U.S., India sign cooperation statement
According to the Press Information Bureau of the Indian government, the FDA and India’s Ministry of Health and Family Welfare have signed a Statement of Intent on Cooperation in the Field of Medical Products.
The signing followed a meeting between FDA Commissioner Margaret Hamburg, M.D., and the Union Minister for Health, Shri Ghulam Nabi Azad.
Azad said the India pharmaceutical industry is growing at a fast pace in terms of volume, and that India exports medicines to about 210 countries and vaccines to about 150 countries. These medicines, while being affordable, are as effective as drugs manufactured in developing countries. He said being affordable should not mean they are “cheap and spurious.” Efficacy of Indian drugs should not be judged on the basis of their cost, as the input cost in India is much less than that in developing countries due to less expensive human resources. The Health Minister said developing countries such as India, which have a growing pharmaceutical industry, should be allowed to grow.
The Minister highlighted several measures India has taken to strengthen its regulatory mechanisms, including capacity building, strengthening laboratories and bringing enhanced transparency through its laws and legislations. Azad said stringent punishment up to life imprisonment is prescribed for those involved in the manufacturing or selling of spurious drugs. Special courts have been set up for speedy trials of those involved in such crimes. Moreover, 16 out of 28 states in India have special courts for speedy trials. The Indian government also has framed rules for compensation due to death during clinical trials.
The Health Minister said the Statement of Intent will go a long way to enhance cooperation between the two countries in framing and strengthening frameworks for transparency and capacity building through seminars and workshops.
Hamburg said India is the second largest exporter of drugs to the U.S. and has a significant contribution in medical equipments and devices. But there is huge expectation and dependence from the public on the FDA to ensure the quality of what people consume through drugs and food.
While Hamburg said quality regulation can go a long way in strengthening the robustness of the clinical industry, she also noted India has made very serious commitments to strengthen regulatory framework to enhance transparency. India and the U.S. need to be effective partners and work on transparency, said Hamburg, as there are common goals and aspirations and both are world leaders in the field of medicines. There should be a common set of standards so that people have quality, safe and efficacious drugs. She said the Statement of Intent will enhance transparency.
The focus of the Statement of Intent between the two countries 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 U.S. or the Republic of India.
- Facilitating each other’s holding (in persons or by teleconference) periodic discussions, possibly once every three 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.