Scan combo drugs

By Archita Bhatta
Published: Wednesday 15 October 2008

commonly used medicines like Becosule, Dexorange and Corex figure in the list of medicines that the government wanted removed from the market last year. But these medicines, classified under fixed dose combinations, or fdcs, continue to be sold. The pharma industry is reviewing the list currently. Health activists fear that companies may use this opportunity to their advantage.

The Drug Controller General of India (dcgi), responsible for controlling the sale of such medicines, had issued an order in October 2007, stating 294 fdcs should be removed from the market. In 2005, the National Commission on Macroeconomics and Health in its report claimed that 10 of the country's top medicine brands were "either irrational, nonessential, or hazardous". Then, in July 2007, a committee comprising mps, health ministry and dcgi officials reviewed the problem, which led to the October 2007 order.

But now the dcgi has rolled back the order and started "negotiations" with the pharma industry on the number of fdcs to be retained in the market.

Most medicines in the market today are a combination of two or more drug. Pharma companies need to prove their efficacy and safety over individual medicines before they are allowed in the market by the government. Their marketing has become a cause of concern for public health.

Besides side effects, combination medicines foster resistance to drugs, when one of the drugs in the combination is not required. Sometimes as in case of anaemia, costly combination drugs have driven less costly but more effective drugs out of the market.

S Srinivasan of Low Cost Standard Therapeutics, an Ahmedabad-based organization working on public health, says involving pharma companies will only exacerbate the existing problems. "The problem of unregulated marketing of fdcs cannot be solved by any negotiation with the industry," he said.

A B Ramteke, deputy drug controller general of India insisted that it was not a process of negotiation with the industry but an attempt find a way to remove harmful fdcs from the market. The issue had reached a stalemate after the pharmaceutical industry had moved the Madras High Court against dcgi's October order claiming there was no proof of ill effects of combination drugs. They got a stay on the order in November 2007.

"We are trying to find a solution to the problem of fdcs by involving experts to find out whether these combinations are effective and safe," Ramteke said, and acknowledged that it is an out of court settlement.

But groups working on public health complained that neither they nor any consumer groups have been called for the dcgi meetings.

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