Draft Report of the High Level Group on Services Sector

5.2.7 Impediments in Expansion of Clinical Research

Although the prospects for outsourcing of clinical research by global pharmaceutical companies look bright there are number of problems that need attention.

1. 
   While the National Accreditation Board for Laboratories (NABL) has a programme for accrediting laboratories certifying their adherence to Good Laboratory Practices, it does not have the international standing for its accreditation to be recognized outside the country. As for Good Clinical Practices there is no organization in India at present, which has been authorized or has undertaken accreditation work. In the result the Indian laboratories and CROs need to be accredited internationally by such organizations as the College of American Pathologists (CAP), thereby incurring additional costs, resulting in lower competitiveness:
   
2. 
   There are weaknesses in the regulatory infrastructure and the Office of the Drugs Controller is understaffed and lacking in capacity to deal with such new areas as stem cell research, GM food etc. There is lack of a world class testing laboratory for validation of tests; and
   
3. 
   Most importantly there is a looming shortage of clinical research personnel, estimated at 30,000 to 50,000. We need more trial investigators, auditors, personnel to serve on Ethics Committees, Data Safety Management Boards and personnel in other categories.