In 2024-25, the Health Budget has budgeted around Rs 75 crore for enhancing state drug regulatory systems, up from Rs 52 crore in the revised estimates of 2023-24.
As India’s drug regulator becomes tighter with drug manufacturing plants, conducting frequent audits and risk-based inspections, the allocation for improving state drug regulatory systems increased significantly in this year’s Union Budget compared to the revised budgetary estimates for 2023-24.
The Health Budget for 2024-25 has earmarked roughly Rs 75 crore for enhancing state drug regulatory systems, up from Rs 52 crore in the revised projections for 2023-24. When compared to 2022-23, the allocation is significantly larger; in the FY23 Union Budget, the Health Budget set aside only Rs 22.87 crore for the purpose. It is flat compared to the interim Budget delivered in February of this year.
The Central Drugs Standard Control Organisation (CDSCO) will soon begin evaluating big pharmaceutical facilities to guarantee compliance with the amended Schedule M rules, which were announced in early January. Schedule M of the Drugs and Cosmetics Rule-1945 establishes good manufacturing principles (GMP) for pharmaceuticals. The audits will focus on approximately 250 companies. The agency is also increasing its workforce by planning to hire at least 250 engineers.
Rajeev Raghuvanshi, the Drugs Controller General of India (DCGI), has proposed the creation of an internal scientific cadre at the CDSCO to assess applications submitted by firms. It began with industrial facilities, then expanded to public testing labs, and is now checking clinical research organisations (CROs). Overall, approximately 600 units have been inspected thus far.
Around 36% of pharmaceutical production units evaluated by the drug authority in recent years were forced to close due to noncompliance with quality standards, he explained. CDSCO has been performing risk-based inspections of manufacturing facilities since December 2022.
“Of those units that had to temporarily shut down, around 10 per cent 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 had said, adding that the move helped in getting rid of the substandard facilities.
India has around 10,000 pharmaceutical production units, with 80 percent of them being micro, small, and medium-sized facilities. MSME units frequently lack properly equipped quality control labs and experience data integrity difficulties.
The funding increase coincides with the CDSCO’s efforts to increase the number of inspectors and improve the whole inspection framework, including inspector training.
More site inspections would necessitate increased state-level staffing. A senior state FDA official told Business Standard that while random market sample testing will be done on a regular basis, facility checks would require additional manpower. “The CDSCO is trying to build a culture of compliance, and that would require strengthening state drug regulators,” according to the official.
Stringent audits and inspections seem to have helped, DCGI had claimed, adding that since July 2023, there have been no significant international quality complaints.
“Earlier, we were getting around two complaints every month,” Raghuvanshi had said, alluding to the aftermath of the Gambia cough syrup controversy where children died in the African nation, following consumption of Indian-made syrups.
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Source – Business Standard
