Pune FDA Cancels Ayurvedic Drug Manufacturer’s Licence Over Substandard Medicines
Pune, 8th August 2026: The Food and Drug Administration (FDA) has permanently cancelled the Ayurvedic drug manufacturing licence of Inducare Pharma Pvt Ltd, located in Jejuri MIDC in Pune district, citing serious violations of drug manufacturing regulations and the production of substandard medicines.
The action followed government analysis that declared six Ayurvedic medicines manufactured by the company substandard. The medicines were Sinhanad Guggul, Punarnavadi Mandoor, Triphala Guggul, Kanchanar Guggul, Hingvashtak Churna and Triphala Churna.
During two inspections of the company, FDA officials found several serious violations of the Drugs and Cosmetics Act and Good Manufacturing Practices (GMP) requirements. The inspections revealed that the company did not maintain adequate records to establish proper manufacturing processes, while batch manufacturing records were also found to be incomplete.
Officials further found that the company had not conducted quality testing of raw materials and did not have essential laboratory facilities. Other violations included poor sanitation in the production area, the absence of proper machinery records and a lack of systems to control temperature and humidity.
The company also did not maintain records related to the sale and distribution of medicines, according to the FDA.
Fungal Growth, Microbial Contamination Found
Government analysis of samples from the six medicines detected fungal growth and microbial contamination beyond the prescribed limits. Black spots were found on some tablets, while insects, larvae and other foreign impurities were detected in some powdered medicines.
Based on the laboratory findings, the medicines were classified as substandard.
Company Failed To Provide Satisfactory Explanation
Following the inspections, the FDA directed the company to immediately stop manufacturing medicines and issued a show-cause notice. The company was subsequently given an opportunity to submit a written explanation and present its case during a personal hearing.
However, the company failed to provide a satisfactory explanation or submit adequate evidence demonstrating compliance with the prescribed regulations, officials said.
After considering the inspection findings, laboratory reports and other documents, the licensing authority ordered the permanent cancellation of the company’s Ayurvedic drug manufacturing licence.
