Drugs (Twelfth Amendment) Rules, 2026: Rule 89 Form 29 Licence Categories Expanded | Pharminho


G.S.R. 713(E)
Dated 6 August 2026
Effective 7 August 2026

MoHFW notifies G.S.R. 713(E), amending Rule 89 of the Drugs Rules, 1945 to bring eight additional manufacturing licence forms within its ambit — expanding the categories recognised for Form 29 applications.

The Ministry of Health and Family Welfare (Department of Health and Family Welfare) has notified G.S.R. 713(E), dated 6 August 2026, further amending the Drugs Rules, 1945. Published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii) (Gazette No. 649, dated 7 August 2026), the notification formally brings into force the Drugs (Twelfth Amendment) Rules, 2026. The amendment touches Rule 89, substituting the list of manufacturing licence Forms it references — from the existing “Form 25 or Form 28” to a considerably expanded set of eight additional forms. For manufacturers and loan licensees planning a Form 29 application, this changes which underlying manufacturing licence categories are now recognised under the rule.

Background: From Draft to Final Notification

This amendment did not arrive without process. The Central Government had first published the draft rules on 21 April 2026 as G.S.R. 299(E), under sub-section (1) of Section 12 and sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940, inviting objections and suggestions from affected persons. Copies of that draft Gazette were made available to the public on 22 April 2026, opening the statutory thirty-day objection window.

Having considered the objections and suggestions received, the Central Government — after consultation with the Drugs Technical Advisory Board (DTAB), as required under Sections 12 and 33 of the Act — has now finalised the rule in its present form. The notification also records that the Drugs Rules, 1945 were most recently amended prior to this via G.S.R. 706(E), dated 30 July 2026, underscoring the pace of rule-making activity on the Drugs Rules through mid-to-late 2026.

Effective date

The Drugs (Twelfth Amendment) Rules, 2026 come into force from the date of their publication in the Official Gazette — i.e., 7 August 2026. There is no separate grace or transition period specified in the notification.

What Changed: Rule 89 Amendment

Rule 89 of the Drugs Rules, 1945 — the rule governing the categories of manufacturing licence forms recognised for the purpose of obtaining a licence in Form 29 — previously referred only to “Form 25 or Form 28”. The amendment substitutes this with a materially longer list of licence forms.

Rule 89 — Prior Position Rule 89 — As Amended by G.S.R. 713(E)
Form 25 or Form 28 Form 25 or Form 25A or Form 25F or Form 28 or Form 28A or Form 28B or Form 28D or Form 28DA or 28E or Form 28F

Forms Newly Brought Within Rule 89

  • Form 25A
  • Form 25F
  • Form 28A
  • Form 28B
  • Form 28D
  • Form 28DA
  • Form 28E
  • Form 28F
Note on scope: The notification itself amends only the cross-reference within Rule 89 — it does not reproduce the substantive text of Rule 89 or redefine what Forms 25A, 25F, 28A, 28B, 28D, 28DA, 28E and 28F individually authorise. Manufacturers should cross-check the current text of Rule 89 and the corresponding Form definitions in the Drugs Rules, 1945 (as amended) to confirm exact applicability to their specific licence category before relying on this expanded list for a Form 29 application.

Compliance Implications

For Manufacturing Licensees

  • Entities holding a manufacturing licence under any of the newly added Forms (25A, 25F, 28A, 28B, 28D, 28DA, 28E, 28F) should re-assess whether they now fall within Rule 89’s ambit for Form 29 purposes, where previously only Form 25 and Form 28 holders were covered.
  • Loan licence holders in particular (Forms typically ending in “A”, such as 25A and 28A) should confirm with their state licensing authority how this expanded list applies to their specific manufacturing arrangement.

For Regulatory Affairs and QA Teams

  • Update internal licence-mapping registers and SOPs that reference Rule 89 or Form 29 eligibility criteria to reflect the amended list.
  • Where a Form 29 application is pending or contemplated, confirm the current underlying manufacturing licence Form is now expressly covered under the amended Rule 89 before proceeding.

How Vaayath Can Help

Vaayath Consulting Services assists manufacturers, loan licensees, and importers in mapping Drugs Rules, 1945 amendments — such as this Rule 89 update — against their existing licence portfolio, and in preparing accurate Form 29 and related applications for submission to the State/Central Licensing Authority. For a licence-category assessment specific to your manufacturing setup, write to us at info@vaayath.com.

Conclusion

G.S.R. 713(E) is a narrow but consequential amendment: by expanding Rule 89’s list of recognised manufacturing licence Forms from two to ten, it widens the pool of licensees who may now rely on this rule when applying for a Form 29 licence. Manufacturers and loan licensees holding any of the eight newly added Forms should review their eligibility promptly, given the amendment is already in force.

Source: Gazette of India, Extraordinary, Part II, Section 3(ii), No. 649, dated 7 August 2026 — G.S.R. 713(E), F. No. X.11014/03/2026-DR, signed by Harsh Mangla, Joint Secretary, MoHFW.

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