Advisory board urges ban on codeine cough drugs, regulator to take call

Codeine formulations constitute 8% of cough and cold market; pharma industry asks govt not to ban a 'safe' medicine for abuse by some

The Drugs Technical Advisory Board (DTAB) has recommended a ban on codeine-based formulations, and now the country’s drug regulator would take a final call on the matter, multiple sources in the know said. If implemented, the ban on codeine preparations, which contribute about 8 per cent of the cough and cold market today, would lead to an impact of around Rs 43 crore.

Codeine-based formulations are under the scanner for misuse as a narcotic product. Several smuggling rackets have been busted and codeine formulations (cough syrups mostly) seized. Many people misuse this medication (which is an opioid product) to get intoxicated.

The DTAB met on September 26 to discuss the matter and multiple industry sources confirmed that it has recommended a ban on codeine based formulations. “The DTAB has recommended a ban on the codeine based formulations. The decision now lies with the Drugs Controller General of India (DCGI) on whether he implements a ban,” said an industry source.

The pharma industry has already made a representation to the government on the matter requesting them to consider not banning codeine which they claim is one of the best antitussive (cold medication) available today.

Daara Patel, secretary general of the Indian Drug Manufacturers Association (IDMA), said that the government should not take any such action because such drugs are clinically safe.

He added that they have written to the Centre on the matter. IDMA has cited seizure data from the Narcotics Control Bureau (NCB) from 2019 to 2021 for seizures versus the consumption of codeine phosphate. For example, in 2021 9,50,000 bottles of codeine based cough formulations were seized by the NCB with an approximate quantity of 9.5 kg of codeine. Total consumption of codeine phosphate in India that year was 55,620 kg, the IDMA letter said, citing NCB data.

“We also wish to point out that the data from a study conducted at National Institute of Mental Health & Neurosciences (NIMHANS), Bengaluru showed that codeine is abused by 0.7 percent of the study samples compared to 21 percent related to alcohol,” IDMA said, requesting the Centre to not ban the product because of abuse.

At present, codeine formulations contribute around 8 percent of the total cough and cold market, said Sheetal Sapale, president-marketing, AWACS, a research and analytics firm. She added that a ban on codeine preparations will lead to an impact of around Rs 43 crore to this market. Many of the top players have their core brands in this market (see chart).

Industry insiders say that pharma companies working with codeine-based cough formulations are implementing steps to prevent misuse. Pharma firms are improving traceability to check cough syrups reaching drug rackets in bulk quantities. “We have started QR code tracing. We have also reduced the batch sizes that we send out to trade – almost half the size of other liquid drugs. This enables closer tracking of the products,” said the chief executive officer of a pharma company who requested anonymity.

Codeine is a by-product of opium, which is processed in India under strict terms. In July, the government for the first time allowed a private company, Bajaj Healthcare, to process opium to extract alkaloids that are used to make painkillers, cough syrups, and even cancer drugs. Two government factories in Uttar Pradesh and Madhya Pradesh process around 800 tonnes per annum of opium gum to extract alkaloids. But Bajaj Healthcare will process the opium and give it back to the government, which would then sell it to the industry.

UNDER SCANNER

• Codeine is a by-product of opium, which is processed in India under strict terms
• Codeine-based formulations under the scanner for misuse as a narcotic product
• Pharma industry claims codeine is one of the best antitussive (cold medication) available and has urged the government to consider not banning it
• Codeine formulations contribute 8% to the total cough and cold market
• A ban may lead to an impact of around Re 43 crore on this market