The DIA's 8th annual conference which concluded here presented the much-needed confidence to the country’s  standstill clinical research industry paving the way for a new environment for human studies.

The three-day event on ‘The new clinical research environment in India: Implications and Opportunities’ covered clinical research, biosimilars, risk based monitoring, evolving pharmaceutical regulations in the regions, data sharing, sales and marketing analytics and  media activism-judicial intervention in clinical research indicated that despite the challenges for growth in a phase where business was at a standstill, there was an impressive emergence of information technology enablers facilitating  better business outcomes.

Clinical trials in India can strengthen the drug development. Human studies need to be carried out ethically because it deals with the patient life. While we appreciate the concerns of the Supreme Court of India to stall all clinical trials and clear five studies that were approved this year after ensuring proper mechanism and procedures to ensure the safety of the patients, this indicates that the stringent controls in the clinical trials space would only benefit the industry in the coming months, said Madan Gopal, principal secretary, Karnataka Health and Family Welfare department, who was the guest of honour for the event.

“So far, Indian clinical trials industry did not have any checks and balances. Major stakeholders have a key  role to be cautious  at every stage. There will be no need to panic if there are regular pre and post prescription drug counseling which would bring in the much-needed confidence to patients. There have been several contagious issues which put both the regulator and the clinical trial industry in a spot. It is time to fine tune polices and the  global pharma should not be deterred to carry out human studies in India,” Gopal said.

According to Larisa Singh, VP, global functional resourcing, Asia Pacific Quintiles and Advisory Council of India Chair, DIA, “Indian clinical research is seen to face several upheavals. There are strong headwinds of challenges. This has affected the growth of existing clinical research organisations and upcoming ones to devise ways of how to move forward. Present scenario is difficult but the DIA is confident that its congregation of experts gathered here would handle the ever more complex challenges since the industry is all for ethics and efficient systems.”

The fast paced growth in information technology, particularly in the area of data mining indicates that India’s clinical research industry would certainly become a strong platform for human studies, said Dr Shoibal Mukerjee, vice president, CMO India and head Asia Medical Sciences Group, Quintiles and program chair for the DIA 8th Annual conference.

Sairamkumar J, senior vice president & global delivery head, Cognizant Life Sciences said that technology is the key solution to ease out the challenges in clinical trials. From now on cloud computing would drive the future of this industry.