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By Sandhya Srinivasan
Contract research organisations are aggressively marketing India's potential for cheap clinical trials to meet foreign drug regulatory needs. The government is actively promoting India as a site for clinical trials. This new fortnightly series points out why we should be concerned about this
The government’s recent announcement that it will improve regulation of clinical trials might sound like good news. The Indian Council of Medical Research (ICMR) has stated that it will establish a registry of all clinical trials conducted in this country. Drug regulators will be trained to ensure compliance with ethical guidelines and good clinical practice. Ashwini Kumar, the Drugs Controller General of India, has been quoted as saying that the government has started training drug inspectors to audit trials.
The subject had come up at a meeting of government officials, industry representatives and doctors called to consider India’s capacity for clinical trials. The government’s assurance seems to have been given because experts at the conference reportedly warned that India’s regulatory apparatus is unprepared for the expected increase in foreign-sponsored clinical trials.
Contract research organisations are aggressively marketing India’s potential for cheap clinical trials to meet foreign drug regulatory needs.
According to IGATE Clinical Research, the “India Advantage” includes the following qualities: large numbers of people with a range of illnesses, relatively low costs, availability of trained humanpower and infrastructure, high enrolment 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). 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.
Just in case drug companies need to know what the right diseases are, IGATE specifies. Apparently we have 40 million asthmatic patients, about 34 million diabetic patients, 8-10 million people with HIV, 8 million epileptic patients, 3 million cancer patients, more than 2 million cardiac-related deaths, 1.5 million people with Alzheimer’s disease; 15% of the population is hypertensive, and 1% suffers from schizophrenia.
And the government does everything it can to encourage India as a site for clinical trials. For example:
The government bowed to the drug industry’s lobbying to announce 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 does not reply within the given period, the application is taken to have been approved.
Starting in January 2005, a change to Schedule Y of the Drugs and Cosmetics Act permits ‘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.)
The draft National Biotechnology Development Strategy proposes import duty exemption for clinical trial equipment. (N Suresh. ‘Industry-friendly biotech policy unveiled’. Biospectrum, April 2005. http://www.biospectrumindia.com/)
According to the drug industry the amended Indian Patent Act will remove barriers to foreign research in India. The Indian Patent Act’s amendments in March 2005 give foreign companies the assurance that data collected in trials of their drugs in India will not be used by local companies to manufacture and market cheap generic versions.
These changes were made because European and US regulatory authorities now permit the use of data from clinical trials in India for approval purposes. What they require is documentation that the research was conducted according to certain standards of good clinical practice.
But drug companies do not seem to have waited for regulations to favour them. Kumar of the DCGI reportedly said that India has nearly 100 ongoing multi-centre drug studies. If all of them started after January 2005, they must have been very well prepared for the amendments.
New regulations actively encouraging foreign clinical trials in this country came into place only in January 2005. Yet as early as April 2005, Quintiles’ India division announced on its website that it had more than 13,000 participants registered in 91 clinical trials testing drugs for cancer, psychiatry, neurology, infectious diseases, and so on. Many of these had already been completed and the data submitted to foreign regulatory authorities. These included “India-only” studies that should not have been possible before January 2005.
Some “highlights” as the company describes them:
Done for foreign regulatory approval
All 19 trials of cancer drugs were conducted as part of multi-country programmes “for regulatory submissions”. Two head and neck cancer studies enrolled 125 patients in four sites and the drug was approved by European regulatory authorities. A study on pancreatic cancer provided “supportive data for US FDA”. More than 100 patients were recruited within 12 months in each of two breast cancer studies. One of these was approved by European regulatory authorities.
A number of drugs are tested only in India with the data used to obtain regulatory approval abroad. A drug for bipolar disorder was approved (presumably somewhere abroad) based only on Indian data. A phase 3 trial of a drug for bacterial conjunctivitis was done only in India and the data used for US FDA approval.
Done super-fast
Thirty patients were recruited in 17 days for a study of Parkinson’s Disease. Fifty patients were recruited in one month for a diabetes study for a European sponsor. Over 550 patients were recruited in less than 10 months for a study for a US client.
It’s interesting to note that 19 trials were in oncology and 17 in psychiatry. More than 3,000 people were being tested with cardiology drugs. Are they going to be available here? Are trials being conducted in India that could not be done in the developed world because they put participants at unreasonable risk with the benefit accruing only to the drug company?
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 exists.
Why should we be concerned?
The DCGI’s announcement is welcome, because there is no way at present to know what is being tested, for what purpose and whose benefit. Are phase 1 studies for safety being done in India so that unsafe drugs can be ruled out? Are expensive drugs being tested here that will never be available to those who need it?
The rest of this series will address some of these concerns.
InfoChange News & Features, November 2005 |
