The product eneuron-P, containing 75 mg of pregabalin and 750 mcg of methylcobalamin, is a ‘drug’ as per Drugs and Cosmetics Act.
Published Jan 27, 2024 | 8:00 AM ⚊ Updated Jan 27, 2024 | 8:00 AM
The said product composition was approved as a ‘drug’ by the Drugs Controller General (India) to treat ‘Peripheral Neuropathy in adult patients’. (Supplied)
The Telangana Drugs Control Administration (DCA) seized products falsely sold as “food products” or “nutraceuticals” earlier this week.
Pregabalin + methylcobalamin, sold as capsules, is a medicine used to treat peripheral neuropathy.
It was being manufactured under a food licence at Akshar Molecules in Haryana and marketed illegally by Elion Health Care Pvt Ltd in Telangana as a food product or nutraceutical under the brand name “eneuron-P”.
Based on intelligence, DCA officials on 23 January raided the premises of Elion Health Care at Tarnaka in Secunderabad.
Pregabalin + methylcobalamin capsules, containing 75 mg of pregabalin and 750 mcg of methylcobalamin, is a “drug” as per the Drugs and Cosmetics Act.
The product composition was approved as a “drug” by the Drugs Controller General of India to treat peripheral neuropathy in adult patients.
“The product ‘Pregabalin and Methylcobalamin Capsules’ shall be manufactured only under a ‘drug licence’ issued under Drugs and Cosmetics Act adhering to the ‘Good Manufacturing Practices’ (GMP) prescribed under Schedule-M of Drugs Rules and shall meet the quality standards prescribed in ‘Indian Pharmacopoeia’ (IP) mandatorily,” said the DCA in a statement.
During the raid at Elion Health Care, DCA officials found around 4,900 capsules of eneuron-P labelled with the composition: “Each soft gelatin capsule contains: Pregabalin 75 mg, Methylcobalamin 750 mcg”.
The composition had other ingredients as well, and bore a food licence.
The DCA officials seized stocks worth ₹93,000 during the raid and lifted samples for analysis.
The product eneuron-P was initially detected by a drugs inspector in Karimnagar on 18 January, when 30 boxes were seized
DCA officers of the Karimnagar zone alerted DCA Secunderabad officers, who raided the premises of the marketer Elion Health Care and seized the fresh stocks.
A similar case of a drug manufactured under a food licence was detected by the Telangana DCA in November last year.
The product NalcobalPG Capsules (claimed to contain pregabalin 75 mg and methylcobalamin 750 mcg) was manufactured by Yaxon Biocare Pvt Ltd at Sonipat in Haryana under a food licence or FSSAI licence.
It was detected and seized by a drugs inspector in Karimnagar and was declared “spurious” by the Drugs Control Laboratory in Hyderabad as the content of pregabalin and methylcobalamin was found to be ‘NIL’ (i.e. zero drug) in the product.
Drugs 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). Such products may have serious implications on consumers’ health.
Manufacturing and selling of drugs without a valid drug licence is punishable under the Drugs and Cosmetics Act with an imprisonment of up to five years.
