Mumbai: The Maharashtra Food and Drug Administration (FDA) has permanently cancelled the manufacturing licences of 10 Ayurvedic drug manufacturers for serious violations of Good Manufacturing Practices (GMP), while 135 other manufacturers were issued show-cause notices following a statewide inspection drive.
Maharashtra has 434 licensed Ayurvedic manufacturers. FDA officials inspected manufacturing facilities and scrutinised technical manpower, quality-control systems, batch records, raw material and finished-product testing, SOPs and other mandatory records.
The 10 units were found with serious lapses, including absence of approved technical personnel, manufacturing without competent technical staff, non-functional quality-control departments, inadequate machinery and testing equipment, unhygienic premises, missing batch and raw-material records, incorrect manufacturing dates on labels, lack of testing records and inadequate measures to prevent cross-contamination.
The licences of Krishna Herbal, Baramati; Lalshah Organic Products, Karanja, Gondia; Aditya Pharma and Angaras Ayurveda, Tiroda, Gondia; Kalidas Gandhi, Pune; Shivnath Ayurvedic Products Company, Sinnar; Inducare Pharma Pvt Ltd, Jejuri MIDC; Hakim Ayurvedic Beauty Care, Amravati; Hilarious Ayurveda, Gondia; and Yashoda Lab Pvt Ltd, Nashik Road, have been permanently cancelled.
FDA Commissioner Tukaram Mundhe said manufacturers must strictly comply with prescribed GMP and quality-control standards to ensure the safety, quality and efficacy of Ayurvedic medicines. Strict action will be taken against units violating the regulations, he said.
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