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Striving Towards Innovative, Affordable and Accessible Healthcare
The advantage of having a new product indigenously manufactured and available to the consumer at low cost with minimum time frame is the best outcome of Natco over Bayer.

There were major game changers in the Indian pharmaceutical industry in the year 2011-2012, which included expiration of patents, 100 per cent FDI, new pricing policy, compulsory licensing, and the recent giving away of free generic drugs, to name a few. S Abhaya Kumar, Managing Director, Shasun Pharmaceuticals Ltd, opines about these changes in the Indian pharmaceutical scenario.

What is your opinion about the impending 100 per cent FDI in pharmaceutical industry?
India is marching towards becoming a diversified sector; pharmaceutical sector is the one that is growing and has achieved tremendous heights.

One way, it is good that new products being covered by patents in other countries are easily available and that too with cost benefit, may be because of leverage in FDI thanks to the Government policies and pharmaceutical industries’ involvement.

Also, this brings the innovative science and technology filling the gap between the domestic and foreign technical services. Definitely, it will hit the per cent GDP growth in positive manner.

What are the implications of current regulatory and tax regime?
I appreciate the Government’s tax concession for companies engaged in R&D and also Government’s move on special focus incentive.

What is your take on compulsory licensing, with the first one issued to Natco over Bayer’s drug?
Compulsory license is part of the Government’s current policy and can be implemented at any time with due review process and approval. Also, as India is part of the Global Patent Cooperation Treaty (PCT), the advantage of having a new product indigenously manufactured and available to the consumer at low cost (covered by drug pricing norms) with minimum time frame is the best outcome of Natco over Bayer.

What is the current situation of R&D, drug approvals and clinical research in India?

India is a pool of good science knowledge and having skilled manpower as compared to any other country around the globe. Many believe that research on new molecules involved money with high risk.

Irrespective of the facts, Indian pharmaceutical companies have achieved many accolades globally either through indigenous research or by joint venture developing science technology and then transferring it.

Many good things were done in the past and have come recently in the field of Biotechnology, Nanotechnology, Nutraceuticals, etc. In many therapeutics areas, the development is still on-going where R&D needs to be more focused on the therapeutic category where less focus has been kept. In the recent past, we experienced some delays in the drug approval process.

Definitely, decentralisation of some of the approval processes resulted in quick grant of the licenses and helped the industries in moving forward with complete confidence.

Globally, it is been said that India is now a clinical research hub and can be very well concluded by the amount of foreign firms current investments. Cost is being considered to be the major factor in clinical research as compared to US and Europe. Around 50 to 60 per cent reduction in the cost with no change in the quality of the outcome definitely increases the confidence level of the Indian institutes as well as foreign firms.

This is very well confirmed by recent reports that the clinical trials applications have been approved by Drug Controller (General) in the current years as compared to the past. Nevertheless, the quality of these studies have been reviewed and well accepted by global regulatory agencies.

What is your opinion on the current pricing policy?
Recent trend shows high export both in bulk drugs and formulation. This may result in less focus of pharmaceutical industry in domestic availability because of the pricing issue. Nevertheless, government is working closely with pharmaceutical industry on price fixation to achieve win-win situation. Reliable source of quality medicines at affordable prices is the key objective of this interaction. What do you think about Indian

government's decision to give away free generic drugs?
It is a good strategy and helps to go beyond the statement of 'affordable prices'. pharmaceutical industries’ participation will be the key to this proposal.