Drugs and Cosmetics Act, 1940

Polity & Governance glossary

Also called: D&C Act · Topic: Statutory, Regulatory and Quasi-judicial Bodies · NCERT: Beyond NCERT

Meaning

The Drugs and Cosmetics Act, 1940 (D&C Act) is India's parent law that controls the import, manufacture, distribution and sale of drugs and cosmetics. It does this through licences and quality standards. The Central and State governments enforce it together. The detailed rules under it are in the Drugs and Cosmetics Rules, 1945.

It matters because almost every check on medicine quality in India comes from this Act or from rules made under it. This includes factory standards, drug schedules and port-of-entry checks. A failure in its enforcement can put unsafe medicines in patients' hands.

Explanation

How the law is built: the Act and its Rules

  • Parent Act (1940): it sets out the basic powers, offences and authorities.
  • Rules (1945): the Drugs and Cosmetics Rules are dated 21 December 1945 and are made under the Act.

  • Recent PIB releases call them the "Drugs Rules, 1945", while India Code calls them the "Drugs and Cosmetics Rules, 1945". Both names refer to the same rules.

  • Delegated legislation (rules made by the executive under powers given by an Act of Parliament):

  • Most changes are made by amending the Rules through a Gazette notification, not by amending the Act.

  • A draft notification is usually published first, with a window for public objections and suggestions.

  • Other rules under the Act: the New Drugs and Clinical Trials Rules, 2019 (the approval route for new drugs) and the Medical Devices Rules, 2017 (for medical devices).

Key parts of the Rules

  • Schedule M: Good Manufacturing Practices (GMP), the standard rules for making medicines safely.
  • It was revised by G.S.R. 922(E) dated 28 December 2023. The revision added a Pharmaceutical Quality System, Quality Risk Management, and Qualification & Validation.
  • It became binding on large manufacturers (turnover above ₹250 crore) from 28 June 2024.

  • Smaller firms (turnover of ₹250 crore or less) got a conditional extension to 31 December 2025.

  • Drug schedules (lists that decide how a drug may be sold), such as Schedules H, H1, K and X.

  • Schedule K lists exemptions.
  • In 2026, formulations with more than 12% v/v ethyl alcohol, in quantities above 30 mL, lost their Schedule K exemption and were moved under Schedule H1.

  • G.S.R. 927(E) of 29 December 2025 withdrew the exemption that let cough syrups be sold in small villages without a licensed pharmacy.

  • Holding a batch: the licensing authority can tell a licensee not to sell a batch whose samples or test protocols it has asked for. The licensee must wait until the authority issues a certificate authorising sale.

  • Imports: health products may come into India only through notified ports of entry.

Who enforces it: a dual Centre–State structure

  • Central Drugs Standard Control Organisation (CDSCO): the central regulator. It sits under the Ministry of Health and Family Welfare (MoHFW) and is headed by the Drugs Controller General of India (DCGI).
  • State Drugs Controllers: they license and inspect sale and most manufacturing within their states.

  • CDSCO and the State Drugs Controllers together carried out risk-based inspections of 400 premises, including MSMEs.

  • Advisory bodies under the Act: the Drugs Technical Advisory Board (technical advice) and the Drugs Consultative Committee (Centre–State coordination).

Limits and gaps

  • Old law, new markets: the 1940 Act was written long before the internet.

  • Draft e-pharmacy rules (G.S.R. 817(E), 28 August 2018) would amend the Drugs and Cosmetics Rules, 1945. They are still not final because the matter is subjudice (pending before courts) in several High Courts.

  • Too few inspectors:

  • CDSCO's sanctioned posts rose from 111 in 2008 to 492 in January 2021.
  • CAG found an 88% vacancy in Karnataka's drugs inspector cadre, and 59% of drugs were used up before their test results came back.

  • In Punjab, only 52 of the 120 drug inspectors required were in post in March 2015.

  • Quality record: a national survey by the National Institute of Biologicals tested 47,954 samples. It found 3.16% not of standard quality (NSQ, meaning the drug failed an official quality test) and 0.0245% spurious (fake).

In the Constitution and practice

  • Constitutional base:
  • "Drugs and poisons" is an entry in the Concurrent List (Seventh Schedule). Both Parliament and the states can make laws on it, which is why enforcement is shared.
  • The Act came before the Constitution. It still applies through Article 372, which keeps existing laws in force until they are changed.
  • Article 47 (a Directive Principle) asks the State to improve public health and to prohibit drugs that harm health.

  • Courts have read a right to health into Article 21, and drug quality checks support that right.

  • Who uses it: MoHFW (which makes the rules), CDSCO and the DCGI (approvals, imports, central licences), State Drugs Controllers (state licences, inspections, sampling) and drug testing labs.

  • How it has worked in practice:
  • Repeated warnings about capacity:
    • A Rajya Sabha committee (2008) on the Drugs and Cosmetics (Amendment) Bill, 2007 found too few drug inspectors and testing facilities.
    • A 2012 parliamentary committee found the regulator understaffed and underqualified.
    • The Mashelkar Committee asked for more drug inspectors with better skills.
    • In 2026, the Parliamentary Standing Committee on Health said long-running Drugs Controller vacancies were still slowing CDSCO's work. It also asked for a specialist cadre.
  • Tightening after the cough-syrup episodes: the revised Schedule M (2023), the end of the village cough-syrup sale exemption (2025) and the alcohol-content shift to Schedule H1 (2026).
  • Planned replacement: the Drugs, Medical Devices and Cosmetics Bill, 2022 would replace the 1940 Act. Among other things, it would let the government set conditions for selling drugs online.

Don't confuse with

  • Drugs and Cosmetics Rules, 1945: the Act (1940) gives the powers. Schedule M, the drug schedules and the batch-hold provisions are in the Rules (1945), not in the Act.
  • Department of Pharmaceuticals: it sits under the Ministry of Chemicals & Fertilizers and handles industry policy (such as PLI). The drug regulator, CDSCO, sits under MoHFW.
  • Food Safety and Standards Authority of India (FSSAI): it regulates food under the FSS Act, 2006. The D&C Act covers drugs and cosmetics. Both come under the Health Ministry.
  • New Drugs and Clinical Trials Rules, 2019: these are rules for approving new drugs and running trials. They are not a separate parent law. The parent law remains the 1940 Act.

Prelims Hooks

  • The Drugs and Cosmetics Rules, 1945 (dated 21 December 1945) are made under the Drugs and Cosmetics Act, 1940.
  • Schedule M = Good Manufacturing Practices. It was revised by G.S.R. 922(E) dated 28 December 2023.
  • Revised Schedule M deadlines: firms with turnover above ₹250 crore from 28 June 2024; firms with ₹250 crore or less, conditionally extended to 31 December 2025.
  • India's drug regulator is CDSCO under MoHFW, headed by the DCGI. It is not under the Department of Pharmaceuticals.
  • Draft e-pharmacy rules: G.S.R. 817(E), 28 August 2018. They are still not final because cases are pending in High Courts.
  • The proposed replacement law is the Drugs, Medical Devices and Cosmetics Bill, 2022.

Mains Points

  • A pre-internet law in an online market:
  • The 1940 Act and the 2018 draft e-pharmacy rules that were never finalised leave online sales of unapproved "wellness" drugs in a grey zone.

  • Passing the 2022 Bill's power to set conditions for online sale would close this gap.

  • Rules on paper vs inspectors on the ground:

  • Stricter standards (revised Schedule M, batch controls) work only if someone checks them.

  • CAG found 88% inspector vacancies in Karnataka and test results arriving after the drugs were used. The Standing Committee asked for time-bound recruitment and a specialist cadre in CDSCO.

  • Centre–State balance in a Concurrent List subject:

  • CDSCO sets standards, but State Drugs Controllers do most inspection and sampling, and their capacity varies from state to state.
  • Reform ideas include steady funding for state testing labs, more accredited labs and mandatory training for State inspectors. These would help protect the right to health under Article 21.

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