india needs new models of drug development

“Is race for generics shunning out innovation from Indian pharma sector?”

 

well, It is true  that many big R and D based  Pharma companies have folded back their special purpose research vehicles, have reduced number of patents they maintain,  reduced number of PhDs they had for the internal R and D and have gone aggressively in pursuit of profits from generics. At the same time, it is also true that many smaller companies have started  filing patents on drug delivery system or improvement of formulation as in the case of diclofenac ( molecule of which is out of patent). interestingly patent wars have begin around such Indian innovations and two companies allegedly infringing the patent on the new formulation  were restrained from manufacturing and marketing the improved non-pain causing pain reduction injection.

 

having said this, what are the new pathways for innovations in pharma sector and how can India achieve distinctions   in this regard by bringing he cost fo developing new drugs drastically. By aping the western models and heuristics, breakthrough are unlikely to be achieved.

 

a)    we should aim at pursuing systems biology approach with multi molecule –multi target drugs rather than single molecule based drugs. The regulatory authorities must modify their protocols to not only permit it  but also encourage it. This approach is closer to what nature does anyway.

b)    They should try to se distributed model of R and d using platform like www.techpedia.in developed by SRISTI so that young tech students are closely involved in the modular approach. The open source platforms like OSDD also need to be replicated for other diseases. But patent and open source can co-exist depending iuon what is patented and what kind of knowledge is kept in open source tp encourage derivative innovations.

c)    There is a huge scope for herbal drugs and the policies as well as institutional support is rather muted or weak. It can be made much more vigorous and I will not be surprised if major breakthroughs come in this space.

National Innovation Foundation in collaboration with ICMR has identified very promising leads for typhoid and other dieses using such an approach. Similarly soil microbial diversity collection of about 3000 cultures dveleoped by SRISTI in its lab based on sil samples collected during thousand of kilometers of walk during shodhyatra have been leveraged by DST for identifying new generation antibiotics in collaboration with IMTECh, CDRI and Karnataka antibiotics. New models of collaborative research are  the  need of the hour. We should explore the opportunity for making a trade off between accuracy and affordability without compromising safety at all.

Anil K Gupta

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