The move to abolish clinical trials of proven drugs will reduce time taken to introduce new drugs in India to just 45 days from 5-6 years.
In a move aimed at speeding up the availability of new drugs, the government has proposed doing away with clinical trials for drugs that have proved their efficacy in developed markets.
According to a proposed new set of rules, a part of which has been reviewed by Mint, the government suggested waiving local clinical trials for drugs that have not had any major adverse effects on patients.
These drugs should have been approved and marketed for at least two years in the European Union, UK, US, Australia, Canada and Japan. The ministry of health and family welfare has sent the draft proposal to the ministry of law and justice for vetting before it can be notified.
The move is expected to reduce the time taken by a company to introduce new drugs in the market from 5-6 years to as few as 45 days. According to the drug regulator, the move will also lower the cost of drugs.
"This will end unnecessary repetition of trials and speed up the availability of new drugs in the country—a win-win situation for both the industry and consumers," Drug Controller General of India G.N. Singh said in a phone interview.
Lengthy clinical trial and approval procedures deprive Indians of advanced medicines, said R.K. Vats, additional secretary in the health ministry.