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AP health ministry gets NHRC notice for not submitting report on illegal clinical trials

A Raju, HyderabadThursday, March 22, 2012, 08:00 Hrs  [IST]

The National Human Rights Commission (NHRC) has issued a notice to health ministry of Andhra Pradesh government for not submitting the reports regarding unauthorized clinical drug trials in the state.

Annoyed with the lackadaisical attitude of the officials the commission has asked the health ministry and state officials to respond within six weeks or face action under law.

The commission had sent notices to Union Health secretary, secretary of Indian Council of Medical Research (ICMR), Drug Controller General of India (DCGI) and Andhra Pradesh chief secretary last year asking them to file reports with regard to unauthorized drugs trials on six tribal women in Warangal and Guntur districts of the state.

Last year during the month of June about 36 innocent women in Guntur district were subjected to clinical trials apparently for breast cancer. Among the 36 subjects who underwent the trial, 6 were hospitalized after they complained of side-effects like severe headache, fever, pain in the chest and nausea.

The innocent women were lured by local agents and were hired for the clinical trials without knowing the consequences. The women were never informed about the medicines they were administered with.

After the incident came to light the police had registered cases against the pharmaceutical companies and hospitals involved in the research, but could not proceed further citing the reason that the women had volunteered themselves to take part in the trials.

In a similar case, about 10 tribal women were also subjected to clinical trial by some unknown pharma company in a village in Warangal district. Among them 3 women severely fell ill and were hospitalized. Later the district Medical Health officials conducted test on all people in the village to ascertain the number of participants and took precautions before any untoward event happened.

Over the past few years, there were many incidents of secret clinical trails that came to light in the state. Most of the pharma companies are choosing innocent, illiterate and poor people for conducting the trials in the state. In fact, Andhra Pradesh leads clinical trials in the country with a number of pharma companies and hospitals involved in research.

Usually the companies who intent to conduct trials should be registered with clinical trials Registry of India, but many carry out clinical research without proper approval from the CTRI fearing legal implications.

 
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