Health Policy

India’s Drug Regulatory Authority to be based on US FDA Model

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At a round table session organised by the Confederation of Indian Industry (CII) on `Indo-US life Science, Health and Public Health Collaborations,’ Ramadoss said the government was having a re-look at the drug policy in the country and was working towards establishing quality standards. As a first step towards the initiative, India would set up two working groups — one comprising bureaucrats and the other a technical group of scientists — in six months’ time to identify key areas of concern in the food and drug industry in the country. “We have already started the process of enacting the law but it would take at least three years for such an authority to be set up. Our long term goal is to see to that any drug approved in India should directly be approved by the US FDA,” Ramadoss said.  The discussions had been arranged in Chennai, capital of the southern state of Tamil Nadu, to coincide with the visit of US Secretary of state for Health Michael O Leavitt. Participating in the discussions, Leavitt noted that his country was spending two trillion dollars per year on imports and had been debating on quality of imported goods for several months. “It’s becoming quite important to American consumers that goods they receive from other countries are safe, healthy and effective.” he stressed. Nations owed it to their citizens to assure them that the products produced within the country were safe first. Then the same reassurance had to go globally. It was important to anticipate problem areas and address them accordingly. In such a context, Levitt said the US was proposing a networking among nations to evolve a regulatory system that would be acceptable to all. He also noted, “Our countries enjoy a fruitful, deep and abundant relationship. We have to work together to make it even stronger. The relationship between India and the US is a powerful force not just between our countries, but in the global market.” Pratap C Reddy, chairman of the CII’s National Helath Care Committee, felt India’s talent pool of doctors, nurses and paramedics could help stem the rising healthcare costs in the US. Reddy also called for a common approach to issues like clinical trials, research and outsourcing, increased US investment in India to augment its capacity in healthcare and mutual recognition of medical degrees.

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