According to reports from NDTV Profit and FDA officials, the Maharashtra Food and Drug Administration (FDA) has permanently cancelled the Ayurvedic drug manufacturing license of Inducare Pharma Pvt. Ltd, a Pune-based company. The action was announced on Thursday, August 6, 2026, by Tukaram Mundhe-led FDA authorities. The cancellation stems from violations of Good Manufacturing Practices (GMP) and provisions of the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. As per FDA officials, the regulator cancelled the license after inspections allegedly revealed repeated regulatory violations and serious failures to meet safety and quality standards. The company's manufacturing unit, located in the Jejuri MIDC area of Purandar taluka, was found to be in violation of the Drugs and Cosmetics Act, 1940, and Schedule-T Good Manufacturing Practices (GMP).
As reported by NDTV Profit, after the FDA discovered drug rules violations, the company was immediately instructed to stop manufacturing medicines and served a show-cause notice. Inducare Pharma submitted a written reply and was granted a personal hearing, but failed to provide satisfactory explanations or evidence demonstrating compliance with regulatory requirements. According to FDA officials, the company failed to maintain proper records showing that approved Ayurvedic ingredients were used in manufacturing, and inspectors found that equipment logbooks, cleaning records and process validation documents were missing. The company's inability to meet regulatory standards led to the permanent cancellation of its manufacturing license.
According to the FDA inspection findings reported by NDTV Profit, six products were declared Not of Standard Quality (NSQ) due to various deficiencies. The violations included Sinhanad Guggul with fungal growth, black spots on tablets, and failure in the Microbial Limit Test; Punarnavadi Mandur with fungal growth and Microbial Limit Test failure; Triphala Guggul failing to comply with prescribed microbial limits; Kanchanar Guggul with total microbial count, yeast and mould counts exceeding permissible limits; Hingvastak Churna with excessive total ash content and foreign impurities; and Triphala Churna with formation of lumps and presence of insects, larvae and foreign impurities. These deficiencies raise serious concerns regarding their quality, safety and public health implications.
As reported by NDTV Profit and FDA officials, the FDA inspection revealed significant gaps in manufacturing practices and documentation. No records were available to establish that ingredients specified in approved Ayurvedic formulations were actually used during manufacturing. Batch Manufacturing Records (BMRs) were found to be incomplete and inconsistent, with critical information including raw material batch numbers, analysis report numbers, manufacturing stages, weight variation, yield calculations and distribution records unavailable. The inspection also found cleaning records, equipment log books and process validation records for manufacturing equipment were unavailable, and raw material quality testing records and excipient testing had not been conducted. Additionally, although microbiological analysis had reportedly been conducted, the company lacked the necessary laboratory, equipment, media records and positive controls.
According to the FDA report cited by NDTV Profit and FDA officials, the manufacturing area was poorly maintained with damaged sieves, damaged flooring, dirty suction filters, oil deposits and unauthorized use of paper inside manufacturing equipment. No hygrometer was available to monitor temperature and humidity, and basic quality management systems including pest control records and packaging material records were absent. The inspection also found that mandatory ingredients prescribed in approved formulations were missing from certain medicines, and distribution and sales records for the medicines under complaint were unavailable, making traceability inadequate. As per FDA officials, the inspection also revealed poor hygiene standards inside the factory with dirty production areas and unclean suction filters.
FDA Commissioner Tukaram Mundhe emphasized the department's commitment to ensuring citizens receive safe, effective and high-quality medicines, stating that strict action would continue against manufacturers that fail to comply with regulatory standards. The cancellation represents a significant enforcement action by the Maharashtra FDA against companies that fail to maintain proper manufacturing standards and regulatory compliance. This case highlights the regulatory scrutiny facing Ayurvedic medicine manufacturers and the consequences of non-compliance with established quality and safety protocols.
