Revised Schedule M gave smaller drug makers one extension, and it ran out on 31 December 2025

Every manufacturer licensed under rule 74, 76 or 78 of the Drugs Rules, 1945 has been bound by the revised Schedule M since 31 December 2025 at the latest: since 28 June 2024 above INR 250 crore, and since 28 December 2024 for a smaller manufacturer that did not file Form A. The only relief we have found is G.S.R. 127(E) of 11 February 2025. It let a manufacturer with turnover under INR 250 crore apply, within three months and with an upgradation plan, for time to 31 December 2025, the last date any instrument we have found gives. As at 14 October 2026, that date is more than nine months past.

What changed, and from when?

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. Rule 5 of the notification substitutes Schedule M in its entirety. Rules 2 to 4 change the words used in rules 74, 76 and 78, the provisions on manufacturing licences, so that a licensee now complies with "Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products" rather than with good manufacturing practices alone.

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, ten months after it was made.

The new Schedule is long. Part I sets out the main principles, and Parts II to XII add specific requirements by product type: sterile products, hazardous substances such as sex hormones, steroids and cytotoxics, biologicals, radiopharmaceuticals, phytopharmaceuticals, investigational products for clinical trials, tablets and capsules, oral liquids, topical products, metered dose inhalers and active pharmaceutical ingredients. Part XIII lists the plant and equipment expected for each dosage form, with minimum floor areas.

Who is caught, and by which date?

Rule 6 of G.S.R. 922(E) does not start the Schedule on one day. It sorts manufacturers by turnover. A large manufacturer, with turnover above INR 250 crore, had six months from publication. Small and medium manufacturers, with turnover at or below INR 250 crore, had twelve. Counted from 28 December 2023, that is 28 June 2024 for the first group and 28 December 2024 for the second.

The rule does not say which year's turnover counts, or whether turnover is the licensee's own or its group's. The form later annexed to G.S.R. 127(E) asks for the turnover of April 2023 to March 2024, which is the closest the instruments come to an answer.

The duty attaches through the licence. Rule 74(o) of the Drugs Rules makes compliance with Schedule M a condition of a licence in Form 25 and Form 25F, rule 76(8) imposes it on licences for drugs in Schedules C and C(1), and rule 78(p) does the same for a licence in Form 28, 28B or 28D. Section 18(c) of the Act then 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.

What did the February 2025 extension actually give?

By 28 December 2024 the twelve months had run for the smaller manufacturers. A draft, G.S.R. 10(E), followed on 4 January 2025 with seven days for objections, and the final rule, G.S.R. 127(E), was published on 11 February 2025 and came into force that day.

It inserts a proviso into rule 6 of the 2023 rules. Three conditions run together:

1. The manufacturer has turnover of less than INR 250 crore.
2. It applies to the Central Licence Approving Authority in Form A within three months of publication, which is by 11 May 2025.
3. The application carries a plan of upgradation.

For a manufacturer that met all three, the proviso says the timeline "shall be extended till 31st day of December, 2025". Form A asks for more than a plan. It wants a gap analysis under eight heads (plant, equipment, laboratory equipment, heating, ventilation and air conditioning (HVAC), utilities, technical staff, documentation and others), 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.

Two features of the extension are easy to miss. It was not automatic: a manufacturer that did not file Form A kept the original date of 28 December 2024. And the extension came in after that date had already passed, so for the forty-four days from 29 December 2024 to 10 February 2025 no smaller manufacturer had any extended date to point to.

What does the Schedule require that the old one did not?

Much of the substance is a move from a list of premises standards to a quality system. Part I opens by making the manufacturer responsible for products that are fit for their intended use and "do not place patients at risk", and places the ultimate responsibility for the pharmaceutical quality system on senior management. Paragraph 1.6 requires management reviews of that system at least annually unless otherwise justified.

Four requirements tend to carry the cost.

Product quality review. Paragraph 2.3 requires regular quality reviews of every product, including products made only for export, normally documented annually. Each review covers starting materials and supply chain traceability of active substances, failed batches, significant deviations, changes, the stability programme, and returns, complaints and recalls.

Quality risk management. Paragraph 2.1 makes risk management a systematic process, applied proactively and retrospectively.

Recall. Paragraph 7 requires a recall system run by the authorised person, written procedures, testing of the arrangements from time to time, and a duty to inform the licensing authorities of any intention to recall a product because it is, or is suspected of being, defective.

Premises and equipment. The note at the head of the Schedule requires the manufacturing premises to be used exclusively for drugs. Part XIII recommends minimum areas and equipment by dosage form, and the sterile and hazardous substance Parts carry their own air handling and segregation rules. These are the items in the Form A gap analysis, and they are the ones that need capital rather than paperwork.

What does the timetable look like on the figures?

The figures below are an illustration only. The turnovers are invented; the dates are the ones the instruments fix.

Manufacturer A, turnover INR 400 crore (2023-24)
  Category under rule 6                  large
  Compliance date                        28 June 2024
  Days from 28 December 2023             183
  Eligible for G.S.R. 127(E)             no

Manufacturer B, turnover INR 180 crore (2023-24)
  Category under rule 6                  small or medium
  Original compliance date               28 December 2024
  Form A filed on                        30 April 2025
  Plan to start by                       31 March 2025
  Upgradation to begin by                30 July 2025
  Extended compliance date               31 December 2025
  Days from 28 December 2023             734

Manufacturer C, turnover INR 250 crore exactly (2023-24)
  Category under rule 6                  small or medium (at or below 250)
  Original compliance date               28 December 2024
  Eligible for G.S.R. 127(E)             on the words, no (not less than 250)

Manufacturer D, turnover INR 120 crore, no Form A filed
  Compliance date                        28 December 2024

Manufacturer B's plan date sits before its application date. Form A asks for a plan starting on or before 31 March 2025, whenever the form is filed, so a manufacturer filing in April or May 2025 had to show work already under way. Manufacturer C is the case the drafting creates: inside the twelve month group under G.S.R. 922(E), outside the extension under G.S.R. 127(E).

What happens to a licence that is not compliant?

The Drugs Rules give the licensing authority the tool directly. Rule 85 allows the Central Licence Approving Authority, or the licensing authority for licences it granted, to act after a show cause notice and by a reasoned written order. The order may cancel a licence, suspend it wholly or for particular drugs, or direct the licensee to stop manufacture, sale or distribution, where the licensee has failed to comply with any condition of the licence. Compliance with Schedule M is one of those conditions under rule 74(o). The licensee has ninety days from receipt of the order to appeal to the Central or State Government, which may confirm, reverse or modify it.

For a board, this places the exposure on the licence and the product rather than on a fine. A suspension can be confined to particular drugs, so a plant that meets the Schedule for tablets but not for its sterile line can lose the sterile line alone. For a company that buys finished product from a contract manufacturer, the same position runs up the supply chain: the licence at risk is the manufacturer's, and the product at risk is the buyer's.

What remains unsettled?

Four questions.

Whether turnover means the licensee's or the group's, and for which year. Rule 6 is silent on both. Form A fixes 2023-24 for the extension, but it does not amend rule 6, and a manufacturer whose turnover crossed INR 250 crore in a later year has no instrument telling it which category it is in.

Whether a manufacturer at exactly INR 250 crore had any route to the extension. G.S.R. 922(E) puts it in the twelve month group. G.S.R. 127(E) reaches only turnover "less than" INR 250 crore. On the words, it had none.

Whether a manufacturer that filed Form A but was refused, or was never told the outcome, had the benefit of 31 December 2025. The proviso says the timeline "shall be extended" for such manufacturers, which reads as following from the application rather than from a grant. Nothing in the instrument provides for a decision on the form.

Whether anything follows 31 December 2025. We have found no notification after G.S.R. 127(E) that moves the date. G.S.R. 127(E) also amends the rules by a name, "Drugs (Amendment) Rules, 2023", that matches neither the original blank nor the corrected title, though nothing turns on that so far.