Alternative medicines regulations: Should AYUSH focus on safe-to-consume or efficacy? – The Times of India Blog

In the post-corona world, if there is a sector with a massive boom ahead, it is of alternative medicines. And as India is home to one of the oldest and highly advanced curative traditions in form of Ayurveda, it is a great opportunity that India can capitalize on, provided we have right policies in place at the earliest that will allow Ayurveda to fill the vacuum that allopathy is leaving behind.

If we dont act soon, greedy market forces will take Ayurveda on the same path that allopathy has gone, i.e., abject commercialization sans social values.The biggest stumbling block ahead for Ayurvedic medicines is to get legal recognition in a world where allopathic drug laws rule the roost.

As allopathic medicines pass through a process of clinical trails to get empirical confirmation for safe consumption and efficacy, the simple regulatory solution is to push Ayurvedic medicines on the same route for approval. The biggest advantage of taking such a regulatory route is that it will allow Ayurvedic medicines to access global market and if we play our IPR game properly, Indian manufacturers can enjoy the massive valuation that western drug companies have been thriving on.

The problem with allopathy-like validation for Ayurvedic medicines is that the curative logic and processes of Ayurveda are not exactly like allopathy where very direct cause-and-effect relationships are immediately visible in all medications. A lot of Ayurvedic medicines target chronic diseases and offer long-term benefits that a conventional clinical trial-based process will not be able to register or confirm. This means that establishing efficacy under the current for-allopathy framework will not be easy for all Ayurvedic medicines.

As allopathy and Ayurveda stem from different model of human body, it is also unfair to demand that a fish has to pass the test of climbing a tree.

So, what could be the way forward if we want Ayurveda to claim a place in the healthcare market?

At this point, AYUSH, the main regulatory authority has opted to solve the problem by going diametrically in opposite direction by accepting that traditional herbs and herbal formulation being in use since ages, they are exempted from seeking statutory approval used for allopathy drugs.

Such a policy may show short term gain, but what it can (and is, if one switches on ones TV set in the afternoon) lead to is rampant and lawless market where false claims will be made by the crooked in the name of AYUSH to make a quick buck.The solution that I see is to separate the safe-to-consume and efficacy and design a policy that forces manufacturers to have transparency about their claims.

AYUSH needs to ensure that any alternative medicine from any stream or tradition is made to pass through tests that prove that its is safe-to-consume.

There can be absolutely no compromise with ensuring safety for consumption, even if it is a traditional practice going back to a thousand years.

One the other hand, the need to establish efficacy should not be mandatory for AYUSH medicines, but with a condition, and that is a clear admission made on the package that the efficacy is based on the traditional knowledge and not established through clinical trials.

If a manufacturer wishes to opt for clinical trials and pass through the process it is clear that that medicine needs no classification as it is as much an allopathic medicine as any.

If AYUSH opts for such a clarity and India communicates this to the world regulators, there is a great possibility that we will find buyers across the world who will trust the backing of Ayurvedic traditional knowledge without having clinical proof as long as there is a clear proof that it is not a harmful-to-consume medication.

As long as a substance is safe to consume, getting into efficacy issue is actually a regulatory overreach as it is not correct for any regulator to go into the faith-based choice of a consumer. In fact, if we start putting allopathic drugs through the same logic, a lot of them may fail when the timeframe of clinical trials is prolonged as we now know that there are many a long-term side effects that escape the scrutiny of clinical trials.

Curing ones body is a fundamental right of a human being and the state must not control ones freedom of choice regarding the option one takes beyond a point.

Views expressed above are the author's own.

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Alternative medicines regulations: Should AYUSH focus on safe-to-consume or efficacy? - The Times of India Blog