The Uttar Pradesh Food Safety and Drug Administration (FSDA) has sent suggestions to the Central government for comprehensive changes in the drug distribution system, to curb the illegal trade in codeine-based cough syrup, a spokesperson said.
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.
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.
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, according to a release.
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. 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.
{{/usCountry}}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. 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.
{{/usCountry}}The proposals 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.
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 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.
UPFSDA clarified that 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.
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 is not affected.