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 and the common short-term side effects and risks associated. An important goal for Phase II trials is to determine the dose and regimen for Phase III trials.
The primary objective of phase III trials is to confirm the therapeutic benefit of a drug. Successful conduct of these trials lead to marketing approvals. Phase IV trials are required to assess the safety of such drug in the post-market scenario.
While it takes over 10-12 years to develop a new drug before it can be marketed, clinical development — the most critical process in new drug development — takes around five to six years.
According to Suneela Thatte, president, Indian Society for Clinical Research, an industry body, “In India, we do not have adequate research centres who are experts in conducting Phase I trials for new molecules. Moreover, ethics and quality of trials conducted abroad would be much better.” According to her, even though costs of overseas trials may be higher, the time to get results would shorten.
While Phase I trials are completed in 4-8 weeks in the US and Europe, in India, historically, it takes 16 weeks to complete the first phase. “Currently, due to ambiguity in rules governing clinical trials in the country, there is no specific timelines available,” added Thatte.
“For new entities developed in India and to be marketed in India, all phases from Phase I to Phase IV may not be mandatorily required to be conducted in India,” said a health ministry source. He added that Phase I and Phase II trials may be conducted outside India and based on that data generated, Phase III trials should be conducted in India to confirm the safety and efficacy of the drug.
Pharma companies, CROs and doctors are optimistic that this regulatory initiative would create a secure environment for developing new medicines in the country.
The government is expected to come out with detailed rules on approval of new drugs and clinical trials, based on Ranjit Roy Committee recommendations, before a Supreme Court hearing on 16 December. The apex court has placed a ban on 157 clinical trials, approved by the health ministry, in the absence of a specific policy governing conduct of trials in India.