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India, Illegal Drug Trials & The remedies

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http://www.orissapost.com/epaper/230213/p8.htm

Doctors are often conceived as gods on Earth by their piteous patients, for they are the only ray of hope during their time of utmost distress.  But, alas! These hapless patients are being used as guinea pigs, by some greedy, unscrupulous Doctors in the guise of treatment. The lure of some monetary benefits and free foreign tours from multinational Pharma companies have laid doctors doing fatal drug trials,(phase wise drug tests applied on Human beings after tested in Laboratory and on Animals),without the consent of the patients. According to the data, presented by the Health & family welfare Minister Mr. Gulam Nabi Azad to parliament, from 2006 till February 2011 total 4066 clinical trials were held in India in which 2163 patients died of Serious Adverse Events (SEAs).In January of this year the apex court of India taking notice of these inhuman drug trials had severely reprimanded Government of India’s apathy towards such happenings. The Court while hearing a PIL filed by an Indore based  NGO  Swasthya Adhikar Manch on Illegal Drug trial cases, has remarked that “The drug trials are creating havoc in the country,” it further jibed the central Government for slipping into “Deep slumber” .The Apex court advised  the Government “to protect the health of the citizens of the country. It is your obligation. Deaths must be arrested and illegal trials must be stopped”.

A glaring example of these inhuman unethical drug trials came to notice when “in 2004, doctors at the Bhopal Memorial Hospital and Research Centre, an exclusive institute for the victims of the 1984 gas leak disaster, recruited unsuspecting survivors for clinical trials, without their knowledge or consent.” The PIL further claims “It is said that 14 participants died during the course of the trials. In an Indore-based hospital, 32 people died in clinical trials between 2005 and 2010.” Growing public outrage forced the Madhya Pradesh Government to set up an enquiry committee to investigate the matter.

There is great reluctance among the people in developed countries, like the US to offer themselves as subjects for clinical trials. Besides the Pharama Giants are also not inclined to conduct drug trials in Developed countries as such trials there involve huge cost owing to various reasons. Hence, Pharma  giants have turned their attentions to third world countries, like India where there is no dearth of opportunities for such clinical trials. It is a fact that the cost of conducting clinical trials in India is the least, keeping in view the various facilities-infrastructural or otherwise available here. A study shows that clinical trials in India cost approximately $20 million while the same would cost between $300 million and $350 million abroad. Similarly India has a largest pool of very talented manpower, besides India has second largest number of plants approved by the USFDA for undertaking clinical trials. Above all, India has a teeming population languishing under staggering poverty and it is because of this the population is ever ready to offer itself for clinical trials in return of money even if such money is no match for the risks that is sure to affect the subjects’ lives or even kill them. Further, unethical clinical trials are rampant in India thanks to the ever growing numbers of greedy and unscrupulous doctors who have sold themselves to the Pharma companies and who shamelessly and surreptiously conduct trials on the unfortunate the patients who approach them for treatment. Not only the doctors, even the Govt. is   surrendering to the arm twisting of the Pharma giants. The revision of the Y schedule of the Drugs and cosmetics Act 1945 and the amendment of the 1970s Patent act  (whereby it has allowed Product Patent in place of process patent) are the results of such arm twisting. Studies by reputed organizations like Gurugaon based Ziven consultancy  show India’s clinical research market was worth Rs 1,345 crore in 2008 and it will cross  50,000 crores by 2015.

However, after the Court’s strong words against Government’s negligence, it came out with a Gazette Notification on 30th January tightening the Clinical Trials compensation Guidelines. The subject of clinical trials would now get free medical treatment as long as required in any untoward condition, or else the Sponsor would be debarred from further tests in the Country. An independent commission would decide the quantum of compensation in case of death of the subject during clinical trials. Anand Rai, a petitioner in the Supreme Court case on clinical trials remarked on the revised guidelines thus

“This is the first time ethics committees will have to report serious, adverse events to the drug controller, and informed consent forms will also be reviewed. These regulatory and monitoring norms should have been in place all along,”

He further expects the Government to “address concerns raised by the victims who have suffered in the absence of these basic regulatory norms.”  According to the guidelines issued by central government if the local Contract Research Organisation(CRO) or its Sponsor MNC(Multi National Company) fails providing free medical treatment as long as required to the Subject incase any untoward incident happens during drug trials, That organization or sponsor would be banned from further tests in India. But the question is– would it be sufficient a punishment for the death or serious injury caused to an Indian citizen due to over dosage or negligence during Clinical Trials? He urged  the Government that it should,“besides deciding on compensation and redressal of victims’ concerns, doctors who violated ethical practices should also be punished to send a strong message,”

               The regulatory bodies responsible for putting a check on illegal drug trials have failed in the main in performing their duty simply because they are severely under-staffed and ill-equipped. Also, they lack the requisite skill to trace any case of illegal drug trial. The 59th report on the functioning of the Central Drugs Standard Control Organisation (CDSCO) by Parliamentary standing committee on Health and Family welfare reveals how and to what extent our regulatory bodies are ill-equipped and under-staffed. Again, the prevalence of corruption in the regulatory bodies has made it well nigh impossible for the  proper execution of the guidelines. Historically, Profit-motivated western MNCs have never cared for ethical responsibilities, so it is implausible to believe that these avaricious mercenaries would abide by the ethical guidelines issued by GOI. The rich people will never be used as subjects in the drug trials; it’s the poor and downtrodden of the Third world countries, who will be subjected to such trials. Governments of these countries have always been succumbing to the bullying of the western countries.

 

 According to Mira Shiva, Head of the Public Policy, Voluntary Health Association of India (VHAI), and coordinator of the All India Drug Action Network, “that these trials are done totally from a market point of view and that too for Western markets…… An extremely ethical trial for a nonsensical drug, does that make it great?” Government should use mass media to bring awareness on the issue of clinical trials among the common people, it should be made compulsory for the local investigators or registered ethical committees to tell the volunteers risks involved in the drug trials in their own mother languages.Criminal proceedings against CROs, Doctors and their foreign sponsors if there is any violation of the Guidelines .We should not let another Bhopal Gas tragedy happen in our motherland.

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