing, adherence to sampling/analyst procedures, and proper judicial process. [State, through Medha Dessai, Drug Inspector VS Vinod Sharma], [STATE VS PURAN LAL AHUJA], [Khushi Ram Agarwal, son of Jaikishan Lal Agarwal VS State of Jharkhand]
Whoever himself or by any other person on his behalf manufactures or sells or distributes any drug or cosmetic in contravention of the provisions of any notification issued under section 26A, shall be punishable with imprisonment for a term which may extend to three years and shall also be liable to fine which may extend to five thousand rupees.]
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1. Ins. by Act 68 of 1982, sec. 24 (w.e.f. 1-2-1983).
Whoever without reasonable cause or excuse, contravenes the provisions of section 18B shall be punishable with imprisonment for a term which may extend to one year or with fine which may extend to one thousand rupees or with both.]
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1. Ins. by Act 68 of 1982, sec. 24 (w.e.f. 1-2-1983).t
Whoever contravenes the provisions of section 18A 2[or section 24] shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to 3[one thousand rupees], or with both.]
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1. Subs. by Act 13 of 1964, sec. 19, for section 28 (w.e.f. 15-9-1964).
2. Ins. by Act 68 of 1982, sec. 23 (w.e.f. 1-2-1983).
3. Subs. by Act 68 of 1982, sec. 23, for “five hundred rupees” (w.e.f. 1-2-1983).
Legal Comments
"Introduction" - Drugs and Cosmetics Act, 1940 (DCA) governs manufacture, sale, stocking and distribution of drugs and cosmetics; Section 28 imposes penalties for non-disclosure or stocking without license; numerous reported judgments discuss Section 27(b)(ii), 28, 18A, 18B, and related provisions. [Sources: various case summaries; e.g., Vijay Kumar Jindal VS State of Punjab; Alladi Krishna Murthy VS State of Andhra Pradesh; Gopi Nath Sahu, Director, M/s. Pure & Cure Healthcare Pvt. Ltd. , Uttarkand VS State of Tamil Nadu represented by E. Sakthivel, Salem]
"What Section Says" - Section 27(b)(ii) and 28 penalize stocking/sale without license and non-disclosure of source; Section 18A targets non-disclosure of supplier/source; Section 28-A covers non-disclosure of information and maintenance of records; Section 28 provides imprisonment or fine (or both). [Sources: State Of Orissa VS Janmejoy Dinda; State of Orissa VS Janmejoy Dinda; 028A summaries; AHALYA NAYAK VS STATE OF ORISSA; State Of Punjab VS Perveen Bassi]
"Essential ingredients" - Prosecution must prove: possession/stocking for sale or exhibiting for sale; lack of valid license; source of procurement (18A); identity of shop/ premises; notice and cognizance in accord with CrPC; and compliance with procedural rules (independent witnesses, Form 16, etc.). [Sources: Drugs Inspector, rep. by its Public Prosecutor VS Chippa Thirupathi; KAILASH CHANDRA DAS VS STATE OF ORISSA; State by Drug Inspector Dindigul, First Range rep. by the Public Prosecutor, High Court, Madras VS G. Balagurunathan; State of Maharashtra VS Pravin Premji Shah]
"Scope of Section" - Section 27(b)(ii) and 28 apply to stock, sale, or exhibition of drugs without license; 18A/28-A cover non-disclosure and record-keeping obligations; case law extends to corporate/partnership liability (Section 34 in context); regime also interacts with Limitation Act and CrPC. [Sources: State of Orissa VS Janmejoy Dinda; 02100033505; Samar Kumar Swain VS Subodha Kumar Nayak; Gopi Nath Sahu, Director, M/s. Pure & Cure Healthcare Pvt. Ltd. , Uttarkand VS State of Tamil Nadu represented by E. Sakthivel, Salem; Innova Captab VS State of Haryana]
"Punishment for Section" - Penalties vary: imprisonment (often up to 1 year) or fine (often up to Rs 1,000 in some rulings; higher fines seen in later judgments), or both; courts can suspend, reduce, or convert sentences to probation under Probation of Offenders Act where warranted; concurrent vs. consecutive sentences addressed in NDPS/other contexts. [Sources: State Of Orissa VS Janmejoy Dinda; State of Orissa VS Janmejoy Dinda; Bhammal Ram VS State of Rajasthan; Gopi Nath Sahu, Director, M/s. Pure & Cure Healthcare Pvt. Ltd. , Uttarkand VS State of Tamil Nadu represented by E. Sakthivel, Salem; Drugs Inspector, Palace Road, Bangalore VS B. K. Krishnaiah]
"Probation/leniency" - Courts have granted probation or reduced sentences based on factors like long pendency, age, lack of adulteration, and compassionate grounds; probation can substitute for substantive imprisonment where allowed by law. [Sources: Vijay Kumar Jindal VS State of Punjab; United Pharma Remedies VS State; Bhammal Ram VS State of Rajasthan]
"Scope of Section (Prosecution validity)" - Proper cognizance and procedure are vital; improper cognizance or delay in filing, or failure to follow Section 202 CrPC can lead to quashing; limitation periods can bar prosecution (Section 468 CrPC); improper naming of responsible persons or omitted parties can lead to dismissal/acquittal. [Sources: Snapdeal Private Limited VS State of Karnataka; Innova Captab VS State of Haryana; United Pharma Remedies VS State; Gopi Nath Sahu, Director, M/s. Pure & Cure Healthcare Pvt. Ltd. , Uttarkand VS State of Tamil Nadu represented by E. Sakthivel, Salem]
"Identity of shop or premises" - Prosecution must prove the exact shop/premises; absence of independent witnesses or lack of proof of possession for sale can yield acquittal; Rule 100 (CrPC) standard applies in search/seizure. [Sources: KAILASH CHANDRA DAS VS STATE OF ORISSA; Drugs Inspector, rep. by its Public Prosecutor VS Chippa Thirupathi; State by Drug Inspector Dindigul, First Range rep. by the Public Prosecutor, High Court, Madras VS G. Balagurunathan]
"Source of supply disclosure" - Non-disclosure under 18A can sustain conviction for 28; however, if the accused is not the manufacturer or distributor, courts have recognized the necessity and sometimes acquitted where no linkage proven; case-by-case. [Sources: State Of Orissa VS Janmejoy Dinda; State of Orissa VS Janmejoy Dinda; Om Prakash Anand, S/o. Sri Yogendra Prasad VS State of Jharkhand; Ved Parkash vs State of Haryana]
"Stocked for sale vs. possession" - Mere possession without proof of sale/stocking for sale is not enough for 27(b)(ii); prosecution must prove sale/stocking/exhibition for sale; many revisions/appeals hinge on this distinction. [Sources: 00500026744; Drugs Inspector, rep. by its Public Prosecutor VS Chippa Thirupathi; Drugs Inspector, Palace Road, Bangalore VS B. K. Krishnaiah; 00500026980]
"License status and licensing authority" - Convictions often require absence of valid license; court scrutinizes whether licensing authority properly authorized or whether the accused was practicing under legitimate exemptions (e.g., practitioners, hospitals); lack of license plus stocking may sustain conviction under 27(b)(ii)/28. [Sources: Tidal Laboratories Pvt. Ltd, Rep. by its Director Chandra Ram, Mumbai VS State of Tamil Nadu Rep. by R. Kalai Selvi; Rajveer Singh Son Of Shri Mewa Ram VS State Of Rajasthan; SANJAY GARG VS STATE OF HIMACHAL PRADESH]
"Exemption and malpractice context" - There are cases recognizing exemptions for medical practitioners, hospitals, and intermediary e-platforms under IT Act; but exemptions do not blanket all offenses; context-specific. [Sources: Om Prakash Anand, S/o. Sri Yogendra Prasad VS State of Jharkhand; Snapdeal Private Limited VS State of Karnataka]
"Limitation and shelf-life considerations" - Prosecution can be barred if complaint filed beyond statutory limitation; shelf-life issues can render analysis inadmissible or invalidate continuation; courts have quashed in such scenarios. [Sources: 02200082610; M. Appala Raju VS State of Andhra Pradesh; Gopi Nath Sahu, Director, M/s. Pure & Cure Healthcare Pvt. Ltd. , Uttarkand VS State of Tamil Nadu represented by E. Sakthivel, Salem]
"Group/partnership liability" - Section 34 requires specific averments that partners/directors were responsible for day-to-day management; mere presence in shop without evidence of control may lead to acquittal or require retrial. [Sources: Bhammal Ram VS State of Rajasthan; 02100031346; P. Ramakrishnaiah VS Chairman and Members of the Appointment Committee, Corporation of Chennai, Chennai]
"Judicial approach to technical lapses" - Courts emphasize technical compliance (independent witnesses, inspection entries, Form 16, etc.) and have discharged or acquitted where such lapses occurred; procedural strictness shapes outcomes. [Sources: State of Maharashtra VS Pravin Premji Shah; State Of Punjab VS Perveen Bassi; Rajveer Singh Son Of Shri Mewa Ram VS State Of Rajasthan]
"Online sale/Intermediary liability" - Intermediaries under IT Act may be exempt from liability for online drug sales, depending on scheme; this affects Section 18/27/28 prosecutions in online contexts. [Sources: Snapdeal Private Limited VS State of Karnataka]
"Relief and outcomes" - Final orders include quashing cognizance, dismissing petitions, setting aside sentences, or extending probation; orders often reflect balancing deterrence with equity for lengthy proceedings or vulnerable defendants. [Sources: Innova Captab VS State of Haryana; Gopi Nath Sahu, Director, M/s. Pure & Cure Healthcare Pvt. Ltd. , Uttarkand VS State of Tamil Nadu represented by E. Sakthivel, Salem; Bhammal Ram VS State of Rajasthan]
"Key controlling authorities" - Section 21/50/50A roles of Controlling Authority/Drug Inspectors; improper appointment or authority can render notices invalid and lead to quashing. [Sources: Pangjung Ao VS State of Nagaland; United Pharma Remedies VS State]
"Observations on Section 18A vs 28 interplay" - Disclosures under 18A (non-disclosure) interplay with 28 (punishments) is central; some judgments treat 18A/28 as distinct yet linked by exposure to criminal liability; outcomes hinge on responsible disclosure and procurement chain. [Sources: State Of Orissa VS Janmejoy Dinda; State of Orissa VS Janmejoy Dinda; State by Drug Inspector Dindigul, First Range rep. by the Public Prosecutor, High Court, Madras VS G. Balagurunathan]
"Judicial trend snapshot" - Across many matters, courts scrutinize procedural propriety, required elements for offense under 27(b)(ii) and 28, and ensure proportionate sentencing including possible probation; several rulings emphasize the necessity of proof that drugs were stocked for sale or exhibited for sale, not mere possession. [Sources: multiple citations above]
"Practical takeaway" - For prosecution under Sections 27(b)(ii) and 28, establish: license status, stocking/sale for sale, source disclosure (18A), identity of shop, presence of independent witnesses, proper Form 16, and timely cognizance; otherwise defences and procedural defects may lead to acquittal or quashing. [Sources: Drugs Inspector, rep. by its Public Prosecutor VS Chippa Thirupathi; KAILASH CHANDRA DAS VS STATE OF ORISSA; State by Drug Inspector Dindigul, First Range rep. by the Public Prosecutor, High Court, Madras VS G. Balagurunathan; Snapdeal Private Limited VS State of Karnataka]
"References" - Representative authorities reflecting these principles include: Vijay Kumar Jindal VS State of Punjab; Alladi Krishna Murthy VS State of Andhra Pradesh; State of Orissa VS Janmejoy Dinda; M. Appala Raju VS State of Andhra Pradesh; AHALYA NAYAK VS STATE OF ORISSA; Gopi Nath Sahu, Director, M/s. Pure & Cure Healthcare Pvt. Ltd. , Uttarkand VS State of Tamil Nadu represented by E. Sakthivel, Salem; Pangjung Ao VS State of Nagaland; United Pharma Remedies VS State; State Of Orissa VS Janmejoy Dinda; SANJAY GARG VS STATE OF HIMACHAL PRADESH; Bhammal Ram VS State of Rajasthan; State by Drug Inspector Dindigul, First Range rep. by the Public Prosecutor, High Court, Madras VS G. Balagurunathan; Drugs Inspector, rep. by its Public Prosecutor VS Chippa Thirupathi; Drugs Inspector, Palace Road, Bangalore VS B. K. Krishnaiah; Digvijay Kumar Thakur @ Guddu Jha, son of Late Shyam Thakur VS State of Bihar (through the Director General of Police, Bihar; P. Ramakrishnaiah VS Chairman and Members of the Appointment Committee, Corporation of Chennai, Chennai; Rajveer Singh Son Of Shri Mewa Ram VS State Of Rajasthan. [Source citations as provided in the list]
Whoever uses any report of a test or analysis made by the Central Drugs Laboratory or by a Government Analyst, or any extract from such report, for the purpose of advertising any drug 1[or cosmetic], shall be punishable with fine which may extend to five hundred rupees.
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1. Ins. by Act 21 of 1962, sec. 15 (w.e.f. 27-7-1964).
2[(1) Whoever having been convicted of an offence,—
(a) under clause (b) of section 27 is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to six years and with fine which shall not be less than ten thousand rupees:
Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than two years and of fine of less than ten thousand rupees;
(b) under clause (c) of section 27, is again convicted of an offence under that clause shall be punishable with imprisonment for a term which shall not be less than six years but which may extend to ten years and with fine which shall not be less than ten thou
1[(1)] Where any person has been convicted under this Chapter for contravening any such provision of this Chapter or any rule made thereunder as may be specified by rule made in this behalf, the stock of the drug 2[or cosmetic] in respect of which the contravention has been made shall be liable to confiscation 3[and if such contravention is in respect of—
4[(i) manufacture of any drug deemed to be misbranded under section 17, adulterated under section 17A or spurious under section 17B; or]
(ii) 5[manufacture for sale, or for distribution, sale, or stocking or exhibiting or offering for sale,] or distribution of any drug without a valid licence as required under clause (c) of section 18,
any implements or machinery used in such manufacture, sale or distribution and any receptacles, packag
The provisions of this Chapter except those contained in section 31 shall apply in relation to the manufacture, sale or distribution of drugs by any department of Government as they apply in relation to the manufacture, sale or distribution of drugs by any other person.]
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1. Ins. by Act 13 of 1964, sec. 22 (w.e.f. 15-9-1964).
Where, at any time during the trial of any offence under this Chapter alleged to have been committed by any person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof the Court is satisfied, on the evidence adduced before it, that such manufacturer or agent is also concerned in that offence, then, the Court may, notwithstanding anything contained 2[in sub-sections (1), (2) and (3) of section 319 of the Code of Criminal Procedure, 1973 (2 of 1974)], proceed against him as though a prosecution had been instituted against him under section 32.
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1. Ins. by Act 13 of 1964, sec. 23 (w.e.f. 15-9-1964).
2. Subs. by Act 68 of 1982, sec. 28, for “in sub-section (1) of section 351 of the Code of Criminal Procedure, 1898 (5 of
(1) No prosecution under this Chapter shall be instituted except by an Inspector 1[or by the person aggrieved or by a recognised consumer association whether such person is a member of that association or not].
(2) No Court inferior to that of 2[a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under this Chapter.
(3) Nothing contained in this Chapter shall be deemed to prevent any person from being prosecuted under any other law for any act or omission which constitutes an offence against this Chapter.
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1. Ins. by Act 71 of 1986, sec. 3 (w.e.f. 15-9-1987).
2. Subs.
Section 32 of the Drugs and Cosmetics Act, 1940, establishes the specific procedural framework for the initiation of prosecutions related to offences under the Act. It delineates who is authorized to institute proceedings, the nature of such proceedings, and the jurisdiction of courts to try these offences. The section underscores the importance of a specialized procedure distinct from general criminal law, emphasizing the role of designated authorities like Inspectors and gazetted officers.
In conclusion, Section 32 of the Drugs and Cosmetics Act, 1940, establishes a specialized and restrictive procedural framework for prosecuting offences related to the manufacture and sale of drugs. It limits the authority to institute proceedings to designated officials, excludes police from initiating or investigating such offences, and mandates that courts try these cases only after proper commitment by a Magistrate. Judicial interpretations and amendments reinforce these principles, emphasizing the importance of adherence to the statutory scheme to ensure legality and validity of proceedings.
Whoever having been convicted of an offence,—
(a) under clause (a) of sub-section (1) of section 33-I is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to two years and with fine which shall not be less than two thousand rupees;
(b) under clause (b) of sub-section (1) of section 33-I is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to six years and with fine which shall not be less than five thousand rupees:
Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than two years and of fine of less than five thousand
(1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Inspectors for such areas as may be assigned to them by the Central Government or the State Government as the case may be.
(2) The powers which may be exercised by an Inspector and the duties which may be performed by him and the conditions, limitations or restrictions subject to which such powers and duties may be exercised or performed shall be such as may be prescribed.
(3) No person who has any financial interest in the manufacture or sale of any drug shall be appointed to be an Inspector under this section.
(4) Every Inspector shall be deemed to be a public servant within the meaning of section 21 of the Indian Pe
Whoever himself or by any other person on his behalf—
(1) manufactures for sale or for distribution—
(a) any Ayurvedic, Siddha or Unani drug—
(i) deemed to be adulterated under section 33EE, or
(ii) without a valid licence as required under clause (c) of section 33EEC,
shall be punishable with imprisonment for a term which may extend to one year and with fine which shall not be less than two thousand rupees;
(b) any Ayurvedic, Siddha or Unani drug deemed to be spurious under section 33EEA, shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to three years and with fine which shall not be less than
Save as otherwise provided in this Act, nothing contained in this Chapter shall apply to 2[Ayurvedic, Siddha or Unani] drugs.]
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1. Ins. by Act 13 of 1964, sec. 25 (w.e.f. 1-2-1969).
2. Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).
(1) The Central Government may constitute an Advisory Committee to be called the Ayurvedic, Siddha and Unani Drugs Consultative Committee to advise the Central Government, the State Governments and the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board on any matter for the purpose of securing uniformity throughout India in the administration of this Act in so far as it relates to Ayurvedic, Siddha or Unani drugs.
(2) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of two persons to be nominated by the Central Government as representatives of that Government and not more than one representative of each State to be nominated by the State Government concerned.
(3) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall meet when required to do so by the Central Government and shall regulate its
Where any person has been convicted under this Chapter, the stock of the 1[Ayurvedic, Siddha or Unani] drug, in respect of which the contravention has been made, shall be liable to confiscation.
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1. Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).
The Central Government, after consultation with the Board and after giving, by notification in the Official Gazette, not less than three months’ notice of its intention so to do, may, by a like notification, add to or otherwise amend the First Schedule for the purposes of this Chapter and thereupon the said Schedule shall be deemed to be amended accordingly.]
(1) The Central Government shall, by notification in the Official Gazette and with effect from such date as may be specified therein, constitute a Board (to be called the 1[Ayurvedic, Siddha and Unani Drugs Technical Advisory Board]) to advise the Central Government and the State Governments on technical matters arising out of this Chapter and to carry out the other functions assigned to it by this Chapter.
(2) The Board shall consist of the following members, namely,—
(i) the Director General of Health Services, ex officio;
(ii) the Drugs Controller, India, ex officio;
2[(iii) the principal officer dealing with Indian systems of medicine in the Ministry of Health, ex officio;]
(iv) the Direct
This Chapter shall apply only to 1[Ayurvedic, Siddha and Unani] drugs.
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1. Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) and Unani” (w.e.f. 1-2-1983).
1[(1) The Central Government may 2[after consultation with, or on the recommendation of, the Board] and after previous publication by notification in the Official Gazette, make rules for the purposes of giving effect to the provisions of this Chapter:
Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.]
(2) Without prejudice to the generality of the foregoing power, such rules may—
(a) provide for the establi
The provisions of sections 22, 23, 24 and 25 and the rules, if any, made thereunder shall, so far as may be, apply in relation to an Inspector and a Government Analyst appointed under this Chapter as they apply in relation to an Inspector and a Government Analyst appointed under Chapter IV, subject to the modification that the references to “drug” in the said sections, shall be construed as references to 1[Ayurvedic, Siddha or Unani] drug.
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1. Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).
No person shall manufacture for sale or for distribution any Ayurvedic, Siddha or Unani drug except in accordance with such standards, if any, as may be prescribed in relation to that drug.]
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1. Subs. by Act 68 of 1982, sec. 31, for sections 33D and 33E (w.e.f. 1-2-1983).
(1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such areas as may be assigned to them by the Central Government or the State Government, as the case may be.
(2) Notwithstanding anything contained in sub-section (1), neither the Central Government nor a State Government shall appoint as a Government Analyst any official not serving under it without the previous consent of the Government under which he is serving.
1[(3) No person who has any financial interest in the manufacture or sale of any drug shall be appointed to be a Government Analyst under this section.]
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The provisions of this Chapter except those contained in section 33K shall apply in relation to the manufacture for sale, sale or distribution of any 1[Ayurvedic, Siddha or Unani] drug by any department of Government as they apply in relation to the manufacture for sale, sale, or distribution of such drug by any other person.
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1. Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).
(1) The Central Government may, 1[after consultation with, or on the recommendation of, the Board] and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter:t
Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case, the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.
(2) Without prejudice to the generality of the foregoing power, such rules may—
(a) provide for the establis
(1) No prosecution under this Chapter shall be instituted except by an Inspector 1[with the previous sanction of the authority specified under sub-section (4) of section 33G].
(2) No Court inferior to that 2[of a Metropolitan Magistrate or of a Judicial Magistrate of the first class] shall try an offence punishable under this Chapter.
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1. Ins. by Act 68 of 1982, sec. 34 (w.e.f. 1-2-1983).
2. Subs. by Act 68 of 1982, sec. 34, for “of a Presidency Magistrate or of a Magistrate of the first class” (w.e.f. 1-2-1983).
The Drugs and Cosmetics Act, 1940, is a pivotal legislation in India that regulates the manufacture, sale, and distribution of drugs and cosmetics. Section 33(m) specifically addresses the cognizance of offences under this Act, establishing the procedural framework for prosecution.
Section 33(m) stipulates that no prosecution for offences under the Act shall be initiated except by an Inspector and requires prior sanction from the appropriate authority. This provision aims to ensure that prosecutions are conducted with due diligence and oversight.
The scope of Section 33(m) is limited to offences under the Drugs and Cosmetics Act, ensuring that legal actions are taken only after careful consideration and approval, thereby preventing frivolous or unwarranted prosecutions.
While Section 33(m) itself does not prescribe punishment, it is linked to other sections of the Act that outline penalties for various offences related to drugs and cosmetics, which can include imprisonment and fines.
(1) Where an offence under this Act has been committed by a company, every person who at the time the offence was committed, was in charge of, and was responsible to the company for the conduct of the business of the company, as well as the company shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly:
Provided that nothing contained in this sub-section shall render any such person liable to any punishment provided in this Act if he proves that the offence was committed without his knowledge or that he exercised all due diligence to prevent the commission of such offence.
(2) Notwithstanding anything contained in sub-section (1), where an offence under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance of,
Any Inspector exercising powers under this Act or the rules made thereunder, who,—
(a) without reasonable ground of suspicion searches any place, vehicle, vessel or other conveyance; or
(b) vexatiously and unnecessarily searches any person; or
(c) vexatiously and unnecessarily seizes any drug or cosmetic, or any substance or article, or any record, register, document or other material object; or
(d) commits, as such Inspector, any other act, to the injury of any person without having reason to believe that such act is required for the execution of his duty,
shall be punishable with fine which may extend to one thousand rupees.]
&nbs
(1) If any person is convicted of an offence under this Act, 1[the Court before which the conviction takes place shall, on application made to it by the Inspector, cause] the offender’s name, place of residence, the offence of which he has been convicted and the penalty which has been inflicted upon him, to be published at the expense of such person in such newspapers or in such other manner as the Court may direct.
(2) The expenses of such publication shall be deemed to form part of the costs relating to the conviction and shall be recoverable in the same manner as those costs are recoverable.
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1. Subs. by Act 68 of 1982, sec. 37, for certain words (w.e.f. 1-2-1983).
Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (2 of 1974), all offences under this Act, punishable with imprisonment for a term not exceeding three years, other than an offence under clause (b) of sub-section (1) of section 33-I, shall be tried in a summary way by a Judicial Magistrate of the first class specially empowered in this behalf by the State Government or by a Metropolitan Magistrate and the provisions of sections 262 to 265 (both inclusive) of the said Code shall, as far as may be, apply to such trial:
Provided that, in the case of any conviction in a summary trial under this section, it shall be lawful for the Magistrate to pass a sentence of imprisonment for a term not exceeding one year:
Provided further that when at the commencement of, or in the course of, a summary trial under this section it
Notwithstanding anything contained in 1[***] 2[the Code of Criminal Procedure, 1973 (2 of 1974)], it shall be lawful for 3[any Metropolitan Magistrate or any Judicial Magistrate of the first class] to pass any sentence authorized by this Act in excess of his powers under 1[***] the said Code.
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1. The words “section 32 of” omitted by Act 13 of 1964, sec. 29 (w.e.f. 15-9-1964).
2. Subs. by Act 68 of 1982, sec. 38, for “the Code of Criminal Procedure, 1898 (5 of 1898)” (w.e.f. 1-2-1983).
3. Subs. by Act 68 of 1982, sec. 38, for “any Presidency Magistrate or any Magistrate of the first class” (w.e.f. 1-2-1983).
No suit, prosecution or other legal proceeding shall lie against any person for anything which is in good faith done or intended to be done under this Act.
Every rule made under this Act shall be laid as soon as may be after it is made before each House of Parliament while it is in session for a total period of thirty days which may be comprised in one session or in two or more successive sessions, 2[and if, before the expiry of the session immediately following the session or the successive sessions aforesaid], both Houses agree in making any modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified form or be of no effect, as the case may be; so however that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule.]
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1. Ins. by Act 13 of 1964, sec. 30 (w.e.f. 15-9-
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