MNCs flock to India for clinical trials

Says Pfizer India’s vice-president (clinical research) Dr Richa Chandra: "Faster patient enrollment would help reduce the time lag to take the drug into the market. With 8-10 years going into clinical research, if this time can be crunched by even a year or so, it’s definitely an advantage".

Quick patient enrollment is a direct function of India’s huge population and the prevalence of a wide spectrum of disease conditions (and even endemic zones). Says Novartis India’s official spokesperson: "The growing competition in Europe and the US for rapid inclusion of adequate number of patients has actually led to a shortage of available patients. But India has a large population of patients with a variety of conditions".

Other intangibles that give India an edge as a preferred destination for clinical trials include availability of top-notch medical professionals with an international exposure (India has the second largest pool of qualified doctors, second only to the US and, even in the US, one in every six medical doctors is believed to be an Indian); high levels of computer efficiency and well-equipped hospitals and laboratories. Fluency in English is perceived as another added advantage, according to Novartis.

Add to this the cost advantage, and clinical trials in India would also make big business sense. Glaxo India says that the cost of clinical trials in India could be half or even lower when compared with that prevailing in the west, depending on the nature of the product/disease.

Says Novartis: "A major cost in trials is investigations — blood tests, cardiograms, CT scans etc. These tests are cheaper in India when compared with costs in the US or Europe. However, there is no hard core comparative data available to make a sweeping statement that Indian trials are less expensive".

But the fast growing Nicholas Piramal, among the few Indian companies doing clinical trials on new molecules, has hard facts (and figures too) to support the India advantage claim. The group’s chief scientific officer, Dr Swati Piramal, says that in the case of a drug for visceral leishmaniasis, a disease more prevalent in the tropics, the company managed to reduce costs by a quarter. "Nicholas Piramal did trials in four north Indian states as per US FDA standards (monitored by Quintiles). We managed to reduce costs by a fourth," she said.

Nicholas Piramal is also doing phase 3 trials for IM 862, a potential treatment for breast cancer, concurrently in India, the Harvard University and University of California.

But Pfizer’s Chandra feels that the cost differential would, in the long run, narrow down as India moves up the "D" ladder (currently most trials undertaken are in phases 3 or 4).

There are three distinct phases in clinical trials. Phase 1 trials focus on the safety, rather than the effectiveness of a new compound and are usually done in a small group of healthy volunteers under close medical supervision. Phase 2, which lasts on an average for around two years, focuses on the compound’s effectiveness against the illness it has been designed to treat. It covers around 100-300 carefully selected patients. Phase 3 trials represent the final stage of human clinical trials and researchers try to confirm the results of earlier tests in a large, worldwide patient population. This phase, which could last for up to five years, can involve up to 10,000 patients. Phase 1V trials are essentially used as a post marketing surveillance tool and are not usually mandatory except in the case of new molecules.

But the "tried in India" label has another tag that researchers are trying hard to shrug off — poor quality. Says Dr Piramal, "For long Indian data has not been perceived as good quality stuff due to inadequate training".

Adds Novartis, "The main reason for non-acceptance of Indian data overseas has been the poor quality of data records and the resulting non-compliance with International Good Clinical Practices (GCP) guidelines. However, with the increasing number of trials, both companies and medical investigators have realised the need for high quality data. For drugs used for tropical conditions like malaria, the European authorities have begun accepting Indian data". The Swiss multinational has, in fact, completed trials on a new drug for malaria, now part of the International Registration dossier. Novartis also has an ongoing trial for a potential treatment for breast cancer.

However, a big beginning to improve the image of the Indian label has probably already been made at Pfizer India’s Jogeshwari headquarters in suburban Mumbai. Dr Chandra points out that Pfizer’s clinical data management team has been able to achieve a zero error rate for about 50 per cent of its submissions, a record of sorts in the entire Pfizer group. This improves even the standards maintained by the American multinational back home (which itself is very low at 0.01). "This achievement has really turned our reputation around," Chandra adds.

The American multinational is currently working on trials for a range of new drugs in the areas of infectious diseases, malaria, cancer and psychiatry (for those cases that do not respond to existing therapy). The American giant earlier discontinued international trials for a potential new anti-cancer drug, when an interim analysis suggested that the benefits of the drug were not statistically significant.