The central government has sanctioned Rs 500 crore for implementation of Schedule Y norms amongst the small and medium scale clinical research organizations.
Each CRO will receive a soft loan of Rs.1 crore at 5 percent interest without collateral. The Planning Commission has transferred the funds to the Small Industries Development Bank of India (SIDBI) for disbursing the amount to the needy companies. The process of funds disbursal will be supervised by union chemicals ministry.
Confederation of Indian Industry (CII) Institute of Quality will work as a custodian and will evaluate the proposals for the funds. It is now in the process of preparing a White Paper to assist the small and medium sector to seek the funds that will help to adhere to Schedule Y norms, which is the basic parameter to offer quality services.
Government recognizes the need for implementing more regulations in the sector and plans to impose a regulatory thrust with a fund of Rs.500 crore to implement Schedule Y for the small and medium sector, informed sources. The key objective of the fund is to ensure maximum number of CROs can avail of the funds. A major benefit is the 5 percent interest rate with no collaterals. The repayment period is fixed for 5 years, but the small and medium scale CROs are now requesting SIDBI to increase the repayment period, stated sources.
CII-IQ is also engaged in creating awareness on the need for Schedule Y which is the first step towards good practices. Further, the guidance extended by CII-IQ to the units will also cover supervision in setting up the infrastructure and the purchase of instrumentation. The funds can be utilized for the small and medium units to gear up to tap the growing clinical trials market which is estimated to be valued at $600 million by 2010.
Right now the estimated number of clinical research organizations is around 120 units in the country. There is a need for higher compliance going by the interest shown from companies in US and Europe to look at India as a cost-effective and reliable site in terms of conducting a clinical trial and availability of patient pool.
Small and medium-sized CROs generally do not comply with Good Clinical Practices (GCP) which is why CII-IQ's role becomes even more vital. While some smaller CROs are not aware of the new mandate, some CROs have been following the traditional processes and practices reluctant to comply with new set of standards. The CII-IQ programme is specifically designed to help the sector gear up for challenges and help make India an even more attractive destination for clinical research and trials," added the source.
There is also an acute shortage of investigators with only 1,000 available against the requirement of 10,000. India also needs over 50,000 site coordinators. The status today is that in spite of huge availability of medical doctors and life sciences graduates they lack the technical skills for working in CROs.