Maharashtra FDA Cancels Licence of Pune Ayurvedic Medicine Manufacturer Over Safety Violations
The Maharashtra FDA has permanently cancelled the manufacturing licence of Pune-based Inducare Pharma Pvt. Ltd. after inspections revealed serious violations of safety and quality standards. The regulator found poor hygiene, incomplete manufacturing records, and multiple GMP violations, while six Ayurvedic products failed quality tests and were declared "Not of Standard Quality" (NSQ). FDA Commissioner Tukaram Mundhe said strict action will continue against manufacturers that fail to comply with regulatory norms.
Pune, Maharashtra: The Maharashtra Food and Drug Administration (FDA) has permanently cancelled the manufacturing licence of Pune-based Ayurvedic medicine manufacturer M/s Inducare Pharma Pvt. Ltd. after inspections revealed repeated regulatory violations, poor manufacturing practices, and serious safety concerns.
The company's manufacturing facility, located in Jejuri MIDC in Purandar taluka, was found to be in violation of the Drugs and Cosmetics Act, 1940, as well as Schedule-T Good Manufacturing Practices (GMP), according to an official statement issued by the FDA.
Major Violations Found During Inspection
FDA inspectors reported multiple deficiencies at the manufacturing unit, including:
•Failure to maintain proper records proving the use of approved Ayurvedic raw materials.
•Incomplete Batch Manufacturing Records (BMRs) lacking raw material batch numbers, testing reports, yield calculations, and distribution details.
•Missing equipment logbooks, cleaning records, and process validation documents.
•Poor hygiene standards across the production facility.
Officials also observed damaged sieves, dirty production areas, oil deposits, unclean suction filters, paper being used inside manufacturing equipment, inadequate pest control measures, and the absence of proper humidity monitoring systems.
Quality Tests Raise Serious Concerns
Although the company claimed to conduct microbiological testing, the FDA stated that the facility lacked the required laboratory infrastructure, testing equipment, and supporting documentation.
Laboratory analysis conducted by the Government Analyst of Maharashtra found that six Ayurvedic medicines failed mandatory quality and safety standards and were declared "Not of Standard Quality" (NSQ).
The affected products include:
•Sinhanad Guggul – Fungal growth, black spots, and failed microbial tests.
•Punarnavadi Mandur – Fungal contamination and failed microbial limits.
•Triphala Guggul – Failed prescribed microbial standards.
•Kanchanar Guggul – Excessive microbial count, yeast, and mould contamination.
•Hingvastak Churna – Excessive ash content, insects, larvae, and foreign matter.
•Triphala Churna – Lumps, insects, larvae, and foreign matter.
Manufacturing Licence Revoked
Following the inspection, the FDA directed the company to halt manufacturing operations and issued a show-cause notice. The company was also given an opportunity to present its case during a personal hearing.
However, according to the regulator, the company failed to provide satisfactory explanations or demonstrate compliance with the required safety and manufacturing standards. Consequently, the FDA permanently cancelled its Ayurvedic drug manufacturing licence.
FDA Reiterates Commitment to Public Safety
FDA Commissioner Tukaram Mundhe said the department remains committed to ensuring that consumers receive safe, effective, and high-quality medicines. He added that strict action will continue against manufacturers that violate regulatory norms and compromise public health.