The Union Health Ministry on January 6 notified revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945.
Key points
- Schedule M prescribes the Good Manufacturing Practices (GMP) for pharmaceutical products.
- The revised Schedule M has been notified as rules to ensure GMP is adhered to, and requirements of premises, plant, and equipment for pharmaceutical products.
- GMP is mandatory standards which builds and brings quality into a product by way of control on materials, methods, machines, processes, personnel, and facility/environment, etc.
- GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, 1945 in the year 1988 and the last amendment was done in June, 2005.
- With the amendment, the words ‘Good Manufacturing Practices’ (GMP) has been replaced with ‘Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products’.
- As per the government, this amendment would bring India’s GMP recommendations at par with global standards, especially to those of the World Health Organization (WHO).
- The changes introduced in the revised Schedule M include introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and a computerised storage system for all drug products.
- The revised rules is to be implemented on the basis of company turnovers. The medium and small manufacturers include those with an annual turnover of less than ₹250 crore who will have to implement the revised rules within 12 months from its date of publication, whereas large manufacturers with an annual turnover of over ₹250 crore will be given six months to do so.
