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.
               
But they are pushing back against other demands, a review of correspondence between companies and regulators showed, including selling one batch to only one buyer and
printing labels that specify where the drug would be sold.
               
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.
               
Sales of the drug in India fell 4 percent to 121 million bottles in the year through August, and 15 percent in the year before, according to IMS Health, a healthcare statistics provider.
               
For drug regulators, the challenge is to strike a balance.
               
"Any non-therapeutic usage is a concern, but you have to weigh the risks versus benefits," said an official at the federal drugs controller in New Delhi.

 

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