Last Updated on June 27, 2026 6:21 pm by BIZNAMA NEWS
Centre Proposes Instant Online System to Ease R&D Drug Imports
A AKHTER / NEW DELHI
In a major regulatory reform aimed at boosting pharmaceutical R&D, the Union Ministry of Health and Family Welfare has proposed sweeping amendments to the Drugs Rules, 1945. The change will scrap traditional licensing requirements for importing small quantities of drugs for testing and analysis (commonly known as Form 11), replacing it with an instant, acknowledgement-based online system.
The draft notification, issued by the Press Information Bureau (PIB) on Friday, has been placed in the public domain for stakeholder consultation.
The Operational Shift: From Approval to Intimation
The proposed amendment completely reimagines the compliance workflow for pharma companies, research labs, and startups importing drugs for analytical and non-clinical testing:
- The New Protocol: Instead of waiting for a formal import license, applicants will simply submit a prior intimation form via a seamless online gateway. An automated acknowledgement will be generated instantly upon submission, which will serve as the legal clearance to import the consignment.
- The Strategic Objective: By eliminating the administrative turnaround time for Form 11, the government expects to significantly lower the compliance burden, allowing domestic firms and startups to accelerate their clinical pipelines and initiate testing without regulatory lag.
High-Risk Exemptions Apply
To maintain bio-safety and national security controls, the simplified acknowledgement system will not apply to high-risk categories. Prior licensing will still be mandatory for:
- Sex hormones and cytotoxic (cancer treatment) drugs
- Beta-lactam drugs (certain antibiotics)
- Biologics containing live microorganisms
- Narcotic and psychotropic substances
Aligning Domestic and Import Regimes
This move marks the second phase of New Delhi’s broader deregulation strategy for the pharma ecosystem this year. In January 2026, the Health Ministry implemented an identical notification-based system for domestic manufacturing test licenses under the New Drugs and Clinical Trials Rules, 2019. This new amendment effectively extends that same “ease of doing business” framework to international imports.
Stakeholder Feedback Window
The government is inviting industry feedback on the draft. Pharmaceutical companies, trade bodies, and legal experts can submit objections or suggestions to the Under Secretary (Drugs) at the Ministry of Health and Family Welfare (Kartavya Bhawan, New Delhi) or via email at drugsdiv-mohfw[at]gov[dot]in.