Approvals and registrations of clinical trials in India are time consuming processes and hence it is advisable that this is taken into consideration during the initial planning phase of a trial. This is especially true for internationally funded trials that need to be conducted in India as they require additional approvals such as FCRA clearance and HMSC approval. These are described below:

FCRA:

• FCRA or the Foreign Contribution Regulation Act (5^th August 1976) – has been introduced to regulate the acceptance and utilisation of foreign contribution and hospitality by individuals and organisations working in areas of national interest.
• The key focus of the Act is to ensure that these foreign contributions are not being used to influence or have a detrimental effect on electoral politics, public servants, judges and other people working in important areas of national life (journalists, news publishers, etc.).
• The Act  and Rules also ensure that these funds are not being diverted into activities that might be detrimental to national interest, and that these individuals and organisations function in a manner that is consistent with the values of a sovereign democratic republic.
• For obtaining registration under the FCRA, the applicant association should preferably be registered under any of the following Acts:
• Societies Registration Act, 1860
• Indian Trusts Act, 1882
• Charitable and religious Trusts Act, 1920
• Companies Act 1956 (Section 25)
• Institutes receiving foreign assistance should ensure that they have the requisite FCRA clearance as per the requirement of DEA (Department of Economic Affairs), Ministry of Finance, Government of India.
• More information

HMSC Approval:

• HMSC is the Health Ministry’s Screening Committee.
• HMSC is a ‘high level committee’ that was constituted by the Government of India in the 1980’s to screen and approve international collaborative proposals in the field of biomedical health research.
• HMSC consists of members from various departments to form a pool of expert reviewers.
• The International Health Division within ICMR acts as the secretariat for HMSC and facilitates the technical review of the proposals for the HMSC.
• The Indian collaborator of the research project is expected to submit the necessary documents and protocol (as required) to ICMR for consideration. Proposals that are submitted to HMSC should be in the prescribed format of the funding agency or the organization. If there is no particular format, the proposal can be drafted as per ICMR’s format.
• There is some information available for scientists on how to develop Indo – foreign collaborative proposals for research in biomedical sciences.
• Useful links / resources:
  • Guidelines for International Collaboration / Research projects in Health Care
  • ICMR’s portal for submission of project proposals to HMSC
  • ICMR’s checklist for HMSC consideration
  • Documents required for HMSC consideration
  • More information is available here.