Indian pharma impeded by regulatory overlaps and lack of structure
Dinesh Thakur is a public health activist who was the whistle-blower behind the prosecution of the Indian drug maker Ranbaxy Laboratories, resulting in the firm being fined US$500 million for malpractice in 2013, while he was awarded $48m. He is now campaigning to improve the regulation of India’s industry to tackle the problem of substandard drugs. Here, he talks about the issues in the sector.
Could you talk about the need for regulation in India’s pharmaceutical industry?
Regulation governing the pharmaceutical industry does exist in India. Unfortunately, the structure and its implementation is riddled with gaps. The current structure of a fragmented regulatory structure is inconsistent with the constitution of India. One of the main reasons for the abysmal quality of drugs in India is the multiplicity of regulators. The nation of India, which is a common market, has 36 different drug regulators – one each for each state and union territory and the central regulator, the Drugs Controller General of India (DCGI). The division of powers, under the drugs and cosmetic act, 1940, between the central and state regulators is complex, confusing, overlapping and thoroughly unsuitable from the regulatory perspective of ensuring uniformity and consistency in standards of drugs quality across the country.
Is the sector poorly regulated compared to other markets? Why is this?
Healthcare in general and medicines in particular has never been a priority for good governance in India. Over the last two decades, the pharmaceutical industry lobby has developed into a powerful entity and has undue influence over policymaking in India. This has resulted in the current regulatory structure, which is largely dysfunctional.
What steps need to be taken?
India needs structural reform of its pharmaceutical industry regulation. The existing fragmented structure needs to be dissolved and a new framework, consistent with globally accepted industry standards needs to be implemented. The supreme court declined to admit either of the petitions [filed by Mr Thakur this month] that address a substantive issue on the quality of medicine and patient safety. We are committed to the cause of putting patients first and will continue to advocate the need for better regulations in the Indian pharmaceutical industry.
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