Ministry issues revised rules to ensure quality in pharma sector

The Ministry of Health and Family Welfare late last week notified revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945. It also has additional sections including — the introduction of a pharmaceutical quality system, quality risk management, product quality review, qualification and validation of equipment, and a computerised storage system for all drug products. Explaining the rationale, a senior Health Ministry official said the pharmaceutical manufacturing and quality domain has evolved significantly in last 15-20 years. Also, observations from ongoing risk-based inspections further emphasise the need for a relook at current Good Manufacturing Practices regulations and quality management systems being followed by pharmaceutical manufacturers.” Based on the above factors and to keep pace with fast-changing manufacturing and quality domain, there was a need to revisit and revise the principles and concept of GMP mentioned in current Schedule M. “This would bring our GMP recommendations on a par with global standards, especially those of the WHO, and ensure production of high quality, globally acceptable drugs,” he added. In August, the Ministry had set a six-month deadline for small manufacturers and 12 months for large units to get their World Health Organization-Good Manufacturing Practices certification.