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Maharashtra FDA cracks down on ayurvedic drug manufacturer for violating DMR Act
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Shardul Nautiyal, Mumbai
September 18 , 2024
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In a significant enforcement action, the Maharashtra Food and Drugs Administration (FDA) has carried out a raid on Gynoveda Femtech Pvt. Ltd., an ayurvedic drug manufacturer located at Global Complex, Kukade, Nashik Highway, Bhiwadi, Thane district. The raid led to the seizure of ayurvedic drugs valued at Rs. 6,08,900.
According to Maharashtra FDA officials, the seized drugs were in violation of the provisions of the Drugs and Magic Remedies (Objectionable Advertisement) (DMR) Act, 1954 and its associated Rules, 1955. The company's actions were deemed unlawful under the provisions of this Act, which seeks to prevent misleading and exaggerated claims in the advertisement of drugs and treatments.
The Maharashtra FDA has launched a full-scale investigation into the company’s manufacturing processes. Based on the findings, appropriate legal action will be pursued against those responsible for these violations. Additionally, the Maharashtra FDA prohibited the further distribution of some other ayurvedic drugs from the same manufacturer due to improper labeling requirements. The value of these prohibited drugs is estimated at Rs. 3,62,60,900, and they will remain off the market until further orders are issued by the Licensing Authority.
The operation was led by drugs inspector (DI) of Thane, Prashant Brahmankar, along with Shashikant Yadav, drugs inspector (IB). The FDA conducted the raid in coordination with senior officials, including Maharashtra FDA commissioner Dadaji Gahane, joint commissioner FDA Vigilance Dr. Rahul Khade, assistant commissioner (IB) V R Ravi, joint commissioner FDA Thane Narendra Supe, and assistant commissioner FDA Thane Mukund Donglikar.
“This action reflects the FDA's commitment to maintaining public health and safety by ensuring that ayurvedic and other traditional medicines meet regulatory standards. Investigations at the manufacturer level will continue, and further actions will be taken in line with the findings of the inquiry,” stated Gahane.
He further added that the case underscores the importance of regulatory compliance in the manufacturing and distribution of pharmaceutical and traditional medicinal products. Legal repercussions for those found violating the law could include penalties, sanctions, and restrictions on future business operations, in line with the stringent provisions of the DMR Act.
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