Ministry of Health and US FDA agree to collaborate

The US Food and Drugs Administration (FDA) and the Ministry of Health and Family Welfare, Government of India, have signed a Statement of Intent on cooperation in the field of medical products. Ghulam Nabi Azad, Union Minister for Health, said that the Statement of Intent between the two countries will go a long way in enhancing cooperation between the two countries in framing and strengthening frameworks for transparency and capacity building through seminars, workshops etc.
 
Margaret Hamburg, Commissioner, US FDA, said, “India and USA need to be effective partners and work on transparency, as there are common goals and aspirations and both are world leaders in the field of medicines. There should be common set of standards so that people have quality, safe and efficacious drugs. The Statement of Intent (SoI) will enhance the transparency in the field of medicine.”
 
The SoI focusses on sharing of information relevant to lack of compliance with accepted current good manufacturing practices (GMP), good clinical practices (GCP), or good laboratory practices (GLP), as appropriate, by manufactures and sponsors of medical products and manufacturers of cosmetics, in one another’s country, or any other information as mutually decided upon.
 
It also emphasises on the need to inform the respective regulatory authorities before undertaking inspections, so that host-country inspectors may join inspections as observers.