No Clinical trials on humans for proven drugs: New Proposal
New Delhi: In order to make new drugs available for critical diseases and to reduce their costs in Indian market, health ministry is planning to waive off clinical trials on humans for proven drugs, which have been already approved in developed markets like the US, European Union, Japan, Canada and Australia for at least two years .
Currently, legal provisions require successful local clinical trials, before these drugs are introduced in the Indian Market. Moreover, waivers are given by the drug regulator, but they are analysed on case to case basis.
However, the Health Ministry is now planning to a policy change in order to do away with local clinical trials for drugs which have a already proven themselves in the international market and have a record of not affecting patients severely.
The draft set of rules has been forwarded by the Health Ministry to the law ministry for vetting. The same shall be notified after the law ministry's nod, reports Mint
Drugs Controller General of India GN Singh told TOI "the recommendations were made by the Ranjit Roy Chowdhary committee some time back. The idea is to take a progressive step in the direction of making essential and innovative medicines available in India at a fast pace."
This step is directed towards stopping many meaningless trials and making available new drugs to the Indian public. Companies, however, will also be required to do post marketing trials and submit data in a specified period after the launch.
“Our primary objective is to ascertain safety and efficacy of the drug in Indian patients. Hence, we will still decide on case to case basis and take a call depending on the need and efficacy of the drug,” Singh said.