Govt is set to ban Codeine-based Cough Syrups and formulations

The use of codeine-based formulations has been under the government scanner for several years.

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Govt of India

Last Updated on August 5, 2022 by The Health Master

The government is set to ban popular codeine-based cough syrups and formulations following concerns raised by MPs recently about their misuse of narcotics and intoxicants.

An expert committee set up by the health ministry has recommended the ban on certain codeine-based combinations to curb their abuse, sources told.

The M S Bhatia-led committee has recommended around 14 products to be banned, sources said. These could include other fixed-dose combinations, not just codeine-laced cough syrups.

Brands marketed by companies including Pfizer, Abbott, Laborate, and Mankind could be potentially impacted once a final decision is taken.

Over five years ago, cough and cold syrups marketed by MNCs Pfizer and Abbott were among the top-selling brands in the pharma retail market, clocking over Rs 200 crore each in annual sales.

The use of codeine-based formulations has been under the government scanner for several years.

In March 2016, these formulations, including cough syrups, were part of the ban on “irrational” 350-odd fixed-dose combination (FDC) drugs, besides wide-selling painkillers, anti-diabetic medicines, and respiratory therapies.

The government had then decided to prohibit the sale of these medicines as they were found to be irrational, “likely to involve risk to human beings”, and without any therapeutic use.

However this was not implemented as the companies challenged the ban, and the court stayed the government’s order.

Codeine is an opioid-based analgesic, mostly used to treat coughs, colds, and pain. Due to high rates of abuse of codeine cough syrups, its use is closely monitored and controlled in developed markets, including the US and Europe.

In 2017, the US Food and Drug Administration restricted the use of codeine and tramadol (therapy to treat pain) medicines in children, due to safety risks.

Codeine and its preparations are under schedule H1, which are dispensed against prescription, but most are available over the counter in India.

Further, there is rampant cross-border smuggling of codeine-based cough syrups in the northeast, West Bengal, and Bihar.

The need for “prohibition and regulation of the use of Corex and Iodex” was raised in Parliament earlier this year.

Hence, the issue was examined by the Central Drugs Standard Control Organisation (CDSCO) and the Ayush ministry, but a final decision is yet to be taken on Iodex, sources added.

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