The research organizations and institutions established for undertaking projects in the area of basic research or clinical research in the drugs and pharmaceuticals would now require a registration under the Drugs & Cosmetics Act.
The Central Drugs Standard Control Organisation (CDSCO) is working on a licensing system for these research organizations (CROs) after the registration rules are brought in with an amendment to the Act.
Once the changes in the Registration Rules were set, the drugs/clinical research organizations, which intends to conduct drug researches and clinical research services will have to apply for license from the Drug Controller General of India by submitting their infrastructure and competency details with supporting documents.
The DCGI is considering the licensing system for CROs, which are currently not regulated by Law, to bring in certain amount of accountability to these institutions as far as their standards and reliability are concerned. At present, the CROs are only required to seek the approval for their specific projects related to clinical trials. However the studies like bioequivalance and bioavailability for existing drugs conducted by these institutions are not under the monitoring of DCGI or any other competent authority.
Currently, although the country is set to offer promising opportunities in the area of clinical research for domestic as well as multinational pharma research institutions and companies, it is yet to take adequate safeguards and precautions for the same while considering accuracy of results and other bioethical issues.