- Maharashtra FDA cancelled licences of 10 Ayurvedic manufacturers for serious GMP violations
- Inspections revealed unhygienic conditions, missing records, and lack of quality tests
- Total of 434 manufacturers inspected; 135 received show-cause notices for non-compliance
The Maharashtra Food and Drug Administration (FDA) has permanently cancelled the manufacturing licences of 10 Ayurvedic medicine manufacturers following inspections that found serious violations of Good Manufacturing Practices (GMP).
The action comes after authorities found deficiencies that could potentially compromise the quality, safety and efficacy of Ayurvedic medicines and pose a serious public health risk.
The 10 manufacturers whose licences have been permanently cancelled are:
- Krishna Herbal, Baramati, Pune
- Lalshah Organic Products, Karanja, Gondia
- Aditya Pharma, Wadegaon, Tiroda, Gondia
- Angaras Ayurved, Wadegaon, Tiroda, Gondia
- Kalidas Gandhi, Pune
- Shivnath Ayurvedic Products Company, Sinnar, Nashik
- Inducare Pharma Pvt. Ltd., Jejuri MIDC, Purandar, Pune
- Hakim Ayurvedic Beauty Care, Amravati
- Hilarius Ayurved, MIDC Mundipar, Gondia
- Yashoda Lab Pvt. Ltd., Nashik Road, Nashik
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A total of 434 Ayurvedic manufacturers were inspected across Maharashtra, whereas the FDA has also handed show-cause notices to 135 Ayurvedic manufacturing entities for non-compliance with applicable rules and regulations.
These manufacturers have been instructed to provide explanations for the deficiencies observed during inspections.
The Authorities also found 14 significant inconsistencies, the major among them being the fact that the production was taking place without authorised and qualified technical experts.
Inspectors also found irregularities like unhygienic production premises, missing batch production records and examples of incorrect production dates being printed on product labels.
The FDA also pointed out that no tests were done on raw materials and finished products. The facilities also lacked procedures to prevent cross-contamination in the manufacture of medicines.
The violations were categorised as serious breaches of Good Manufacturing Practices under Schedule T.
Manufacturers of Ayurvedic medicines are required by law to comply with the GMP requirements laid down under Schedule T of the Drugs and Cosmetics Rules, 1945.
These requirements are designed to ensure that medicines are manufactured under appropriate conditions, with adequate quality-control systems, trained technical personnel, proper testing and safeguards against contamination.
This latest action by the FDA follows inspections of Ayurvedic manufacturing units in Maharashtra to check compliance with these requirements.
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