At a time when clinical trials (testing of new drugs on humans) have ground to a virtual halt in India due to a regulatory imbroglio and the resultant crackdown by the Supreme Court, the government is making an effort to make the relevant policy more pragmatic and conducive for the development of new medicines germane to Indian population.
According to government sources, the health ministry has decided that introductory Phase I and exploratory Phase II clinical trials of new chemical entities (NCEs) being developed and to be marketed in India can be conducted abroad. This means the Indian drug regulator will approve data generated from trials conducted on foreign soil as far as these two phases are concerned. Based on such approvals, subsequent phases of trials — Phase III and IV — can be done in India. As per rules, all four phases of any new drug being developed to be marketed in India has to be conducted within the country.
The advantage of the new policy, sources said, is that the time required for drug development can be reduced and new medicines can be launched faster. India doesn’t have enough capacity to deal with the requirements of Phase I and Phase II trials, often adding to delays and cases of misconduct by the investigators.
Experts said the new policy will give an option to drug innovators to shift trials to countries like Europe, US, Canada, China, Malaysia and Turkey which not only have greater expertise in conducting Phase I and II trials, but also have shorter turnaround times.
A negative fallout could be a possibly diminished potential of India in the global clinical trial business. India was touted as an emerging clinical trials hub thanks to the diverse genetic profile of Indian population and the relatively low cost of doing trials in the country.
Currently, no new clinical trials are being approved in India, since policies governing approval and conduct of clinical trials have become tangled in the judicial-regulatory thicket. On account of the limbo in approval of clinical trials, the industry estimates a loss of around $150-200 million this year alone.
Phase I trials are conducted on a small group of healthy volunteers to estimate the safety and tolerability of a new molecule under investigation, while Phase II is a therapeutic exploratory trial, conducted on a larger pool of people to evaluate the efficacy of the drug