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Lack of focus by regulatory authorities dented growth of clinical trial industry in India said ISCR President, Dr. Krathish Bopanna

Indian clinical trial industry is now under pressure as lack of focus by regulatory authorities has dented its growth.  There are serious concerns now for the sector. India is no longer preferred for human studies as countries like South Korea and Philippines are now favourable going by the speedy regulatory clearances, told Dr Krathish Bopanna, President, Indian Society for Clinical Research (ISCR) and President & Chief Executive Officer, Semler Research Center Pvt Ltd to Pharmabiz in a telecon on the sidelines of the 6th Annual ISCR Conference being held in Mumbai from January 4-5, 2013 at Hotel ITC Maratha.

Paucity of clear cut guidelines and poor clarity on the moves by Indian regulatory authority have led to a pall of gloom descend on the country’s 120 clinical trial companies.   Although India has been much sought after hub for human and animal studies, now with the Supreme Court directive to stop illegal trial has now further construed a wrong impression on the companies, Dr Bopanna told Pharmabiz.

Pharma companies who have a new drug applications (NDAs)  are unable to predict when it would be cleared by the regulatory authority for a clinical trial. Even clinical trial companies have to register in the Clinical Trial Registry of India (CTRI).   Undue delays will cascade into unemployment  and revenue loss, leaving many clinical trial organizations with the only option of shutting down, he added.

The government does not comprehend the need for fast track approvals nor transparency. Therefore we do not see any reformation for this sector which has helped generate revenues not just for the pharma industry but healthcare providers too as many human studies are conducted in hospitals, informed the ISCR president.

While drug trials are critical for pharma companies to bring in more efficacious medicines for the increasing patients in the country, the conduct of a human study has always been an emotive issue.  There are far more allegations that patients have succumbed during a clinical trial or no consent was sought or even volunteers  were  treated as guinea pigs. Though we do not deny faults, shortcoming and inefficiencies which could exist if companies are not responsible,  a handful of these instances have marred the reputation of well known and accountable clinical trial  companies. But collectively we are all responsible for the current deficiencies of a few companies, said Dr Bopanna.

There are surprise audits at trial sites and studies  are  conducted adhering to all regulatory norms. With inordinate delays on the part of the Indian regulators, the country is missing the bus.  This is an age of patent expires leading to generic drug and biosimilars growth opportunities which require country specific human studies. India is a leader in generics with its expertise in reverse engineering. But now global pharma majors are looking at the Far East for the expertise, economies of scale and efficiency of faster turnaround, he said.

The global economic slowdown together with the slackness of Indian regulatory authority we have lost 60 per cent of the business. Only those companies engaged in bio-equivalence studies are able to survive and those focusing on clinical trials cannot succeed.  While the slowdown of the economy has eroded front-end clinical trials business, the back-end jobs have survived.

In order to endure in a negative environ of regulatory delays, ISCR is on an aggressive drive to bring back the sheen of clinical trial business by creating massive awareness and convincing the positive factors of the companies engaged in human studies, said Dr Bopanna.



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