Drugs Amendment Rules, 2025

What it does

The Rules, published as G.S.R. 127(E) on 11 February 2025, amend the Drugs (Second Amendment) Rules, 2023, which substituted a revised Schedule M to the Drugs Rules, 1945. Schedule M states the good manufacturing practices and the requirements for premises, plant and equipment that a drug manufacturer must meet. The 2023 amendment gave manufacturers a period to comply, and this instrument changed that period for some of them.

It inserts a proviso into the transition rule of the 2023 amendment. A manufacturer with turnover of less than INR 250 crore could apply to the Central Licence Approving Authority in a prescribed form, within three months of publication, with a plan of upgradation. For a manufacturer that met all three conditions, the timeline was extended to 31 December 2025.

The extension was not automatic. The application form asks for a gap analysis under eight heads, among them plant, equipment, laboratory equipment, heating, ventilation and air conditioning, utilities, technical staff and documentation. It asks for a compliance plan starting on or before 31 March 2025, the time sought, capped at 31 December 2025, and a justification. It ends with an undertaking, signed by a director, partner, proprietor or authorised signatory, to begin upgradation within three months of the application.

Who it binds

Manufacturers holding licences under rules 74, 76 and 78 of the Drugs Rules, 1945, and in this instrument only those with turnover under INR 250 crore that applied in time. The Central Licence Approving Authority is bound as the body that receives and acts on the applications. A manufacturer above that turnover, or one that did not file, had no extension.

What has changed, and when

The Ministry of Health and Family Welfare notified the revised Schedule M as G.S.R. 922(E) on 28 December 2023 under the Drugs and Cosmetics Act, 1940. A corrigendum of 25 October 2024 named it the Drugs (Second Amendment) Rules, 2023. Its transition rule gave a manufacturer with turnover above INR 250 crore six months, ending 28 June 2024, and a smaller one twelve months, ending 28 December 2024.

A draft of this amendment, G.S.R. 10(E), followed on 4 January 2025 with seven days for objections, and the final rule came into force on publication on 11 February 2025. Three months from publication ended on 11 May 2025, which was the last date to file. The extended date of 31 December 2025 has passed, and the site's note records that no later instrument giving more time has been found.

What turns on it in practice

Because the extension came after the original date had passed, no smaller manufacturer had an extended date for the forty-four days from 29 December 2024 to 10 February 2025. A manufacturer that did not file kept the original date of 28 December 2024.

The consequence is now plain. Since 31 December 2025 at the latest, every manufacturer licensed under the rules named above has been bound by the revised Schedule M. The duty attaches through the licence: compliance with Schedule M is a condition of the licence, and section 18(c) of the Act prohibits manufacture for sale except in accordance with the conditions of a licence. A manufacturer that does not meet the Schedule is outside the terms on which it may make the product at all.

The questions that arise for a client in the healthcare sector are practical. A buyer or a contract manufacturing customer may ask whether a supplier filed the form in time and whether its upgradation plan was carried through. A supplier that relied on the extension needs the application and the acknowledgement on file. An acquirer of a plant should treat the manufacturer's Schedule M status as a point of diligence, because the cure is capital expenditure on premises and quality systems and not a filing.

The rule does not say which year's turnover decides the threshold, or whether it is the licensee's own or that of its group. The form annexed to this instrument asks for the turnover of April 2023 to March 2024, which is the nearest the instruments come to an answer.