The Union Ministry of Health and Family Welfare has announced proposed amendments to the Drugs Rules of 1945. These changes aim to streamline the process for obtaining permission to import drugs for examination, testing, or analysis, commonly referred to as through Form 11. The amendments will introduce an acknowledgment-based system for importing all drugs in small quantities for analytical and non-clinical testing purposes.
The proposed amendment is expected to alleviate the compliance burden on applicants by removing licensing requirements for importing small quantities of drugs for testing or research and development purposes. This move is anticipated to boost research and innovation while enhancing the ease of doing business in the pharmaceutical sector, allowing startups and industries to promptly commence testing or analysis, as per an official statement.
Under the revised provisions, applicants seeking to import such drugs will need to submit a prior intimation form. Upon submission of this intimation, they may import the drug based on the acknowledgment generated. However, certain drugs such as sex hormones, cytotoxic drugs, beta-lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic substances will still require prior licensing, as stated by the ministry.
The Ministry of Health and Family Welfare had previously amended the New Drugs and Clinical Trials Rules of 2019 in January 2026, introducing a similar notification system for domestic test licenses. The current proposed amendment extends this system to cover imports as well. An online intimation system will provide a seamless and immediate gateway for stakeholders. Additionally, the amendment aligns with the government’s ongoing efforts to enhance the regulatory environment, promote business ease, and encourage innovation in the pharmaceutical sector, according to the statement.
Stakeholders are invited to submit objections and suggestions on the draft legislation to the Under Secretary (Drugs), Ministry of Health and Family Welfare, as highlighted in the statement.
