PharmaView: In India, Is Seeing Believing?

Can a whirlwind trip to India's pharma facilities prove skeptics wrong?

By Paul Thomas, Senior Editor

After witnessing an explosion in the Indian IT industry a decade ago, experts assumed that the country’s drug industry would follow a similar arc—becoming a Silicon Valley, if you will, of clinical trial research firms, contract manufacturers, and local and multinational branded manufacturers. While India’s pharmaceutical sector has done well for itself—it ranks fourth in the world in terms of output, and branded multinationals (from GSK to Pfizer) have settled in comfortably—there has not been the uninhibited stampede from abroad that might be expected towards a nation of a billion people whose workforce is educated, largely English speaking, and low-wage, and where there is low cost of market entry for foreign manufacturers.

What’s held Indian pharma back? Earlier in the decade, it was a failure to protect established patents. More recently, you’ll hear people refer to quality issues in drug manufacturing (from Ranbaxy on down), regulatory uncertainty, a lack of qualified personnel in critical skill areas, supply chain risks, and so on. And these concerns are not unfounded.

But they are concerns that can be raised about doing business in the life sciences in most places in the world, maintains Jim Worrell, CEO of Pharma Services Network (Charlotte, N.C.), a firm which assists U.S. companies in finding global outsourcing partners. What’s still nagging Indian pharma, Worrell says, is fear—not of anything specific really, just a fear of the unknown. Whether CRO’s or CMO’s, people just don’t know Indian pharma well enough, Worrell believes.

Worrell has been doing business in India for 25 years. He was one of those who worked in and witnessed the Indian IT boom and is monitoring the Indian pharma boomlet. “I keep thinking, ‘This is the year. This is the year,’” he says. “But the logjam just doesn’t seem to break.”

Worrell’s expertise is in clinical trials and understands reluctance to launch trials in India, especially among firms that do not have the resources to send advance teams to conduct due diligence. “I’ve lost several studies with small companies who simply refused to take their compound to India,” he says. “They say that if there’s any hiccup or delay, they’re toast.”

Other fears are less grounded in reality. Another potential client refused to run trials for a diabetes drug in India because the company believed that—despite medical research to the contrary—Indians metabolized sugars differently than people in other parts of the world, and the data would conflict with that gathered elsewhere.

In manufacturing, there are concerns as to whether or not Indian facilities adhere to “Western” GMP standards and can deliver quality product—on time. A lot of drug companies, especially the smaller ones, might say, “We’ve heard stories, but we don’t know if they’re true or not,” says Sam McClintock, a former Merck executive and now president of MccL Pharma Consulting (Hudson, Quebec).

Therein lies the real problem—a lack of knowledge, rather than fear. In the past, Worrell found that whenever he took clients to India to tour facilities, meet key people, and learn, they came away impressed. McClintock, who used to count himself among the India skeptics, has seen a dramatic improvements in quality in Indian pharma, especially since FDA started conducting audits there and now established offices there.

If only the India skeptics could see for themselves, say Worrell and McClintock. Sensing opportunity, Worrell’s firm recently launched Pharma Tours, guided one-week excursions that take pharmaceutical decisionmakers inside some of India’s best facilities—all FDA-audited and vetted in advance. Worrell conducts trips oriented towards clinical research, while McClintock serves as a “domain expert” who guides CMC tours of solid oral dose, API, and analytical service facilities. The pharma “tourists” walk the sites, meet with executives as well as operations, QA, and regulatory affairs personnel, and get to know the culture of the Indian pharma business.

Tours are “choreographed and well-managed,” but can be customized to a specific type of facility. Worrell and McClintock aren’t sure what shape the trips will eventually take, since there haven’t actually been any conducted as of yet. It’s a new business, whose underlying mission is not only to educate the pharma world about the Indian drug industry, circa 2010, but also to provide the opportunity for clients to network and build business relationships.

The success or failure of Pharma Tours will depend upon whether or not the business can, as Worrell says, capture the “skeptics market”—those in the industry who’ve heard horror stories, or hype, about running trials or manufacturing drugs in India, but just don’t know whether to believe them.

Editor’s Note: To learn more about Pharma Tours, visit the PSN home page at http://www.pharmaservicesnet.com/.

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