The Ministry of Health and Family Welfare (MoH&FW) on May 25, 2026, issued the Drugs (Third Amendment) Rules, 2026, further to amend the Drugs Rules, 1945.
The following has been stated:
• Schedule B and Schedule B(1) have been substituted, which prescribe the fees charged by Central and State Drug Laboratories, the Pharmacopoeial Laboratory for Indian Medicine (PLIM), and Government Analysts for testing and analysis of drugs, vaccines, sera, homeopathic medicines, herbal medicines, and AYUSH products.
• The revised schedules introduce a comprehensive and updated fee structure covering animal-based assays, microbiological tests, identification tests, physical and chemical tests, chromatography, vaccine potency and stability testing, sterility testing, toxicity studies, and analysis of herbal and homeopathic medicines.
• The amendment also provides that the concerned laboratory authorities will determine fees for tests not specifically listed and that all prescribed testing and analysis fees will automatically increase by 5% annually.
• These amendments will come into force from August 30, 2026.
[Notification no. - G.S.R. 407(E)]
