The Hindu Business Line : A painful predicament

THE SAGA OF the Cox II family of non-steroidal anti-inflammatory (NSAIDS) drugs has placed the Indian regulatory authority in an unenviable position. The Drug Controller-General's Office appears finding it difficult to deal with the repeated global recall of these drugs, whose copies however continue to sell in India. The Cox II medicines are said to cause side-effects including stroke, heart attack and a rare skin disease. Now the Drug Controller-General's Office has to decide whether a copied Cox II drug can be allowed to sell in India, when the original patent-holder has withdrawn the molecule. In matters of public health caution should be the watchword. But having said that it is not easy to ban drugs approved under the domestic regulatory process in the absence of documented local clinical data on the side-effects.

The Cox II drugs-recall story started last September, when Merck withdrew Vioxx, its brand of Rofecoxib, used for pain and arthritis. The United States Food and Drug Administration's concern was over side-effects, including stroke and heart attack. Subsequently, the makers of several me-too Rofecoxibs were directed by the Drug Controller-General to take their generic versions of the medicine off the shelves. After the global recall of Rofecoxib, there was a question mark over the entire family of drugs, including Celecoxib, Valdecoxib and Etorecoxib. However, with innovator companies, such as Pfizer for Celecoxib and Valdecoxib, claiming that these medicines were safe, domestic pharma companies actively promoted their copies.

But the ghost returned to haunt the Cox II family, with the US FDA recently directing Pfizer to withdraw Bextra, its brand of Valdecoxib. The concerns were over such side-effects as heart-related problems and a serious rare skin-disease. Though not launched in India, numerous copies of Bextra are available. Ranbaxy has withdrawn the drug unilaterally, but other companies are watching developments at the USFDA. The Indian regulator is reviewing the situation, but it is largely relying on the direction the USFDA will take. Whether the drug will be withdrawn indefinitely, or be allowed to sell with a black box warning is not clear. The situation gets more piquant, with the USFDA also contemplating allowing sale of Rofecoxib, with a warning.

The Drug Controller-General's course of action will largely depend on the safety data on the Cox II drugs, generated by the patent holder. Local industry representatives admit to reproducing product inserts and data from the innovator company; not much of data is generated locally. This system of giving a copied drug approval to sell in India based on its safety profile elsewhere is no longer acceptable. Given the risk the local population is exposed to, the regulator will have to tighten its approval systems, and fortify itself with complete knowledge on the safety of a drug from data generated locally. It should also make the reporting of Adverse Drug Reaction much more stringent. The regulatory system may be getting strengthened with the implementation of the Patents Amendment Act, 2005. Yet, the regulator cannot be cautious enough: It is better not to launch a drug until convinced of its benefits, rather than risk the lives of the local population, relying on insufficient data.

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