Maharashtra FDA permanently cancels Pune-based pharma firm's license over six contaminated medicines, GMP lapses
The Maharashtra Food and Drug Administration (FDA) on Thursday (August 6, 2026) permanently cancelled the Ayurvedic medicine manufacturing license of Pune-based InduCare Pharma Pvt. Ltd
The Maharashtra Food and Drug Administration (FDA) on Thursday (August 6, 2026) permanently cancelled the Ayurvedic medicine manufacturing license of Pune-based InduCare Pharma Pvt. Ltd. after six medicines failed quality tests, with some found contaminated with fungi, insects and larvae, and widespread Good Manufacturing Practice (GMP) violations. This action was taken after the manufacturing facility was inspected twice. The inspection revealed incomplete manufacturing records, poor hygiene, inadequate quality-control systems and the omission of ingredients specified in approved Ayurvedic formulations, according to the press release. The FDA said these violated provisions of the Drugs and Cosmetics Act, 1940, Rules, 1945, and GMP requirements.
The company failed to provide a satisfactory explanation despite a show-cause notice, a hearing, and a joint inspection, it added. “Providing citizens with safe, quality, and effective medicines is the top responsibility of the Food and Drug Administration,” Tukaram Mundhe, Commissioner, FDA, Maharashtra. “Drug manufacturers are legally bound to strictly adhere to the Drugs and Cosmetics Act, 1940, its rules, and GMP standards. Strict regulatory action will be taken against any manufacturer showing negligence regarding drug quality,” Mr. Mundhe said. Medicine samples were sent for analysis, which revealed that a total of six medicines were ‘Not of Standard Quality’ (NSQ) medicines and had severe defects.
According to the statement, samples of Sinhanad Guggul and Punarnavadi Mandur had fungal growth and failed the Microbial Limit Test. Samples of Hingvastak Churna and Triphala Churna contained insects, larvae, and other foreign impurities. Other samples of medicines like Triphala Guggul and Kanchanar Guggul exceeded prescribed microbial limits. Essential ingredients that were specified in approved formulas were omitted during the actual manufacturing for certain medicines, it said. The facility’s Batch Manufacturing Records were incomplete and inconsistent, and it was missing testing and distribution records, inadequate laboratory facilities, poor sanitation, damaged equipment and missing pest-control documentation, the release noted.
The FDA also found that sales and distribution records were not available for medicines that had complaints against them, making it difficult to trace the product, the statement said. This is part of the FDA’s enforcement campaign across the State between May 25, 2026, and July 31, 2026, focusing on food safety, drug quality and consumer protection.
The BriefWire