Biotech regulator : Does India need one?

The Economic Times reports that the Department of Biotechnology plans to set up a National Biotech Regulatory Board to regulate biotech drugs and vaccines. The board, it says, will be set up to distinguish between biologics and chemical-based products. While the report did not overtly say so, I am assuming that the department’s primary target is not originator drugs. These are already approved by western regulators and in India what’s good enough for the FDA and EMEA is good enough for us. The primary target has to be biosimilars.

As I read this report, my head was buzzing with questions that I currently have no answers to. So just to turn down the buzz I am unloading my thoughts here :

1. There are a whole host of biosimilars in the market today. If, as the unnamed official in the department who was quoted in the article believes,  “biologics cannot be treated as traditional chemical-based drugs and regulated under the same norms,” I’d like to know what they are doing there and how I am supposed to react to these as a doctor or a patient. If that’s not exactly what he means, well then he shouldn’t say anything until he is absolutely sure. It is not alarming when the US FDA makes such a statement – currently they don’t approve biosimilars in the US (with perhaps the exception of human growth hormone where they were dragged to court by the biosimilar manufacturer).  But it is unsettling when an Indian government official does given the large biosimilars industry in India.

2. Why can’t the office of the Drugs Controller General of India (DCGI) be charged with the task and why do we need a separate regulator? After all, medical devices – where a case can, in fact, be made out for a separate regulator– there is none and it is the DCGI who oversees with the help of state administrations. Why, when it comes to biotech drugs should it be any different?There can always be consultations between departments but why should regulatory powers be split? In the long run, this can be sub-optimal as regulatory oversight can fall between two stools.

3. What, in God’s name, has happened to the Central Drug Authority Bill which was supposed to create India’s answer to the US FDA – a super regulator with oversight of food, drugs (chemical and biotech), and devices ? And should various departments of the government be wasting time and energy working on various iterations in their own little spheres of activity? To give you an example : the department of science and technology after much hard work and diligence came up with The Medical Device Regulation Bill, 2006. The Bill seemed well-intentioned and was based on suggestions from none other than S Valiathan, founder director of Sri Chitra Tirunal Institute for Medical Sciences and Technology (remember the Chitra heart valve, India’s first indigenous heart valve), the “go-to” person for any suggestions on medical device legislation. Yet, there has been no traction on what at first glance seems a very practical and progressive Bill apparently since the CDA bill is already pending before Parliament.

4. Is this another sign that India is moving towards tighter barriers to entry for biosimilars?

If anyone has answers, I’d love to hear them.


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