Pharmaceutical companies in India are expressing concern over the lower rate of clinical trial approvals in the country for some years now. The slow rate of trial approvals is not only hindering the new drug discovery initiatives in the country but also losing out huge business opportunities to other countries like Malaysia, Indonesia and Philippines in the clinical trial segment.

According to the Indian pharmaceutical alliance (IPA), during the past one year till June 2014 there have been only about 25 clinical trials approved in the country. Having learned this, majority of drug manufacturing firms in India are concerned over the lower rate of clinical trial approvals, as free and fair testing of drugs is essential to come up with new medicines in the country.

Though regulating clinical trials is important to ensure ethical practices and transparency, at the same time it should not become a blockade for the overall growth of the clinical trial industry. The IPA representing pharma companies in the country feels that the number of approvals for clinical trials must be increased, so that it will enable the Indian pharma Industry to compete effectively with advanced nations in the new drug discovery segment.

While commenting on clinical trials in India, Dr. Anita Krishnan, a Consultant, at Nova Specialty Hospitals said, “clinical trial business in India has huge potential as the country offers low costs facilities coupled with state-of-the-art technology and increasing R&D investment by pharmaceutical companies. However, India as a clinical trial market still occupies a small portion in the overall global pie. Besides this, there are other challenges such as unethical trials and lack of exclusive data,”

While new drug discovery is important, it is equally important that clinical trials are carried out in the prescribed manner and with the rights of participants fully protected, opined a healthcare activist in Hyderabad.

Health activists have held up trials when there are disputes over how these are being conducted. On the other hand, Pharma companies complain that this is slowing down research into new drugs. Only seven new medicines have got go-ahead this year. Last year 35 new drugs had got clearance.

In a letter to the central health minister the IPA has asked for the central drugs and standards control organisation to intervene and look into the issues of both the companies as well as the participants. The IPA’s complaint is that the government focuses too much on the rights of the participants (people on whom the trials are conducted) and this is slowing down research. The IPA stated that compromising the development work will only harm patients in the long run.