By Deborah Borfitz
March 1, 2008 | As a place to conduct clinical trials, India has become strategic to the growth of biopharmaceutical companies and large clinical research organizations (CROs) contending for patients on a global scale. All the major industry players are doing trials here with the help of in-country partners and some of them have established an on-the-ground research presence.
“India’s participation is reducing time to complete trials and helping bring drugs to market sooner,” says Ferzaan Engineer, CEO for Quintiles India. “India is also a large and growing market for pharmaceuticals.”
Companies conducting trials here include GSK, Pfizer, Novartis, Eli Lily, Roche, and Eisai, as well as international CROs Quintiles, Covance, PPD, Parexel, Icon, Omnicare, and Clintec. A number of Indian CROs such as SIRO and iGate have also been growing in stature, according to Utkarsh Palnitkar, a leader in the policy and investment advisory services of Ernst & Young in Hyderabad. “The quantum of outsourcing to India has also seen a steady increase year on year,” he says.
Mid-size multinationals and even some smaller biopharmaceutical companies are starting to arrive, some of which are outsourcing all their clinical work. By 2011, forecasters predict that India will be conducting more than 15% of global clinical trials. “The next growth phase is likely to be even more dynamic,” says Engineer.
India currently participates in about 1% of worldwide biopharma clinical trials, involving 757 sites, according to a recent study in Nature Reviews Drug Discovery. But its average relative annual growth rate is nearly 20%. Moreover, India’s emerging economy is growing at a 9% annual clip, says Engineer, and the country has more than 1.1 billion people with both the need for, and potential to do, clinical trials. The prevalence of the English language in medicine and education doesn’t hurt either.
India’s ethnically diverse, largely treatment-naïve populace can be recruited about three times faster than in the United States. Thousands of graduates every year are “easy to integrate into Western-style business,” says Steve Powell, senior vice president of worldwide sales for Phase Forward. Investigators in India have also proven themselves capable of delivering clean data.
Over the past several years, Quintiles has sailed through all five audits of its clinical work by the FDA, says Engineer, adding that many drugs have been approved in Europe and the United States with significant data from India. “The audits suggest India is a very acceptable geography,” he says, “in line with other, more experienced geographies we routinely work in.” The number of investigative sites that can work in any given therapeutic area has also increased, he adds. “Ten years ago we had less than ten clinical sites. Now we have 1,704.”
Staffing costs, especially at the more junior levels, are economically attractive in India, adds Powell. Intellectual property protections have tightened in the past couple of years. “Industry now feels as protected in India as other countries of the world,” says Powell. There is also strong government support for turning India into a global hub for clinical trials. Infrastructural improvements have been made by both the government and private sector in terms of new campuses, highways, telecommunications, and housing.
Improvements in air transport and IT infrastructure in India have enabled Quintiles to migrate from the country’s metropolitan areas to dozens of smaller cities and towns where equally competent investigators can be found, says Engineer.
“We move investigators up the experience ladder by monitoring and mentoring them more intensely than we would in an established center,” says Engineer. This has meant investments in training, on-site study coordinators, development of standard operating procedures, and, in some cases, physical infrastructure such as study rooms and computer facilities.
Oversight of clinical trials by the Drugs Controller General of India is “pretty similar” to that of the FDA and staffing has been strengthened to deal with the growing number of applications for carrying out trials in the country. Ethical guidelines have been published by the Indian Council of Medical Research.
The overall regulatory environment may soon get a complete overhaul. A proposal before the Indian cabinet would move the current, under-financed drug authority into a single, larger organization — modeled after the FDA — that also incorporates other areas of drug development, such as bioequivalence testing, biotechnology, and genetic research. “Bigger, bolder steps” like these are needed to ensure resources keep pace with research growth in India and regulatory approvals happen in a timely fashion, says Engineer.
Schedule Y of India’s Drugs and Cosmetics Act of 1940 was amended in 2005 to make it “globally contemporary,” says Ernst & Young’s Palnitkar. “The major amendments…have been the removal of phase lag requirements, thereby enabling concurrent participation in global Phase II and Phase III trials. The requirements relating to the setting up of the ethics committee, formats for informed consent, and reporting of serious adverse events are some other significant amendments. The timelines for approval of a clinical trials application have also dramatically improved.”
On the Downside
The country still has a few disadvantages, including a shortage of potential employees with higher level skills and experience in clinical drug development, says Phase Forward’s Powell. But they quickly grasp EDC and, relative to their Western counterparts, tend be more teachable as well as grateful for the opportunity to be involved in clinical research.
Quintiles was the first international clinical research organization on the scene in 1997 and across India now employs 964 people in clinical research, much of it in data management and drug safety monitoring. Nearly half of them are stationed at a Bangalore data management center, the largest companywide. Quintiles has also established a pair of cardiac safety labs in Mumbai and Bangalore, a pharmacovigilance and drug safety monitoring unit in Bangalore, and a Quintiles Central Laboratory in Mumbai.
“In ten years, we’ve done 226 clinical trials,” says Engineer. “Across all services, we’ve been involved with more than 1,033 trials/projects.” These include 371 trials utilizing Quintiles for data management and another 436 for cardiac monitoring.
“India is one of our fastest growing geographies,” says Engineer. “We’re winning functional service provider deals in the clinical, data management, biostatistics, and pharmacovigilance areas…in which we put 200-300 people in a dedicated unit.” Four such projects are ongoing and another two have recently been awarded.
Phase Forward has just created its own Indian subsidiary, Phase Forward Software Services India, based in Hyderabad. Since 2000, Phase Forward has supported several hundred hosted clinical trials in the region. “We have worked with two major offshore partners in the region for the past five years, which currently account for a significant portion of our services resources globally,” says Powell. But with so many top pharmas outsourcing their clinical development work, coupled with the push among Indian pharmaceutical companies to become international players, Phase Forward believed “the time was right” to expand its commitment to the region.
Current partner Virtusa Corporation, a leading IT services company, will help Phase Forward incubate its subsidiary by offering infrastructure support, says Powell. The subsidiary has half a dozen India-based employees and will grow during the year. “The focus in 2008 is deployment of technologies that use our [data management] software and integration with other third-party products or in-house systems,” says Powell.
“With the rapid growth of the industry in India, at this point in time demand for trained clinicians outstrips the supply,” says Palnitkar. But a number of training institutes have emerged in the public and private sector to augment the “relatively small” number of investigators trained in Good Clinical Practice.
This article appeared in Bio-IT World Magazine.
Subscriptions are free for qualifying individuals. Apply Today.