Maharashtra FDA Cancels Licences of 10 Ayurvedic Units, Issues Notices to 135
The Maharashtra Food and Drug Administration (FDA) has permanently cancelled the manufacturing licences of 10 Ayurvedic drug manufacturers across the state following a statewide inspection drive that revealed severe violations of Good Manufacturing Practices (GMP). In addition to the cancellations, the state regulatory body issued show-cause notices to 135 other Ayurvedic drug manufacturers after inspecting facilities in locations including Baramati, Pune, Jejuri MIDC, Sinnar, Nashik Road, Amravati, Karanja, and Tiroda.
The regulatory action follows comprehensive inspections conducted across Maharashtra, which has 434 licensed Ayurvedic manufacturers in total. During the inspection drive, FDA officials evaluated manufacturing facilities and scrutinised various operational aspects, including technical manpower, quality-control systems, batch records, raw material testing, finished-product testing, standard operating procedures (SOPs), and other mandatory documentation.
According to the FDA, the statewide drive uncovered serious procedural and operational lapses at the 10 non-compliant manufacturing units. Among the major violations cited by officials were the absence of approved technical personnel and carrying out drug manufacturing without competent technical staff on site. Inspectors also found non-functional quality-control departments, inadequate machinery, and a lack of required testing equipment.
Furthermore, inspecting teams reported unhygienic premises at several manufacturing facilities, missing batch and raw-material records, incorrect manufacturing dates displayed on product labels, a complete absence of testing records, and inadequate measures to prevent cross-contamination during production processes.
The 10 Ayurvedic drug manufacturing units whose licences have been permanently cancelled include Krishna Herbal in Baramati, Lalshah Organic Products in Karanja, Gondia, and both Aditya Pharma and Angaras Ayurveda in Tiroda, Gondia. The list also includes Hilarious Ayurveda in Gondia, Kalidas Gandhi in Pune, Inducare Pharma Pvt Ltd in Jejuri MIDC, Shivnath Ayurvedic Products Company in Sinnar, Yashoda Lab Pvt Ltd in Nashik Road, and Hakim Ayurvedic Beauty Care in Amravati.
FDA Commissioner Tukaram Mundhe addressed the regulatory action, stating that manufacturers must strictly comply with prescribed Good Manufacturing Practices and quality-control standards. He emphasised that strict adherence to these regulations is essential to ensure the overall safety, quality, and efficacy of Ayurvedic medicines distributed to the public. Mundhe warned that strict action will continue to be taken against any units found violating the regulations.
