Putting an end to the speculation that India may not allow foreign players to conduct phase I clinical trials of molecules developed outside the country, Dr Venugopal Somani, deputy drug controller India (West Zone), said the country is well on course to allow foreign players to carry out these trials.
Despite the relentless efforts of the industry and drug administrator's bold initiatives to bring in an amendment to the current regulatory framework to allow the foreign players to conduct phase I clinical trials of molecules developed outside India, the failure to make a political decision on it is making the Centre hesitant to take a final call on the matter, he noted.
However, he reiterated that India would surely allow pharma multinationals to conduct these trials. But he quipped it was difficult to say as to when it would happen, blaming it on the failure to make a political decision on it.
"We have taken every possible step to allow foreign players to conduct phase 0 and phase I clinical trials in India. The draft is prepared and as everybody knows the bill is gone. Now, only the political decision has to be made. Certain forces were trying to thwart our move lambasting we were up to make the Indians 'guinea pigs' for the benefit of the multinational companies. However, we have made the facts clear to the technical people. Now, they are in the process of convincing these forces to win the much needed political decision. It may happen anytime sooner or later," said, Dr Venugopal Somani to Pharmabiz.
Since the drug controller general of India (DCGI) announced the plans to allow foreign pharma players to conduct phase 0 and phase I clinical trials in India, there have been widespread protests from different corners to thwart this initiative. No one seemed to have taken the DCGI's repeated promise that India would only go for it once systems (guidelines for effective monitoring and supervision in the country and other such requirements) were in place, no matter how long the whole process would take.
The main opponents of the government's stand were some civil rights groups and non-government organisations (NGOs), who highlighted the recent death of 49 children at the All India Institute of Medical Sciences (AIIMS), to make the union health minister Dr Anbumani Ramadoss ponder over the repercussions of amending current regulatory framework for allowing foreign pharma players to conduct phase 0 and phase I clinical trials.
"The DCGI is working toward setting internal timelines, framing of SOPs and guidelines, standard formats and starting of inspection of clinical trials to create a safe regulatory environment before allowing foreign firms to conduct phase I trials in India," apprised Dr Venugopal Somani.
The DCGI is also planning training of investigators, experts, technical officers by US Food and Drug Administration (FDA), World Health Organisation (WHO) and Health Canada in India and other countries, apart from future Schedule Y amendment, he added.
The clinical trails market was worth more than US $100 million in India in 2007 and various estimates suggest that it would touch US $300 million this year. Besides, by 2011 India is projected to carry out more than 15 per cent of total global clinical trials.