Global pharma giants roped in for H1N1 trials

The health ministry is also hopeful that it would be able to successfully persuade the fourth player, French firm Sanofi Aventis soon. ?Around eight to nine sites across the country have been already identified to conduct the trials. In most likelihood the sample size of the soon to start clinical trial would be around 600 to 800 adults,? said V M Katoch, first secretary, department of health research (DHR).

The Centre had written to these players to let India participate in at least the final stages of the clinical trials and has been holding regular meetings with them to convince them about holding these clinical trials here. This is in alignment with the government’s overall strategy of importing and creating a stockpile of H1N1 vaccine from international companies as their Indian counterparts are lagging a few months behind in developing the swine flu vaccine. The companies mentioned above have already conducted their clinical trials abroad and are in the process of rolling out the swineflu vaccine.

The step is meant to ensure the safety and test the efficacy of the new injectible drug on Indian population. Based on the results of the clinical trials, the government would take a call on which player(s) to import vaccine from and also decide on the quantum of vaccines to be imported. Although price of the vaccines is yet to be determined, it is likely to be around Rs 400-500 per dose, according to sources. The government’s apprehensions also stem from the US experience of 1976 mass flu immunization drive that had to be abandoned and abruptly withdrawn as the vaccine produced dangerous side effects in many people, mainly related to central nervous system, crippling and paralyzing some subjects.

Also, under the current law, drugs discovered abroad do not get marketing approval here unless the drug makers have conducted part of the final stage of clinical trial here. According to Drug Control General of India (DCGI), the authority that grants marketing approval to drugs, 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 be expedited in this case because of the exigencies and priorities attached. Three domestic biotech companies, Pune-based Serum Institute of India Ltd, Bharat Biotech and Panacea Biotec, are also working on vaccines. The vaccine, however, is not expected before March-April next year. A fourth player Cadila Ltd has also decided to join the race.