Back to the first phase

Back to the first phase

To the dismay of many in the CRO community, the likelihood of India opening up to first-on-human trials of foreign drugs has been pushed further into the future. The enthusiasts in the global pharma fraternity looking to tap the ‘India advantage’ would have to wait longer, indefinite though, before they can get the green from the regulators here, Sriram Iyer writes

What is at stake is a fair share in an expected global market, for CROs, which amounts to $24 billion by 2010. Having said that, it should also be noted that despite a few hang ups, regulatory or otherwise, the contribution of the Indian companies to the present global market ($14 billion), has been on the rise. Given the increasing significance of Indian CROs in research activities, globally, many find the elusive regulatory approval for Phase I trials of foreign drugs, quite appalling. It would be worthwhile to mention that the present set of rules allow Phase I trials for Indian drugs and for foreign drugs that are past the said stage to the next level of trials or for those drugs for whom the pre-clinical trials were also done here.

However, at the time, it is worth noting that when these rules were enacted, they were apt for the kind of domestic market and society in place. Given the low level of public awareness and inadequate infrastructure among others, the law was meant to have a check on them, in the light of possible misuse. Though the intention is right, the laws have way overlived their existence. As Dr Jaishankar, the Managing Director of the Chennai based Quest Life Sciences, puts it, “They have stayed too long and it is time to amend them.”

Good, bad and ugly

Dr Jaishankar, Managing Director,

Quest Life Sciences

Adding to the apprehensive attitude is the lack of infrastructure. Despite the commendable growth during the last few years, the present infrastructure is not geared to meet the spate of opportunities that might come up, once the restriction is eased. The number of research centers, after the considerable increase, is still abysmally low and this is a vicious circle. The low absorbing capacity of the centers in India leads to lesser projects and since there are lesser projects coming there is less chance of growth. “The private approval centers are excellent in India. But their number is not enough,” says Jaishankar.

Allowing Phase I trials may not just add up to the number of trials in India but can also extensively benefit the industry in the country. These trials will create more opportunities for the industry to grow but there has to be a simultaneous development of infrastructure and trained manpower, the shortage of which has been increasing consistently. If this continues, chaos would set in and that would only be detrimental to burgeoning industry, preview to which is already being seen. “Young professionals, with a degree in M Sc and less than three years of experience, become trial leaders and travel across the world,” laments Dr Raman Shetty, Head—Clinical Research, Allergan. In a short time a rival CRO poaches them. Objectively, the fat pay packets and designations do not reflect their true skills. Balanced growth is extremely important to sustain it.

Added to the above, the lack of public awareness is still a prevalent issue in India. The lack of support from the media, in creating some positive awareness for clinical trials, has disappointed the stakeholders in the industry. According to Shetty, “It is only the negative aspects of trials that get highlighted.” In the absence of failure in any trial, there is no talk at all. “If people in Europe and America can take the trials, why not Indians?” asks Shetty. Dr Ramesh, Assistant Professor of surgery in Bangalore Medical College, agrees and adds, “After all somebody has to undergo these tests. Otherwise, new drugs cannot enter the market.”

However, to blame the media alone, for such widespread ignorance regarding clinical trials would not be fair. In fact, the lack of media coverage extends from the media-shy, or rather lax, attitude of the regulatory authorities. “Throughout, the Ministry of Health has not made a statement in this context. Why so?” asks Jaishankar, expressing his angst over the existing apathy within the regulatory institutions.

While ‘the lack of political will’ has been a predominant factor why the state of affairs in the industry haven’t improved to their potential, it is also true that the these separate regulatory bodies have issues that could also be a restraining factor. DCGI, for instance, has been, according to industry sources, consistently plagued by the extremely lacking manpower—both in quality and quantity. The small number of people comprising the DCGI seems even smaller considering that they are responsible for anything that is in relation to drugs in India, results of which are quite obvious. What could be detrimental is that this shortage of staff could lead to lobbying. On a more basic level, it would take awfully long time for them to process papers and thereby we lose the speed, which apparently gives us an edge over others.

The increasing role of Indian companies in global clinical trials in the last few years has been quite obvious. Yet, India still finds itself competing with other emerging markets like Eastern Europe and Brazil, most of which have allowed first-on-human trials of drugs, irrespective of their origin. The market per se in Singapore, which also figures in the list of emerging pharma economies, is not so big and yet these trials are not restricted and the market has, supposedly, gained considerably from the move.

However, cost is not just what is attracting MNCs to India. “Carrying out these trials in India need not be necessarily cheaper. The amount of monitoring needed in India is a lot more than other countries,” claims Shetty. According to him, and many others in the industry, it is the huge pool of skilled professionals and the access to more patients that work in the country’s favour. There are other feathers to add to our cap as well. “For a HIV drug, where an American company took about six months to finish a trial on 100 patients, we have seen earlier that an Indian company was able to do it in just about a month,” says Jaishankar. This number of affected patients is not to be found easily in other advanced economies, making India among the most preferred destinations for such trials.

What is the answer?

There is no quick and snappy answer to the issue. “To open up suddenly is not the best thing to do. It will lead to widespread exploitation,” says Shetty. It is a fact that the country is still not completely prepared to face the challenges that would entail, once the trials are allowed. Strict guidelines have to be set up, so that patients are given full information and freedom, and establish mechanisms to ensure that these guidelines are followed. “Before allowing these trials, we have to be sure what sort of standards are to be adopted. We are willing to help the government in framing these standards. They should be in line with the global standards,” said Shetty, emphasising on the need of the hour. He also said that many more multinational corporates have been showing keen interest in effecting the necessary changes.

The Schedule Y is indeed a stride forward and according to Shetty, it has managed to define and demarcate clearly; which was absent earlier. But the Schedule’s accomplishments are limited to that. There have been reports in the media of several recommendations made to the ministry and now, after years none of them have been implemented, in any form. At some point all stakeholders have to get their act together, replacing the individual and unorganised efforts—the sooner the better.