Tough regulatory rules likely for sale of codeine-based cough syrups after MPs raise concerns

New Delhi: The government is reviewing the policy to ban manufacturing and sale of codeine-based cough syrups after several MPs raised conc...

New Delhi: The government is reviewing the policy to ban manufacturing and sale of codeine-based cough syrups after several MPs raised concerns that they are being used as narcotic drugs than as medicine.

Codeine is an opioid-based analgesic, mostly used to treat coughing, pain and diarrhoea, and it is one of the natural plant alkaloids found in extracts of opium.

Based on the request by several politicians to health minister Mansukh Mandaviya to ban cough syrups, a copy of which was accessed by News18.com, the health ministry had asked the Drug Controller General of India (DCGI) in March to “conduct a review and submit recommendation”.

Recently, the DCGI has submitted its review to the health ministry.

“The top selling brands using codeine are Pfizer’s Corex, Abbott’s Phensedyl and Laborate Pharmaceuticals’ Eskuf among a few others,” the government official privy to the development said, adding that “the states where the consumption of these syrups is high include Uttar Pradesh, Gujarat, West Bengal and Karnataka.”

The official said discussions have been going on. “Tightening the regulatory noose on codeine-based medicines is becoming a need of an hour. However, a holistic approach will be adopted.”

While discussions to ban codeine-based cough syrups have taken place frequently in the last few years starting 2015, nothing concrete has been decided so far.

The Narcotics Control Bureau (NCB) in 2017 had asked the DCGI to “substantially reduce” the availability of codeine-based cough syrups saying they are being used as narcotic drugs.

It had said these formulations are being abused and their availability must be substantially reduced so that the bureau can identify their movement in the market.

Concerned over the increasing noises to ban codeine-based drugs and regular interference of NCB, several drug-makers have already tweaked the ingredients of the popular syrups. For instance, Alembic Pharma removed codeine from its popular cough syrup brand, Glycodin.

What did MPs' complaint say?

According to the copy of complaint, several MPs including Ajay Pratap Singh (Rajya Sabha member from Madhya Pradesh), Dr Kanimozhi (Tamil Nadu), Dr V Sivadasan and Elamaram Kareem (from Kerala), Fauzia Khan (from Maharashtra) and Amar Patnaik (from Odisha) have demanded prohibition on the sale of codeine-based cough syrups.

“These days, in markets, ‘Corex syrup’ has become one of the substances for drug abuse. Corex otherwise is a cough syrup but it is used more for recreational purpose than a medicine,” Singh had told Rajya Sabha on March 15, and several other members concurred.

“After its consumption, both brain and body go numb, body becomes loose, and nowadays, our youngsters are increasingly consuming it,” he had warned.

Corex, manufactured by US Pharma giant Pfizer, is a combination medicine used for treating dry cough. While not all variants of the medicine use codeine, Corex T cough syrup is a combination of two medicines – Codeine and Triprolidine. Here, codeine works as cough suppressant. It suppresses cough by reducing the activity of cough centre in the brain. Triprolidine is an anti-allergic.

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