The Supreme Court on Thursday said uncontrolled clinical trial of drugs on humans by multinational companies was creating “havoc” in the country and slammed the Centre for failing to stop the “rackets” which has caused deaths.
Observing that the Government has slipped into “deep slumber” in addressing this “menace”, the court ordered that all drug trials will be done under the supervision of the Union Health Secretary.
The apex court said the government has failed to put in place proper mechanisms to stop “rackets” of multinational companies, which are conducting illegal clinical trials, and asked it handle the problem on an urgent basis.
“You have to protect health of citizens of the country. It is your obligation. Deaths must be arrested and illegal trials must be stayed,” the bench comprising R.M. Lodha and A.R. Dave said.
“You have slipped into deep slumber. It pains us that children of the country are being uses as guinea pigs by the companies. You do not have even respect of the Parliamentary Committee which has said that the companies are running racket and you are showing just draft rules,” the bench said when the Additional Solicitor General Siddhath Luthra contended that Centre is considering to frame rules.
It pilloried the government after it was contended that various committees have been set up to look into the issue and that it will come back to the court after getting suggestions from them.
“You can get back to the court but what about those people who are losing their lives in such clinical trials. People who lost their lives can’t get their lives back,” the bench observed.
“It is very easy to form a committee or a commission. It is done just to divert people’s attention on the issue. It is the best way to divert attention on important issues,” the bench said.
“Give us performance of even one committee during the last 21 months. We gave you many opportunities,” it said adding, “Your officials are not working in a manner they should work. If there is foolproof mechanism then we would not have interfered in the matter”.
Clinical Research is always a soft target. In India the lack of regulations in the early stage of clinical trials should not lead to terming each trial as "dubious". World has to see innovations in research, but with it comes an obvious window of risk (and there is no denying it). Rightly,people who misuse the opportunity during the process of bringing a new medicine in a market should be damned, but simultaneously let us not discourage the honest and ethical efforts. Let us not forget doctors and people from pharmaceutical companies are experts in their field. Somebody said that we should get only clinically tested drugs!! how does one clinically test it without these trials??!! Would you like to take a drug which have only gone through pre-clinical testing (one which is actually done on rodents)?!
Nevertheless as my teacher says "whatever goes through fire and survives, is only getting stronger"- gives me all the hope to see the best days of clinical research in India.
The medical (hospital+pharma) industry has clear control over the licensing and supervisory authorities and the details are in the frontline report. (here is a sample - letters recommending approval for Cipla's pirfenidone were received by the DGCI from four different sources in Delhi, Mumbai and Chandigarh and Secunderabad on the same day and recorded under consecutive reference numbers).
Even the courts are not very keen to bring the executive to task other than issuing warnings. While the parliamentary committe report has been idling for seven months for followup, the court has given it one more - the matter is posted for hearing four weeks later. Finally the court will note the assurances of some secretary or AG and close the petition.
In this country there is no limits of fraud sources of incomes even in
medical fields. There are many doctors who are even found to be done
Homeopathy course but running Allopathy medical clinics. Nobody to
scan and nobody to stop their license. Then on that basis even the
prescription also will be the same level of treatments then. This is
one of the incorrect way of medication that is widely followed in this
country in many places but our Great Government and IMA is yet silent
show watcher. Their hands are tied up to stop all these by many their
own reasons. We just have to sit and tolerate these until we ourselves
blow off all the corruptions just like Aparichit movie.
This is an important article. First there in formal Institutional review board.Second, most of the drug companies write their own protocol and have well known physicians do their"trials". The MNCs by looking at the sheer numbers of patients embark on a project to improve their bottom line.
A similar situations is in the USA where most Clinical Psychiatrist have been promoted to drug salespeople. The FDA in India can be compared to a toothless tiger.
Unless this is done ethically it will be hard to justify and drug that is released in India.Mere rubber stamping is not enough to protect patient's interests.
The doctors who prescribe these medicines to be checked thoroughly and
they should be shamed for their acts if they are found to be prescribing
these medicines. Also the Govt should make use of social websites to
issue the banned medicines list and to create awareness among the
public.
Govt is really missing great opportunities in connecting with public
through social websites and other media where people are glued always.
Many news item appears in this regard of exploiting poor patients in the name of clinical trial without explaining them of that purpose and also not compensated as per international standards. Now at leat apex court pulled government to take stringent action against MNC’s and prepare for the standards for that in India. Compnaies targets less educated region and starts its clinical trial and if the victim died of that will not provide compensation and is their any system of monitoring number of deaths and survivals of clinical trials need to be check.
Now , It is proved Why, India Has maximum Number Unnatural Death due to
Clinical research of Untested Drugs. What a Bizarre and unethical
system is going on In India. The Health Department Should have little
Knowledge that Only Clinically tested Drugs should be sold publicly.What
the HELL the Health department is doing ///??????? A Lay man is well
known , how many untested drugs are Flowing in our country every
day........It is BARE truth THAT the Health department IS IN DEEP
SLUMBER FOR EVER.....
The Health ministry is very keen in banning Smoking at every level which has very little impact on society while check on clinical trials and use of banned drugs and recalling faulty drugs are hardly known. The reason is Third world countries have been the right place to test any new drug as there is no system to regulate the practice and no mechanism to fix or compensate loss. I have never seen any drug publicly recalled in India via mass media. I have hardly heard of compensation for side effects caused by drugs which are not mentioned on label. But somehow such companies get sued for Millions in Western World for the same reason. The Next action of Health ministry will be to sell all tobacco in white pack with a terrible picture which will hit the news and welcomed by all making people forget what SC just demanded. Meanwhile the commission will takes it cool time and suggest the same thing what SC told and implementation will only be on paper.
Yes, this is a serious issue. Two weeks back, I was at a drug store buying medicines for my parents. An elderly woman came and asked the drug store person: "The hospital asked me to sign a form. After that the diabetes treatment is free. Medicines are free and there is no doctor fees. Shall I sign it?" She mentioned the famous diabetic center. Myself and the drug store person could immediately sense that it was for drug trial. Thankfully, he told her not to sign it. I was aghast at how this popular hospital was cruelly targeting unsuspecting, low educated, elderly people for their own commercial purpose.
In India there is no system for clinical trials. Individual research centres have made their own systems for clinical trial registrations. There should be a national system where all the trials should be listed. And the drug company should be a party to the legal system. This way the system will be transparent. Today, you go to OPD of any specialist doctor and you will see a team of MR queing up there. We should learn something from the UK system of critical health care.
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