India, which has banned only 94 drugs so far, has decided crack the whip on combination drugs of more than 300, including Phensedyl cough syrup by Abbott, according to Joint Secretary K.L. Sharma of the Union Health Ministry. The step follows review of a committee to review more than 6,000 combination drugs in the market without approval.
Bangladesh has long been urging India to stop the smuggling of Phensedyl that was banned but being smuggled by some drug cartels as it has Codeine content that is unusually high and attracts addicts, who pay three times the rate in India to buy these cough syrup bottles.
“This Indian decision will hit a huge cartel of drug smugglers operating on the India-Bangladesh border,” said Anirban Roy, who as a former journalist had done expose of these cartels. Phensedyl reportedly contributed $300 million to Abbott’s revenue from India alone.
The banned combination drugs include Corex made by Pfizer. India has become a dumping ground where half the drugs sold in 2014 were clasfied “fixed dose combinations.” Though combination drugs are not banned per se, failure to adhere to ratios in drug mix has led to mushrooming of combination drugs in the country, especially by Hyderabad-based medicine manufacturers.
The committee reviewed 6,000 combinations in the market based on state government authorities’ approval and asked the pharmaceutical companies to prove their safety and efficacy. After classifying the drugs into rational, irrational, and those require further study, the committee has recommended more than 300 drugs which will be prohibited, Sharma told Reuters.
Compared to other sectors, Indian pharmaceutical market grew at 12 percent year-on-year in February, clocking an average of 12.9 percent since April 2015, primarily due to high volumes, price hikes and new launches.
While World Health Organization is warning against the increased use of antibiotic combinations due to increased resistence, India is facing an overwhelming market for combination drugs than generic drugs, not seen in other markets. Several reports in the past have highlighted how certain combination drugs are hitting the market without approval, while they are not allowed in the United States, Europe, Japan or Australia.