Relaxed clinical trial rules in India designed to woo global investors
12 months ago Christopher 0
Regulations governing pharmaceutical research have been relaxed in India as part of an attempt to make the country more attractive to organisations with money to spend on development. Under the new rules, which were approved by central government, researchers in India will be permitted to carry out as many clinical trials as approved by an ethics committee; previously, the number of trials permitted was just three.
The decision and rule changes were made early last month, when it was also decided that there would be no stipulations regarding the minimum number of beds in hospitals that decided to conduct research. Irrespective of the number of beds, any hospital conducting research would have to have emergency facilities for the care of patients and the necessary equipment for any rescue care.
Ethics committees will decide how many trials are appropriate in researching new drugs depending on the complexity of the research required and the risk involved.
It is estimated that research in India can up be up to 60 per cent cheaper than in the United Kingdom or in North America. India also offers the benefit of a large number of patients who are willing to take part in clinical research.
The cap of three trials had been set after patient deaths; however, this trial cap was perceived as unwieldy by a number of organisations hoping to relocate to countries for cheaper research, with nations being chosen over India including China, Argentina and Russia.
The cost of research is a significant negative factor in the development cost of new drugs. For some companies, this makes outsourcing research to countries such as India more attractive. The high cost of some medicines has been blamed for a number of deaths, according to a report in the Guardian.
If you are thinking about conducting research or accessing a range of clinical staffing solutions, it would make sense to consult a specialist provider such as G and l scientific.
Bringing down the costs of developing pharmaceuticals could make them more accessible to the poorest people of the world. Indian scientists also hope to raise their international profile by conducting more research and hope that relaxing the regulations will provide more opportunities to demonstrate their skills and attract more work.