Introducing a guest column by Dr S M Sapatnekar who has remained a member of the National Advisory Committee for Bioethics Education in India and is Medical Director of Mumbai-based clinical research organisation Karmic Life Sciences. Views expressed are personal.
In recent months, clinical trials conducted in India have been in the news for all the wrong reasons. Here are five reasons why they may continue to be.
POLICY DEFICIT
India’s Eleventh Five Year Plan (2007-12) had identified clinical research as a priority. In 2006, the Planning Commission’s Working Group on Health Systems Research, Biomedical Research and Development and Regulation of Drugs and Therapeutics in 2006 recommended that “a new initiative in clinical research should be developed in partnership with other research funders, industry and healthcare providers.”
Even before that, in 2005, the Government of India had assured intellectual property rights protection with stringent legislation. In clinical research, it brought in Schedule Y to the Drugs & Cosmetics Rules and did away with the phase lag between trials conducted globally and those conducted in India. This sent signals to the global community that India was serious about claiming a sizeable proportion of the global outsourcing of clinical trials. The country was suitably rewarded with a 21 per cent compounded annual growth rate in the clinical trials market.
Yet, in the last couple of years there appears to be a rethink. The office of the Drugs Controller General of India which approved applications to conduct drug trials in six to ten weeks now needs over 6 months per application. In this period, a host of queries are lobbed at the applicants – sequentially and not in parallel- in what appears to be an effort to buy time and postpone decision-making. These six months do not necessarily contribute to enhanced rigour or protect trial subjects better. However, they do result in inordinate delays and uncertainty. So while written policy suggests that India desires to encourage clinical research, its actual practice suggests otherwise.
ENFORCEMENT DEFICIT
India is one of the rare countries that has given the sanctity of Law to what most of the world treats as guidelines for the ethical conduct of medical research. This is evident in the addition of Schedule Y to the Drugs & Cosmetics Rules in 2005. This schedule borrows heavily from the so-called ICH GCP guidelines – the global standard for the ethical conduct of clinical research. But enforcement is weak. There has been no role assigned to administrations in various states. The Food and Drug Administrations in the states do not have any authority in law to inspect or otherwise oversee conduct of a clinical trial. Without decentralization, clinical trials cannot be overseen and schedule Y cannot be effectively implemented.
PERCEPTION DEFICIT
There is a serious perception issue that threatens to mar rational decision-making. For instance, multinational corporations are almost by definition seen as out to take advantage of the Indian population. Illiterate people are considered not intelligent enough to understand the concept of clinical research and act on this understanding. These perceptions are all pervasive – seen not just within government agencies but also among non-profits, and sections of the media. This leads to misguided calls for blocking clinical trials by all foreign companies or banning the conduct of trials on illiterate persons without giving a thought to the possible benefits of foreign-owned interventions or the need for experimental cures among illiterate persons who might be terminally ill and have tried approved treatments in vain.
TRUST AND COOPERATION DEFICIT
Parliamentarians do not trust the government. The government is suspicious of the private sector which, for its part, is paranoid about government. The media too is viewed with distrust. In such an atmosphere, it is impossible for meaningful co-operation to occur among various groups to resolve the current state of affairs. Much of this lack of trust can be dispelled by timely communication by government itself. However, given the atmosphere of paranoia no government official sees any merit in doing so and thus exposing himself or herself to censure from one or other group.
If these deficits aren’t made up, then the golden era of clinical research in India might well end up being the period when none was being conducted in the country.
Pic sourced from http://www.karmiclifesciences.com
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An excellent analysis by Dr. Sapatnekar.
The substantial growth in market and profits for India’s pharmaceutical industry will be very short-lived unless India can conduct world class clinical research with globally accepted standards for clinical trials and pharmacovigilance.
Today, India profits from its ability to inexpensively copy and produce bio-equivalent generics of small molecule drugs. But that market will quickly evaporate as the so-called patent cliff reaches its peak. By the end of 2014 the US and EU pharma market will be dominated by biologic drugs for which bio-equivalents generics cannot be produced.
At best the generic companies that try to produce generic biologics or bio-similars will be able to market “interchangeable” but not “bio-equivalent” products. Proving “interchangeability” of bio-similars will demand clinical research, human trails and pharmacovigilance for which India, today, seems poorly equipped.
Since the overwhelming bulk of India’s pharmaceutical slaes are in developed countries, the ability for India to get its the house in order for clinical research will determine whether India will be able to maintain its position as a global leader in pharmaceutical research.
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