Chennai: India is seeing a decline in the number of human clinical trials because of time-consuming government approvals and rising allegations of unethical tests further hindering possibilities of gathering a large sample size of people.

Out of 118,804 human trials in 178 countries, less than 2,000, or 2%, are being done in India compared to 9,352, or 8%, in neighbouring China, according to the US government’s www.clinicaltrials.gov web site.

Photo: Bloomberg

“There is a tremendous amount of concern about the drop in clinical trials and an urgent need to increase the number," M.D. Nair, a Chennai-based healthcare consultant, said at a conference addressing clinical trial issues in the Tamil Nadu capital on Friday.

The nation’s clinical trial market is valued at more than $300 million (Rs1,400 crore) with a compounded annual growth rate of 30%, according to a 2009 report by consultancy Ernst and Young (E&Y) and industry lobby group Federation of Indian Chambers of Commerce and Industry (Ficci).

The main reason for this optimism was the low cost of these activities in India that are typically 40-60% lower than in developed countries and around 10-20% lower than in other emerging economies, the E&Y and Ficci report said.

While India was seen among the fastest growing clinical research destinations in the world, human drug trials haven’t been monitored closely leading to several unethical practices, forcing the Indian government to strengthen regulations in this area. It can take drug makers several months in India to get a nod for conducting clinical trials.

Top pharmaceutical companies conducting trials in the country are Pfizer, Glaxo SmithKline, Aventis, Novartis, Novo Nordisk, Astra Zenica, Eli Lilly, Dr Reddys, Nicholas Piramal, Cipla and Lupin, according to Assocham.

Such trials have been conducted in areas such as oncology, endocrinology, traumatology, sports medicine, pulmonary diseases, paediatric diseases and infectious diseases.

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