Bare Acts
THE DRUGS AND COSMETICS ACT, 1940
The Drugs and Cosmetics Act, of 1940 (hereinafter referred to as “the Act”) was enacted in order to provide a comprehensive regulatory framework controlling the importation, manufacturing, distribution, and sales of drugs and cosmetics in India. The Act says that this law is also subject to the Dangerous Drugs Act, of 1930, and any other law which may be enforced from time to time.
Objective of the Act
The objectives of the Act are multiple but mainly ensuring safe medications, and improving quality standards on drugs and cosmetics thus protecting public health. The key reasons why this legislation was enacted include:
Consumer protection: Through laying down stringent regulations and standards, the Act guarantees consumer safety against possible harm arising from use of unsafe drugs or cosmetics.
Quality control: Under the act set standards must be observed during the manufacture, storage, and distribution of drugs and cosmetics. It ensures responsible conduct within the sector while at the same time providing a buffer against trade in substandard or adulterated substances that have an impact on human life through public health.
Ensuring safety and efficacy: To ensure that they are safe for consumers, it is a mandatory requirement under the Act that drugs and cosmetics sold in India must be rigorously tested and evaluated.
Advertising oversight: Guidelines have been put in place by the Act to control the advertising of drugs and cosmetics so as to prevent misleading advertisements. This will make sure that the information given in the ads is correct, thereby avoiding being misled by false expectations which could lead to wrong purchasing decisions.
Industry oversight: The Act compels drug and cosmetic manufacturers to adhere to good manufacturing practices for consistent product quality and safety. The guidelines set by the Act should be followed when making, distributing, and selling drugs as well as cosmetics.
Trade compliance: India’s importation or exportation of drugs, comes under regulations of this act in order to maintain suitable standards. This ensures no hazard to the health of customers.
Measures taken against adulterated products: The Act incorporates strict measures to prohibit the manufacturing, distribution, sale, and use of adulterated drugs and cosmetics. It also includes provisions for penalties for those who engage in the production, distribution, and sale of such spurious products.
Authorization and permits: The Act makes it mandatory for the manufacturers, distributors, and sellers of drugs and cosmetics to obtain license and registration with the competent regulatory authority. This process ensures that the process and the personnel have complied with the regulatory requirements.
The Act plays a pivotal role to ensure that the pharmaceutical and cosmetic industries comply with the regulatory requirements and operate ethically while giving priority to the health and safety of the public at large.
Features of the Act:
The Act is a crucial piece of legislation in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics. The salient features of the Act are as follows:
Control of manufacture, sale, and import of drugs and cosmetics: The Act provides detailed regulations for import, manufacture, and sale of drugs and cosmetics to ensure that the products meet quality standards and assured safety.
Licensing: The Act provides that the due license be issued to those involved in the import, manufacture, distribution, and sale of drugs and cosmetics. This was a measure to control those few entrusted individuals or firms dealing with the items in question.
Standards and Quality Control: Sections 8 and 16 of the Act provide for standards of quality of drugs and cosmetics. It includes that a drug must comply with the standard set out in the Second Schedule of the Act. Moreover, a cosmetic has to comply with such standards as may be prescribed. This prevents the selling of adulterated or substandard products.
Labeling and Packaging: Section 12 of the Act empowers the Central Government to make rules which also include frame rules that require the label to notify the product with its contents, date of manufacturing, date of expiry, and the instructions for use regarding the product.
Misbranded, adulterated, and spurious drugs and cosmetics: Sections 9 to 9D provide for drugs and cosmetics that will amount to misbranded, adulterated, and spurious.
Prohibition on import: Section 10 of the Act provides for a list of drugs and cosmetics that are prohibited by the Act to be imported. Such products are products of sub-standard quality, misbranded, spurious, adulterated, etc. Section 10A further empowers the Central Government to put a ban of the import of certain drugs and cosmetics in the public interest.
Power to make rules: Section 12 of the Act empowers the Central Government to make rules for the purpose of giving effect to the provisions of Chapter III which deals with the import of drugs and cosmetics.
Offenses under Chapter III: Section 13 of the Act provides for a list of offenses that prescribes a punishment of imprisonment and fine. Section 14 further provides that when an offense under Section 13 has been committed, the consignment of drugs and cosmetics shall be liable to be confiscated.
Increased punishment for subsequent offenses: Section 13(2) provides for increased punishment for a subsequent offense committed under the Section.
Jurisdiction: Section 15 of the Act provides that no court subordinate to the court of a Metropolitan Magistrate or of a Judicial Magistrate of the first class shall be empowered to try an offense punishable under Section 13 of the Act.
Prohibition of manufacture and sale of certain drugs and cosmetics: Section 18 of the Act provides that the State Government can prohibit any person from manufacturing and sale of certain drugs and cosmetics, which includes, misbranded, adulterated, spurious, or substandard quality drugs and cosmetics.
Government analysts: Section 20 of the Act provides that the appropriate government can appoint such a person as it hins fit, who meets the prescribed qualification, as a government analyst.
Inspectors and their powers: Section 21 of the Act provides that the appropriate government can appoint such a person as it hins fit, who meets the prescribed qualification, as an inspector. Section 22 provides for the powers of those inspectors. It empowers an inspector to inspect any premise; take samples of any drug or cosmetics, etc.
Prohibition on manufacturing, sale, or distribution of certain drugs and cosmetics in the public interest: Sections 26 A and 26B provide that the Central Government can by notification in the Official Gazette, regulate, restrict or prohibit the manufacture, sale, or distribution of certain drugs and cosmetics in the public interest.
Penalties: Sections 27 and 27A provide for penalties for those who are responsible for manufacturing, sale, or distribution of drugs and cosmetics which are prohibited under Chapter IV of the Act.
Advisory Boards and Committees: Sections 5, 6, and 7 of the Act provide for the Drugs Technical Advisory Board; the Central Drugs Laboratory, and the Drugs Consultative Committee respectively. It provides that the Central government can consult these boards with respect to matters of a technical nature arising out of this Act.
Exemption to Ayurvedic, Siddha, or Unani drugs: Section 33A of the Act exempts Ayurvedic, Siddha, or Unani drugs from the application of Chapter IV of the Act. Chapter IVA of the Act explicitly deals with Ayurvedic, Siddha, or Unani drugs.
Summary trial: Section 36A provides for offenses that can be summarily triable by the Court. It provides that all offenses punishable with a term of imprisonment up to 3 years (except the offenses triable by Special Court under Section 36AB or Court of Session) will be tried summarily.
Amendments and Updates: The Act has already undergone various revisions in the past to adapt to new challenges and technological developments. That demands that such legislation be updated and modernized to meet today's requirements for regulating new drugs and cosmetics accordingly.
By having those features in it, the Act lays down the way that will ensure that medicines and cosmetics available on the Indian market are both safe and of good quality.
The Drugs Technical Advisory Board, Central Drugs Laboratory, Drugs Consultative Committee
The primary purpose of this Act is to ensure that all drugs and cosmetics sold in the country are safe and efficacious and meet the required quality standards. The Drugs Technical Advisory Board, the Central Drugs Laboratory, and the Drugs Consultative Committee are critical in making and enforcing the rules and regulations for the manufacture, sale, and import of drugs and cosmetics to ensure that they are safe, effective, and of high quality in consonance with the provisions of the Act. Here is a brief detail of each:
The Drugs Technical Advisory Board: Section 5 of the Act provides for the Drugs Technical Advisory Board. The provision is as follows:
Composition: The Central Government forms the DTAB with its members appointed, who are persons of different qualifications in the field of drugs and cosmetics. It comprises government officials, members of the pharmaceutical industry, medical practitioners, and researchers.
Functions: The Board has the following functions:
Advises Central and State Governments on matters of a technical nature concerning the administration of the Act and other functions as assigned by the Act. (Section 5)
Recommends amendments to the said Act and Rules to keep the Acts, Rules, etc., up-to-date in light of the most recent scientific and technical developments. (Section 12, 33)
Reviews and suggests changes in standards for drugs and practices about them to safeguard public health. (Section 8, 10, 16, 18)
The Central Drugs Laboratory: Section 6 of the Act provides for the Central Drugs Laboratory. The provision is as follows:
Establishment: It is to be set up as the central laboratory to test and analyze drugs and cosmetics.
Functions: Section 6(2)(a) provides that the Central government after consultation with the Board make rules prescribing the functions of the Laboratory. Clause 3 of the Drugs and Cosmetics Rules, 1945 provides the functions of the Laboratory. It is as follows:
Carries out testing and analyses samples of drugs and cosmetics forwarded by public regulatory authorities.
Carry out such other duties as entrusted by the Central Government, or with the permission of the Central Government, by a State Government after consultation with the Board.
Role in implementation: The results from this Laboratory will assist the regulatory authorities in initiating action against the manufacture or sale of substandard, misbranded, adulterated, or counterfeit drugs and cosmetics. It gives analytical reports that form the basis of the legal proceedings against the offenders.
The Drugs Consultative Committee: Section 7 of the Act provides for the establishment of the Drugs Consultative Committee. It prescribes as follows:
Composition: Section 7(2) of the Act provides that the members of the Committee will be two representatives of the Central Government that will be nominated by the Government and one representative to be nominated by the concerned State Government.
Function: Advise the Central Government, State Government, and the Board on any matter tending to secure uniform enforcement of the Act throughout India.
Meeting: Section 7(3) provides that the Committee shall meet when it is required by the Central Government. It also has the power to regulate its own procedure.
These regulatory bodies ensure that the drugs and cosmetics manufactured, distributed, and sold in the country meet the regulatory requirements at levels that would assure public health and safety in India.
The Drugs and Cosmetics Rules, 1945
The Drugs and Cosmetics Rules, 1945 (hereinafter referred to as “the Rules”) was framed for proper implementation of the Act. The Rules include some of the following principal features that control the manufacture, distribution, and selling of drugs and cosmetics in India:
Classifications of Drugs and Cosmetics:
Schedules: There are different schedules, like Schedule C, Schedule D, Schedule H, and Schedule X, which provide specifications concerning each category.
Licensing Requirements:
It is compulsory to obtain a license for the manufacture, sale, and distribution of drugs and cosmetics. Specific licenses have to be obtained for different categories of drugs (e.g., Schedules C, C(1), and X).
Copies of the licenses and any certificate of renewal shall be kept on the approved premises and shall be produced for inspection on demand by an Inspector appointed under the Act.
Standards for Drugs and Cosmetics:
Quality Control: Drugs and cosmetics must conform only to the standards of quality, purity, and strength specified in the rules.
Labeling and Packaging: The labeling provisions include what a label shall contain in detail to provide for adequate identification and use.
Provisions for Specific Categories:
Schedule C and C1: The biological and special products, vaccines, sera, etc., are mentioned here with the specific requirements.
Schedule G, H, and X: This includes prescription drugs. There are gradations of control on their sale and distribution.
Conditions for Grant of Approval/Permission:
The raw material and formulations shall conform to the test specifications approved by the Licensing Authority .
Moreover, there is a requirement for approval for the import of raw materials which are new bulk drug substances, and approval for manufacturing new drug formulations under specific rules; for example, 122 A/122 DA, 122 B, 122 D.
Quality Control and Testing:
Each consignment of imported drugs should be accompanied by a test/analysis report to make sure that the quality of drugs at the point of importation is ensured.
All raw materials and packaging materials, as well as the finished products, should be strictly tested and should adhere to certain standards.
Storage and Distribution:
Storage Conditions: Certain conditions of storage are required for the stability and potency of drugs and cosmetics.
Distribution Practices: In order to maintain the principle of distribution, the drugs are handled, stored, and distributed in a proper way.
Documentation and Record-Keeping:
Documentation is an integral part of the quality assurance system. Proper documentation of all processes related to manufacturing, testing, and distribution needs to be kept. This assures traceability and liability.
Documents shall be approved by authorized persons with signatures and dated signatures; such documents shall be available for inspection, and easily accessible.
Labeling and Packaging:
Labels should be clear, and legible, and include all relevant details about the drug or cosmetic. This includes the approved name of the drug, Dosage form, composition, indications, Date of manufacture, expiry date, etc.
Various stages of a product like under test, approved, or rejected should be indicated through differently colored labels to avoid mix-ups and to take proper handlings.
Compliance and Inspections:
The manufacturer shall allow entry to inspectors; inspection of facilities; taking of samples and inspection of records for verifying compliance to provisions of the Act and Rules .
Changes in technical staff or the constitution of the firm shall need to be intimated immediately to the Licensing Authority.
Provisions for Ayurvedic, Siddha, and Unani Drugs:
Part XVI of the Rules is designated for the manufacturing process, labeling, and sale of Ayurvedic, Siddha, and Unani Drugs.
Prohibition and Penalties:
Manufacturing and selling of drugs and cosmetics which do not conform to the prescribed standards is forbidden. In case of failure, there are penalties, and licenses may be suspended or canceled.
Specific provisions of Cosmetics:
The manufacturing and importing of cosmetics are regulated by separate regulations, which include registration certificates, labeling, and quality measures by control over these products.
Cosmetics shall not contain any dye, color or pigment unless it is one of those specified by the Bureau of Indian Standards and in Schedule Q.
Special Economic Zones:
Drugs and cosmetics imported for manufacture and export by the units situated in Special Economic Zones shall have special conditions and shall not be diverted for sale in the domestic market unless they comply with all the requirements of import and registration.
Clinical trial: The Drugs and Cosmetics Rules, 1945, detail miscellaneous provisions for clinical trials to be conducted in India regarding the safety standards, efficacy, and ethical standards of such trials. These are as follows:
Mandatory submission of applications requiring approval by the Central Drugs Standard Control Organization and by Ethics Committees, which need to get registered with it.
Informed consent has to be taken from the participants.
All trials must adhere to the principles of GCP.
Trials have to be registered with the Clinical Trials Registry - India (CTRI) before the first participant is enrolled.
The sponsor shall notify all serious adverse events within 24 hours and shall prepare a periodic safety update.
The participant has the right to receive compensation for injury or death caused due to clinical trials.
The sponsor should have an arrangement for post-trial access to beneficial drugs for the participants.
Upon completion of the trial, a detailed clinical trial report shall be submitted to CDSCO.
Taken collectively, these provisions ensure that drugs and cosmetics manufactured, imported, and sold in India adhere to certain stringent quality and safety standards, in the interest of the protection of public health.
What are the penalties under the Drugs and Cosmetics Act, of 1940?
The Act prescribes punishment for certain offenses. These are as follows:
Offenses under Section 13: Whoever imports-
Any adulterated drug as specified under Section 9A spurious drug as specified under Section 9B or any spurious cosmetic as specified under Section 9D or any other cosmetic as provided under Section 10 (ee): Imprisonment for a term which may extend to 3 years and a fine which may extend to Rs. 5000.
Drugs or cosmetics other than those mentioned in the above clause, import of which is prohibited under Section 10 or any rule made under Chapter III: Imprisonment for a term which may extend to 6 months, or with fine which may extend to Rs. 500, or with both
Drugs or cosmetics in contravention with notification issued under Section 10A: Imprisonment for a term which may extend to 3 years, or with fine which may extend to Rs. 5000, or with both.
Offences under Section 27: Whoever manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes-
Any adulterated drug as specified under Section 17A or spurious as specified under Section 17B when used by any person is likely to cause his death or grievous hurt as per Section 320 of IPC: Imprisonment for a term which shall not be less than 10 years but can be extended to life imprisonment and fine which shall not be less than ten lakhs rupees or three times value of the confiscated drugs, whichever is more.
Drug without a valid license as required under Section 18(c): Imprisonment for a term which shall not be less than 3 years but can be extended to 5 years and fine which shall not be less than one lakh rupees or three times the value of the confiscated drugs, whichever is more.
For subsequent offense: Section 30(1)(a) provides that for a subsequent offense, the person shall be liable to be punished with imprisonment for a term which shall not be less than 7 years but which may extend to 10 years and with a fine which shall not be less than 3 lakh rupees.
Spurious drug as per Section 17B but does not fall under the above clause (a): Imprisonment for a term which shall not be less than 7 years but can be extended to life imprisonment and fine which shall not be less than three lakhs rupees or three times value of the confiscated drugs, whichever is more.
For subsequent offense: Section 30(1)(b) provides that for a subsequent offence, the person shall be liable to be punished with imprisonment for a term which shall not be less than 10 years but which may extend to life imprisonment and with fine which shall not be less than 3 lakh rupees.
Any other drug other than mentioned in above clause (a) or (b) or (c): Imprisonment for a term which shall not be less than one year but can be extended to 2 years and fine which shall not be less than twenty thousand rupees.
For subsequent offense: Section 30(1)(c) provides that for a subsequent offense, the person shall be liable to be punished with imprisonment for a term which shall not be less than 2 years but which may extend to 4 years and with fine which shall not be less than fifty thousand rupees, or with both.
Offenses under Section 27A: Whoever manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes-
Any spurious cosmetic as prescribed under Section 17D or adulterated as prescribed under Section 17E: Imprisonment for a term which may extend to 3 years and fine which shall not be less than fifty thousand rupees.or three times the value of the confiscated cosmetics, whichever is more.
Any cosmetic other than mentioned in the above clause: Imprisonment for a term which may extend to 1 year or with a fine which may extend to twenty thousand rupees, or with both.
For subsequent offense: Section 30(1A) provides that for a subsequent offense under Section 27A, the person shall be liable to be punished with imprisonment for a term which may extend to 2 years, or with a fine which may extend to two thousand rupees, or with both.
Penalty for non-disclosure of the name of the manufacturer: Section 28 provides that any person who contravenes the provisions of Section 18A or Section 24 shall be liable to be punished with imprisonment for a term which may extend to 1 year or with a fine which shall not be less than twenty thousand rupees, or with both.
Penalty for not keeping documents or non-disclosure of information: Section 28A provides that any person who contravenes the provisions of Section 18B shall be liable to be punished with imprisonment for a term which may extend to 1 year or with fine which shall not be less than twenty thousand rupees, or with both.
Penalty for manufacture, distribution or sale of any drug or cosmetic in contravention of Section 26A: Section 28B provides that any person who contravenes the provisions of Section 26A shall be liable to be punished with imprisonment for a term which may extend to 3 years and with fine which may extend to five thousand rupees.
Penalty for use of Government Analyst’s report for advertising: Section 29 of the Act provides that whoever uses the report of a test or analysis made by a Government Analyst for advertising of a drug or cosmetic shall be liable to be punished with a fine which may extend to five thousand rupees.
For subsequent offence: Section 30(2) provides that for subsequent offence under Section 29, the person shall be liable to be punished with imprisonment for a term which may extend to 2 years, or with a fine which shall not be less than ten thousand rupees, or with both.
Confiscation: Section 31 of the Act provides that whenever any person is convicted under Chapter IV of the Act, the drugs and the cosmetics involved in the offense shall be confiscated. Additionally, implements or machinery used in that offense shall also be liable to be confiscated.
Penalty for vexatious search or seizure: Section 34AA of the Act provides that any inspector while exercising his power under the Act or the rules acts vexatiously and unnecessarily shall be liable to be punished with fine which may extend to one thousand rupees.
Case laws related to the Drugs and Cosmetics Act, 1940
In the case of Laborate Pharmaceuticals India Ltd. & Ors. v. State of Tamil Nadu (2017), the Tamil Nadu Drug Inspector collected a sample of "Cherry Lab Cough Syrup" from a retail shop on September 5, 2011. The analysis report declared the drug substandard on January 27, 2012. The accused company to whom a show cause notice was issued, challenged the findings by demanding re-analysis, which was refused. Subsequently, the Drug Inspector filed a complaint under the Drugs & Cosmetics Act, of 1940. The accused preferred an appeal before the Madras High Court, placing reliance on the proposition that the limitation for filing an appeal should commence from the date of receipt of the sample and not from the date of receipt of the report. The High Court held that a 28-day appeal period from the date of receipt of the report would apply. The Supreme Court, however, came out on the accused's side by upholding their right to challenge the test results, quashing the prosecution, and setting aside the order of the High Court. This ruling marked an increased focus on procedural fairness and statutory rights in regard to prosecutions related to the quality of drugs.
In the case of Drugs Inspector & Anr. v. Fizikem Laboratories Pvt. Ltd. & Anr. (2008), an appeal was filed against an order of the Andhra Pradesh High Court, pertaining to the territorial jurisdiction of a Drugs Inspector under the Drugs and Cosmetics Act, 1940. He had initiated prosecution for allegedly manufacturing and selling Ayurvedic drugs, namely Ozomen capsules and Ozomen forte, which contained sildenafil citrate, a component for the manufacture of which a licence was requisite under the Act. The High Court held that a prosecution under Section 32 of the Act could only be launched by an Inspector appointed under Chapter IVA, which applied to Ayurvedic, Siddha, and Unani drugs. This was challenged on the ground that the drugs involved contained an allopathic ingredient, namely, sildenafil citrate, which was outside Chapter IVA and therefore within the ambit of Chapter IV. However, the Supreme Court reversed this judgment and allowed prosecution under Chapter IV by the Inspector therein authorized. The Court pointed out offensive acts of the accused under Section 18 of the Act, which relates to, inter alia, the manufacture and sale of drugs not conforming to the standard quality or being misbranded, punishable under Section 27. Thus, the ruling brings out the statutory interpretation of the question of jurisdiction and application of Chapters V and VI of the Act in prosecuting offenses connected with the standard of drugs and licensing.
The case of Glaxosmithkline Pharmaceuticals Ltd. & Anr v. State of M.P. (2011) was an appeal against a complaint under the Drugs and Cosmetics Act, 1940, for the failure of Betnesol tablets to conform to the standard specification in an analysis. The appellants, a drug company and its officers challenged the validity of the analysis and the complaint for which the prosecution was launched. The Court found that appellants were bound by the analyst's report as they failed to challenge it within the statutory 28-day period. As such, they could not dispute the conclusion at any time after the proceedings thus, in law, re-affirming the conclusiveness of an analyst's report under the Act.
In the case of M/S. Medicamen Biotech Ltd. & Anr vs Rubina Bose, Drug Inspector (2008), the appeal relates to the Enalapril Maleate tablets manufactured by the appellant, which were sampled by the Drugs Inspector and sent for analysis to the Central Drugs Laboratory, which reported them as not of standard quality. The appellant challenged the report and applied for re-analysis which was not promptly disposed of. The principal controversy in the case was about Sections 23 and 25 of the Drugs and Cosmetics Act, 1940, and the appellants' right to challenge the primary analysis and get the sample sent to the Central Drugs Laboratory for re-testing. The court held that there was no delay on the part of the appellant in challenging the primary report and, therefore, they were entitled under Section 25(4) to re-testing. The court quashed the proceedings against the appellant on the ground that there was much delay in filing the complaint followed by procedural defects.
Thus, the Drugs and Cosmetics Act, of 1940 forms one of the strong pedestals of the Indian regulatory framework, minutely governing the import, manufacture, distribution, and sale of drugs and cosmetics in the country. Enacted particularly for having safeguards to public health and consumer safety, the Act accomplishes these objectives through rigorous regulation, enforcement of quality standards, and checking mechanisms. It ensures licensing requirements, adherence to the strict manufacturing practice, and penalties for violation in order to check malpractices. The Act has undergone many changes, proving its adaptability in meeting newly emerging challenges and advances in technology, strongly setting the base for a marketplace that does not compromise on safety, efficacy, and quality. In view of the strides that India has been taking in the healthcare and cosmetic industries, it is unfazed in its commitment to public trust and health outcomes in the country.
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