US seeks common safety standards for health products

By IANS

Chennai : India and the US Monday began a major collaborative effort to ensure a common food and drug regulatory regime – on the lines of the US Food and Drug Administration (USFDA) – that will enable the US and the international community to accept India’s healthcare standards.


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Visiting US Secretary for Health and Human Services Michael O. Leavitt emphasised here that his country’s focus in the coming years would be on ensuring “import safety”, and urged partner nations like India to collaborate on guarantees that all exports related to health and healthcare would meet international standards.

“There is a need for India and the US to come together to form a network of a global alliance to ensure the quality and integrity of imported food and consumer products, from the healthcare perspective,” Leavitt said.

“Though countries like the USA currently have good regulatory system to deal with products imported from across the world, the systems would not be adequate to cope with the future challenges in terms of health risks,” he added.

The health secretary is on his first visit to India. He said raising the issue of “import safety” did not mean that the US has no confidence in Indian products. The US wants to emphasise that India should “maintain the integrity of the ‘Made in India’ brand”, especially in all products that affect public health.

The cautionary note from the US official came in the wake of recent rows over several products including toys and toothpaste imported by the US from China.

“Our concerns on import safety is not because of one country or about just imports into USA. The idea of collaborating with India is to link different systems for achieving a common goal, good health of the people of our two countries”, he said.

Health Minister Anbumani Ramadoss, playing host to the American delegation which includes Andrew Von Eschenbach, commissioner of the USFDA, promised that in the next three years, India will have in place two important pieces of legislation.

The Clinical Establishments Act will regulate and provide a mandatory licensing standard for all Indian clinics, labs and hospitals and the “Indian Public Health Standard”, Ramadoss said.

Conceding to international demand for greater quality from Indian hospitals, pharma companies and healthcare product manufacturers, Ramadoss said by the year-end, India’s own Central Drug Authority, being established on the lines of the USFDA, with technical collaboration of a number of American institutions, will be cleared by parliament.

The Healthcare Working Group will have two divisions, one made up of bureaucrats to take care of the legal and other issues and will be headed on the Indian side by the secretary, health and family welfare.

The second division will be technical, to have on it N.K. Ganguly, former director general of the Indian Council of Medical Research (ICMR), R.A. Mashelkar and Drug Controller of India M. Venkateswarulu.

“The working group will in six months identify areas of concern and commonality” with the USFDA and the US healthcare system, Ramadoss said.

Then within a recommended time frame, the Indian Central Drug Authority will be set up. It will have ten departments, looking into different aspects like research and trials, products, implements manufacturing standards, licensing etc.

“Standard is an issue in India as well. We want that citizens living in India get medicines and health products of the same standard that people in the USA and other developed countries get.”

Leavitt is on a six-day tour of India that will also include visits to Kochi and Hyderabad.

In Chennai, he visited the country’s pioneering HIV care centre at the government hospital in Tambaram, where the second line of ART drug is being rolled out and opened the “Celebrating Life or C-Life” programme, to be used as a tool to orient the young entrants to the HIV initiative at the Red Ribbon Club of the prestigious Loyola College in the city.

Leavitt said the initiative was a “path-breaking endeavour that will have a positive impact on young people’s ability to cope with the pangs of growing up and discover the untapped potential in each of them.”

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