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Regulatory uncertainties after the Ministry of Health came out with patient compensation guidelines in case of clinical trials conducted in India, have put clinical research organisations (CROs) in the country in the risk of losing new business, as drug companies are in a wait-and-watch mode before things become more clear at a policy level.
As a senior official in a leading Bangalore-based CRO points out, "The recent regulations that were published in end of January, say that the patient has to be compensated in case of injury during trial because of placebo. Now, placebo groups (where a group of patients are not given any medicine or a dummy one) is an essential part of clinical research. They are used in new drug studies when there are no known drugs to compare with." Also, the new regulations say that patients have to be compensated in case of lack of therapeutic effect of a drug. "When a medicine is new, it is difficult to know about its efficacy, which is the sole purpose of conducting the trial," the official said.
CROs like Quintiles, Veeda and Lambda feel that this would definitely hinder research in the long run. Another official in an Ahmedabad-based CRO said, "Clients are not prepared to expose themselves to unlimited amounts of compensation, and that too when things are done in an unscientific manner. This is forcing them to take their phase one trials out of India, which, in turn, means loss of business for local CROs."
He further added on grounds of anonymity that many drug companies are shifting their phase one research for molecules that are developed domestically out of India, particularly to countries like UK, Netherlands and Malaysia, where it is easier to conduct clinical research. While this increases the research and development cost of companies, it also means losing business for CROs.
Industry associations as well as drug companies have made presentations to the ministry of health to look into the new regulations, and address the issues. "Everyone is waiting for regulations to change sooner and later, and are thereby delaying their decisions of outsourcing clinical research. If the situation continues for long, there would hardly be any new business during this year," said an industry insider.
Apurva Shah, group managing director of Veeda Clinical Research said, "While safety issues are very important indeed, the complex process and delays have virtually put the entire process of approvals on hold. This is bad news for the future of the CRO industry, as well as for the future of research and development (R&D) in India. If we want to develop drugs as par our need, we need to encourage R&D."
As a survival measure, some CROs have started to look at peri-clinical services for business growth, while others are also looking at increasing focus on other geographies. As for Quintiles, around 30 per cent of its business comes from clinical trials, while the remaining is from data-related services, processing bio-markers etc. Veeda has recently set up a phase one unit in Malaysia, so has Lambda Therapeutic Research too has opened a center in Thailand.
