Chinmaya IAS Academy – Current Affairs Chinmaya IAS Academy – Current Affairs
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The U.S. is using the Ranbaxy experience to create a bogey
Allegations of widespread fraud concerning generic drugs manufactured overseas, especially in India, were recently highlighted in the U.S. Much focus was on the contamination found in one drug made by Ranbaxy. I do not wish to support Ranbaxy’s deplorable behaviour. Nor do I wish to belittle the importance of the ongoing efforts to fix India’s drug regulatory framework. The point here is that this focus has been deployed to undermine foreign generics. For instance, the Ranbaxy saga unfolded 14 years ago. Since then, several pharmaceutical companies, both foreign and local, generic and innovative, have been implicated in similar or worse behaviour. Notable examples include those of Martin Shkreli’s Turing Pharmaceuticals, which hiked the price of a drug to 5,000%, and Purdue Pharmaceuticals, a company currently implicated for causing the opioid crisis. The strategy of raising fears of ‘contaminated’ foreign generics has successfully prejudiced Americans against valid generic drugs, even though they have remained a viable option.
FDA’s regulatory overreach
Instead, the FDA has positioned itself as a ‘global regulator’. For example, in a recent statement, it mentioned that it inspects all brand-name and generic manufacturing facilities around the world based on information from whistleblowers or out of concern for drug safety. Arguably, this amounts to regulatory overreach as there is no international instrument standardising American CGMP practices as the global standard.
For India, the discussion in the U.S. is notable not only because it houses generic manufacturing facilities but also because India is a nation on the verge of breaking into the innovation market. Thus, it is time India took a more robust role to ensure public availability of facts on both the importance of generics and their limitations. The country needs to create strong voices and partnerships that can highlight the benefits and pitfalls alike to create a robust space for innovation that can coexist with access to medication. After all, innovation and policy failings need not be an excuse to deny access to lifesaving medication to productive workforces.
Srividhya Ragavan serves as a Professor of Law at Texas A&M University School of Law
