New Delhi : To 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 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. The health ministry also suggested exemption from trials for drugs that show no evidence of having a significantly different effect on the Indian population in terms of their absorption rate and efficacy. “Local trials may not be required for those where there is no evidence, on the basis of existing knowledge, of significant difference in Indian population of the genes involved in the metabolism of the new drug,” the health ministry proposal said.
