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 (commonly known as Form 11), according to a draft notification published on June 26, 2026. The proposal introduces an acknowledgement-based system that replaces prior licensing requirements for small quantities of drugs imported for analytical and non-clinical testing, significantly reducing the compliance burden on importers and R&D entities.
Key Features of the Simplified Procedure
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 Ministry stated. The simplified procedure shall be applicable for import of drugs for analytical and non-clinical testing, except for certain categories that shall continue to require prior licensing:
| Category | Examples / Notes |
|---|---|
| Sex hormones | Synthetic or natural hormones affecting reproductive system |
| Cytotoxic drugs | Chemotherapy agents |
| Beta lactam drugs | Penicillins, cephalosporins |
| Biologics containing live microorganisms | Vaccines, live bacterial preparations |
| Narcotic and psychotropic substances | Controlled substances under NDPS Act |
The online intimation system is designed to offer a seamless and instant gateway for stakeholders, according to the Ministry.
Background and Previous Reforms
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 this simplified approach to imports, aligning domestic and import procedures for R&D-related drug testing, the Ministry noted.
Expected Impact on Pharmaceutical R&D and Ease of Doing Business
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, according to the Ministry. 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 initiative is expected to provide a major boost to research and innovation in the country while facilitating a more efficient and streamlined regulatory process, the Ministry added.
Implications for Customs and Import Clearance
The shift from a prior-licensing regime to an acknowledgement-based system for eligible imports streamlines border clearance processes. Importers and customs brokers will no longer need to submit multiple licence applications for small-volume test imports, reducing administrative delays and costs. The online intimation portal will serve as the single interface for import authorization, replacing the previous paper-based Form 11 approval workflow. This aligns with the Government’s continued efforts to improve the regulatory ecosystem, promote ease of doing business, and foster innovation in the pharmaceutical sector.
Stakeholder Consultation and Next Steps
The draft notification has been placed in the public domain for stakeholder consultation, the Ministry confirmed. Industry participants, research organizations, and trade professionals are invited to submit comments before the notification is finalized. The date of final notification and implementation will follow after the consultation period closes.
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