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Draft Drugs Rules amendment: drug makers to authorise a batch-release person

By CAShorts DeskPublished Source: PIB (Ministry of Health and Family Welfare); Gazette of India notifications and the Drugs and Cosmetics Act, 1940, as published by CDSCO.

Draft Drugs Rules amendment: drug makers to authorise a batch-release person
Illustration (AI-generated)

In a draft notification dated 28 October 2026, the Union Health Ministry proposed amending the Drugs Rules, 1945. Applicants for drug manufacturing licences would have to authorise a qualified, experienced person for batch release. Records would be kept for every batch, with a prescribed Batch Release Certificate. The changes would apply three months after final publication.

Syllabus: GS2 · Statutory & Regulatory Bodies; GS2 · Government Policies; GS2 · Health, Education & Human Resources

Why this matters for UPSC

GS2 health and regulatory bodies: drug quality control under the Drugs and Cosmetics Act, 1940. Prelims can ask what Schedule M requires and who the DTAB advises; Mains, accountability in drug regulation.

Why it matters

A patient buying a strip of tablets cannot test them, and has to trust that someone at the factory checked that batch before it left. That check is required today, yet a firm seeking a licence need not say who will make it. If the draft becomes law, every release decision would carry a known person's signature and a record in one standard form. An inspector tracing a faulty batch could then see who cleared it and on what evidence, and a company could not spread the blame across its staff. The change is part of a wider shift in drug regulation, from catching bad medicines after they reach shops to preventing them on the factory floor.

Prelims pointers

  • The Drugs and Cosmetics Act, 1940 bars making any drug for sale or distribution except under, and on the conditions of, a licence granted under the Act.
  • Under the Drugs and Cosmetics Act, 1940, the Centre makes rules after consulting, or on the recommendation of, the DTAB, and after first publishing them in draft.
  • In urgent cases the Centre may make rules without consulting the DTAB, but must then consult the Board within six months.
  • The Director General of Health Services chairs the DTAB ex officio; the Drugs Controller, India and the President of the Pharmacy Council of India are among its members.
  • Drug manufacture, sale and distribution are regulated mainly by State authorities; central authorities approve new drugs and clinical trials, set standards and control imported drugs' quality.
  • Schedule M lays down good manufacturing practices and requirements of premises, plant and equipment; Schedule U lists the particulars a maker's records must carry.
  • The revised Schedule M of 2023 also covers active pharmaceutical ingredients, biological products, sterile products and phytopharmaceuticals in separate parts.

Practise a UPSC-style question

With reference to rule-making under the Drugs and Cosmetics Act, 1940, consider the following statements:

1. The Central Government makes rules under the Act after consulting the Drugs Consultative Committee and after previous publication in the Official Gazette.

2. Where rules are made without consulting the Drugs Technical Advisory Board in urgent circumstances, the Board must be consulted within six months.

Which of the statements given above is/are correct?

  1. (a) 1 only
  2. (b) 2 only
  3. (c) Both 1 and 2
  4. (d) Neither 1 nor 2
Show the answer

Answer: (b) 2 only

Answer: (b) 2 only. The Act ties rule-making to the Drugs Technical Advisory Board, not the Drugs Consultative Committee.

Statement 1: incorrect. The Drugs and Cosmetics Act, 1940 lets the Centre make rules after consulting, or on the recommendation of, the DTAB and after previous publication.

Statement 2: correct. The Act lets the Centre skip consultation in urgent circumstances, but the DTAB must then be consulted within six months of making the rules.

Eliminate: Statement 1 names the wrong body: the rule-making power runs through the DTAB, so it is incorrect. Out: (a), (c).

Eliminate: Statement 2 is the Act's safeguard for urgent rules, six months, so it is correct. Out: (d).

Trap: Look-alike names. The Drugs Consultative Committee is set up under the same chapter of the Act as the DTAB, but the rule-making consultation is with the DTAB.

Remember: Drug rules: DTAB consulted, draft published first; urgent rules need DTAB consultation within six months.

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