State of Clinical Trials in India

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India like any other commonwealth country which has risen out of a long drawn imperial abuse is deeply ridden by poverty, which for most westerners is unimaginable. But that’s not what this country is famous for these days. In today’s neoliberal world India is synonymous with the word outsourcing. Its english speaking  highly educated human resource has been harnessed to bring about a radical change in how businesses are run these days. May it be the textile industry, diamond cutting, information technology  or technical and management consulting. Pharmacuticals clinical trials too are now outsourced to India and this industry is estimated to be worth  $2 billion by 2010. India ranks number one country  for clinical trials.

This situation begs to ask the question is “Why India has suddenly become a lucrative hot spot for Western Biopharmaceutical Companies to conduct their clinical trials?”

Here are a few pointers;

Indian government is doing all it can to make India a hot spot of clinical trials.

The amendments made in the Drug Patency Act which was passed in 2005 made the indian legal environment congenial for pharmaceutical   companies to conduct their research in India by protecting their research data collected in India on their newer drugs  from local completive  India pharmaceutical  companies. This protect their intellectual property and protect them from cheap local knockoffs to be produced in India.

The government has also decreased the limits for the time taken for drug trial applications to be cleared – 90 days for phase 1 trials, 45 days for phase 2 trials and 45 days for phase 3 trials. If the DCGI( Drug Control ler General of India) does not reply within the given period, the application is taken to have been approved.

Schedule Y of the Drugs and Cosmetics Act permits also has the ‘same phase’ drug trials in India as in other countries and also permits phase 1 trials of foreign drugs. Till then, the law required that any foreign drug tested in India should be tested at a phase ‘behind’ what was already done elsewhere – the three phases for human trials being: phase 1 for safety to be tested on healthy volunteers, phase 2 for safety and efficacy and phase 3 a much larger sample for efficacy. (These tests must be preceded by laboratory tests suggesting the drug works and in toxicology test on animals for the drug’s safety.)

Though the Drug Controller General of India Ashwini Kumar is quoted saying that the government has started training drug inspectors to audit trials, lapses in regulations have surfaced time and again. The latest uproar was about the Death of 49 infants at one of the prestigious AIMS institute. The London based biopharma company Shire is researching on a drug for Gaucher’s disease and the trial population has to be between 1 to 2 yrs of age. About 1500 children had been a part of this trial and there was a sudden death of 49 infants. The said drug is currently in front of the US FDA for approval. Instances like these have raised question about the ethical ground s of conducting research in countries like India. (http://www.timesonline.co.uk/tol/news/world/asia/article4568717.ece )

According  to IGATE Clinical Research the “Indian Advantage” for clinical trial is :large numbers of people with a range of illnesses, relatively low costs, availability of trained humanpower and infrastructure, high enrollment rates (higher than in the West), good patient compliance/ retention, and an “increasingly accommodating regulatory environment” (http://www.igatecorp.
com/icri/html/aboutus/tia.htm
) is responsible for the explosion of drug trials in India. IGATE also mentions that India has people with the right diseases. They’re also ‘treatment naïve’ – they will not have been able to afford treatment – so they are ideal for testing new drugs.

These trials done in India have cut the cost of clinical trials by 60% and the trials can be conducted at a record pace.

Things sound too good to be fair

The Helsinki Declaration on ethical guidelines for biomedical research on humans, and the ICMR’s guidelines on the same subject, state unequivocally that drugs must be tested against the best proven treatment and it is unethical to use a placebo (sugar pill) if an effective treatment exist. But there have been in instances in which these rules have been bent. In case of a trial done by a US based company for Bipolar disorder the patients in the clinical trial where kept off the standard drug for bipolar disorder prior to starting the trial to cleanse there system of  the drug and prevent any biases.

In case of the drug trial for Bipolar medication Risperdal : One was given the experimental treatment Risperdal, the other group were given a placebo. This effectively leaves some patients without any form of treatment during the trial which is essentially unethical.

In case of a anticancer drug the patients were never told of the standard treatment for that(pancreatic cancer) and where offered only the drug on trial.(M4N)

What is our concern?

The current environment for clinical trials raises five main ethical issues:

  • Patient recruitment onto drug trials
  • Informed consents
  • The trust between a doctor and their patient
  • The methodology implemented during a drug trial
  • The cost and accessibility of drugs in the developing world

The human rights groups are asking three basic changes in this existing structure:

  • Do clinical trials for conditions or diseases prevalent in that subpopulation a
  • Make those drugs available to the patients included in the trial at subsidized rate after the trial was successful and the drug approved
  • Make stringent regulations to prevent violation of informed consent

Important Links:

http://www.wired.com/medtech/drugs/news/2005/12/69595

http://bioethicsbytes.wordpress.com/2008/08/06/drug-trials-the-dark-side/

http://www.timesonline.co.uk/tol/news/world/asia/article4568717.ece

http://infochangeindia.org/20051110275/Health/Features/Open-house-on-drug-trials-in-India.html

Insightful Video:

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4 Responses to “State of Clinical Trials in India”

  1. ghebre Says:

    The complexity of conducting sound and ethical clinical trials are not unique to India. I believe we can turn to conduct of HIV international trials to learn some of the lessons. At some point there must be an increasing awareness by the Indian population to drive changes in conduct of clinical trials.

  2. asamarth Says:

    I would suggest Clinical Trials should be limited to few institutions, so that we take care of the ethical issues and patient rights. We can have state level boards to regulate these trials. The general awareness/knowledge of the population and the patients participating in these trials has to be increased.

  3. HaYso Says:

    India is no slack in terms of in acting laws and regulations, in fact, India is very good at it and has been a pioneer in some fields such as animal welfare laws. Enforcing the law is rather India’s problem. Law enforcement infrastructure needs resources (human and financial) , a lot of it. India is a promising developing country , but with mundane social challenges to over come . It can not be done at any faster pace than its being executed in India. It is just vast.

    I suggest,however, that creating new Ethical clinical trail advocates and strengthening the existing ones to target the financial sponsors and the consumers of the products of these ethically challenged clinical trials is a key. These advocates have a lot to learn from the long history of battle the US went through to make sure today’s clinical trials meet ethical standards.In this ‘flat world’ as Tom Friedman argued in his book ‘international collaboration is key’ to get things done. People in the developed countries are good people and they do care about people in the developing countries. Westerners boycotted( or threatened to ) Nike products in protest of child labour at China based Nike plants. Consumers in USA/Europe/ Japan/Australia/Canada boycotted(threatened to) against cosmetic companies to stop inhumane use of rabbits to test the safety of their products. The aforementioned advocacy campaigns changed the world.
    So one needs to educate and convince people in developed countries about the suffering of people forced to participate in unethical trials in India or other countries in order to make a tangible difference.
    Sound advocacy can change the world to the better!

  4. dokchai Says:

    the current trend in clinical trial field is more and more clinical trials are transferring from developed countries to developing countries, especially to Eastern except Japan. The major reason is lower cost and less guidelines in developing countries.It is not a political issue, it is about profit for pharmaceutical companies.The developing countries may set up strict guidelines and supervise clinical trials well.The guidelines should be a universal one and be used in all of the countries conducting clinical trials.However, I doubt whether the governments of developing countries have the power to influence people’s choice, in many cases, people have no choice except taking part in clinical trials to get free treatment. Therefore, the guideline for clinical trials is important in developing countries. It should be as good as guideline in developed countries.

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