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Home / IAS Preparation / Drugs & Cosmetics Act 1940

Drugs & Cosmetics Act 1940: Background, Features & More | UPSC Notes

Last Updated on Feb 07, 2025
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The Drugs and Cosmetics Act, 1940 is an important piece of legislation of India established on the import, manufacture, sale, and distribution of drugs and cosmetics. It makes sure that products sold to the public would be safe, effective, and of quality. The main gist of this Act is the assurance that medicines and cosmetics will not harm users or fail to conform to prescribed standards.

Drugs and Cosmetics Act forms part of the General Studies Paper II under the subject of Governance, Constitution, Polity, Social Justice, and International relations for the UPSC examination. Also, it is an important area under the regulatory framework aspect of health policies in India.

GS Paper

General Studies Paper II

Topics for UPSC Prelims

CDSCO, Categories of Drugs, Regulatory Framework for New Drugs

Topics for UPSC Mains

Drug Safety and Efficacy, Role in Controlling Drug Abuse, Policy Recommendations for Strengthening the Act.

About the Drugs and Cosmetics Act 1940

The Drugs and Cosmetics Act, 1940 was an Act established under British rule and is, therefore, one of the oldest acts relating to the regulation of pharmaceuticals and cosmetics in India. It has been amended several times and lays down stringent guidelines for assuring the safety, efficacy, and quality of finished drugs and cosmetic products sold in the country. While initially, it was set up to check the quackery and fraudulent activities related to drugs manufacture and sale, with time it expanded its perimeter to other dimensions, such as clinical trial, quality control, and the branch of cosmetology.

Background

The origin of the Drugs and Cosmetics Act appears upon the growing concern about the proliferation of spurious and low-quality drugs during the beginning of the 20th century. Recognizing the potential dangers of non-regulated drugs and the consequences to public health, the government commissioned the Bhore Committee to provide an overview. Various suggestions and insights from such committees ushered in the Drugs Act of 1940, known later as the Drugs and Cosmetics Act of 1964-a watershed movement to bring in regulated health products into India.

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Key Features of the Drugs and Cosmetics Act

The Act encompasses various features that are highly essential for the governance of the pharmaceutical and cosmetics industries, respectively.

  • Licensing of Manufacture and Sale: The act renders it imperative that the manufacture and sale of drugs and cosmetics must be duly licensed. The license ensures that only competent persons in the industry are engaged in supply and dispensation.
  • Quality Control: Fixation of control measures to establish the quality, safety, and efficacy of drugs by laying down standards which the manufacturers have to conform to.
  • Testing and Analysis: Statutory testing of the drugs and cosmetics by the government laboratories before they are cleared for the market.
  • Drug Technical Advisory Board (DTAB): This is a statutory body constituted for advising the Central and State Governments on technical matters arising out of the administration of the Act.
  • Drug Consultative Committee (DCC): Committee constituted to ensure that there is consistency in the implementation of the Act between States.
  • Enforcement Authorities: Provision for inspectors and other officers to enforce the Act’s provisions, including the power to conduct searches and seize stock suspected of being substandard.
  • Penalties and Offenses: Describes the different offenses under the Act in detail, stating respective penalties with strict stipulation on violation.

Read the article on Bulk Drug Parks!

Important Schedules of the Drugs and Cosmetics Act

The Act consists of several schedules, each containing standard provisions related to both drugs and cosmetics, the methods of manufacture of drugs, as well as standards of composition. Among these, major ones are included in:

  • Schedule M: Relating to requirements concerning premises, plant, equipment, maintenance, and records.
  • Schedule Y: This lays down norms for the conduct of clinical trials regarding ethics in drug testing, the need for informed consent, and regulatory oversight.
  • Schedule H: This lists drugs available only on prescription and not to be sold without a prescription from a registered medical practitioner.
  • Schedule J: This lists diseases/ailments like AIDS, diabetes, epilepsy, and drugs for which advertisements cannot be issued.
  • Schedule W: This covers cosmetics and explains the requirements for their manufacture and sale.

Read the article on the Drug Price Control Order!

Importance of the Drugs and Cosmetics Act

The importance of the Drugs and Cosmetics Act is its integrated approach toward ensuring safety, efficacy, and quality of drugs and cosmetics available in the market. It has contributed to some important aspects given below :

  • Public Health Protection: The Act endeavors to safeguard public health by regulating the quality of drugs and cosmetics.
  • Standardization: It enforces standardized manufacturing practices, whereby the consumer obtains products that are in accordance with the regulatory standards.
  • Consumer Trust: It builds trust within consumers by ensuring the availability of safe and effective pharmaceutical products.
  • Ethical Compliance: The act guarantees ethics in the development of drugs including clinical trials.

Read the article on the narcotic drugs and psychotropic substances act 1985!

Issues in the Drugs and Cosmetics Act

Despite the broad framework of the Act, the following are some of the issues attributed to it:

  • Enforcement and Compliance: It is tough for full, uniform enforcement of the Act across the states to take place. Hence it causes discrepancies in regulatory practices.
  • Outdated Provisions: Due to developments in medicine and technology, certain provisions of the Act can be regarded as outdated. This means they need to be renewed in a way that regards the modern standards.
  • Spurious Drugs: Spurious drugs is an issue of great concern, the menace makes it more of a challenge for regulators, and even it can be life-taking.
  • Overlapping Regulatory: Overlapping issues and coordination between the state and central drug regulatory machinery can create complications in enforcement.
  • Limited Resources: Laboratories for control of drugs and their enforcement agencies generally lack resources, and this is an influencing factor in regulatory efficiency.

Read the article on the online sale of drugs!

Conclusion

The Drugs and Cosmetics Act, 1940, therefore, so far has been the backbone in the regulation of pharmaceutical and cosmetic industries in India. Although it works satisfactorily in safeguarding the public health and standards of quality, the modern challenges call for continued modification and updating in line with the dynamics of today. More careful, strict enforcement and periodic review will proceed to compose this framework stronger.

Key Takeaways for UPSC Aspirants

  • Drugs and Cosmetics Act, 1940: It is an Act of the Parliament of India that has been enacted to regulate the import, manufacture, distribution, and sale of drugs in India.
  • Introduction: Given the importance of safeguarding safety, efficacy, and quality of the drugs and cosmetics being manufactured and sold within India, it becomes very relevant to deliberate on this particular act. It prohibits substandard, adulterated, and misbranded products from coming into the market.
  • Provisions under the Act: The Act prescribes standards concerning drugs and cosmetics, regulates their distribution, prescribes penalties for non-conformity, and constitutes regulatory authorities.
  • Regulatory Authorities: This includes the Central Drugs Standard Control Organization - CDSCO, State Drug Control Authorities, and the Drug Controller General of India (DCGI).
  • Amendments: Since its inception, the Act has undergone numerous amendments to keep pace with emerging issues and improvements within the pharmaceuticals and cosmetics industry.
  • Implementation: Implementation is done through a multi-tier system involving central and state regulatory agencies, which inspect and test samples, taking punitive measures against those who flout the Act.
  • Significance: Ensures good-quality drugs and cosmetics, keeps public health in good fettle, and advances the integrity of the healthcare system.
  • Impact: Provides a spur to consumer safety, aids growth in the pharmaceutical industry, and ensures compliance with international standards. It helps in maintaining public trust in healthcare products.
  • Issues to be addressed: This would include effective regulatory oversight, rapid changes in industry, regulatory gaps, and counterfeiting among others.
  • Result: This will safeguard consumers against harmful products, efficacy of therapeutic goods and will enhance standards within the pharmaceutical and cosmetic industries.

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Drugs and Cosmetics Act UPSC FAQs

The requirement for keeping pace with the advances in medicine, technology, and international best practices requires updating the Act from time to time through appropriate amendments to keep it on a path of relevance and effectiveness.

The main objective of the Drugs and Cosmetics Act of 1940 is the regulation and monitoring of drugs and cosmetics available in the domestic market with a view to ensuring the safety, quality, and efficacy of the drugs.

The Drugs and Cosmetics Act was first enacted in 1940.

Schedule H prescribes drugs that are not to be sold by retail, except on, and in accordance with, a prescription written by a duly registered medical practitioner.

The Drug Technical Advisory Board (DTAB) advises the government in technical matters arising under the said Act.
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