The role and responsibilities of the drug regulators have changed due to expansion and advent in pharmaceutical sciences. Now, their role is not limited only to issue permissions/licenses but to take a proactive role in ease of doing business in India.
Dr. G.N. Singh, Drugs Controller General of India said that the safety, quality and effectiveness of products and services are of paramount importance for any drug regulator. The Drug regulatory system needs to be transparent, time bound and ready to facilitate the industry to produce quality medical products.
CDSCO has started imparting training to drug regulators and analysts from State and Central Governments for inspection of manufacturing units with respect to GMP and GLP based on the components of this document.
Accordingly, CDSCO has prepared “checklist of Risk Based Inspection of the Pharma Manufacturing Facilities” for verification of GMP compliance as per the provisions stated under Schedule M of Drugs and Cosmetics Rules, 1945 to ensure consistency and uniformity in the inspection process.
World Health Organization Technical Report Series (WHO TRS)/ Pharmaceutical Inspection Co-operation Scheme (PICs) /other references stated in the checklist are meant for those organisations who intend to comply voluntarily for international market. For domestic pharmaceutical manufacturers, only Schedule M of Drugs & Cosmetics Rules are applicable.
This check list would be used by drug regulatory enforcement agencies as a science based tool. It is also envisaged that Pharma industry would also find this checklist useful for self-assessment.
