Indigenus

Here's the truth about clinical trial volunteers in India -- the number of registered volunteers has seen a steady rise ever since the Clinical Trials Registry (CTRI) was set up at the National Institute of Medical Statistics of the Indian Council of Medical Research (ICMR) in July 2007. Just to get a hang of how India has embraced clinical trials, despite the criticism of weak 'evidence-based' studies and lack of experienced clinical research professionals, the number of hits on the CTRI site crossed the 24,000 mark in April 2009 with more than 600 users registered.

CTRI also reports a rise in registered trials from 148 in December 2008 to 235 in April 2009. As of now, about 100 trials are pending with registrants for modifications/clarifications, while 50 trials are awaiting approvals from the Drug Control General of India. Biomedical journals in India have also shown their faith in the registry pledging to publish papers of clinical trials only if they are registered.

The move to create the registry for India and a few neighbouring countries who don't have their own registries was to "re-establish public trust in clinical trial data" following unethical practices adopted by the pharmaceutical companies for monetary gains.

Looks like the much needed regulatory push to clinical trials in India is finally in place. Have all the ethical questions surrounding good clinical practice (GCP) compliance been answered?

Posted by Subhra Priyadarshini on September 07, 2009
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There's no reason to panic, the health authorities in India tell us. The official figure of confirmed swine flu cases in the country has risen from five to 15 in a week. Swab reports of five suspected cases are awaited. But such isolated cases don't indicate anything and there isn't much to be alarmed as long as case clusters are not reported.

Health ministry officials pacify our nerves saying we are in the 'containment stage' or lower level of spread of the virus.

Meanwhile, what is bothering public health administrators is the illegal sale and purchase of Tamiflu as an over-the-counter drug in some metro cities. The drug, given free to infected patients at the designated swine flue treatment centres, is being black marketed freely at exorbitant prices. This, more than being an offence, also means people taking the drug out of panic might develop drug resistance to the fast mutating influenza bug. The World Health Organisation has cautioned again self-medication as if might only worsen the situation.

For a guide to swine flu, click here. For India helplines, dial 1075 or 011-23921401.

Posted by Subhra Priyadarshini on June 12, 2009
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A group of health workers (picture above), clutching certificates of specialised HIV care training, emerged from the first convocation of HIV medics in New Delhi today (June 8, 2009). The young medics aim to do their bit in addressing the acute shortage of trained healthcare workers in a country currently housing over 2.4 million people living with HIV and AIDS (UNAIDS global report, 2008).

They underwent a three-month orientation into HIV/AIDS care giving jointly organised by the AIDS Healthcare Foundation, the largest provider of specialised HIV medical care in the US, and the Indira Gandhi National Open University (IGNOU). The paraprofessionals will now assist clinicians in providing antiretroviral therapy (ART) to patients. Additionally, they will provide initial patient screenings, complete patient histories and refer patients to physicians for physical exams and initiation of ART.

The special care givers will draw blood, dispense medications and provide medication adherence counselling and HIV testing. This would eventually free up physicians, nurses and other healthcare professionals for more complex tasks and enable them to see more patients.

The idea is to contribute to the overall goal of increasing the number of people receiving ART and improving the quality of care.

The HIV Medic training has been designed for students who have passed high school with no prior medical training or experience. The training programme has 6 weeks of class-room learning and 6 weeks of hands-on experience. They get a basic grounding in anatomy & physiology, common diseases in various organ systems, sexually transmitted infections and opportunistic infections of HIV, TB, the natural history and life cycle of HIV, mechanisms of anti-retroviral drugs, side effects or toxicity, HIV in pregnancy, paediatrics, counseling, adherence and social and ethical aspects of HIVAIDS.

AHF has had success with similar programmes in Uganda, Zambia and Rwanda, training local youth as healthcare workers in the fight against HIV/AIDS. It’s a good start in India with 30 energetic youths every year. Hope AHF can replicate its success here.

More info here.

Posted by Subhra Priyadarshini on June 08, 2009
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The debate on whether India should be allowed to become the 'clinical trials hub' of the world is slowly losing fire. When multinational companies zeroed-in on India about a decade back, critics called it their ploy to get "human guinea pigs" in India. Undoubtedly, India's disease burden in cancer, diabetes and tuberculosis -- far more than most countries -- was the prime attraction. Add to that the huge population, cheaper operational costs, easy patient procurement, English speaking physicians and IPR preparedness -- the perfect setting.

The country's clinical trials market in 2006 was US$ 140m and is growing at a compounded annual rate of 40%. It is estimated to touch US$ 600m by 2010.

What's your take on the clinical trials scenario in the country? Do you think India has overcome the initial setback of lack of experienced investigators and clinical research professionals? Is there better awareness of good clinical practice (GCP) compliance? Are ethics always in place?

Posted by Subhra Priyadarshini on May 21, 2008
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