Source: The Economic Times, 14th october'08
The investigational new drug (IND) filing process in the Indian regulatory system needs to change drastically to meet competitive challenges from China and Eastern Europe, geographies that are becoming powerhouses in clinical trials. India has made a mark in the low-end bio-equivalence testing for generic drugs, and western regulators are accepting Indian dossiers. It is, however, the more skill-based and high-tech process of doing phase I to III trials which are proving to be much more difficult.
In the past, Phase I trials were allowed only for Indian discovery molecules . This was done to stop Indians becoming “guinea pigs” for foreign companies. Phase II and onwards was allowed for other MNCs wanting to do a clinical study in India. Foreign companies did begin to do Phase 3 trials in India where this country became a part of the worldwide trials. Phase III and the other bio-equivalence work formed the bulk of the revenue of most of the CROs in India. India proved to be adept at following worldwide GCP (Good Clinical Practice ) methods and many scientists from abroad returned home to provide international methodology.
Bio-analytical work is also another lucrative technology process. Here, the Indian skill base is low and the cost of equipment is a few crores each. This kind of expensive equipment is not available in academic institutions and companies have to train fresh young recruits on these million-dollar machines. Eventually, the scientists are poached by other CROs and the cycle starts again. The government should start training bioanalytical scientists to fill this crucial and unmet need.
Recently, the drug regulator announced that the ban on Phase I studies by foreign companies is to be lifted . This makes eminent sense in the globalised world as it is becoming hard to determine what is “Indian.”
Many Indian companies may do parts of the research on foreign shores in their own subsidiaries and today’s NCE is being researched across the globe from Taiwan to Toronto. The expertise for approval of Phase I studies needs to be built whether the molecule is Indian or global.
The real hurdle is that the time taken to constitute the IND committee for a Phase I molecule is 6-8 months. From the time a proposal is made to the drug regulator, and it passes through the various health secretarial desks and an office order, it takes 6 months just for a committee to be formed. After this, the committee deliberates on the approval. In sharp contrast, the time taken for Phase I approval is just 28 days in Canada, Europe , the UK and other countries. India is lagging behind. At least 10 sitting committees must be formed by therapeutic areas (cardiology, oncology etc).
They can call on international skilled and experienced scientists to assist them. If we are to become the medicine maker to the world we must build world-class skills, quality and experience to provide affordable drugs not just for India but for the whole world. What is required is to ensure the key tenets of care, backed by solid, dynamic action, in turn rooted in deep knowledge. These are critical to the democratisation of healthcare and the reduction of disparities.
(The author is director, Piramal Healthcare)
