The Ministry of Health and Family Welfare (MoH&FW) on March 11, 2026, issued the Draft Drugs (...... Amendment) Rules, 2026, to further amend the Drugs Rules, 1945.
The following has been stated:
• The amendments primarily introduce revised provisions for the manufacture and regulation of drugs intended exclusively for export. Manufacturers producing export-only drugs will be required to obtain a specific manufacturing licence and comply with prescribed quality, labelling, and documentation requirements in accordance with the importing country’s standards.
• The draft rules also clarify regulatory procedures, strengthen oversight of export-oriented drug manufacturing, and ensure that such products are not diverted into the domestic market.
• These amendments aim to align India’s drug regulatory framework with international export practices while maintaining safety and compliance standards.
• Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall- C Wing, first floor, Kartavya Bhawan-1, New Delhi, 110001 or emailed at [email protected], by April 10, 2026.
[Notification no. - G.S.R. 173(E)]
