The Indian government has continued its efforts to promote research and innovation and improve the ease of doing business in the pharmaceutical sector. In the latest development, the Ministry of Health and Family Welfare (MoHFW) has proposed amendments to the Drugs Rules, 1945, to simplify the process for obtaining permission to import drugs for examination, testing, or analysis — commonly referred to as Form 11.
Under the proposed amendment, an acknowledgement-based system will be introduced for the import of all drugs in small quantities intended for analytical and non-clinical testing purposes.
As per the revised framework, applicants will only need to submit a prior intimation form and will be permitted to proceed with imports once an acknowledgement is generated upon submission.
However, the simplified procedure will not apply to certain categories of drugs, including sex hormones, cytotoxic drugs, beta-lactam drugs, biologics containing live microorganisms, and narcotic and psychotropic substances. These categories will continue to require prior licensing approval.
In January 2026, the MoHFW had amended the New Drugs and Clinical Trials Rules, 2019, introducing a similar notification system for domestic test licences. The latest proposal extends that approach to imported drugs.
According to the ministry, 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 research and development purposes. The move is also expected to support start-ups and pharmaceutical companies by enabling quicker initiation of testing and analysis activities.
The planned online intimation system is intended to provide stakeholders with a faster and more seamless approval pathway.
The government believes the measure will strengthen India’s research and innovation ecosystem while creating a more efficient and streamlined regulatory environment for the pharmaceutical industry. The proposal 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 released for public consultation. The draft Gazette Notification is available on the e-Gazette portal.
