Drugs Trials
Drugs have achieved great significance in the lives of the people. Be it Cancer, Aids, Diabetes, Tuberculosis or even the latest H1N1 virus, all of them are treated with the help of drugs. With the advancement of technology, provided an impetus to drug development, thereby resulting in a variety of drugs being dispensed for treating most of the common ailments that have plagued mankind. Their importance is utmost for human tranquility and serenity.
The drug industry has been experiencing tremendous growth in the past few years. All the major pharmaceutical companies have been investing a significant portion of their earnings into research and development thus fueling drug discovery and drug developments. Drug Development though very essential, has to be handled with great care and caution especially in the clinical trial phase. Clinical trials are developed in such a way that it not only helps the discovery of new drugs but also ensures the safety of those who undergo the trials.
Clinical trials are generally divided into three phases Phase 1,2 and 3. In phase, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In phase 2, the drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Further in phase 3, the drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Finally in Phase 4, studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.Generally the number of people who have been administered the drug for trial purposes increases as the phase increases. So it is required, ethically, by drug companies to carry out trials in phases sequentially, inorder to protect the trial volunteers from the ill-effects, if any, of the drugs. But this is something which is not generally followed. With an intent to release a drug at the earliest, companies generally carry out these trail phases concurrently in different countries, thus subjecting the lives of several thousands of people to risk.
In India until 2005, pharma companies wanting to carry out drug trials were allowed to carry out a phase of trial only if a phase of higher number was carried out in other countries. But since 2005, after effecting an amendment to the the Drugs and Cosmetics Act 1940, this requirement has been let gone. This is widespread clinical trials on a large number of people in India.
India, owing to its size and genetic diversity, which tends to be a plus point when it comes to clinical trials, is the preferred location for carrying out clinical trials by many foreign pharmaceutical companies. The cost of carrying out these clinical trials, a huge population of illiterate,poor and gullible people, and recent relaxing of restrictions have served as enabling factors for this practice. There have been numerous situations, where poor, sometimes illiterate individuals, recruited from city slums or else tribal communities, are used in the trials without giving proper informed consent – that is, without fully understanding what they are signing up for. To state a few
1) The recruitment of hundreds of tribal girls without parental consent for an immunization study sponsored by the Bill and Melinda Gates Foundation on the nod of the warden of their government hostel. Several girls subsequently died. The study was halted by the federal authorities.
2) The use by drug companies of survivors of the world's worst poisonous gas disaster in Bhopal as "guinea pigs" in at least 11 trials without proper informed consent.
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