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U.S. Department of Health and Human Services

About FDA

Regulatory Oversight Bodies

Description: Develop and maintain an understanding of the Government of India's regulatory oversight for FDA regulated products. This includes developing familiarity and knowing about the different government agencies designated as responsible for these products and collecting, familiarizing and understanding the current and proposed national legislation and keeping up-to-date on the changing regulations and regulatory structures in India. Knowing and understanding the regulatory systems, developing appropriate contacts and relationships with the various responsible regulatory agencies will increase the ability and appropriateness of FDA to interact and engage with its counterparts to improve or assure food and medical product safety.

Accomplishment: The India Office reached out to the various Indian regulatory agencies directly, through meetings and other forums, including telephone and e-mail. Knowing who and where and then establishing appropriate contacts increased the Office’s understanding of the numerous entities and offices involved in the regulation of FDA-regulated products at India’s central, and state levels. The Office researched and analyzed the current regulatory structure of food, drug, and medical device oversight, recognizing that the regulations of these product types are at various stages of a legislative process to centralize authority at a national level. This presented unique challenges and currently centralization is still not completed, offering multiple situations when pathways and responsibilities are not so transparent. Therefore, the Office continues to gather information and scrutinize both current and proposed national legislation in an effort to maintain an understanding of India’s evolving regulatory environment.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Collect and maintain e-mail and telephone contacts for key Indian regulatory officials

12/15/2009

Completed 12/15/2009

B. Identify, read and analyze India regulatory processes

1/31/2010

Completed 2/15/2010

C. Prepare and update draft food, drug and medical device regulatory environment and profile papers for FDA internal usage as well as for use in State cables, when appropriate

4/30/2010

Completed 4/22/2010

D. Maintain an understanding of the status of pending rules, regulations and laws that apply to FDA-regulated products; assess on a quarterly basis

3/15/2010

6/15/2010

9/15/2010

12/15/2010

Completed 12/15/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.