The Ministry of Health and Family Welfare issued draft amendments to the Drugs Rules, 1945, requiring manufacturers to inform licensing authorities of changes in manufacturing, excipients, packaging, shelf life, specifications, testing, or documentation. Major and moderate quality changes need prior approval, while minor changes require annual reporting. Objections may be submitted within thirty days.
On 9 March 2026, the Ministry of Health and Family Welfare issued draft amendments to the Drugs Rules, 1945, under the Drugs and Cosmetics Act, 1940. The proposed rules require manufacturers to notify licensing authorities in writing of any changes in manufacturing processes, excipients, packaging, shelf life, specifications, testing, or documentation.
Quality changes are categorized into three levels: major (Level I), moderate (Level II), and minor (Level III). Major and moderate changes demand prior approval due to potential adverse impacts on drug identity, strength, quality, purity, or potency.
Minor changes may be implemented without prior approval, except for shelf-life modifications, but must be reported annually in the first quarter. Certain rules also mandate notification within 30 days of changes. These conditions will be incorporated into multiple licensing forms.
The draft rules are open for public objections or suggestions within thirty days of publication in the Gazette of India, addressed to the Ministry’s Under Secretary (Drugs).