Will try to ensure new therapeutics reach patients at earliest, says DCGI

Dr G N Singh, Drug Controller General of India (DCGI) has sought cooperation from all the stakeholders in ensuring the safety and ethical practices during clinical trials


New Delhi: The clinical research scenario in India has been affected very badly over the period of five years due to drastic decline in the number of approvals to the clinical trials. From booming industry in 2010 to merely 480 trials (with 253 approved) in 2012 and further to 207 (with 73 approved) in 2013, it scaled down to two figure statistics in next few years. The reason was huge negative public opinion and media attention generated through political rhetoric and judicial activism. The fluctuating regulations added to the uncertainty. As a consequence, India was no longer considered to be a favorable place for carrying out trials.

However, since last one year, there has been some positive movement on the front. The repeated regulator-industry meetings and assurances from the ministers have given some confidence to the industry. In fact during 2015, the health ministry proposed pre-submission meetings in a bid to enable technical deliberations between stakeholders and the drug regulator before clinical trial applications are submitted.

Now on a fresh note, reiterating the commitment of Central Drugs Standard Control Organisation towards the availability of drugs for major diseases, Dr G N Singh, Drug Controller General of India (DCGI) in his recent message mentioned, “CDSCO is committed in this journey to enable newer therapeutic options being made available to Indian patients at an earliest. I urge all clinical research stakeholders to reiterate their commitment to patient safety, ethics and quality and to work together to ensure we address our growing disease burden effectively and efficiently.”

The regulator in the message on the occasion of International Clinical Trials Day posted on CDSCO website on 20th May, 2016 also lauded the patients who volunteer to join the clinical trials.

“I would like to applaud the noble efforts of patients who participate in clinical trials and thank the clinical fraternity for the contribution in bringing new, safer and more effective drugs to market,” stated Dr Singh.