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Tom Pike, Quintiles CEO : India steps in again for Clinical trials

Tom Pike, during his 16 years journey with Accenture, has seen and contributed alot to make India a key resource for the IT consulting firm.

Now, as CEO of US-based Quintiles, he’s equally gung-ho about the country.

Quintiles is a Fortune 500 company and the world’s largest provider of biopharmaceutical development and commercial outsourcing services. On a visit to Bengaluru, where Quintiles has one of its biggest centres, Pike tells that the regulatory changes last year relating to clinical trials of new drugs on patients will help bring more drugs to India.

The industry went through a trying phase in 2013 and 2014. Have the revised clinical trials’ guidelines of 2015 improved the environment for you? Which changes have been the most significant?

There were two major changes last year. The first is related to compensation in a trial in the event that a patient has an adverse reaction. The government rules of 2013 had said compensation would have to be paid regardless of whether the drug was the cause of the reaction. That was very unusual and contrary to the global practice and standards. Now the new rules

allow compensation only up to the point that the drug did the damage. With this change, India has returned to global standards and this should open up more opportunities to do trials here. Secondly, the regulators have indicated that audio visual recording of informed consent is not mandated for all clinical trials, though more clarity is awaited. Mandated audio visual recording precluded many who were not comfortable with being recorded due to socio-cultural and religious reasons.

Are pharma companies starting to do more trials in India now?

We see them getting interested. In our industry, it takes a while to rebuild. It may take about 16-18 months before we see an uptick. One exciting development is that approvals for clinical trials are now taking about six to seven months, which is the global standard. It used to be 15 months in India a couple of years back.

Do you still see hurdles in the regulatory framework?

The changes have brought back the basic competitiveness. One thing we would like to see is the authorities doing regular inspections of the doctors who participate in the trials. The rest of the world does this to ensure there is adequate quality associated with data that is prepared during the trials.

Mandakini is a bioscience enthusiast and loves to portray a picture of “Science” like never before. Serving as an Editor in Biotecnika she has penned down many interesting news and articles in the past and has also helped in posting just the right job for you. Follow her for more updates in the industry !!