Usually, before introducing any drug into the market, the companies carry out clinical trials on human beings to study their effects. Such human beings on whom the trials are carried out are known as 'subjects' and the trial is carried on a subject only after their 'informed consent'. The informed consent states that the subject is aware of the trials going on him and their consequences.
Such safety for subjects is only provided in the United States but not in India, because the guidelines for clinical trials in India are not that strong when compared to United States. The drug trials which cost $150 million could be done in India for $ 90 million and getting subjects for clinical trial is also very easy here. This has led to flourishing of clinical trial industry with a growing capital worth Rs 1,56,870 crore.
There are many NGOs working on this issue. Indore-based civil right activist Amulya Nidhi along with his friends is working under the banner of 'Swasthya Adhikar Manch', based in Indore and is fighting on the issue of illegal clinical trials of drugs on humans. They have printed a notice saying: “Are you getting free medicines? Have you been asked to return the empty medicine bottles? If so, contact us…”
They have printed around 10,000 copies of this notice and are displaying them in government hospitals and healthcare institutions in the state to alert the illiterate and poor people who usually fall into this trap of illegal drug trials.
Dr. Anand Rai, former Ophthalmic Surgeon from MGM Medical college Indore, presently working as Medical officer in State Health Department, who was the whistle blower in the case on illegal drug trials has been working for the welfare of these people and had submitted a PIL in Supreme Court on their behalf.
He told this citizen journalist , “I came to know about this scam while I was working in MGM medical college. I immediately informed the college authorities, but instead of looking into the issue, they (authorities) placed me under suspension.”
He added that lack of awareness in people about the problem is the only reason for the illegal clinical trials. “Conducting clinical trials is the need of the hour, but government should conduct only such trials, which are needed for our country and not for the western countries. But till now all the clinical trials have been conducted only for MNC's. This is all because of the poor intellectual property rights (IPR) law and guidelines of our country. The laws are in favor of the pharmacy companies; there is no human angle to it.”
The Clinical Trials Registry- India (CTRI) is a free and online public record system for registration of clinical trials being conducted in India. Registration at CTRI has been made mandatory by the Drugs Controller General (India) (DCGI). Any researcher who plans to conduct a trial involving human participants as a subject should register the trial in the CTRI. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etc before the enrollment of the first patient.
But this system is not followed and about 96 percent of patients who undergo clinical trials did so because their primary physician encouraged them to do so, and the patient didn't even know that he is being used as subject for clinical trial.
One such victim is Dhanunjay Srivastav, 56-years-old, asthma patient, who was a Roadways driver. He went to MGM medical college, Indore for treatment of chronic obstructive pulmonary disease. Dr. Salil Bhargav, who was looking into his case, advised him to come to his research center for better treatment.
Mr. Srivastav was given medicines for two to three months and was told that the “government is providing free medicines to you”. But the poor patient didn't know that he has become a subject for clinical trial and a drug called BI 1744 CL (Olodaterol) is being tested on him.
After a few days, suddenly Mr. Srtivastav's condition deteriorated; his body started to swell and the temperature came down and he was getting paralysed. Now he is disabled and has cataract problem which is all because of the ‘illegal clinical trials’ on him.
Helpless, Mr. Srivastav can't even go to work now. His wife is running a tiffin center and his children are doing part-time jobs for the survival of the family. “My only request to the government is to provide me free treatment for my illness, which is all because of the illegal clinical trials on me. And I request the MP government to take action against (the people responsible for) this issue, rather than saving doctors and health ministers,” he told this citizen journalist.
Many such people are becoming the victims of illegal clinical trials and the reason behind this is the innocence and illiteracy of the people. They are clueless about the system, medicines and rights of patients. Ironically, even the educated people are unaware of their rights. The government should take some steps in raising the awareness on this issue.
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