India appears to have become a dumping ground for banned and untested drugs. A report by the parliamentary standing committee on health and family welfare reveals that medicines which were banned and withdrawn in developed countries decades ago are being sold freely to Indian consumers. It points to an unholy nexus between officials of the Drug Control Organisation, the pharmaceutical industry and medical experts. The report also draws attention to the sale in India of new drugs, which were not subjected to clinical trials in the country. Forty-two drugs that were picked up randomly were found to have received approvals through procedures that seriously violated rules. Files of approval for three drugs were untraceable. In the case of 11 drugs, the mandatory Phase III of clinical trials was not conducted. Buclizine, for instance, which is administered to babies to stimulate their appetite, has been approved for sale although the drug was not subjected to clinical trials.
The report provides troubling insights into the unethical behaviour of pharmaceutical companies, which manufacture and knowingly sell unsafe and banned drugs in developing countries. Also complicit are the governments of the origin countries. The Danish government, for instance, has banned the sale in Denmark of Deanxit, an anti-depression drug. But it has not banned its manufacture; hence the pharmaceutical company continues to manufacture and peddles it in developing countries. While their unscrupulous conduct must not be overlooked, pointing an accusatory finger at predatory MNCs and western governments doesn’t tell the full story. Indian pharmaceutical companies too engage in questionable practices and they must be pulled up. Besides, the role of our watchdog bodies and medical experts in facilitating this dirty trade is as morally reprehensible.
By approving banned and insufficiently tested medicines for sale in India, watchdog bodies like the Central Drugs Standard Control Organisation are putting the interests of the pharmaceutical industry above those of the public. One of the problems these bodies face is that they are understaffed, enabling the less principled among their officials to quietly endorse dubious drugs. In response to the parliamentary committee’s report the government has appointed a panel to make recommendations to spruce up the system.
But more advisors to oversee existing regulatory bodies will not solve the problem. We don’t need more watchdogs as that will only reduce accountability. Instead, existing bodies should be pulled up to perform. Officials who violated rules to allow sale of dubious drugs must be tried under the law.
