Major initiative to regulate the supply chain of codeine-based cough syrup across the country
Manufacturers advised to supply only through their authorised CFAs and established local stockists
Ban on wholesale-to-wholesale sales and a digital track-and-trace system advocated
Step taken after inter-state investigations found the medicine not reaching the retail market and being diverted through parallel distribution channels
During inspection of 332 wholesale drug establishments, the department had got FIRs registered against 161 firms
Lucknow, November 2026 : To effectively curb the illegal trade in codeine-based cough syrup being used as an intoxicant, the Uttar Pradesh Food Safety and Drug Administration (FSDA) has sent suggestions to the Central Government for comprehensive changes in the drug distribution system. The department's investigation revealed that large quantities of codeine-based cough syrup were being billed, but the products were not reaching the authorised retail market. This raised concerns about their non-medical use and commercial diversion instead of medical use. For a permanent solution to this problem, the department has suggested measures to control the entire supply chain, from manufacturers to wholesalers.
FSDA Secretary and Commissioner Dr. Roshan Jacob, in a reminder sent to the Union Ministry, has requested an early decision on six key regulatory proposals and the issuance of the necessary guidelines. The department stresses that codeine-based syrup should be supplied only through established and authorised distribution channels, and that the record of movement of every consignment should be available with the concerned state.
In fact, the inter-state investigation into the manufacture and supply of codeine-based cough syrup in the state had indicated parallel distribution networks. The investigation found difficulties in monitoring the actual movement and final destination of products coming from Ranchi, Himachal Pradesh and other outside routes. In many cases, physical stock matching the billing was not found, nor were reliable records available showing that the drugs had reached retail sale.
The department inspected and verified the records of 332 wholesale drug establishments across 52 districts. On the basis of serious irregularities, FIRs were registered against 161 firms in 36 districts under the BNS and the NDPS Act. Proceedings for cancellation of their licences have also been initiated.
Manufacturers should dispatch goods only through their authorised CFAs
Among the key aspects revealed by the investigation is that some manufacturers were appointing separate stockists for codeine-based syrup, apart from the normal distribution system. Many of these were located outside Uttar Pradesh. Through them, large consignments were being billed to the state's wholesale traders. At many establishments, neither the actual stock nor satisfactory purchase-sale records were found. To improve this system, it has been suggested that Laborate, Abbott, 3B, Wings and other major companies supply their products only through their authorised CFAs and through established and valid stockists in Uttar Pradesh. The arrangement of creating separate parallel distribution channels by bringing in outside persons only for codeine products should be stopped. This will help fix accountability for every consignment and get the medicines to the authorised retail market.
Supply should be decided after scientific assessment of demand
The department's emphasis is not merely on giving production quotas to companies, but on a scientific assessment of the actual medical needs of the states. The quantity of codeine-based cough syrup required by Uttar Pradesh should be decided on the basis of past years' consumption, patients' needs and actual market demand. After that, companies should supply transparently to their authorised CFAs located in the state, and from there to licensed wholesalers. This will reduce the scope for unnecessary stocking and possible diversion.
Drug Controller must be informed before dispatch
The proposals also suggest a system for manufacturers under which the concerned state's Drug Controller must compulsorily be informed before dispatching consignments of codeine-based cough syrup and other controlled drugs. This will allow the state to know in advance the quantity, batch, supplier and destination of the drugs. Along with this, a ban on wholesale-to-wholesale sales has been advocated, so that supply reaches the retail level through the authorised distribution system.
Digital tracking on the lines of TB drugs
To prevent diversion of drugs, it has been suggested that, like TB drugs, a QR code/barcode-based track-and-trace system be implemented for codeine-based syrup as well. Under it, batch-level reporting, real-time monitoring and risk-based alerts should be developed. This will make digital monitoring of every consignment possible, from the manufacturer to the final sale.
In addition, a proposal has also been sent to the Centre to create a separate Schedule H3 for drugs with a higher risk of misuse, and to set stocking limits based on actual consumption in the states. The department believes that these measures can establish effective control over the illegal diversion of codeine-based cough syrup without affecting legitimate medical use.
Medicine should remain available to patients, diversion for intoxication should stop
Codeine-based cough syrup is neither a spurious drug nor a completely banned medicine. It is a recognised medicinal drug, used on a doctor's advice for severe cough and other prescribed treatment needs. Such patients should be able to get this medicine easily at medical stores for treatment. The aim of the UPFSDA's initiative is also not to obstruct its legitimate medical availability, but to stop the large-scale non-medical diversion of the drug. The investigation has also raised concern about alleged illegal supply in border districts and towards Nepal and Bangladesh. The department wants effective curbs on such supply meant for intoxication, and in its place wants adequate quantities of the medicine to remain available in the authorised retail market in line with actual medical demand, so that the treatment of needy patients are not affected.
