The Centre is likely to set up fresh regulations for monitoring the supply and distribution of codeine-based cough syrups, also known as CBCS. This comes in the wake of the World Health Organisation (WHO) sounding an alarm on four ‘substandard’ India-made products typically used to treat cough symptoms in the Western African country Gambia. The cough syrups are believed to be linked to the death of 66 children in Gambia. The WHO said that the products contained “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.”
Sources said that the Indian government was considering a complete ban on codeine-based cough syrups, but gave in to the pharma industry’s request of implementing stricter guidelines to monitor their supply.
Manufacturers of codeine-based cough syrups currently have a manufacturing quota, but the government might introduce restrictions for distributors and sellers to ensure these syrups don’t end up in outlets such as paan shops, etc.
A representative of the Indian Drug Manufacturers’ Association (IDMA) who didn’t want to be identified said, “We have requested the Central government not to ban cough syrups containing codeine. Rather, the government should make its supply difficult.”
Although there have been reports of codeine-based cough syrups being seized from paan shops or from unauthorised distributors, it is a medically proven cough syrups, hence should not be prohibited, the IDMA representative said.
According to the official data, the overall consumption of codeine phosphate in the last three years was 1.50 lakh kg, but only 21.5 kgs of CBCS were seized, implying that only 0.014% of the amount consumed was seized. In 2015, the Narcotic Drugs and Psychotropic Substances (NDPS) Act categorized codeine as an essential narcotic substance, the IDMA representative said.
The representative said that a high-level conference was held with top authorities and several ideas were discussed. “As of now, it looks like codeine-based cough medicines won’t be banned, but their availability will be constantly watched. To prevent the misuse of cough syrups containing codeine, new regulations may be implemented. If an unauthorized individual is caught selling it, the distributor who sold the syrup to that person will be liable. Doctors may also be told to write prescriptions with specific codeine instructions,” stated an IDMA official.
According to Jashvant Patel, present, Federation of Gujarat State Chemists and Druggists Association, “Because of the NDPS Act’s jurisdiction, most retail pharmacies abide by the regulations. There are some supply chain leaks that allow for unauthorised users. To prevent abuse, codeine monitoring needs to be tightened up.”