CDSCO Takes Action Against Drug Manufacturing Units for Quality Issues

A senior government official revealed that around 36% of pharmaceutical manufacturing units inspected by the Indian drug regulator recently were shut down due to not meeting quality standards.

The Central Drug Standards Control Organisation (CDSCO) has been carrying out risk-based inspections of manufacturing facilities since December 2022.

At the Indian Pharmaceutical Alliance’s (IPA) Global Pharmaceutical Quality Summit in 2024, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi stated that about 400 units were inspected, and nearly 36% had to close because they did not meet the required standards.

“Of those that had to temporarily shut down, about 10% were permanently removed from the system as they realized they couldn’t comply with the quality standards. The rest returned with corrective and preventive action plans,” Raghuvanshi said, noting that this move helped eliminate sub-standard facilities.

India has around 10,000 pharmaceutical manufacturing units, with nearly 80% being micro, small, and medium-scale facilities.

Most of these units are failing in documentation, validation processes, and many lack fully equipped quality control laboratories. Essentially, the quality management system is failing, Raghuvanshi said.

The strict audits and inspections seem to have helped, according to the DCGI, who added that since July 2023, there have been no significant international quality complaints.

“Earlier, we were receiving about two complaints every month,” Raghuvanshi said, referring to the aftermath of the Gambia cough syrup controversy where children died after consuming Indian-made cough syrups.

The CDSCO is increasing its efforts to audit facilities connected with the pharmaceutical ecosystem. It started with manufacturing sites, then moved on to public testing labs, and is now inspecting clinical research organizations (CROs). In total, around 600 units have been inspected.

Starting July 1, the regulator will begin auditing large pharmaceutical units to check for compliance with the revised Schedule M guidelines, which were notified in early January. Schedule M of the Drugs and Cosmetics Rule 1945 prescribes good manufacturing practices (GMP) for pharmaceutical products. About 250 companies have been identified for audits starting next month.

The regulator is also increasing its manpower by planning to recruit at least 250 engineers.

Raghuvanshi also suggested the idea of having an internal scientific cadre at the CDSCO to review applications made by companies.

“This is a significant gap we have identified. There is no scientific cadre to review the applications that come in, and we rely entirely on external subject expert committees. We have discussed this with the Centre, and hopefully, things will move forward soon,” he said.

The official expects that having an in-house scientific cadre can handle 50-60% of the file reviewing process internally, which will improve consistency in decision-making.

The CDSCO is also adopting strict measures to ensure commitment to good practices within the organization. Raghuvanshi said 207 transfers were made last year, and there have been departmental inquiries for malpractices that have led to the termination of employees. An internal auditing process has been initiated, and the CDSCO is looking into its own operations – auditing ports and airports for process improvements.

Coordination with states has also increased. There are monthly meetings with state drug controllers. The DCGI has been meeting stakeholders twice a week at his office since February. “More than 100 issues have been resolved as a result of these walk-in meetings with stakeholders,” he said.

INSET: Digital Drug Regulatory System to Launch Soon

A request for proposal (RFP) has been issued for the Digital Drug Regulatory System (DDRS), which will be an umbrella portal for all things related to pharmaceutical regulations. DCGI Rajeev Raghuvanshi said that initially, it would be an improved version of the SUGAM portal, and all activities of the CDSCO will be on the portal.

Eventually, state drug controllers will also come on board, followed by other agencies like Customs, GST departments, the Indian Council of Medical Research, and the Indian Pharmacopoeia Commission (IPC). The supply chain track-and-trace mechanism will also be added to track raw material sources, and finally, retailers will be connected to know about real sales in the market. Raghuvanshi said the idea is to have a raw material-to-patient structure all under one roof.