New Delhi: Union Ministry of Health and Family Welfare proposed amendments to the Drugs Rules, 1945, to simplify Drug import rules for research, examination and testing. The proposal introduces an acknowledgement-based system. As a result, applicants can import eligible drugs without obtaining prior licences in most cases.
The new system requires applicants to submit an online prior intimation form. They can import the drugs after receiving the acknowledgement generated by the portal. Therefore, the process will become faster and easier.
The revised Drug import rules will apply to imports of small quantities meant for analytical and non-clinical testing. However, sex hormones, cytotoxic drugs, beta lactam drugs, biologics containing live microorganisms, and narcotic or psychotropic substances will continue to require prior licences.
Drug import rules support faster research
Earlier this year, the ministry introduced a similar notification-based system for domestic test licences under the New Drugs and Clinical Trials Rules, 2019. Now, it plans to extend the same approach to imported drugs.
Officials said the amendment will reduce compliance requirements for startups, research organisations and pharmaceutical companies. Moreover, the online system will help them begin testing and analysis without unnecessary delays.
The ministry added that the proposal supports innovation, research and ease of doing business. At the same time, it aims to strengthen the pharmaceutical regulatory framework.
Meanwhile, the ministry has placed the draft notification in the public domain for stakeholder consultation. Interested stakeholders can submit objections or suggestions before the prescribed deadline.
