The Centre has written to US-based Baxter, Swiss company Novartis, GSK and a Chinese company to let India participate in at least the final stages (phase III and IV) of the clinical trials. It expecta their reply this week, said VM Katoch, first secretary, department of health research (DHR).
The step is to ensure the safety of the new injectible drug. India has also expressed the desire to be a part of the initial stage clinical trials, if possible, according to health ministry sources. If the companies agree to the demand and the move proves to be successful, the government may have to make an exception in the law, depending on which stage of human clinical trials the company is working on.
Currently, Indian laws permit MNCs to conduct only phases II, III and IV of the trials here. But if the company has conducted phase-0 and phase-I trials in at least two other countries, they are allowed to do the same here. Domestic companies, however, are allowed to conduct drug trials at all stages in the country. According to Drug Control General of India (DCGI), time taken to give clearances for phase-I trials is 90 days, for phase-II, the period is 45 days and for phase-III, 60 days. The duration for granting clearances may also be expedited.
At the current pace, it is likely that international players will outpace their domestic counterparts by at least six to seven months.
Three domestic biotech companies, Pune-based Serum Institute of India Ltd, Bharat Biotech and Panacea Biotec, are working on vaccines. The vaccine, however, is not expected before March-April next year. Cadila has also decided to join the race. Additionally, around six companies have expressed their desire to the government to develop the diagnostic kit, used for testing samples for the H1N1 strain.