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| Edited By: Maitri Porecha |Source: DNA |Updated: Dec 10, 2016, 08:20 AM IST
As a country with unique medical needs, India needs expansion in the clinical research arena. We have, what's called as a 'triple disease burden'. There are diseases of emerging economies like multi-drug resistance tuberculosis, and vector-borne diseases like Malaria and Dengue. There is also a rise in cases of diseases of a developed economy. The number-one killer in India today is cardio-vascular ailments and not TB, as was the case in the past. Then there are global health threats by viral epidemics like Zika and Ebola.
There is a lot of attention on Alzheimer's. It is a difficult disease to tackle, as it deals with degeneration of nerves. We are still not anywhere near solving the problem. A lot of drug research is also taking place on Lung, Breast, Head, Neck, and Colorectal Cancers.
At the moment, India is not contributing significantly. It's a myth that India is a sought after destination for clinical trials. With 1.2 billion persons, we constitute 16 per cent of the global population, and share 20 per cent of the world's disease burden. Against this, India's contribution to global clinical trials is a mere 1.4 per cent.
Between 2005 to 2010, we saw a lot of growth in this sector. However, the government mechanisms did not grow along. We needed to fill the gap of improved regulations and patient safety. A lot of regulation changes have been brought in since.
I do not know the facts of the case to comment. Also, the matter is sub-judice. India has one of the most stringent regulatory environments. It has undergone a lot of changes over the past six years and become more robust now.
This is a myth. Drug development is an expensive affair. Companies won't risk taking research to a region where regulations are not stringent, as that will put a question mark on the collected data. The data has to be acceptable to global regulatory authorities, or it's not worth anything.
These are mainly cancers of the lung, breast and colorectal cancers. And also rare diseases like Pompe's, Progeria, Rett Syndrome, Gaucher's. Alzheimer's is another conditions. Unfortunately, even Indian companies developing drugs on these, shifted trials out of India due to the constant regulatory changes. Due to this, Indian patients do not stand to benefit.
India has a three-tier regulatory structure, that is needed considering the prevalent socio-economic conditions. From 12 subject-expert committees, we now have a rule for 25 subject-expert committees to consider the proposal. The proposal is is then vetted by a technical committee before an apex panel headed by the Health Secretary sanctions it. We are perhaps the only country where it's mandatory for patient's consent to be audio-visually recorded.
