Maharashtra’s Food and Drug Administration inspected 434 licensed Ayurvedic drug manufacturers and issued show-cause notices to 135 firms for alleged regulatory violations. FDA cancelled licences of 10 manufacturers on finding issues including unhygienic premises, missing tech staff, inadequate testing facilities and incomplete production records.
The Maharashtra Food and Drug Administration (FDA) has taken action against several Ayurvedic drug manufacturers following a statewide inspection drive that covered 434 licensed units. The department issued show-cause notices to 135 manufacturers and cancelled the licences of 10 firms after inspectors found serious violations linked to manufacturing practices, quality control and safety requirements.
The inspections were carried out to check compliance with the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and Good Manufacturing Practices (GMP) under Schedule T.
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FDA finds serious manufacturing lapses
According to the FDA, inspectors found several facilities operating in unhygienic conditions. Some manufacturers were allegedly producing medicines without qualified technical staff, while others did not have functioning quality-control departments.
Inspectors also found inadequate arrangements for testing raw materials and finished products.
Other deficiencies included missing or incomplete batch production records, raw material records and standard operating procedures. In some cases, manufacturing dates printed on product labels were reportedly incorrect.
The FDA also found units without essential machinery and equipment required for production and testing.
The department said these shortcomings could affect the quality, safety and effectiveness of Ayurvedic medicines and therefore pose a public health concern.
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10 licences cancelled
The FDA cancelled the licences of 10 manufacturers following the inspections.
The firms named by the department include Krishna Herbal in Baramati, Pune; Lalshah Organic Products in Karanja, Gondia; Aditya Pharma and Angaras Ayurveda in Wadegaon, Tiroda, Gondia; Kalidas Gandhi in Pune; Shivanath Ayurvedic Products Company in Sinnar, Nashik; Induke Ayur Pharma Pvt Ltd in Jejuri MIDC, Purandar, Pune; Hakim Ayurvedic Beauty Care in Amravati; Hilarious Ayurveda in MIDC Mundipar, Gondia; and Yashoda Lab Pvt Ltd in Nashik Road, Nashik.
The FDA said the violations at these facilities were considered serious enough to warrant licence cancellation.
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Missing records and testing facilities
During the inspection drive, officials examined manufacturing premises, technical manpower and quality-control systems.
They also checked batch production records, testing records for raw materials and finished products, distribution records, complaint registers, calibration details and stability data.
The department found that some facilities did not have approved site plans required under Schedule T. Others lacked medical examination and training records for technical staff.
Inspectors also reported missing control samples and master formula records. Some units allegedly lacked proper procedures to prevent medicines from becoming contaminated during manufacturing.
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FDA warns manufacturers
FDA Commissioner Tukaram Mundhe said Ayurvedic medicines are widely used and manufacturers have a responsibility to ensure that their products meet prescribed standards.
He said classical Ayurvedic medicines must be produced according to recognised reference books, while patent and proprietary medicines must comply with prescribed quality requirements.
Mundhe warned that strict action would be taken against manufacturers that fail to meet regulatory requirements.
The FDA has directed the 135 firms issued show-cause notices to explain the deficiencies identified during inspections. Further action will depend on their responses and the findings of the department.
The FDA stressed that manufacturers must follow GMP requirements under Schedule T to ensure the quality, safety and efficacy of medicines.
The latest crackdown comes after the Maharashtra FDA stepped up inspections and raids across the state following Mundhe’s appointment as FDA commissioner in May. The department has recently attracted attention for action against food establishments, including several well-known eateries.
(With inputs from agencies)
