India battles big pharma over cough syrup abuse, reducing supplies

Indian regulators are privately pressuring major drug firms to better police how they sell popular codeine-based cough syrups to tackle smuggling and addiction, a move that is reducing supplies of a medicine doctors say is an effective treatment.

India’s Cipla stopped making the product last year owing to regulatory demands, and U.S.-based Abbott Laboratories and Pfizer have had to reduce batch sizes by up to half, cutting how much medicine their factories can produce.

Regulators want to make it easier for law enforcement agencies to track cough syrup abuse in the country and bottles smuggled to neighbouring Bangladesh, where it was banned in the 1980s but is still sought by addicts.

Retailers worried about liability from potential abuse by people addicted to the opiate codeine are in some cases refusing to stock the cough syrup, said J.S. Shinde, president of pharmaceutical lobby group All India Organization of Chemists and Druggists.

For drug regulators, the challenge is to strike a balance.

According to an industry executive, the likes of Pfizer and Abbott, who control most of the $103 million market for the drug, face a “significant” increase in costs as plants run well below capacity because of changes demanded of them.

According to minutes of a July meeting of state and federal drug regulators, there was a recommendation to ban the sale of the syrup altogether because of “rampant misuse and its illegal exports to neighbouring countries.”

Pfizer’s India unit said in a statement the company takes all steps to maintain the highest standards of regulatory compliance, including supply-chain audits.

Abbott India said they believed existing Indian drug laws were adequate to control the abuse and the company had taken steps to support enforcement agencies.

Last year, the International Narcotics Control Board (INCB) billed the abuse of medicines containing narcotics and their smuggling from India among the “greatest drug-related challenges” facing South Asia.

About 83,000 bottles of codeine-based cough syrups were seized in India in the six months through March. In meetings with companies, Indian regulators called the “menace of abuse” a “growing concern”.

Abuse is particularly common in Bangladesh. At a treatment centre in the capital Dhaka, tales abound of ruined careers and family struggles.

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Source:Reuters