Maharashtra FDA Proposes INR 500 Cr Plan to Strengthen Drug Testing and Regulatory Infrastructure

The scheme follows a cost-sharing model between the Centre and the state, with 60% funding from the Centre and 40% from Maharashtra, subject to approval criteria.

The Maharashtra Food and Drug Administration (FDA) has proposed an INR 500 crore plan to strengthen the state’s drug regulatory framework and laboratory infrastructure by reviving a Centrally Sponsored Scheme (CSS) that ended on March 31, 2025.

The proposal has been submitted to the state government and is expected to be forwarded to the central government for approval. The scheme follows a cost-sharing model between the Centre and the state, with 60% funding from the Centre and 40% from Maharashtra, subject to approval criteria.

Originally launched in 2016–17 and funded from 2018, the CSS was designed to improve drug safety oversight by upgrading laboratories, enhancing manpower, and expanding testing capacity. The earlier phase had a total outlay of INR 136 crore.

Under the new proposal, the FDA aims to upgrade existing drug testing systems and address operational gaps in regulatory enforcement. A key focus is ensuring that medicines available in the market meet safety, efficacy, and quality standards through improved testing infrastructure.

As part of the previous phase, drug testing laboratories in Pune and Nashik have already completed civil construction. However, these facilities remain non-operational due to the pending installation of equipment, internal infrastructure setup, and recruitment of technical staff. The FDA has now sought approval for manpower recruitment to make these labs functional.

Manpower shortage remains a major concern for the regulatory body. Out of 200 sanctioned drug inspector posts, only 45 are currently filled, leaving 155 vacancies. In Mumbai, the situation is more constrained, with only seven inspectors in place against a required strength of 21. Officials say this shortage has impacted inspections, drug sampling, and compliance checks across the state.

The proposed INR 500 crore plan also highlights the need to expand both technical and field-level staff to strengthen enforcement capabilities. Authorities believe that improving laboratory capacity and filling vacant positions will enhance drug quality surveillance and speed up testing processes across Maharashtra.

If approved, the renewed scheme is expected to significantly strengthen the state’s regulatory infrastructure at a time of increasing pharmaceutical activity and rising demand for stricter quality control mechanisms.

Stay tuned for more such updates on Digital Health News