Regulators round the world have become increasingly concerned about pharmacovigilance, the post-marketing surveillance of a drug for its entire life. Quintiles is offering this service to customers across the globe. About 500 of Quintiles’s staff in India are engaged in this work; global staff in the same operation are also led from India. Work in India has grown in the last four-five years.
Traditionally, sponsors have wanted to keep this strategic operation mandated by regulators close to their chest. As the time taken to report an event to the regulator is critical, outsourcing has stepped in to take care of speed, compliance and quality. “The end-game of pharmacovigilance is signal detection,” says Mir Imran Ali, head of phamacovigilance at Quintiles. Is there a trend of a development among a significant number of patients taking a drug? If this is so, then “it can result in updating of indication in labelling and package insert.”
The journey Quintiles has travelled in India mirrors that of some of the country’s top software companies. “We see the emergence of a post-BPO narrative,” from data outsourcing to data management, and “closer integration to the clinical process,” says Anil Raghavan, managing director, Quintiles India. Players with such integration between clinical work and data are going to dominate the post-BPO scene, and those with centralised process delivery and technology capabilities that go with it are going to benefit.
“China is key in bringing the cost of manufacturing down. India is key in bringing the cost of integrated services down. The processing capability of India and our (Quintiles’s) ability to integrate that with technology will be core to our competitive differentiation for many years,” Raghavan adds.
Another exciting area for the future of Quintiles in India, or out of India, revolves round cardiac safety. If ECGs are being screened in India, then there can be more to do with other bio-markets in the future. Plus, the scenario in the domestic Indian market, rudimentary till 2009-10, is looking up. Indian drug companies, which arrived on the globe by delivering generic molecules from conventional chemistry, are now trying to get into a similar space in biotechnology, by trying to develop bio-similars. The burden of evidence for bio-similar manufacturing is significantly greater. “Domestic customers know they have the enterprise. But to take these bio-similars to market, they need help from a large player who has been there and done that in biotechnology and bio-similars,” explains Raghavan.
He says Quintiles has been growing in India at 20-30 per cent. “We clearly see that kind of growth continuing, especially as the confluence of technology, process play and ability to process bio-markers takes place. That becomes the indicative back-end for new health, especially as it is dynamic,” he adds.
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But there is a dark lining to this silver cloud. The Indian regulatory system and clinical research have been mauled over the past two to three years. Poor regulation has led to abuses being exposed by activists. This has created regulatory uncertainty and delay in approvals of trials. So much so Indian drug companies are seeking to shift clinical trials to costlier geographies. This is not good for clinical research in India, once seen as a promising area. Not only does drug discovery go in step with clinical research, “medicines do not generally work across populations. We need to understand what works for us. We are taking medicines to the domestic market with potentially insufficient data on its impact on us,” he warns.
Quintiles was one of the firms which paid compensation to the relatives of 22 who died in clinical trials during 2010. Of the deaths in 2011, 32, the second highest were from Quintiles trials. A report in The Independent of the UK referred to a trial sponsored by Theravance, run by Quintiles, during which three patients died and two soon after. It has not been ascertained if the deaths occurred due to participation in the trial, and the high figure in the case of Quintiles could be due to the large number of studies undertaken by it.
On the current uncertainties and debate, Raghavan says, “If we are going to have this fluidity in terms of an effective framework, it is going to impact us. Research as a whole is seen as dubious and that will have an impact on the doctors’ willingness to experiment.” The clinical side of business has been affected by the recent controversies, specially approval timelines (there are some recent signs of improvement) and lack of clarity round compensation policy. On the issue of ‘informed consent’, at the heart of the current controversies (illiterate patients being misguided by doctors), Raghavan asserts there has to be a penal system to address malpractice.
As for internal lessons, he says, “We need to be extremely careful in selecting sites.” The quality of internal practices, the intent of the practicing physician, the support system in terms of ethics committees and the quality of staff are important issues. “So, our qualification process has become a lot more stringent now.” Data can also be used to help exercise vigilance. For example, if a site has a very high rate of success in screening patients for trials, a warning bell should ring.
The last of the two-part series on clinical research