The Hindu Business Line : Caution on drugs

IT IS THE same story being played out and with disconcerting frequency. When the United States Food and Drug Administration (USFDA) recently wanted new labels for impotence drugs such as Pfizer's Viagra and Eli Lilly's Cialis to include information on possible eyesight loss, a ripple was felt in the Indian drug market. Though Viagra is not marketed in India and Cialis is only poised for a launch here, clones of both are available. But the Drug Controller General of India (DCGI), the regulatory authority, is yet to take a call on whether Indian companies making similar versions of the impotence drug should run the same caution on their labels.

Late last year, the DCGI's office faced a similar situation when Merck voluntarily recalled its painkiller drug rofecoxib, sold globally under the brand name Vioxx. Eventually, the DCGI's office did order Vioxx clones in India to be taken off the shelf. Soon, questions began to be raised on the safety of other members of the Cox II drugs family, to which Vioxx belongs. But the Indian companies continued to promote this class of drugs with little direction from the DGCI. The reason was that the Indian market had no reports of adverse events regarding these drugs, at least none in public domain. With independent data on medicines rarely generated in India by companies making their copies, the regulator often has to rely on information disseminated by the FDA. Though drug companies claim to have in place adverse-event-reporting systems to record side-effects, developments such as the Vioxx-recall exposed the ill-preparedness of both the regulator and the firms making copies.

Equally little information is available on medical devices. Stents, used in heart-related procedures, are sold in India without too much monitoring. For instance, when Boston Scientific recalled its stents worldwide in 2004, no independent information was available in India on how many of these devices may have been used or if any patient had reported any adverse event. The only information available was from the company. So also with Johnson & Johnson's recall of drug-eluting stents. Medical devices, a largely unregulated market, are now being brought under the purview of the Drugs and Cosmetics Act, 1940. The delayed response of Indian regulators to drug side-effects or device recalls may be because they feel that the US regulators prefer to err on the side of caution to stave off litigation. However, in the interest of the health of consumers, there needs to be a dynamic response to adverse events related to medicines or medical devices.

Till an active system is put in place to capture independent data and make an assessment of the issue in the Indian context, the DGCI will have to take its cue from the USFDA. The logic being that drug approvals are granted in the country on the safety profiles set by the USFDA. The same rationale should extend to adverse event reports as well. But for the long term, without burdening the drug industry with more bureaucratic procedures, a scientific and independent body needs to be set up to capture drug and medicine-related data. It should also be able to take quick decisions on adverse drug reactions and medical device recalls to protect consumer health.

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