Health Budget focuses on strengthening state drug regulatory systems

As India's drug regulator gets stricter with drug manufacturing units with regular audits and risk-based inspections, this year's Union Budget saw the allocation for strengthening state drug regulatory systems increase significantly from the revised budgetary estimates of 2023-24.

In 2024-25, the Health Budget has allocated around Rs 75 crore for strengthening state drug regulatory systems, which is up from Rs 52 crore in the revised estimates of 2023-24. When compared with 2022-23, the allocation is far higher — in FY23 Union Budget, the Health Budget had set aside only Rs 22.87 crore for this purpose. It is flat when compared to the interim Budget presented in February this year.

The Central Drugs Standard Control Organisation (CDSCO) will soon begin auditing large pharmaceutical units to ensure 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. Around 250 companies have been identified for the audits. The regulator is also ramping up its manpower by planning to recruit at least 250 engineers.

Drugs Controller General of India (DCGI) Rajeev Raghuvanshi has floated the idea of having an internal scientific cadre at the CDSCO that will review the applications made by companies. Last month, he told reporters that the CDSCO is stepping up efforts for auditing facilities connected with the pharma ecosystem. It started with manufacturing sites, then moved on to public testing labs, and now is also inspecting clinical research organisations (CROs). In all, around 600 units have been inspected so far.

Around 36 per cent of pharmaceutical manufacturing units inspected by the drug regulator in recent times were forced to shut down due to non-compliance with quality standards, he had said. CDSCO has been conducting 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 pharma manufacturing units, 80 per cent of which are micro-small and medium-scale facilities. MSME units often lack fully-equipped quality control labs, and also have data integrity issues.

The budgetary allocation increase comes at a time when the CDSCO is increasing the number of inspectors and improving the overall inspection framework, including training inspectors as well.

More site inspections would require more manpower at the state level. A senior state FDA official told Business Standard that while they would routinely do random sample testing from the market, regular facility audits would require more manpower. "The CDSCO is trying to build a culture of compliance, and that would require strengthening state drug regulators," the official added.

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.