The Food and Drug Administration (USFDA), Department of Health and Human Services of the Government of the United States of America, and the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare (MOHFW) of the Government of the Republic of India, hereinafter collectively referred to as the “Participants,” and individually referred to as “Participant,” recognize the importance of timely and effective collaboration, communication, and information exchange in the promotion and protection of public health. The Participants share a mutual high regard for the crucial role that their respective regulatory systems perform to ensure medical products that each Participant regulates are safe and effective. The Participants intend to build on the areas outlined in the Statement of Intent between the Food and Drug Administration of the United States of America and the Ministry of Health and Family Welfare of the Republic of India on Co-Operation in the Field of Medical Products, signed on February 10, 2014.
- PURPOSE AND SCOPE
This Memorandum of Understanding is intended to develop and strengthen opportunities for cooperative engagement in regulatory, scientific, and technical matters and public health protection that are related to medical products the Participants regulate. The Memorandum of Understanding covers medical products that both Participants have authority to regulate.
- AREAS OF COOPERATION
The Participants acknowledge they share a common interest in strengthening bilateral cooperation in regulatory systems to promote and protect public health through supporting collaborative partnerships in the following areas:
- Ensuring the safety, effectiveness, manufacturing quality, and security of human and veterinary medicines, vaccines, and other biological products, medical devices and diagnostics;
- Determining the clinical safety and effectiveness of medical products through well-designed, scientifically robust, and ethically conducted clinical trials with systems in place to assure the adequate oversight of human clinical trials;
- Furthering medical product innovations and development to increase access to medical products for saving lives, restoring health, and treating and preventing diseases, including but not limited to considerations for fostering medical product innovation to address issues of global concern and emerging areas of public health;
- Continuing to strengthen and harmonize regulations in keeping with international standards; and,
- Maintaining long-term global efforts to help ensure timely and secure availability of high quality, safe, and effective medical products to consumers, and to prevent the distribution of sub-standard or unsafe medical products.
The Participants, in accordance with their respective laws and regulations, intend to collaborate as appropriate to implement this Memorandum of Understanding to facilitate effective exchange of information, develop and strengthen cooperative efforts and initiatives, and coordinate, when appropriate and effective, with other regulators, including state and territorial entities, multilateral organizations, and other key stakeholders relevant to medical product regulation, provided that such exchange of information and cooperative efforts are to be routed through CDSCO or the USFDA, as appropriate.
The Participants intend to explore mechanisms for regular meetings and other types of engagements to develop plans for exchanging information, capacity building, and strengthening regulatory cooperation.
The activities intended to be planned and performed under this Memorandum of Understanding may include, but are not limited to, the following activities:
- Information Sharing: In support of public health and medical product safety, quality, and effectiveness, the Participants intend to share, as appropriate and permissible under applicable law, information relevant to the lack of adherence to accepted current Good Manufacturing Practices or Good Clinical Practices, as prescribed under the Participants’ respective laws, by manufacturers of medical products in one another’s country; and applicable information on regulatory science-based decision-making;
- Observed Inspections: Each Participant intends to continue to engage collaboratively as an observer in medical product facility inspections conducted by the other Participant as per specific terms to be decided and as time and resources allow on the principles of mutual applicability.
- Collaboration With Other Entities: For the purpose of collaboratively working to ensure the safety, effectiveness, security and high quality of medical products, the Participants intend to support engagements to strengthen relationships with public and private sectors, various ministries and agencies, state and local governments, industry and trade groups, universities and other educational institutions, professional societies, and other relevant stakeholders provided that these collaborations are mutually decided upon by the Participants.
- Meetings and Other Engagements: The Participants intend to collaborate in relevant regulatory, policy, and scientific meetings, symposia, seminars, and other appropriate venues that may be organized either in the United States of America or the Republic of India. Such engagements include recurring and periodic discussions to report and assess progress on current collaborations and implementation of this Memorandum of Understanding, to address concerns and resolve issues leading to strengthening and improving the bilateral relationship, and to identify new areas for collaboration.
This Memorandum of Understanding does not provide for the sharing of any proprietary or confidential business information between the Participants. In any activities under this Memorandum of Understanding, Participants should not share any non-public information, including confidential commercial, financial information, or trade secret information obtained by or provided directly to Participants from a third party, subject to applicable law.
The Participants intend for all activities carried out pursuant to this Memorandum of Understanding to be conducted in accordance with the applicable laws and regulations of the United States of America and the Republic of India, and to be subject to the availability of personnel, resources, and available funds. This Memorandum of Understanding does not create any binding obligations under international or domestic law.
- DURATION AND PROCESS
The activities under this Memorandum of Understanding may commence upon signature by both Participants and are expected to continue indefinitely until the Memorandum of Understanding is otherwise modified or discontinued. The Participants intend to evaluate the Memorandum of Understanding every five (5) years. The Memorandum of Understanding may be modified by mutual written decision of the Participants and may be discontinued by either Participant at any time. A discontinuing Participant is expected to give 60 days' advanced written notice to the other of its intent to discontinue participation in this MOU.
- POINT OF CONTACT
Each Participant intends to designate, within 30 (thirty) calendar days after the signing of this Memorandum of Understanding, a primary Point of Contact (POC) for itself, and intends for the selected POC to be responsible for: (1) facilitating routine and emergency communication between leaders and staff in organizational components of the Participants; (2) preparing proposals for collaboration to the leadership; (3) creating and managing working groups as appropriate; (4) developing and implementing any working plans, preparing agendas; and (5) recording meeting highlights as necessary and appropriate.
Signed at New Delhi on the 24th day of Feb 2020, in two originals each in the English and Hindi languages.
Ambassador of The United States of America
Secretary, Ministry of Health and Family Welfare
Government of India