Around 36% of the pharmaceutical manufacturing units inspected by the Indian drug regulator recently were shut down due to non-compliance with quality standards, a senior government official stated. The Central Drug Standards Control Organisation (CDSCO) has been conducting risk-based inspections of manufacturing facilities since December 2022.

Speaking at the Indian Pharmaceutical Alliance’s (IPA) Global Pharmaceutical Quality Summit, 2024, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi said about 400 units were inspected, and nearly 36% had to close for failing to meet standards. “Of those temporarily shut down, around 10% permanently exited the system, realising they couldn’t comply with the standards. The rest returned with corrective and preventive action plans,” Raghuvanshi said, noting this helped eliminate sub-standard facilities.

India has around 10,000 pharma manufacturing units, with nearly 80% being micro, small, and medium-scale facilities. Most of these units struggle with documentation, validation processes, and lack full-fledged quality control laboratories. The quality management system is generally failing, Raghuvanshi added.

The stringent audits and inspections appear to have had a positive impact, as since July 2023, there have been no significant international quality complaints. “Previously, we received about two complaints monthly,” Raghuvanshi said, referring to the Gambia cough syrup controversy where children died after consuming Indian-made cough syrups.

The CDSCO is intensifying efforts to audit facilities within the pharma ecosystem. It began with manufacturing sites, then public testing labs, and now includes clinical research organisations (CROs). So far, around 600 units have been inspected. Starting July 1, the regulator will audit large pharma units for compliance with the revised Schedule M guidelines, notified in early January. Approximately 250 companies have been identified for these audits.

The regulator is also boosting its workforce by planning to recruit at least 250 engineers. Raghuvanshi suggested establishing an internal scientific cadre at the CDSCO to review company applications, addressing a significant gap. “We currently rely entirely on external subject expert committees. Having an in-house scientific cadre could handle 50-60% of file reviews internally, improving decision-making consistency,” he said.

The CDSCO is also adopting strict measures to ensure good practices within the organization. Raghuvanshi reported 207 transfers last year and departmental inquiries into malpractices that led to employee terminations. An internal auditing process has been initiated, examining ports and airports for process improvements, with increased coordination with states. Monthly meetings with state drug controllers and twice-weekly stakeholder meetings since February have resolved over 100 issues.

A request for proposal (RFP) has been issued for the Digital Drug Regulatory System (DDRS), an umbrella portal for all pharmaceutical regulations. Initially, it will be an improved version of the SUGAM portal, encompassing all CDSCO activities. Eventually, state drug controllers and other agencies like Customs, GST departments, the Indian Council of Medical Research, and the Indian Pharmacopoeia Commission (IPC) will be linked. The system will include a supply chain track-and-trace mechanism to monitor raw material sources, and retailers will also be connected to track real sales in the market. The goal is to have a comprehensive raw material-to-patient structure under one platform, Raghuvanshi explained.

(Source: Business Standard)