Government ministers told Outsourcing-Pharma.com that in the past a number of companies have “flouted” certain regulations because the rules were not strict enough.
Areas of concern include the fact contract research organisations (CROs), clinical research associates (CRAs) and ethics committees have not been required to officially register themselves with the authorities.
Deputy drug controller S Eshwar Reddy told us that by tightening the laws the Government hopes to boost the clinical research industry in the country.
He said: “In India we don’t have a system of registration of ethics committees, so they are independent bodies. So as an India regulator we don’t have any control over them, or the decisions taken by the committee considering patient safety and well-being.
“We have seen the weakness in the system and we will go about registering ethics committees. Same about clinical investigators (…) and we are also going to have registration of CROs. These are our proposals. Now we will make it law.”
Secretary of Commerce S R Rao also told us the Government will “engage” firms who are getting into the clinical trials, adding that the Department of Commerce recognises the sector as an "emerging opportunity" for Indian trade.
He said by changing “some loosely worded regulations” the Department of Commerce hopes to rid the industry of those not acting in accordance with the rules without punishing those who act in-line with policy.
“When 80 per cent of industry – a significantly large number – follow the rules there are a couple of companies who come and sour the pitch. Fly by night operators. We do not want to tax the industry but we certainly do not want anyone to take advantage of loosely based regulations,” he told us.
Additional Secretary of the Department of Commerce, Rajeev Kher, added that the Government hopes the changes will help strengthen ties with foreign pharma firms in particular, and will attract more clinical trial outsourcing in India.
“Clinical trials are one area where there is a huge potential for us,” he said. “We also believe that we are in a position to make it (changes ) a reality and recognising this we are developing a new regime around clinical trials that would be in line with global practices in the developed world."