India invites public comments on amendment to Drugs Rules, 1945
TL;DR
India has proposed amendments to the Drugs Rules, 1945 for ASU drugs, inviting public comments until March 21, 2025. Key changes include removing annual license declarations, adding QR codes and font size requirements on labels, and updating qualification criteria and GMP standards. These aim to modernize regulations, enhance transparency, and improve quality control.
Tags
India has released a draft amendment to the Drugs Rules, 1945, focusing on Ayurvedic, Siddha, and Unani (ASU) drugs, inviting public feedback until March 21, 2025. The proposed changes aim to modernize regulatory frameworks, enhance transparency, and align with evolving industry standards. Key revisions include the removal of annual self-declaration requirements for ASU drug manufacturing licenses, while retaining their perpetual validity. Labels will now mandate QR codes for ingredient details and a minimum font size of nine points for readability, alongside explicit disclosure of base material quantities.
The amendments also broaden qualification criteria for ASU drug testing personnel, recognizing degrees under the National Commission for Indian System of Medicine Act, 2020, and pharmacy (ASU) graduates from recognized institutions. For microbiologists, eligibility expands to include those with relevant experience or postgraduate qualifications. Additionally, the draft introduces stricter Good Manufacturing Practices (GMP), such as mandatory five-micron air filtration, stainless-steel workbenches, and separate storage for flammable materials.
Manufacturers of ASU drugs approved via accelerated stability studies must submit real-time data for shelf-life determinations beyond two years. The proposed rules also designate NABL-accredited laboratories under the Ministry of Ayush as Central Drug Laboratories for ASU drugs. These updates reflect efforts to standardize quality control, reduce regulatory burdens, and improve consumer information, potentially influencing compliance costs and market competitiveness for pharmaceutical stakeholders. The comment period remains open until the specified deadline.
