New Delhi, June 26 (IANS) The Union Ministry of Health and Family Welfare on Friday said it has proposed amendments to the Drugs Rules, 1945 to simplify the procedure for obtaining permission for import of drugs for examination, test or analysis, commonly known as through Form 11.
The amendment introduces an acknowledgement-based system for import of all drugs in small quantities for analytical and non-clinical testing purposes.
The amendment is expected to significantly reduce the compliance burden on applicants by eliminating licensing requirements for importing small quantities of drugs for testing or R&D purposes.
The move will promote research and innovation along with enhancing ease of doing business in the pharmaceutical sector enabling start-ups and industries to quickly initiate testing or analysis, an official statement said.
Under the revised provisions, applicants seeking import of such drugs must submit a prior intimation form and may import the drug based on the acknowledgement generated upon submission of such intimation.
“The simplified procedure shall be applicable for import of drugs for analytical and non-clinical testing, except for certain drugs belonging to the categories of sex hormones, cytotoxic drugs, beta lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic substances, which shall continue to require prior licensing,” the ministry said.
The Ministry of Health and Family Welfare had already carried out amendments to the New Drugs and Clinical Trials Rules, 2019 in January 2026 introducing a similar notification system for domestic test licences. The present proposed amendment expands it to imports also.
The online intimation system will offer a seamless and instant gateway for the stakeholders.
The amendment also aligns with the government’s continued efforts to improve the regulatory ecosystem, promote ease of doing business and foster innovation in the pharmaceutical sector, the statement said.
Stakeholders can submit objections and suggestions on draft legislation to the Under Secretary (Drugs), Ministry of Health and Family Welfare, the statement noted.
–IANS
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