Licence Cancelled: Tukaram Mundhe-Led FDA Cracks Down on Pune's Inducare Pharma

Tukaram Mundhe-led Maharashtra's Food and Drug Administration (FDA) has permanently cancelled Ayurvedic drug manufacturing licence of Pune-based Inducare Pharma Pvt. Ltd, the regulator said in a release on Thursday, August 6, 2026.

 The action has been taken for violations of Good Manufacturing Practices (GMP) and the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.

After the FDA found drug rules violation, the company was immediately instructed to stop manufacturing medicines and served a show-cause notice. Although Inducare Pharma submitted a written reply and was granted a personal hearing, it failed to provide satisfactory explanations or evidence demonstrating compliance with regulatory requirements, the regulator said.

Six Medicines Declared Not Of Standard Quality 

Six products were Not of Standard Quality (NSQ) due to certain deficiencies, raising serious concerns regarding their quality, safety and public health implications. 

• Sinhanad Guggul: Fungal growth, black spots on tablets and failure in the Microbial Limit Test.
• Punarnavadi Mandur: Fungal growth and failure in the Microbial Limit Test.
• Triphala Guggul: Failed to comply with prescribed microbial limits.
• Kanchanar Guggul: Total microbial count, yeast and mould counts exceeded permissible limits.
• Hingvastak Churna: Excessive total ash content along with insects, larvae and other foreign impurities.
• Triphala Churna: Formation of lumps and presence of insects, larvae and other foreign impurities.

What Did FDA Find  During Inspection?

• No records were available to establish that ingredients specified in the approved Ayurvedic formulations had actually been used during manufacturing.
•  Batch Manufacturing Records (BMRs) were incomplete and inconsistent. Critical information such as raw material batch numbers, analysis report numbers, manufacturing stages, weight variation, yield calculations and distribution records were not available.
• Cleaning records, equipment log books and process validation records for manufacturing equipment were unavailable.
• Raw material quality testing records and testing of excipients had not been carried out.
• Although microbiological analysis had reportedly been conducted, the company lacked the necessary laboratory, equipment, media records and positive controls.
• The manufacturing area was poorly maintained, with damaged sieves, damaged flooring, dirty suction filters, oil deposits and even unauthorized use of paper inside manufacturing equipment.
• No hygrometer was available to monitor temperature and humidity.
• Basic quality management systems, including pest control records and packaging material records, were absent.
• Mandatory ingredients prescribed in approved formulations were missing from certain medicines.
• Distribution and sales records for the medicines under complaint were unavailable, making traceability inadequate. 

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