After codeine racket, wholesale drug licencing reforms on the cards | Hindustan Times

After codeine racket, wholesale drug licencing reforms on the cards

By, Lucknow
Published on: Dec 28, 2025 04:18 AM IST

FSDA to submit a proposal to the state government seeking procedural changes in the licencing system

After flagging the sale of 3.27 crore bottles of codeine-based cough syrups worth 704 crore in Uttar Pradesh, Food Safety and Drugs Administration (FSDA) has decided to push for systemic changes in the wholesale drug sale licencing framework to prevent illegal diversion and misuse of pharmaceuticals, senior FSDA officials confirmed on Saturday.

A representative image of cough syrup. (Photo credit: Shutterstock)
A representative image of cough syrup. (Photo credit: Shutterstock)

FSDA commissioner Roshan Jacob said the department would submit a proposal to the state government seeking procedural changes in the wholesale drug licencing system. She said the aim was to strengthen oversight and plug gaps that allow excessive and unverified supply of narcotic-category medicines.

“At the same time, FSDA is writing to the Government of India (GoI) seeking the issuance of necessary notifications and guidelines to regulate and ensure proper documentation of the supply of codeine-based cough syrups, particularly in cases where supply volumes appear disproportionate to actual production and legitimate medical consumption in the state,” Jacob said.

“The entire FSDA team is further working under the directions of chief minister Yogi Adityanath to investigate the supply chain and expose each and every individual involved in this illegal practice,” she noted.

The move follows a two-month-long enforcement drive during which the department found, from official records, that huge quantities of codeine-based cough syrups were routed through a limited number of super-stockists and stockists, raising red flags about possible illegal diversion.

As per the department’s findings, ‘New Phensedyl’, manufactured by Himachal Pradesh’s Abbott Healthcare, accounted for the largest share, with 2,23,92,311 bottles valued at approximately 506 crore sold in the state. This was followed by ‘Ascoff’, manufactured by Laborate Pharmaceutical, accounting for 73,16,755 bottles worth about 154.38 crore. Other brands together accounted for 24,87,092 bottles valued at around 43.77 crore.

The crackdown covered 52 districts, during which over 332 wholesale drug establishments were inspected. Based on evidence of illegal diversion, FSDA has registered 161 FIRs across 36 districts under provisions of the Bharatiya Nyaya Sanhita (BNS), 2023, and the NDPS Act, 1985.

The FSDA officials said investigations were going on to trace the supply chain, determine the role of stockists, and assess the misuse of codeine-based medicines beyond therapeutic purposes.

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The Food Safety and Drugs Administration (FSDA) of Uttar Pradesh plans to reform the wholesale drug sale licensing framework following the sale of 3.27 crore bottles of codeine cough syrups worth ₹704 crore. FSDA seeks to enhance oversight and curb illegal diversion, with ongoing investigations into stockists' roles. This follows a crackdown revealing significant illicit supply.