The fate of the much-hyped mandatory generic prescription plan

It appears that the Ministry of Health has put a kibosh on the much-discussed mandatory generic prescription plan after all. Newspaper reports say that they have advised the Prime Minister’s office of a potential scarcity of “quality” medicines should the administration proceed with their plans. The report further says that the Ministry anticipates if “unbranded generics” were procured exclusively by Jan Aushadi stores, in about two years time, we may make a dent in addressing the underlying problem.

This admission by the MoH begs several questions. First, how could the PMO let the Prime Minister make such a public proclamation of a potential scheme without basic understanding of the dynamics that affect the current situation? Doesnt this volte-face damage the PM’s credibility? What lessons does the PMO derive from this fiasco?

Second, in recommending that the supply-chain for Jan Aushadi stores be exclusively “unbranded generics” while at the same time, acknowledging that our supply chain largely consists  of therapeutically unproven and and potentially unsafe medicines, what does the MoH’s recommendation do to Public Health? Are they saying that somehow unbranded generics will all be of good quality and proven therapeutic efficacy in two years? Where is the plan to make that happen?

We can continue to distract the attention of our citizens with phrases like “doctor-big pharma nexus” and “big pharma-chemist nexus”, both of which have some truth to them; but unless we are ready to address the underlying problem, I am willing to bet that even after five years we will still be talking of these same issues.

The underlying problem we refuse to acknowledge is that we do not have a regulatory framework and robust institutions to ensure good quality, affordable medicines in our country. And until that changes, we will continue to debate and argue about these peripheral issues; and nothing will change. Let me illustrate it with a few examples.

Despite the mis-directed rhetoric about “fake-news” and “witch-hunt” in the context of Russian meddling in the US elections last year; no reasonable person, I mean no one (well, other than extreme partisans) questions the ability of the FBI and Special Counsel Robert Muller to get to the bottom of this issue. Have you asked yourself why? Because, successive US administrations across political parties over years have built the institution of the Federal Bureau of Investigation and its reputation as an independent investigative agency. Everyone knows that the FBI will do its job and the guilty will be brought to justice. It is never seen as a “caged-parrot” and that is why, even the most ardent supporters of the current US President cannot take potshots at the agency. Now, ask yourself do you have similar confidence in our institutions? Especially the CDSCO and the MoH? How well has political patronage served us as a nation?

Second, the US FDA has a new Commissioner, someone who has significant ties to the industry and has been a prominent member of a right-wing think tank. After his confirmation, his public actions have been toward addressing the same issues we are dealing with here in India, including access and affordability. If you look at his blog and the actions he has taken in the last two months, they are all based on factual data, like encouraging more competition by making public a list of drugs that have a single manufacturer to reduce drug-shortages.  Scott Gottlieb demonstrates exceptional leadership through his actions and his understanding of the industry guided by the principle of protecting Public Health of the citizens of the US. When was the last time you saw such leadership at the MoH and the CDSCO? And why should we accept any less?

If we are serious about providing affordable, good quality medicines to our citizens, lets us learn from what others are doing that is actually making a difference, not by announcing ill-conceived schemes. Get the right leadership at the MoH and the CDSCO. Overhaul the Drugs and Cosmetics Act and enforce the law of the land and hold manufacturers who make substandard medicine accountable. These are concrete actions that the PMO can take today, without any harebrained schemes.  The million dollar question is, will it?

4 thoughts on “The fate of the much-hyped mandatory generic prescription plan

  1. Hey thanx for sharing this blog over here. It seems useful to start career in clinical research. We will look forward for more updates.

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