STATEMENT OF INTENT 


BETWEEN 


THE FOOD AND DRUG ADMINISTRATION OF 


THE UNITED STATES OF AMERICA 


AND 


THE MINISTRY OF HEALTH AND FAM ILY WELFARE OF 


THE REPUBLIC OF INDIA 


ON CO-OPERATION IN THE FIELD OF M EDICAL PRODUCTS 


The United States Food and Drug Administration (FDA) and t he Ministry 

of Health and Family We lfare (MoH&FW) of the Republic of India, 

hereinafter collectively referred to as the "Participants/' and individually 

referred to as "Participant". 

• 	 Acknowledging that the Participants seek to strengthen bilateral 

cooperation in the area of regulatory systems for medical products, 

to promote and protect public health; 

• 	 Acknowledging that the safety, effectiveness, manufacturing 

quality, and/or security of human and veterinary medicines, human 

vaccines and other biologica l products, cosmetics, and medical 

devices including diagnostic devices are responsibilities common to 

national regu latory authorities; 

• 	 Understanding that there is a need in the interest of public hea lth 

to establish dynamic and effective collaboration to strengthen and 

achieve convergence in regu lations in keeping with international 

standards; 

• 	 Acknowledging the importance of safe medical products, to saving 

lives, restoring health, treating and preventing diseases; 

• 	 Recognizing the growing public health interest in raising public 

awa reness of, and in the dissemination of accurate, science-based 

information about, medical products manufacturing quality, 

effectiveness, safety and security; 
• 	 Acknowledging the importance of long-term global collaborations 

to help ensu re timely ,and secure availability of quality, safe, and 

effective medical products t o consumers, and to prevent the 

distribution of substandard or unsafe medical products and unsafe 

cosmetics; 

• 	 Sharing the common objectives of improving the safety, 

effectiveness and manufacturing quality of medical products, in the 

United States of America and the Republic of India; 

• 	 Sharing the common belief that a knowledge of clinical safety and 

effectiveness of medical products is best determined through well ­

designed, scientifically robust, ethically-conducted clinical trials, and 

acknowledging the need to have in place systems to assure the 

appropriate oversight of human clinical trials: 

• 	 Recognizing the need to effectively address the challenges of the 

quality, safety, effectiveness and security, as appropriate, of 

medical products and cosmetics in a sustainable manner, and to 

work together towards achieving these goals; 

• 	 Acknowledging that both countries, within the ir respective national 

circumstances, capacities and laws, can work together t o promote 

effective and sustained outcomes to strengthen public health 

through appropriate regulatory efforts as well as effectiveness and 

transparency; 

Hereby express the following intentions. 

1. Within the framework of this Statement of Intent and taking into 

account the limitations of existing human and financia l resources and 

within the parameters of domestic legal and administrative 

requirements the Participants expect to cooperate in the following 

areas: 

• 	 Sharing of information relevant to lack of comp liance with accepted 

current Good Manufacturing Practice, Good Clinical Practice, or 

Good Laborato ry Practice, as appropriate, by manufactures and 

sponsors of medical product s and manufacturers of cosmetics, in 

one another's country, or any other information as mutually 

decided upon. 
• 	 Engaging collaboratively as observers in medical and cosmetic 

product and inspections conducted by the other Participant as per 

specific terms to be agreed and as time and resources allow. 

• 	 Informing the respective regulatory authorities before undertaking 

inspections, so that host-country inspectors may join inspections as 

observers. 

• 	 Collaborating in relevant scientific meetings, symposia, seminars, 

and other appropriate venues that may be organized either in the 

United States of America or the Republic of India. 

• 	 Facilitating Participants' holding (in persons or by teleconference) 

periodic discussions, possibly once every three (3) months, to 

report and assess progress on current collaborations and 

implementation of this Statement of Intent, to address concerns 

and resolve issues leading to strengthening and improving the 

bilateral relationship, a1nd to identify new areas for collaboration . 

• 	 Facilitating information-sharing between Participants as 

appropriate and allowable by law, in support of public health and 

product safety, quality, and effectiveness, as appropriate. 

2. Each Participant intends to designate, within 60 (sixty) calendar days 

after the signing of this Statement of Intent, a primary Point of Contact 

(POC) for the Participant who will be responsible for facilitating routine 

and emergency communication. 

3. Each Participant is expected to bear all of its respective costs for 

activities under this Statement of Intent, unless the Participants decide 

otherwise; in such instances, the Participants intend to prepare a 

document that sets forth financial and technical responsibilities of each 

Participant. When alternative funding mechanisms have been decided 

upon, the Participants intend that the specific activities are to 

commence only after said document is approved by the Participants. 

4. Thi s Statement of Intent does not create rights or obligations. 
5. Cooperation under this Statement of Intent will commence on the date of 

its signature by both Participants and will continue for a period of five (5) years. 

This St atement of Intent may be modified at any time by mutual written 

consent of the Participants. Either Participant may terminate this Statement of 

Intent through written notice of not less than ninety (90) days to the other 

Participant. The Participants may also extend this Statement of Intent by 

excha nge of letters for a further period of five (5) years. 

Signed at New Delhi, on this lOth day of February 2014, in two originals in the 

English language. 

ON BEHALF OF ON BEHALF OF 

THE UNITED STATES MINISTRY OF HEALTH & FAMILY 

Name: Hambu;gf'D ­

---/s/---

WELFARE OF THE REPUBLIC OF INDIA 

Name: Keshav Desiraju 

---/s/---

Designation: Designation : 

COMMISSIONER SECRETARY 

FOOD AND DRUG ADMINISTRATIION DEPARTMENT OF HEALTH & FAMILY 

WELFARE 

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