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As Maharashtra continues to evolve as a pharmaceutical hub, the Maharashtra Food and Drug Administration (FDA) remains steadfast in its mission to ensure quality, efficacy, and safety of drugs through enhanced vigilance, infrastructure upgrades, and technological innovation, even in the face of manpower constraints.
Maharashtra houses a diverse pharmaceutical sector, including 900 allopathic manufacturers, 440 ayurvedic manufacturers and 408 cosmetic manufacturers.
In a major regulatory push, the Maharashtra FDA has enhanced regulatory oversight to ensure compliance to Good Manufacturing Practices (GMPs) by inspecting all allopathic, ayurvedic and cosmetic manufacturing units in the state on an annual basis.
It has also enhanced vigilance to track movement of spurious drugs and detect any such clandestine activity which is detrimental to public safety and health.
According to an official, “Show Cause Notices (SCNs) have been issued followed by suspensions and cancellations based on violations or non- compliances by the respective drug manufacturers. Besides this, Maharashtra FDA has inspected all public testing laboratories approved and licensed by the Maharashtra FDA. These public testing labs are equipped with highly advanced and sophisticated instruments to help those manufacturers which lack such facility to assess the drug quality effectively.”
The state regulator has also uncovered violations of the Drugs and Cosmetics (D&C) Act during routine inspections conducted between April 2024 and March 2025. There are 105,000 retail and 32,000 wholesale license holders in the state.
The official further added that in order to ensure the quality of the blood, the Maharashtra FDA has also ensured that all 392 blood banks in the state have been inspected once in a year. Notably, officials also detected a significant case of spurious drugs supplied to government hospital pharmacies, raising serious concerns about public health and safety.
“Despite facing a severe shortage of manpower, the Maharashtra FDA has shown commendable vigilance. Out of 200 sanctioned posts for drug inspectors, only 55 inspectors are currently deployed in the field. The remaining 145 positions lie vacant. To address this, the Maharashtra Public Service Commission (MPSC) has already initiated recruitment for 109 new drug inspectors through a recently floated advertisement,” the official informed.
Spurious drugs in government hospitals
A particularly alarming discovery was made when Maharashtra FDA officials, during routine sampling at government hospital pharmacies, unearthed spurious drugs that had entered the supply chain through local purchases. Following inputs from pharmacists, the officials conducted discreet sampling and found that the counterfeit drugs originated from a closed veterinary food supplement factory in Uttarakhand.
The operation was reportedly orchestrated by individuals from Uttar Pradesh, making it a cross-state illicit drug racket. Despite the complexity and intelligence required to crack this case, the Maharashtra FDA successfully traced and identified the perpetrators.
Inspections across manufacturing units
While the D&C Act mandates inspections every three years, Maharashtra FDA has taken a proactive stance by inspecting all manufacturers annually to ensure drug safety and efficacy. These inspections have uncovered several violations, including cases of adulterated ayurvedic products containing allopathic ingredients such as ibuprofen, paracetamol, and diclofenac, especially in medicines marketed for rheumatic pain.
Despite regulatory challenges, Maharashtra’s bulk drug industry continues to thrive in regions like Mahad, Roha, Palghar, Raigad, and Boisar, with the Maharashtra FDA’s strong compliance framework. All risk-based inspections in Maharashtra assigned by the Central Drugs Standard Control Organization (CDSCO) are being carried out diligently in joint operations with central regulator inspectors, based on specific risk signals, complaints, or non-standard quality (NSQ) reports.
Strengthening drug testing infrastructure
To meet the growing demands of drug testing and regulation, procurement of high-end testing instruments has been completed for both Mumbai and Aurangabad labs, boosting their testing capabilities.
The Maharashtra FDA has equipped its laboratory infrastructure with state-of-the-art analytical instruments including High-Performance Liquid Chromatography (HPLC), Infrared (IR) Spectroscopy, Ultraviolet (UV) Spectroscopy and Liquid Chromatography-Mass Spectrometry (LC-MS). These high-end technologies along with upgradation in manpower are expected to significantly enhance quality and capacity of drug testing thus ensuring compliance and patient safety.
“Currently, drug testing labs operate in Mumbai, Aurangabad and Nagpur. The Mumbai laboratory currently has the capacity to test 4,000 drug samples, Aurangabad laboratory with capacity to test 2,500 samples and Nagpur lab with a capacity to test 1,000 samples currently. The aim is to increase drug testing capacity to over 30,000 samples annually,” according to an official.
CSS to enhance drug testing infrastructure
The Centrally Sponsored Scheme (CSS) scheme, which was initiated in 2016–17 and received fund sanctioning in 2018, aims to strengthen the drug testing ecosystem in Maharashtra. It operates under a financial partnership model, with 60 per cent funding from the Central government and 40 per cent from the State. The funding window was valid until March 31, 2025, with a total project cost of Rs. 136 crore.
The scheme is focused on upgrading existing labs and establishing new ones to meet the increasing demand for drug sample testing, ensuring public safety and enhancing regulatory compliance.
“The Pune Divisional Office and Laboratory, along with the Nashik Divisional Office and Laboratory, have completed their civil construction work under the CSS-State Regulatory Scheme. However, critical components such as partitioning, equipment procurement, lab establishment, and recruitment of trained personnel are still pending before the laboratories can become fully operational. The government plans to establish one lab per division, and has recently acquired land in Pen (Raigad district) for setting up a dedicated lab for the Konkan division,” according to official sources.
As per the Maharashtra FDA records, Maharashtra currently has 189 sanctioned posts across its existing drug testing laboratories for Mumbai, Aurangabad and Nagpur. However, 56 of these posts remain vacant. In response, the government has taken steps to expedite recruitment. Notably, for Class 3 positions, particularly lab chemists, the government has hired Tata Consultancy Services (TCS) to conduct examinations.
Examinations for these posts have already been conducted, and the results are awaited. Following the declaration of results, the Maharashtra FDA expects to induct 56 new lab chemists to bolster its workforce.
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