The union government's recent amendment to Schedule Y of the Drugs and Cosmetics Act has given a fillip to clinical trials by multinational drug companies operating in India, reports Nisha Das.

Pfizer, Eli Lilly, GlaxoSmithKline, Sanofi-Aventis and Roche are already doing it. Others are scrambling to get started. We are talking about clinical trials of new drugs. A number of the world's top pharma MNCs have already kick-started simultaneous and standalone clinical trials on various therapeutic segments in India. The reason? The union government's recent move to amend Schedule Y of the Drugs and Cosmetics Act, allowing MNCs to conduct simultaneous clinical trials, both overseas and in India. However, the government has not yet given permission for MNCs to conduct phase-I trials in India so far.

It isn't just big pharma that's looking in. Many new contract research organisations (CROs) have also outlined plans to tap India's large pool of patients suffering from cancer, diabetes and other maladies, for various drug indications.

Pharma gaint Pfizer has already picked a city in one of the north-eastern states of India to conduct clinical trials on 300 patients for a new malaria cocktail drug that combines chloroquine (to which several Indian malarial strains have developed resistance) and azithromycin, an antibiotic. Pfizer is also carrying out clinical trials for drugs to treat osteoporosis, breast cancer and schizophrenia. According to industry sources, Pfizer's cumulative investment on clinical research in India is believed to be $13 million.

Dr C N Potkar, Pfizer's director of clinical research told this reporter, "We have gradually increased our activity spectrum across a range of therapeutic areas. A group of about 40 clinical research professionals is engaged in conducting phase-II, III and IV studies. The volume of work done in India is gradually rising, but still insignificant when compared to the developed countries." At present, Pfizer is conducting around 20 clinical trials. It has independently conducted more than 40 good clinical practices (GCP) workshops and has trained more than 2,000 investigators and other professionals.

The company has also contributed to research infrastructure development at various institutes through clinical trials that have already been conducted. For instance, it has contributed dual energy X-ray absorptiometry (DeXA) machines — costing over $600,000 — to develop osteoporosis centres at leading hospitals in the country.

Belgium-based CRO Trainor and Partners (T&P) has decided to launch its Indian operations. Speaking to domain-b, T&P's clinical quality management consultant Susan Trainor said, "We are extremely bullish on India. We are scouting for partners to start a franchise. India is the right destination to carry out clinical trials in many therapeutic segments."

Global consultancy McKinsey & Co estimates that by 2010, global pharma majors would spend up to $1.5 billion just for drug trials in the country. A Rabobank India report says that India has the largest pool of patients in many diseases, including cancer and diabetes. The Rabo study pinpoints that India's biggest advantage is its low cost. For instance, trials for a standard drug in the US can cost up to $150 million. A similar drug could be tested in India for less than half of that amount.

According to industry sources, the pace at which drug trials are being instituted in the country is so fast that the Clinical Data Interchange Standards Consortium (CDISC), USA, a non-profit organisation committed to the development of clinical research organisations' standards the world over, is looking at setting up a chapter in India.

Eli Lilly India managing director Rajeev Gulathi said, "We were among the first pharma firms to start good clinical practices in India. With a favourable policy supporting us, our clinical trials practice in India will accelerate." Eli Lilly has over 17 large and small clinical research projects running in 40 hospitals across India. Many of them are simultaneous clinical trials. The company has already held clinical trials involving more than 600 patients for human insulin and insulin lispro. It is also conducting trials on oncology, as well as developing a new molecule for lung cancer.

GlaxoSmithKline Plc (GSK) has started seven simultaneous clinical trials of its vaccine and pharma molecules. The company has also tied up with a series of hospitals to do the trials. Speaking to domain-b, a GSK spokesperson said, "We have identified clinical trials in India as a significant area of activity. Data from Indian trials is extremely important for us." He was reluctant, however, to divulge any more details about the company's activities.

Aventis Pharma's director of medical research and regulatory affairs Dr Dhananjay Bakhle is very positive about developments. "The Schedule Y amendment will give a boost to clinical trials by pharma MNCs in India. Now, MNCs can do simultanous trials across the globe," he said. However, Dr Bakhle was reluctant to give details on what Aventis is doing in India. Company sources say that Aventis is conducting clinical trials in the cardiovascular, diabetics and oncology segments. The company is presently in the process of setting up its clinical trials infrastructure in the country.

Industry sources say Roche, the Swiss pharma major, has set up clinical trial sites in India as part of its global trials for treatment of a new drug for a particular variant of lung cancer. One of the reasons for including India is that it has a vast patient population afflicted by this type of lung cancer, which is primarily triggered by use of tobacco products. The company is also considering India as a prospective site for Roche's future clinical trials involving new drugs and therapies for treatment of different variants of blood cancer and colorectal diseases.

Putting the picture in perspective, the secretary general of the European Forum of Good Clinical Practices, Francis Crawely, explains: "Though, China, Singapore and east European countries are the principal focus areas for MNCs to conduct clinical trials, India is a favourite destination because it offers a vast variety of population, high educational standards and has a number of emerging small biotech firms."