Inside India: special series

Clinical trials in India: 'The wind is blowing'

By Kirsty Barnes

- Last updated on GMT

Related tags: Clinical trial, Contract research organization

An industry veteran gives Outsourcing-Pharma.com an update on the
state of the contract research organisation (CRO) industry in
India.

"The wind is blowing in India,"​ said Dr Vasudeo Ginde, a clinician with over 20 years experience in the Indian clinical research industry and currently president and managing director of Indian-based CRO iGATE Clinical Research. "There have been lots of positive regulatory developments in the country since the beginning of the year,"​ he said. Prior to January, the turnaround time for a company to obtain permission form the regulator to run a clinical trial was between 10 and 16 weeks. However, now trial applications are divided into two categories, A and B. Category A trials are those that already have the protocol approved in one of a number of countries on an approved list. This has allowed turnaround time for the approval of these trials to be slashed to between two and four weeks. The remainder of trials are placed in category B and even these are now approved in between six and eight weeks, said Ginde. "The industry has experienced definite improvements through these changes."​ In addition, he said that the Indian drug regulatory body has pledged to start auditing clinical trial sites, CROs and pharma companies involved in clinical research - through spot checks or planned inspections - which is something that has not been occurring and will no doubt raise the bar of the overall quality of the industry. "The regulator is currently building up the manpower in order to begin these inspections and it is assumed they will be ready to commence by the end of the year." ​ Furthermore, the country is slowly building up its capabilities in the preclinical and early-phase research arena. Currently only a very small amount of preclinical and early phase studies are being conducted in the country and India also does not allow first-in-man trials to be run on foreign molecules. However, more and more Indian firms are now getting their foot into the door of the early-phase area, through partnerships, collaborations and co-development agreements with international pharmaceutical firms who are now active in the country, and this is creating an evolution of capabilities. There has been much discussion in the country of late around the idea of amending the laws to make them more amenable to early-phase research, in particular allowing first-in-man trials on foreign drugs. India's regulators and law makers are largely in favour of such changes and there is current movement behind the scenes to bring them about. However, any changes to the rules would still have to be approved as an amendment in law under the Drugs and Cosmetics Act and this process will take an unknown amount of time. It could take six months, it could take 18 months, it could take longer, said Ginde. As part of the industry's evolution, Ginde also said that more and more Phase III and II trials are now being entrusted to the county - previously most of the trials being conducted in India were Phase IV. Meanwhile, Ginde said he has also been witnessing two other main trends in the CRO industry of late. Firstly, more and more CROs are engaging heavily in new business development and expanding their range of services offered, particularly in the areas of data management and clinical trials management. Until 2000 no companies were really offering these services so these areas need a lot of investment, he said. Another evident trend according to Ginde is contract staffing amongst the CROs. This is largely due to the huge problem of recruitment and retention of experienced clinical staff in the country, with demand far outweighing supply. "The average staff attrition rate amongst firms operating in India is 45 per cent. However, I don't think contract staffing is the answer. It is not good for the industry,"​ said Ginde. "It leaves too many people in the middle of nowhere in a company, and their sole motivation becomes to learn as much as they can and then move on. This only increases the attrition rate." ​ Ginde stressed that to combat the problem, staff need to feel that they are part of the company and have the opportunity to progress with time into a diverse range of roles and develop multidisciplinary and interdisciplinary skill sets.

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