Generic medicines are an important part of providing care to millions of patients in low-income countries and the emergence of an Indian pharmaceutical industry has played no small part in making this possible. In the last decade, Indian manufacturers have produced both on-patent and off-patent drugs in such high enough numbers they now comprise the third largest pharmaceutical industry in the world.
The importance of Indian drugs in the developing world is probably best known in HIV care. Not long ago, the annual cost of caring for a patient infected with HIV was upwards of $10,000. In 2001, the Indian manufacturer Cipla released a combination pill that cost just 1$ per day. Since then, India’s generic manufacturers have found a special place in the hearts of many practitioners of global health the now had an affordable option for treating patients in low-resource settings. And the reach of India’s drugs have extended well beyond HIV care and well beyond the developing world. In one recent study, Indian drugs for gout, heart disease, and diabetes were found to be cheaper than their generic equivalents that were produced in nine European countries.
As good as the original?
However, a recent report by an Indian parliamentary panel reports some shocking information on the current quality of some of these drugs. A BBC article summarizes the parliamentary findings, making note that numerous drugs randomly scrutinized by the committee had irregularities in documentation, lacked trial data to support their efficacy, or questionable processes by which they were approved. In fact, the report notes that every month one drug is approved in India without trials.
While this report has received little attention here in the U.S., it brings devastating news for countries that rely heavily on Indian pharmaceuticals. Though it is likely that many of the drugs coming out of India continue to be high quality equivalents to their Western-made counterparts, the findings of this report rightfully place doubt into the mind of the practitioner prescribing an Indian generic or the countries that buy these medicines en masse. That is not even to mention the impoverished patients who may already have been wary of western medicine.
It is no secret that croneyism and corruption in India is rampant. In this case, however, alleged collusion between corrupt officials and fraudulent manufacturers (the bad side of public-private partnerships) may well lead to dangerous care for millions of people and the loss of trust in the Indian pharmaceutical industry. While Cipla and India’s other original generic manufacturers opened avenues for providing HIV (and other) care for millions of individuals, their accomplishment and their reputation may well be tarnished by an unchecked drug industry that now includes more than 10,000 drug makers.
I have no doubt that Indian manufacturers are capable – as Cipla was – of producing high quality medicines at a low cost. In that way, I disagree with the title of this blog entry. But it is incumbent on the Indian government to ensure that low prices does not equal low quality. It is not yet clear to me if is more shameful that fraudulent manufacturers would put the lives of patients at stake or that India’s drug commission (Central Drugs Standard Control Organization) would have allowed this to happen.