Indian Regulator Shuts Down 36% Of Drug-Making Units: DCGI

As per DCGI, a significant number of these units lack proper documentation, validation processes, and fully equipped quality control laboratories, leading to shortcomings in the quality management

Over 36 per cent of the 400 drug manufacturing units inspected by  India's drug regulator since last year have been directed to cease operations, said a senior government official on Thursday. Since December 2022, the Central Drugs Standard Control Organization (CDSCO) has been carrying out risk-based inspections of manufacturing facilities.

During the Indian Pharmaceutical Alliance’s (IPA) Global Pharmaceutical Quality Summit 2024, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi reported that approximately 400 units were inspected, with nearly 36 per cent being shut down due to non-compliance with standards.

“Of those who had to temporarily shut down, around 10 per cent of the units were permanently moved out of the system as they realised they would not be able to comply with the quality standards. The remaining came back with corrective and preventive action plans,” Raghuvanshi said, adding that this measure aided in eliminating sub-standard facilities.

India hosts approximately 10,000 pharmaceutical manufacturing units, with nearly 80 per cent categorised as micro, small, and medium-scale enterprises. According to Raghuvanshi, a significant number of these units lack proper documentation, validation processes, and fully equipped quality control laboratories, leading to shortcomings in the quality management system.

According to the DCGI, stringent audits and inspections have proven effective, noting that there have been no major international quality complaints since July 2023.

"Earlier, we were getting around two complaints every month," Raghuvanshi remarked, referencing the aftermath of the Gambia cough syrup controversy, which resulted in fatalities among children in the African nation after consuming Indian-manufactured cough syrups.

The CDSCO has intensified its auditing efforts across various sectors within the pharmaceutical ecosystem. Beginning with manufacturing sites, the scrutiny expanded to encompass public testing laboratories and now includes inspections of clinical research organisations (CROs). In total, approximately 600 units have undergone inspection.

Starting July 1, the regulatory body will commence audits of large pharmaceutical units to ensure adherence to the updated Schedule M guidelines, which were officially notified in early January. Schedule M of the Drugs and Cosmetics Rules 1945 outlines the standards for good pharmaceutical production manufacturing practices (GMP). About 250 companies have been earmarked for these audits, scheduled to begin next month.

In addition, the regulator is also increasing its workforce by aiming to hire a minimum of 250 engineers.