Status of clinical trials in India
Clinical trials of bio-tech and medicinal products for approval purposes are done usually in hospitals in India. Most of the hospitals conduct clinical trials, if they have doctors interested in this activity. Information on the terms and conditions and the cost is not readily available.
All types of hospitals carry out clinical trials, large and small as also municipal and government hospitals. Large private hospitals and clinics too perform this work. The basic requirement is the presence of doctors who have an interest in this work.
On the basis of preliminary enquiries, there are already companies or agencies engaged exclusively for clinical trials in India. Examples are Quintiles in Ahmedabad, Clinfarm Consultants and Specialty Ranbaxy in Mumbai and Kumar in New Delhi. Quintiles and Specialty Ranbaxy have foreign tie-ups giving them the technological advantage over the purely local ones.
Outlook for Bio-tech/Pharma Sectors:
India at present recognises only process patents. However, by 2005 by virtue of WTO rules, India will have to implement product patents. This will lead to widening of the market for indigenous (say, Ayurvedic products) as they will have the authenticity of internationally recognised product patents. Product patent protection will encourage multinational companies to import technology into India to develop new products.
These developments will open up increased opportunities for the clinical trials of bio-tech and medicinal products.
Assessing marketing viability involves the following steps:
A) estimating and forecasting the market (i.e., demand) for clinical trials for the next 10 years (in terms of number of products and total cost);
B) estimating and forecasting the supply of clinical trial service and segmenting it among: (i) large hospitals, (ii) small hospitals and (iii) contract clinical companies;
C) quantifying the demand-supply gap for clinical trial service available to contract research organisations during the next 10 years; and
D) estimating and projecting the revenues of the proposed contract research organisation for the next 10 years and thus establishing its marketing viability.
|
Topic Tags: 
