India and US sign SoI on cooperation in the field of Medical Products


The Union Minister for Health, Ghulam Nabi Azad met Margaret Hamburg, M.D., Commissioner of Food and Drugs, USA, during her recent visit to New Delhi. A Statement of Intent (SoI) on Cooperation in the Field of Medical Products was signed between the Food and Drugs Administration, USA and the Ministry of Health and Family Welfare, India.

Speaking at the occasion, Ghulam Nabi Azad said that India Pharma industry is growing at a fast pace in terms of volume. He stated that India exports medicines to about 210 countries and vaccines to about 150 countries in the world. These medicines while being affordable are as effective as drugs manufactured in the developing countries, he mentioned. He further said that being affordable should not mean that they are ‘cheap and spurious’. Efficacy of the Indian drugs should not be judged on the basis of their cost as the input cost in India is much less than that in the developing countries due to the less expensive human resources, the Health Minister stated. The Health Minister further stated that developing countries such as India who have a growing pharma industry should be allowed to grow.

The Minister highlighted that India has taken several measures to strengthen the regulatory mechanisms in terms of capacity building, strengthening laboratories and bringing enhanced transparency through its laws and legislations. He stated that stringent punishment up to life imprisonment is prescribed for those involved in manufacturing or selling of spurious drugs. Special courts have been set up for speedy trails of those involved in such crimes. Moreover, 16 out of 28 states in country have special courts for speedy trials, he said. The Indian government has also framed rules for compensation due to death in clinical trials, he said.

He said that the Statement of Intent between the two countries will go a long way in enhanced cooperation between the two countries in framing and strengthening frameworks for transparency and capacity building through seminars, workshops etc.

Margaret Hamburg, M.D., Commissioner of Food and Drugs, USA congratulated India for its success in polio eradication. She commended India’s leadership and powerful presence in the Pharma industry. She said that India is the second largest exporter of drugs to USA, and has a significant contribution in medical equipments and devices. But there is huge expectation and dependence of public on the regulator to ensure the quality of what the people consume through drugs and food, and also whether there are barriers being created to new opportunities, Hamburg stated. While she stated that quality regulation can go a long way in strengthening the robustness of the clinical industries, she also noted that India has made very serious commitment to strengthen regulatory framework to enhance transparency. India and USA need to be effective partners and work on transparency, she further added, 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, she noted. She said that the Statement of Intent will enhance the transparency in the field of medicine.

The focus of the Statement of Intent between the two countries, signed on Feb 10 is 

– Sharing of information relevant to lack of compliance with accepted current good manufacturing practices, good clinical practices, or good laboratory practices, 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.

– Engaging collaboratively as observers in medical and cosmetic product and inspections conducted by the other country 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 each other’s 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, and to identify new areas for collaboration

– Facilitating information-sharing between the two countries as appropriate and allowable by law, in support of public health and product safety, quality, and effectiveness, as appropriate

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