The Central Government has issued draft rules proposing amendments to the Drugs Rules, 1945 after consultation with the Drugs Technical Advisory Board. The draft introduces requirements for manufacturers to inform the licensing authority regarding changes in manufacturing process, excipients, packaging, shelf life, specifications, testing or documentation. The draft rules have been published for public comments which may be submitted within thirty days from the date the Gazette is made available to the public.

In the Drugs Rules, 1945, provisions are proposed to be inserted after:

• rule 74 (after sub-rule (g))
• rule 74A (after sub-rule (i))
• rule 74B (after sub-rule (3))
• rule 78 (after sub-rule (f))
• rule 78A (after sub-rule (3))
• rule 122P (after sub-rule (iv))

The inserted provisions require manufacturers to notify the licensing authority regarding any change in manufacturing process, excipients, packaging, shelf life, specifications, testing or documentation.

Major and moderate quality changes require prior approval from the licensing authority, while minor quality changes may be implemented without prior approval (except changes relating to shelf life), with annual submission to the licensing authority in the first quarter of every calendar year.

Further, a new condition is proposed to be inserted in Form 25, 25A, 25B, 25C, 25D, 25E, 25F, 28, 28A, 28B, 28C, 28D, 28DA and 28E requiring manufacturers to inform the licensing authority of such changes and obtain prior approval for major or moderate quality changes.