Maharashtra’s Food and Drug Administration (FDA) has permanently cancelled the manufacturing licences of 10 Ayurvedic drug units after a statewide inspection found serious violations affecting manufacturing and quality-control standards.
The action followed inspections of all 434 licensed Ayurvedic manufacturing establishments in the state, with 135 units receiving show-cause notices for various lapses.
The regulator said the most serious violations included manufacturing without qualified technical personnel, non-functional quality-control departments, inadequate equipment, unhygienic premises, missing production and testing records, and a lack of safeguards against cross-contamination.
FDA Commissioner Tukaram Mundhe said Ayurvedic medicines are widely used by the public and warned that manufacturers failing to follow prescribed standards would face strict action.
Serious Lapses Found Across Manufacturing Units
The FDA’s inspection drive examined whether manufacturers were complying with the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and Good Manufacturing Practices prescribed under Schedule T for Ayurvedic medicines.
Among the 10 units whose licences were cancelled, officials found several basic safeguards missing. These included the absence of approved technical personnel, non-functioning quality-control departments, inadequate machinery and testing equipment, and premises that did not meet prescribed hygiene standards.
Inspectors also found missing or inconsistent batch and raw-material records, incorrect manufacturing dates on labels, a lack of testing for raw materials and finished products, and missing records related to staff training and medical examinations.
Some units also lacked control samples, Master Formula Records and procedures to prevent medicines from being cross-contaminated.
Mundhe stressed that compliance cannot be treated as optional simply because the medicines are based on traditional systems of treatment.
“Ayurvedic medicines are widely used by the public,” he said, adding that classical medicines must be manufactured according to recognised reference texts, while patent and proprietary medicines must meet the standards laid down in the applicable rules.
He warned that strict action would be taken against manufacturers that fail to meet these requirements. The FDA has also issued show-cause notices to 135 other manufacturers, giving them an opportunity to respond to the violations identified during inspections.
Part Of A Wider Maharashtra Enforcement Drive
The latest action comes amid a broader enforcement push by the Maharashtra FDA under Mundhe. In May, the department conducted a separate statewide crackdown on misleading advertisements and misbranded medicines, seizing drug stocks worth more than ₹73 lakh from establishments across seven regions.
The FDA said some Ayurvedic products were being promoted with claims of guaranteed cures, miraculous results or treatment for serious illnesses.
The cancellation of 10 manufacturing licences therefore marks a significant escalation from inspections to permanent regulatory action.
At the same time, the 135 show-cause notices indicate that not every identified lapse has resulted in the same penalty.
Manufacturers have been asked to explain the deficiencies found at their facilities, while the FDA continues to emphasise compliance with manufacturing, testing, documentation and quality-control requirements.
For consumers, the issue goes beyond Ayurveda versus modern medicine: medicines of every system need to be manufactured safely and consistently before they reach the public.
The Logical Indian’s Perspective
Traditional medicine is an important part of healthcare for millions of people, but trust in any treatment system depends on transparency, safety and accountability.
Regulatory action should protect consumers without unfairly targeting legitimate manufacturers, while manufacturers must recognise that basic quality standards are not obstacles to their work but safeguards for the people who rely on their products.
Strong inspections, fair hearings and clear enforcement can help build confidence in Ayurveda while protecting public health. Do you think stricter quality checks can strengthen public trust in Ayurvedic medicines while supporting responsible manufacturers?
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