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      Testing Times

      Posted AtThe Times of India

      Now that the government has announced it will make it mandatory to register clinical trials, India should be more open to an industry that can, by 2010, become as important as the BPO and information technology sectors. Yet fears about rogue clinical trials are justified.

      Although the Streptokinnese case (eight deaths in experiments without subjects' consent) is well remembered, it's not the only instance of malpractice. In 2003, over 400 women were administered Letrozole to study if it induced ovulation, without their consent or knowledge.

      Considering that such activities were deemed crimes against humanity by the international tribunal in Nuremberg in 1947, public outrage in India is understandable.

      But the drug controller-general of India has announced a transparent registry and safeguards system similar to those in the US and UK, so it's time to snap out of victim mode. Big companies like Novo Nordisk, Aventis, Novartis, GlaxoSmithKline, Eli Lilly and Pfizer have been testing drugs here, and not all chose India for its lax regulatory system.

      India has a huge multiracial, multi-ethnic gene pool, and a high incidence of cancer, diabetes, cardiovascular diseases, epilepsy, Alzheimer's and so on. Also, India provides cheap labour and low running costs: There are 14,000 hospitals with 7,00,000 beds, over half a million practising doctors, and 200 recognised colleges graduating over 17,000 doctors each year. By conducting trials in India, overseas drug companies can slash R&D costs by 30 per cent to 50 per cent. So, clinical testing can turn into the BPO story all over again. To get there we need vigilant and scrupulous regulatory bodies and mechanisms in place.

      Indeed, the Confederation of Indian Industry (CII) reckons revenues from this sector could touch $5 billion by 2010. It makes sense to make all trial data public because of the inter-national attention and scrutiny.

      The pharmaceutical industry earns two-thirds of its profits in the US, and according to a Harris poll, Americans were repelled by recent reports of unethical practices.

      Moreover, the US FDA does not accept unethically obtained clinical data. If procedures used in India were to be made public, pharma companies would be too concerned about possible international bad press and lawsuits to try corrupt practices here

      October 24, 2005


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