"Quality shouldn't be an afterthought but an integral part of manufacturing process"

At the 63rd Annual Day Celebrations of the Indian Drug Manufacturers' Association (IDMA) held in Mumbai on February 8, Dr Rajeev Raghuvanshi, Drugs Controller General of India (DCGI), emphasised the importance of execution over excessive regulation.

- Bhagwati Prasad

Speaking at the event, themed “Innovating Today For Healthier Tomorrow”, he advocated for a balanced approach where compliance is strengthened through practical implementation rather than regulatory overreach. In an interaction with BioSpectrum he has called for industry-wide collaboration, urging larger pharma companies to mentor MSMEs and elevate standards. Edited excerpts:

How does the revised implementation of Schedule M align India’s pharmaceutical sector with global GMP standards?

Schedule M has been revised to align Indian pharmaceutical manufacturing with global Good Manufacturing Practices (GMP), bringing India closer to international regulatory expectations, and making our pharmaceutical products globally more competitive. The objective is to ensure consistent quality, safety, and efficacy, thereby strengthening India's reputation as a trusted supplier of medicines.