The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945 to simplify the procedure for obtaining permission for import of drugs for examination, test or analysis. This is commonly known as 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 Ministry of Health and Family Welfare said on Friday.
Under the revised provisions, applicants intending to import such drugs will be required to submit a prior intimation form and may import the drug based on the acknowledgement generated upon submission of such intimation.
“The simplified procedure will 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 will continue to require prior licensing,” the Ministry said.
“It may be recalled that 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 Ministry said.
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.
This will play a substantial role in deregulating the R&D sector in pharmaceuticals and enable start-ups and industries to quickly initiate testing or analysis.
The online intimation system will offer a seamless and instant gateway for the stakeholders.
The initiative is expected to provide a major boost to research and innovation in the country while facilitating more efficient and streamlined regulatory process.
It 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 draft notification has been placed in the public domain for stakeholder consultation.