Lax drug regulatory system takes its toll on pharma sector

Written by Swarleen Kaur | Baddi | Updated: Jan 28 2010, 03:43am hrs
A lax drug regulatory system in India is coming in the way of pharma sector, which has huge potential in the country.

Major players in the field are thriving on Indian talent and it is high time that the country puts in place a sound regulatory system.

Speaking at a symposium, 'Manthan 2010', Manu Chaudhary, deputy MD, Venus Remedies said due to lack of coordination between drug regulatory authority and patenting authority, pharma companies are losing the benefit of patents, which is demoralising them. YK Gupta, head of the department of pharmacology, All India Institute of Medical Sciences (Aiims) said, India is a global hub for clinical research activity with the fourth-largest pool of medical professionals in the world and the largest genetically diverse population in any country.

There is a need to review and design good clinical practices (GCP) guidelines and regulations to conduct clinical trials in accordance with international community for Harmonisation (ICH) guidelines.

Manthan 2010 is organised by Venus medicine research centre, the research and development wing of Venus Remedies Ltd.

The objective of the symposium was to provide an opportunity to the industry, scientific community and regulatory agencies to come together to discuss new initiatives with the purpose of finding new drugs and improving the quality of existing drug products.

The message of GCP should not be limited up to the pharma industry level, but it needs to percolate down to the clinical research fraternity, for example investigators, clinical research Associates (CRAs), staff, who are instrumental in following up the GCP guidelines, Chaudhary said.