Drugs (Second Amendment) Rules, 2023

What it does

The Ministry of Health and Family Welfare notified G.S.R. 922(E) on 28 December 2023, under sections 12 and 33 of the Drugs and Cosmetics Act, 1940, after a draft first published as G.S.R. 999(E) on 5 October 2018. Its principal effect is to substitute Schedule M to the Drugs Rules, 1945 in its entirety.

Schedule M sets the standard of good manufacturing practices, and the new Schedule is titled "Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products". The notification also changes the words of rules 74, 76 and 78, the provisions on manufacturing licences, so that a licensee is bound to the revised standard and not to good manufacturing practices alone.

The revised Schedule is long. Part I states the main principles. Later parts add requirements for particular products, including sterile products, hazardous substances such as sex hormones, steroids and cytotoxics, biological products, radiopharmaceuticals, phytopharmaceuticals, investigational products for clinical trials, tablets and capsules, oral liquids, topical products, metered dose inhalers and active pharmaceutical ingredients. A further part lists the plant and equipment expected for each dosage form.

Who it binds

Every manufacturer that holds a licence under rule 74, 76 or 78 of the Drugs Rules, 1945. The duty attaches through the licence. Compliance with Schedule M is a condition of the licence, and the Act prohibits manufacture for sale except in accordance with the conditions of a licence. A manufacturer that does not meet the Schedule is therefore outside the terms on which it may make the product.

The notification does not apply on one day to everyone. It sorts manufacturers by turnover, and the date by which each had to comply depends on the group.

What has changed, and when

The notification went out without a number in its short title. A corrigendum, G.S.R. 666(E) of 25 October 2024, named it the Drugs (Second Amendment) Rules, 2023.

Rule 6 gave a manufacturer with turnover above INR 250 crore six months from publication, which ended on 28 June 2024, and a smaller manufacturer twelve months, which ended on 28 December 2024. A later notification, G.S.R. 127(E) of 11 February 2025, let a manufacturer with turnover under INR 250 crore apply within three months, with a plan of upgradation, for time up to 31 December 2025. The site's note on revised Schedule M records that this is the last date any instrument it has found gives, so the Schedule binds every licensed manufacturer as at 28 October 2026.

What turns on it in practice

For a manufacturer, the question is not whether the Schedule applies but how far the premises, equipment and records meet it, and what the licensing authority will accept as evidence. The extension was available only on application and with a plan, so a manufacturer that did not apply by the stated date has no relief to rely on. Turnover, which decided the group a manufacturer fell in, is not defined with precision in the rules, and the form later annexed to the extension asks for the turnover of the year ended March 2024.

For a company that buys from, invests in or acquires a drug maker, compliance with the revised Schedule is a diligence item with consequences for the licence and for the continuity of supply. A finding of non-compliance can affect the licence on which the business depends, and the cost of upgrading a plant is a matter for the price. The firm's healthcare practice treats the revised Schedule as one of the standing conditions of a manufacturing licence, read with the Drugs Rules, 1945 and the later amending rules.