Govt plan to ban Codeine-based cough syrups opposed by drugmakers

The aim is to stop the misuse of these codeine-based formulations, the health ministry and several other government departments are in discussion on the proposed ban
The aim is to stop the misuse of these codeine-based formulations, the health ministry and several other government departments are in discussion on the proposed ban
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NEW DELHI : A government plan to ban Codeine-based cough syrups (CBCS) for distribution and sale to prevent their misuse as intoxicants has run up against the pharma industry.
The health ministry and several other government departments are in discussion the proposed ban.
However, the Indian Drug Manufacturer Association (IDMA) has reached out to the authorities to not enforce a ban, saying cough syrups are popular among medical professionals in managing post-operative cough, persistent dry cough in tuberculosis patients, and for managing cough in covid-19 patients.
“The aim is to stop of the misuse of these codeine-based formulations. So, the government is discussing the matter at multiple levels," said an official requesting anonymity.
According to a 2019 report jointly published by the ministry of social justice & empowerment and the National Drug Dependence Treatment Centre, AIIMS, India is home to 7.7 million people with opioid use disorders, of whom 2.5 million use pharmaceutical opioids.
“We have submitted our representation to the government highlighting our points that they should not take any action to ban the sale of CBCS, based on an alleged abuse angle for clinically safe codeine-based cough formulations," said Daara Patel, secretary general at IDMA.
“The abuse angle needs to be effectively dealt with through appropriate regulations as per the NDPS Act, 1985 and by the enforcement agencies. Banning the drug will jeopardize the interest of the patients at large."
He said a ban will also affect the livelihood of around 100,000 farmers in Madhya Pradesh, Uttar Pradesh and Rajasthan who are dependent on poppy cultivation.
“These farmers are already distressed for last two years due to covid-19 and the ban on CBCS will further kill their livelihood."
The industry is committed to working with the authorities to support government initiatives to curb any misuse, Patel added.
IDMA has told the department of revenue that a ban could spell a loss to the exchequer for ₹300 crore in the sales value of codeine phosphate API sold by the Government’s Opium and Alkaloid Factory (GOAF), including GST.
Dr Atul Ambekar, professor of National Drug Dependence Treatment Centre, at AIIMS New Delhi said, “The problem of drug use or drug use disorders is fairly large in India but is still at a manageable level. However, the most worrying category of drugs in India is opioids, with prevalence of opioid use in India being three times the global average.
He said in recent years, the trend in northern Indian states is that access to cheaper and low-potency natural opioids like opium/doda (poppy husk) is now very limited. This has forced people to look for alternatives in the form of either heroin or pharmaceutical opioids.
The Narcotics Control Bureau seized around 950,000 bottles of CBCS and 9.50 kg of Codeine Phosphate from different locations in India last year.
Queries sent to the health ministry spokesperson did not elicit a response.