Mumbai, : In one of India’s largest pharmaceutical crackdowns in recent years, the Maharashtra Food and Drug Administration (FDA) has cancelled 215 drug licenses—including 176 retailers and 39 wholesalers—for distributing substandard or counterfeit medicines. The canceled licenses span major cities such as Mumbai, Pune, and Nagpur, affecting essential treatments for diabetes, hypertension, and bacterial infections used by millions of patients.
The action follows a sweeping inspection in which 5,000 drug samples were tested, with 12% failing to meet quality standards, a figure described as “deeply alarming” by state FDA Minister Narhari Zirwal, who disclosed the findings in the Maharashtra Assembly. Many non-compliant medicines were traced to lax supply chains in Uttar Pradesh and Gujarat, raising concerns about systemic failures across India’s pharmaceutical distribution network.
The FDA has imposed ₹5 crore in fines, and the fallout has triggered a national probe. V.G. Somani, Director of the Central Drugs Standard Control Organisation (CDSCO), announced an immediate pan-India audit of drug manufacturing and distribution practices across 10 states where similar issues have been reported.
The scandal gained momentum on social media after reports linked two patient deaths in Mumbai to the affected drugs, intensifying public scrutiny. Health experts warn that the episode exposes longstanding vulnerabilities in India’s $50 billion pharmaceutical sector, the world’s third-largest by volume.
Dr. Rishi Kumar of AIIMS urged the government to adopt blockchain-based drug tracking to eliminate supply chain tampering and improve traceability. Meanwhile, opposition leaders demanded accountability from major pharma firms, including Sun Pharma, over allegations of weak oversight and third-party manufacturing risks.
The crackdown aligns with persistent warnings from the World Health Organization, which estimates that fake or substandard drugs cause more than 100,000 deaths globally each year. Analysts say the Maharashtra investigation may set a new precedent for regulatory enforcement as India faces increasing domestic and international pressure to ensure drug quality.
With CDSCO’s national audit now underway, industry leaders fear further suspensions and compliance costs but acknowledge that tougher supervision is crucial for safeguarding patient safety and preserving India’s global reputation as a leading generic medicine producer.
