India to Regulate Clinical Drug Trials by Foreign Companies

(MoneyWatch)  The Indian government is proposing new regulations to control drug trials in its country. India seeks to create a Central Drug Authority to monitor the ativities of U.S. and European drug giants who have outsourced much of their clinical testing to India, China and Africa. There are currently no rules governing drug trials in India, according to the Times of India.

The news comes after 49 children died during clinical trials at the All India Institute of Medical Sciences. The Times of India:

The Central Drug Authority (CDA) bill finalised by the health ministry will frame laws as well as tighten existing regulation on clinical trials, and introduce a central licensing mechanism for manufacturing approvals.

"The CDA will have the statutory backing to take legal action against companies which violate norms or those who conduct trials without permission. As of now, there are no penal provisions, and nothing much can be done beyond issuing them notices and warnings", sources said.

The Indian Pharmaceutical Alliance is welcoming the law because it demonstrates to the international pharma companies that India is willing to modernize its regulatory structure. But small Indian pharma companies oppose it because they think it favors big pharma:

... it will effectively end the era of affordable medicines in India if [small and medium enterprises] do not provide competitiveness.

Previous BNET coverage of foreign drug trials

NEJM: Foreign Drug Trials Could Hurt U.S. Patients