As many as 49 babies have died in drug tests at one of India’s top hospitals, raising concerns that ethical standards are being compromised as the country becomes the world’s leading destination for clinical trials, The Times of London reports. The deaths occurred over 30 months at the All India Institute of Medical Sciences, an elite medical college and public hospital renowned for providing low-cost treatment to the poor.

The victims were among the 4,142 infants who were used in a total of 42 clinical trials at AIIMS since January 2006, many for Western drugmakers. Of the children used in the trials, 2,728 were aged under a year old. The mortality rate among the babies, many of whom were seriously ill before they were enrolled in clinical trials, was 1.2 per cent, significantly below the 4 per cent for all patients treated.

However, the age of those selected for testing has prompted fears that the increasingly lucrative drug-testing industry may be cutting corners because of a shortfall of staff trained in medical ethics and best practice. Manish Tiwari, a spokesperson for the Congress party, which heads India’s coalition Government, tells the Times: “The practice of using infants like guinea-pigs for drug testing must end.”

India has become the leading destination for global drugmakers to outsource clinical trials, largely because of the diverse genetic pool offered by its population and the low cost of doing business. Clinical trials are forecast to become a $2 billion-a-year industry in India by 2010. About 139 new trials were ousourced to India last year, putting it well ahead of the second-placed China, which had 98.

According to the Indian Pharmaceutical Alliance, GlaxoSmithKline and Johnson & Johnson are most active in testing new drugs in India, each conducting 22 trials over the past year. There is no suggestion that either is involved in the testing that led to the deaths, the Times writes. Documents show that Shire was named by the hospital as being among the five leading testers of drugs at AIIMS. The drugmaker, which is testing a treatment for Gaucher’s disease, said no children died in its trials.

Recent research by the Indian Government’s Planning Commission highlighted a chronic shortage of trained staff. A report found that the country is short of between 30,000 and 50,000 research personnel, including trial investigators, auditors, staff qualified to serve on ethics committees and data safety management boards, the Times reports. The country’s regulatory infrastructure is weak and the office of the Drugs Controller, which has to approve drugs trials, is understaffed.

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