In a major move to boost pharmaceutical research and innovation, the Union Ministry of Health and Family Welfare has proposed a draft amendment to the Drugs Rules, 1945. The amendment introduces a simplified, acknowledgement-based system for importing small quantities of drugs intended for analytical and non-clinical testing, significantly enhancing the ease of doing business in India.
Under the revised framework, applicants will no longer face the rigid, prior-licensing requirements traditionally known as Form 11. Instead, they can submit an online prior intimation form and immediately proceed with imports using the instantly generated acknowledgement. This seamless digital gateway is designed to slash compliance burdens, allowing startups and established industries to initiate testing and R&D activities without regulatory delays.
To maintain safety standards, prior licensing will remain mandatory for critical drug categories, including sex hormones, cytotoxic drugs, beta-lactam drugs, biologics with live microorganisms, and narcotic or psychotropic substances.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
