Tukaram Mundhe-Led FDA Cancels Inducare Pharma's Licence For GMP Violations

The Maharashtra Food and Drug Administration, led by Commissioner Tukaram Mundhe, has permanently cancelled the Ayurvedic drug manufacturing licence of Pune-based Inducare Pharma Private Limited. The regulator announced the action on Thursday, August 6, citing alleged violations of Good Manufacturing Practices and provisions of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.

According to the FDA, Inducare Pharma was directed to stop manufacturing medicines immediately after violations were detected. The company was subsequently issued a show-cause notice and asked to explain why regulatory action should not be taken against it. The manufacturer submitted a written response and was also granted a personal hearing as part of the proceedings.

The regulator said the company failed to provide satisfactory explanations or sufficient evidence demonstrating compliance with the applicable manufacturing and quality standards. Following an assessment of the company’s response and the inspection findings, the FDA decided to cancel its manufacturing licence permanently. The action prevents the company from continuing to manufacture Ayurvedic medicines under the cancelled authorisation.

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Six products manufactured by Inducare Pharma were declared Not of Standard Quality after deficiencies were detected. Sinhanad Guggul reportedly showed fungal growth and black spots on its tablets and failed the Microbial Limit Test. Punarnavadi Mandur was also found to contain fungal growth and did not meet the prescribed microbial requirements, according to the regulator.

Triphala Guggul failed to comply with prescribed microbial limits, while tests on Kanchanar Guggul showed that its total microbial count and levels of yeast and mould exceeded permissible limits. The findings raised concerns about whether the products had been manufactured and stored under conditions that adequately protected their quality and safety.

The FDA also reported excessive total ash content in Hingvastak Churna, along with insects, larvae and other foreign impurities. Triphala Churna was found with lumps as well as insects, larvae and foreign matter. The regulator said the deficiencies raised serious concerns regarding product quality, consumer safety and public health, prompting the permanent cancellation of the company’s Ayurvedic manufacturing licence.

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