Hyderabad: The officials of Drugs Control Administration, Telangana, raided premises of Elion Health Care, Tarnaka, Secunderabad on Tuesday, for its alleged involvement in marketing the product ‘Pregabalin and Methylcobalamin Capsules’ under brand name ‘eneuron-P’ without proper license.
The firm Elion Health Care markets the product as per the product’s label, after getting it manufactured illegally at Akshar Molecules located at Phase-I, HSIIDC, Barhi, Haryana. The FSSAI license falsely claims it as a food product/nutraceutical.
The product ‘Pregabalin and Methylcobalamin Capsules’ containing 75 mg of Pregabalin and 750 mcg of Methylcobalamin is a ‘drug’ as per the Drugs and Cosmetics Act.
The said product composition was approved as a ‘drug’ by the Drugs Controller General (India) to treat Peripheral Neuropathy in adult patients.
The DCA officials said the product ‘Pregabalin and Methylcobalamin Capsules’ shall be manufactured only under a ‘drug license’ issued under the Drugs and Cosmetics Act, and adhering to the Good Manufacturing Practices (GMP) prescribed under Schedule-M of Drugs Rules. The firm shall also meet the quality standards prescribed in ‘Indian Pharmacopoeia’ (IP) mandatorily.
During the raid at Elion Health Care, the DCA officers found seized stocks worth Rs. 93,000.
The product ‘eneuron-P’, falsely manufactured and sold under a food licence and sold in the market, was initially detected by the Drugs Inspector, Karimnagar and 30 boxes were seized. The DCA officers of Karimnagar zone alerted DCA Secunderabad officers who raided the premises of the marketer Elion Health Care, Tarnaka, Secunderabad on Tuesday and seized the stocks.
A similar case of a ‘drug’ manufactured under a ‘food licence’ was detected earlier by DCA, Telangana in November, 2023.
The DCA officials said the drugs which are falsely manufactured and sold under a food licence are not manufactured in accordance with ‘Good Manufacturing Practices’ (GMPs) and also fail to meet the quality standards prescribed in Indian Pharmacopoeia (IP) and such products may have serious implications on patient’s health.
Manufacturing and selling of ‘drugs’ without a valid ‘drug licence’ is punishable under the Drugs and Cosmetics Act, with an imprisonment up to five years.
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