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Unethical practices plague clinical trials market

According to a McKinsey report, released in June this year, the clinical trials outsourcing opportunity in India is estimated to touch Rs 5,000 crore by 2010.

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MUMBAI: Free medical attention, promises of better health and medicine are luring many ailing and healthy people to volunteer for clinical trials. But medical experts believe it is the illegal monetary benefit that is attracting more people into the field.

According to a McKinsey report, released in June this year, the clinical trials outsourcing opportunity in India is estimated to touch Rs 5,000 crore by 2010. 

Talking to DNA, Dr Shoibal Mukherjee, senior director, medical and research division, Pfizer Ltd, said, “The Indian clinical trials market is growing at 60-70% and global pharma companies are eyeing the country due to large availability of volunteers and patients.”

When asked about illegal clinical trials, Dr Mukherjee said, “Pfizer conducts clinical trials only after taking permission from drug control authorities. The company has always complied with all formalities and procedures before conducting any trials.”

 “However, there are few Indian companies that carry out illegal trials by offering huge sums of money, ranging between Rs 1 lakh and Rs 1.5 lakh per week,” said a highly placed source with Pfizer.

“Companies resort to illegal trials only when the drug is patented by some other pharma company. And such companies are located in Gujarat, Maharashtra and Hyderabad,” the source added without divulging company names.

On condition of anonymity, a physician admitted that contract research organisations (CROs) even lure poor patients by offering Rs 7,000 per day. The boom in the industry is evident as the number of CROs in the country has gone up to 50 from 5 a decade ago, stated a medical expert.

Even as the market is on a growth trajectory, getting volunteers is not easy. Most pharma companies either place advertisements in newspapers or resort to the internet for responses.

Vijay Moza, chief executive officer and vice-chairman, IRL (ICRI Research Pvt Ltd), said, “We approach general physicians to get data on patients. After getting lists of patients suffering from various ailments, we approach them directly and explain all legal procedures relating to clinical trials and compensation packages that will be offered to them,” Moza added.

While the lure for money is one factor that is driving the industry, the country’s large geographic spread, varied climatic conditions and numerous ailments are making it the most sought after market for clinical trials.

Shiv Raman Dugal, chairman, ICRI Research (P) Ltd (IRL), said, “Our aim is to raise Indian clinical research standards to the international level by delivering reliable and speedy patient recruitment with high quality research data to clients.”

According to sources, Pfizer uses its Indian facility for clinical studies and has been setting aside around  $12.5 million since 1995 for the purpose. GlaxoSmithKline PLC’s is another company that is actively conducting high-end statistical data analysis for clinical trials in India

Seeing the market potential, The Indian Council of Medical Research (ICMR) has stated that it will establish a registry of all clinical trials conducted in the country.

“Drug regulators will be trained to ensure compliance with ethical guidelines and good clinical practice,” ICMR said.

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