The Jewel in the Crown?

In 2000, a group of Indian entrepreneurs and dignitaries came to London on a trade mission. They had three themes – transport, energy and biotechnology. They were well received, and gave a seminar at the CBI offices at Centre Point. The themes were presented throughout the morning and biotechnology came on stage third in a short-spell just before lunch. Rather apologetically, speakers admitted that there were small beginnings and that India’s contribution should be discussed in terms of potential rather than actual; a UK consultant even watered down the claims his clients were making about the time to growth and global impact.

In 2007, an ad hoc survey of UK companies interested in government-supported visits to India showed a complete transformation. All described India as a market that not only they, but also the movers and shakers of the pharma and biopharm industries were falling over themselves to get into. They not only saw business opportunities for themselves, but were swept along by the ambition that was erupting from within India and the enthusiasm to get established inside the market from both major global players and smaller companies. Despite pessimistic reviews by journalists between 2004 and 2006, India has had a vote of confidence about its future role in world pharmaceutical development. The criticisms and concerns are deep but possible to address, and entrepreneurial companies are finding ways of doing this – building on India’s great capabilities and natural advantages in this market.

THE CRITICISMS

Lack of strong enforcement of regulation apparently allows companies practices that would not be allowed by the FDA or EMEA. The result over the years has included: poor (adverse) outcomes for patients volunteering for trials; questionable ethical controls for trials, including the achievability of informed consent, and the quality of ethics committees and independent review boards (IRBs); poor understanding of Western regulatory culture and procedures; inadequate control from central administration (trial irregularities are discovered after mistakes have happened, not before); and in-built delays compared to the West in undertaking trials. Many CROs have not yet been subject to full Western regulatory scrutiny for approval of their contribution to development pathways. Indeed, it is still the case that the FDA will only accept a minority proportion of trials conducted in regions such as India in granting approval for drugs to proceed towards the market.