The amendment to the Act has removed the "phase lag"
between trials. Phase-II trials were initiated in India only after these trials have been completed abroad and the initiation of phase-III trials there. Phase-III trials were allowed in India only after the drugs were marketed abroad. Now phase-II and phase- III trials in India can be held concurrently with the trials abroad. "It is, therefore, all the more necessary to put in place a set of rules that are more stringent, and ensure that the rights of Indian subjects of trials are given full protection
," points out Rajya Sabha member Ms. Brinda Karat in her letter addressed to the Health Minister, Anbumani Ramdoss.
Mr. Ramadoss, reiterates that stringent measures are in place, including provisions for 'informed' consent.
However, Ms. Karat points out that the presence of an 'impartial person', at the event of an illiterate candidate signing the consent form, will not actually amount to stringent measure. "You are also no doubt aware that not a single paisa has ever been given to a single patient who has suffered the adverse consequences of trials
," Ms.Brinda adds.
International clinical trials have several advantages if properly conducted.
The following are some of the advantages of these drug trials -
- In the year 2005, contract research in India was estimated at $100-120m, growing all the while at a rate of 20-25 per cent each year.By the year 2010, it is estimated to hit a target of 1bn US dollars.
- For these trials to be conducted foreign sponsors, including India, must adhere to certain regulations and monitoring in alignment with the International standards. It would help India to develop its own sets of 'Good clinical Practice'.
- More regulations are likely to come into force.
- Outsourcing of clinical trials make transfer of technology possible. This would help in advancing medical research and knowledge to find better cure for diseases.
- Clinical infrastructure, in the form of new equipments and research centres, is likely to get a boost.
- The Indian hospitals and doctors get an exposure to a work discipline of working meticulously and efficiently.
- It would help patients with advanced forms of cancers or diseases where there are no treatment options or hope for a cure to prolong their survival.
- Clinical trials give new job opportunities to graduates from medical/science disciplines.
The Dark Side
• In a country like India, there are allegations
that the poor, illiterate and sometimes even the mentally-challenged
are being used for clinical trials.
• It is more than likely that these individuals do not
fully understand the implications
of the procedures involved.
• Sometimes clinical trials can carry a lot of risk
. A glowing example comes from a clinical trial conducted by Pfizer on the cholesterol-reduction drug - Torcetrapib.
The trial came to a grinding halt due to the high death rate recorded among the 15,000 candidates, in three continents.
during the trial, from undertrained /unskilled staff is a possibility in India.
• In case of damage, the trial victims may not be able to claim any damages
if the clause of indemenity is not framed in favor of the patient. If a foreign insurance company is involved the claim process may not take place in India. This would make it difficult for the patient to make the claim.
• Lack of vigilance
or timely enforcenment of laws is likely to make India a 'hotbed of risks and controversies'. Ethical Issues
There are several ethical issues concerning clinical trials in India.
• If the drugs are too expensive it will be of little benefit
to the majority of people in India.
• These trials are being conducted in India because of the larger number
of candidates who are available and who can be convinced and recruited. This is not possible in a developed country, like the USA, with its good health care system. So are Indians the guinea pigs? Making Clinical Trials safe for Indian Patients
Three scientific bodies - Drug Controller General of India (DCGI), Department of Biotechnology (DBT) and Indian Council of Medical Research (ICMR) are looking at the possibility of liaising with the US 'Food and Drug Administration' (FDA) to enforce regulations with regard to clinical trials and research in India.
With regard to patient benefit the following measures should be followed-
• There should be no element of coersion when recruiting patients for clinical trial.
• The subject should clearly understand the advantages and disadvantages. Informed consent
should be available in all the local languages, besides English, and the patient being taken on the trial should be a given a copy of the consent form. They should be made to read all sections and sign all the page of the consent form.
• There should be no monetary inducements
to the patients to join the trial and this should be clearly stated in the consent.
• Insurance certificate covering the clinical trial
should be from an Indian Insurance company and any indemnity clause should be part of the agreement document. The insurance cover should be adequate and this should be reviewed from time to time. Currently, the recommended cover is about Rs.1 crore.
As far as possible the trial agreement
should be signed between the investigator/hospital along with the principal company and an 'Indian Clinical Research Organisation' (if involved in the trial).
Being poor or illiterate does not qualify a person to serve as a guinea pig. The way we treat our citizens, especially the under privileged, will definitely lay the foundation to the manner in which foreigners will regard us- as a people. Therefore, let us hope that government bodies put up a regulatory mechanism
in place that ensures the safety
of the patients besides addressing the issue of the disadvantaged, like the minors, illiterate or mentally challenged.
Let them strive to be uncompromising
when it comes to upholding the common man's interests, and, never hesitate to address the fears of the Indian public. India has a huge number of patients who can help to contribute to the advancement of medical sciences. By using India, the multinational pharma companies were hoping to tap into this rich resource and to fast forward their turn-round time for the trials; but this should not mean any compromise on safety standards. It is important for all parties involved in these clinical trials to get this message loud and clear.
Dr. REEJA THARU/S