MUMBAI: Against the backdrop of rising cases of counterfeit and spurious drugs, the Maharashtra Food and Drug Administration (FDA) has proposed a state-wide “Track and Trace” system to the Central government to digitally monitor medicines across the supply chain.
The proposal comes in the wake of several large-scale seizures of fake drugs across Pune, Thane, Palghar, Nagpur and Latur, and heightened concerns following the cough syrup tragedy in Chhindwara, Madhya Pradesh, in October last year, where at least 25 children died after consuming contaminated medicines.
In a proposal submitted to the Union government, the FDA has sought ₹26.50 crore in initial funding for the system, which is estimated to cost ₹100 crore in total. The state government has proposed to bear the annual maintenance costs and eventually integrate the system with the central drug regulatory framework.
The proposed digital platform aims to enable end-to-end tracking of medicines -from manufacturers and distributors to retailers and hospitals- through QR codes. It will allow batch-level monitoring, real-time dashboards, mobile applications for field inspectors, and alerts for suspicious transactions, illegal diversions and recall situations. The system will also track inter-state movement of drugs to curb unauthorised procurement and circulation of spurious medicines.
The move follows a series of crackdowns by the FDA over the past three to four years, during which cases of unlicensed manufacturing and false labelling have surfaced. Counterfeit versions of medicines such as Telma and ciprofloxacin were recently seized in Thane and Nagpur.
After the Chhindwara incident, the Maharashtra FDA intensified inspections, particularly targeting the over-the-counter sale of cough syrups without prescriptions. Between April 1 and November 30, 2025, inspections of 750 retailers found 224 in violation of norms, with 64 facing licence cancellation. Among Allopathic, Ayurvedic and cosmetic manufacturers, 13 units face suspension for violations of manufacturing rules.
In 2024-25, the FDA cancelled 271 retail licences and took cancellation action against 15 manufacturers. In the previous year, 303 retail licences were cancelled and 21 manufacturers lost their licences.
FDA minister Narhari Zirwal said, “We have submitted the proposal to the Union Health Minister. The system will help curb the supply of spurious drugs. We are hopeful that the proposal will be sanctioned.”
FDA officials said the Track and Trace system would significantly enhance transparency, improve recall efficiency and plug supply chain gaps. “Real-time monitoring will strengthen public health safeguards and prevent the circulation of fake medicines,” an official said.
If approved, Maharashtra could become one of the first states to roll out a comprehensive digital drug surveillance ecosystem, positioning itself as a regulatory leader in the pharmaceutical sector.
Apart from the tracking system, the FDA has also proposed other reform initiatives, including a WhatsApp chatbot-based complaints registration system (estimated cost ₹10 crore), a pharmaceutical industry incubation centre ( ₹300 crore), and a self-sufficient pharma park ( ₹1,200 crore).
