Glaxo Plc, under fire for large-scale global clinical trials of a diabetes drug that is said to spawn heart risks, is looking to shift the trials to countries like India, Pakistan and China.

“The Drugs Controller General of India (DCGI) has given them permission to conduct the trials in India,” said Chandra M Gulhati, editor of Monthly Index of Medical Specialties (MIMS), a journal on drugs available for prescription in India.

Efforts to contact the DCGI, Surinder Singh, were unsuccessful.

Gulati said Glaxo has started recruiting patients in India, Pakistan, China owing to the difficulty in getting subjects in the west.

“Two potential sites for the trial in the US have already withdrawn citing, difficulty in finding patients. Hence they are coming to India,” Gulati said.

A Glaxo spokesperson told DNA Money institutional review boards and ethics committees around the world have approved the study, and patient safety is monitored by an independent data monitoring committee, which includes international experts in heart diseases, diabetes, and statistics.

Glaxo has added 53 new testing sites for the medicine since March this year.

Of these, 10 are in India -Bangalore, Kochi, Karnal, Mumbai, Nashik, Pune, Kottayam and Vijayawada.

The company is conducting trials to assess the cardiac safety of diabetes medicine rosiglitazone compared with another of its products, pioglitazone.

The trials, codenamed TIDE, are being conducted on 16,000 people in 14 countries.

“This is unethical as the aim of the trials is to prove which of the two drugs is more dangerous,” said a healthcare expert, not wishing to be named.

The US Food and Drug Administration is also assessing the situation.

Ruth Macklin of the department of epidemiology & population health, Albert Einstein College of Medicine, New York, said the Glaxo trials violate principles in research ethics.

Read More....