UP drug regulator proposes tighter wholesale drug licensing rules amid codeine syrup probe

Lucknow, Dec 30 (PTI) Seeking to choke a vast illegal network dealing in codeine-based cough syrup, the Uttar Pradesh Food Safety and Drug Administration (FSDA) has proposed a major overhaul of the wholesale drug licensing system, including stricter verification, real-time monitoring and tighter accountability norms, a senior government official said on Tuesday.

The proposals have been sent to the state government, while a separate set of recommendations has been forwarded to the Centre, the official said, amid an ongoing crackdown that has exposed large-scale diversion of regulated medicines through shell billing, WhatsApp-based coordination and unverifiable supply chains.

Key measures proposed by the FSDA include geo-tagging of wholesale drug establishments, mandatory verification of licensed storage capacity, photographic documentation of premises and stocks, and authentication of experience certificates of technical personnel by drug inspectors. The aim is to eliminate gaps in the wholesale supply chain that allow highly regulated medicines to be diverted for non-medical use, the official told PTI, requesting anonymity.

The department has also sought fresh central notifications and uniform guidelines governing the manufacture, bulk supply, distribution and monitoring of codeine-based cough syrup, officials said, stressing that existing rules have proved inadequate in preventing misuse.

The proposals were finalised after FSDA teams scrutinised purchase and sale records of wholesalers during inspections in Uttar Pradesh, Delhi and Ranchi, which revealed systemic non-compliance. In several cases, wholesalers failed to establish receipt of stocks, produced transactions only on paper or could not furnish sales bills for retail outlets. Even where records were submitted, actual movement of cough syrup could not be substantiated, officials said.

Investigators have alleged that procurement and billing were coordinated through WhatsApp groups, while physical stocks were either missing or diverted through a parallel distribution network linked to super-stockists based outside the state.

Over the past three months, the FSDA inspected more than 332 wholesale drug establishments across 52 districts for illegal stocking, purchase, sale and diversion of codeine-based cough syrup and other NDPS-category medicines. Probes were also carried out in Jharkhand, Haryana, Himachal Pradesh and Uttarakhand, where evidence of business links between super-stockists and Uttar Pradesh-based wholesalers was gathered.

Officials said that in 2024-25, the volume of codeine-based cough syrup supplied to Uttar Pradesh was several times higher than actual medical requirements. More than 3.25 crore bottles were supplied during the period, including about 2.23 crore bottles of Phensedyl, over 73 lakh bottles of Ascoff and around 25 lakh bottles from other manufacturers. None of these supplies could be conclusively validated for legitimate medical use, they said.

So far, police and the FSDA have registered 79 FIRs against 161 firms and operators in 36 districts under provisions of the Bharatiya Nyaya Sanhita and the NDPS Act, arresting 85 accused. The Allahabad High Court has recently upheld proceedings under the NDPS Act and dismissed writ petitions in 22 cases, also rejecting pleas seeking protection from arrest.

The crackdown intensified after authorities uncovered networks involved in smuggling cough syrup to other states and across the border. Chief Minister Yogi Adityanath subsequently constituted a Special Investigation Team to conduct a detailed probe, which is expected to submit its report next month.

Asset-tracing and seizure proceedings have also been initiated against key accused, with district magistrates directed to invoke the Gangster Act to attach properties allegedly acquired through the illegal narcotics trade, officials said. PTI KIS MAN MR