The Indian Clinical Research Organisations (CROs) see a slump in demand for conduct of human studies in India, following the union health ministry’s stance on mandating a wide range of norms including the latest calculation of compensation for trial subjects. CROs feel the compensation is too high and fear an increase in disputes which could result in huge decline in patient studies and retard growth of medical research in India, said DA Prasanna, chairman & founder, Ecron AcuNova.

Growing risks have led to fall in investor interest in Indian pharma services, making the environment for CROs even more challenging. There is clear evidence of stagnation and decline in global and Indian CROs. India is losing its experienced clinical research professionals who are opting for secure jobs in pharma industry. Clinical research as career has become unattractive to talented doctors and pharmacy professionals as can be seen from the fact that today there are hardly any takers for degree and diploma courses in biotechnology and clinical research. This is a huge blow to drug development which impacts its bringing cost-effective cures to society, Prasanna told Pharmabiz.

CROs today are ready to represent a pharma company with DCGI as an applicant. This is only if a pharma company is willing to give ‘back-to-back indemnity’ before it takes up a human study.

“Compensation calculation is not on par with global practice. In the US, compensation is paid at the end, after determining if the cause was the drug or the patient’s condition. If it is the former, then the onus is on the pharma company. Europe has a no fault compensation where medical management is borne by the sponsor. But in India, compensation issue is making it uncertain and expensive to conduct medical research,” he added.  

In China conducting clinical trials is complex, but the government has identified 150 exclusive sites from its 15,000 hospitals for global companies to carry out the human studies. This makes China predictable and attract medical research way ahead of India, he informed.

Now India has certain competitive advantages in generic drugs and if trials cannot be done, it would only weaken the Indian pharma industry. India’s  recognition as a potential pharma hub has a negative perception with the  DPCO 2013, compulsory licensing, recent judgment on IPR, patient compensation rules, uncertainty on approvals and overregulation of clinical research. Global interest has steeply declined and even local pharma companies are considering for medical research countries outside India.

“We are already present in US, Canada, Europe and South East Asia besides China through a partnership mode,” said Prasanna who is credited with globalizing his research operation to a Rs.140 crore CRO.

In the interest of safe conduct of research, it is using Manipal University ethics committee, the first EC in India accredited by AAHRPP in 2012. “Our growth is a result of safe conduct of medical research. Our position amongst Indian clinical CROs has gone up to the top and today we are an acknowledged global leader in certain therapy areas like diagnostic contrast agents and cell therapy,” said Prasanna.