Drugs (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. Rule 5 of that notification substitutes Schedule M of the Drugs Rules, 1945 in its entirety. Schedule M is the schedule of good manufacturing practice, and the replacement is the revised Schedule M. Rules 2 to 4 change the words in rules 74, 76 and 78 of the Drugs Rules, the rules on manufacturing licences, so that a licensee complies with good manufacturing practices and the requirements of premises, plant and equipment for pharmaceutical products rather than with good manufacturing practices alone.

The new Schedule is long. Part I states the main principles, and later parts add requirements by product type, including sterile products, biologicals, tablets and capsules, oral liquids and active pharmaceutical ingredients. A final part lists the plant and equipment expected for each dosage form.

Who it binds

Every manufacturer licensed under rule 74, 76 or 78 of the Drugs Rules, 1945. The notification does not start the Schedule on a single day. It sorts manufacturers by turnover. A manufacturer with turnover above INR 250 crore had six months from publication, which ran to 28 June 2024. A smaller manufacturer, at or below that figure, had twelve months, which ran to 28 December 2024.

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. A later notification, G.S.R. 127(E) of 11 February 2025, refers to it as the Drugs (Amendment) Rules, 2023, a name that matches neither the original blank nor the corrected title. This page is written for the name as it appears in that later notification, and it deals with the same December 2023 instrument. A reader citing the rules should use the notification number as well as the title.

The only relief the site has found is the Drugs Amendment Rules, 2025 (G.S.R. 127(E) of 11 February 2025). It allowed a manufacturer with turnover under INR 250 crore to apply, within three months and with an upgradation plan, for time to 31 December 2025. That is the last date any instrument found gives. No later notification moving the date has been found.

What turns on it in practice

A manufacturer in the smaller class that did not file the form for an extension has been bound since 28 December 2024. One that did, and was given time, has been bound since 31 December 2025 at the latest. As at 28 October 2026 that date is past, so the question for a licensee is no longer whether time is available but whether its premises, plant and quality system meet the Schedule, and what a licensing authority may do if they do not.

For an acquirer or investor in a pharmaceutical maker, compliance with the revised Schedule is a diligence point, since the Schedule is now a condition of the manufacturing licence. The naming problem is a practical one too. A pleading, contract or compliance record that cites the instrument by one of the three names should give the notification number so that the instrument is not misidentified.