Indian regulator issues uniform regulatory procedures for CoPP and GMP inspections

India's Central Drugs Standard Control Organization (CDSCO) has issued new guidelines for state inspectors on how to prepare for and handle good manufacturing practice (GMP) inspections of drug manufacturing facilities. As per the new procedures, all GMP inspections including that of CoPP will be focusing mainly on the requirements of Schedule M of Drugs and Cosmetics Rules, 1945 with respect to establishing shelf life, conducting validation studies and ensuring prompt and effective recall besides WHO GMP requirement.

According to it, the inspection should be conducted between two and five days (depending on the size and complexity of the manufacturing site). Also regulatory action needs to be undertaken immediately in those cases where inspection observations revealed conditions that could compromise drug quality, safety and efficacy. Inspection team shall prepare inspection plan, conduct opening meeting and exit meeting on the final day to summarise and discuss the observations with the manufacturers. CDSCO also said that state inspectors must carry out a minimum of 5 inspections a year. As per the new procedures, the State Drug Control Authorities shall also initiate the process to qualify inspectors for inspection of vaccines and pharmaceutical manufacturing facilities based on experience and training.

The final report of inspection may be finalized within one week, critically reviewed by zonal officers and forwarded to state licensing authority for necessary action along with copy to CDSCO (HQ) and manufacturers for compliance, if any. Many Indian manufacturers received warning letters or had plants banned by the FDA in recent years after they were found to be faking or manipulating required tests for active pharmaceutical ingredients or finished products.