Lucknow: The Uttar Pradesh Food Safety and Drug Administration (FSDA) has sent a set of recommendations to the Centre seeking major reforms in the drug distribution system to effectively curb the illegal trade of codeine-based cough syrups that are increasingly being misused as intoxicants.
An investigation by the department revealed that large quantities of codeine-containing cough syrups were being billed, but many of these products were not reaching the authorised retail market. This raised concerns about their diversion for non-medical use and unauthorised commercial distribution.
Aiming to find a long-term solution, the department has suggested measures to regulate the entire supply chain, from manufacturers to wholesalers.
In a reminder sent to the Union Ministry, FSDA Secretary and Commissioner Dr Roshan Jacob urged an early decision on six major regulatory proposals and requested the issuance of necessary guidelines. The department emphasised that supplies of codeine-based syrups should be routed only through established and authorised distribution channels, and that records of every consignment’s movement should be available with the state authorities concerned.
Earlier, an inter-state investigation into the manufacture and supply of codeine-based cough syrups in Uttar Pradesh indicated the existence of parallel distribution networks. The probe found difficulties in tracking the actual movement and final destinations of products arriving from routes linked to Ranchi, Himachal Pradesh, and other locations outside the state. In several cases, the physical stock did not match the billed quantities, and reliable records proving retail distribution were unavailable.
Based on serious irregularities, FIRs were lodged against 161 firms in 36 districts under the Bharatiya Nyaya Sanhita (BNS) and the Narcotic Drugs and Psychotropic Substances (NDPS) Act. Proceedings for cancellation of their licenses have also been initiated.
Among its proposals, the department has urged major companies such as Laboratories, Abbott, 3B, Wings and others to supply their products only through authorised Carrying and Forwarding Agents (CFAs) and legally established stockists within Uttar Pradesh. The practice of creating separate parallel distribution channels involving external individuals exclusively for codeine products should be discontinued. This would improve accountability for every consignment and ensure that medicines reach authorised retail outlets, it said.
The FSDA has also stressed that the focus should not be limited to allocating production quotas to companies. Instead, the actual medical requirement of each state should be scientifically assessed. The required quantity of codeine-based cough syrup for Uttar Pradesh should be determined based on previous consumption patterns, patient needs, and genuine market demand.
Thereafter, companies should transparently supply products to their authorised CFAs within the state and from there to licensed wholesalers. This would reduce unnecessary stockpiling and limit opportunities for diversion.
Further, the drug regulator proposed that manufacturers of codeine-based cough syrups and other controlled medicines must inform the concerned state drug controller before dispatching any consignment. This would enable state authorities to know in advance the quantity, batch details, supplier information, and destination of the medicines. The department has also advocated restricting wholesale-to-wholesale sales while ensuring that supplies move through authorised distribution networks to the retail level.
To prevent diversion, the FSDA has suggested implementing a QR code/barcode-based Track and Trace system for codeine-based syrups, similar to that used for tuberculosis medicines. The system would include batch-level reporting, real-time monitoring, and risk-based alerts, allowing digital tracking of every consignment from the manufacturer to the point of final sale.
Additionally, the drug regulator has proposed the creation of a separate Schedule H3 category for medicines with a higher risk of misuse and the introduction of stock limits based on actual consumption patterns in different states.
According to the department, these measures would help establish effective control over the illegal diversion of codeine-based cough syrups without affecting their legitimate medical use.
Codeine-based cough syrups are neither counterfeit medicines nor completely prohibited drugs, but a legally approved pharmaceutical product prescribed by doctors for severe cough and other specified medical conditions. Patients who genuinely need the medicine should continue to have easy access to it through medical stores.
–IANS–
