New tool available on Indian regulatory systems

21st February 2008

PATH´s India office has produced an interactive tool on the Indian regulatory systems for product approval in the areas of drugs, vaccines, biopharmaceuticals, medical devices and diagnostics, and biofortified foods. Available on a CD, this interactive tool allows users to build and analyze various scenarios of product approval applications. Easy-to-navigate and hyperlinked flowcharts provide indicative timelines for approvals, so users can map the various stages in the approval process. 

"The CD is a valuable product, with a plethora of information on the Indian product approval regulatory processes," says Dr. Rajat Goyal, project director. "Ten months of intensive and painstaking research has gone in to make the CD as useful and comprehensive as possible for all those involved in India-centric product development activities," added Rajat.

The CD also contains the following information:

  • A broad comparison of the Indian and US Food and Drugs approval process.
  • A list of key institutions and individuals in India involved in the regulatory approvals, with a detailed description of their roles and responsibilities.
  • A list of organizations, committees, and groups that are part of the regulatory system, including information on their membership, roles, and interdependencies in the approval process.
  • A database of referenced extracts of key legislations, forms, and templates.

The tool is an outcome of a project undertaken by the India office at the initiation of the Bill & Melinda Gates Foundation for its grantees. On the invitation of the Foundation, a four-member project team made a personal debriefing on the project at the Foundation´s office in Seattle in September, which was attended by a large number of their key staff.

Members of the project team from PATH´s India office included Dr Rajat Goyal, Shilpa Raut Kalpana Anthony, Balaji K. Ananth, Malti Sachdev, and full-time consultant Naga Anand. Expert advice was received from Dr A.B. Ramteke, Joint Drugs Controller General of India and Dr. S.D. Seth, Chair, Clinical Pharmacology at the Indian Council of Medical Research, both of who have first-hand experience in this area.

For more information on the project, please contact Balaji Ananth at


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