Sir,
This refers to news item published in TOI, New Delhi, Lucknow, and Bangalore editions on 3rd June 2011 (Friday) entitled “ Indore DOCS flout clinical trial norms, earn lakhs“ by Rema Nagarajan.
It is very unfortunate and shocking to learn that the most trusted news paper TOI is publishing a totally unconfirmed biased , derogatory unscientific and misleading report on an extremely sensitive issue of clinical drug trials in India.
The published report is based on an entirely baseless, mischievous , biased and motivated propaganda on clinical drug trial research conducted at M.G.M.Medical College, Indore by a section of local press with ulterior motives, fueled by some people with vested interests during last 10 months.
The fact remains that all the clinical drug trials undertaken by us have been multicentre/ multinational endeavors and have been conducted following all the existing rules , regulations and available guidelines in the country. Such studies, as ours , have also been conducted simultaneously all over the country including centers like AIIMS, New Delhi, PGI, Chandigarh, SGPGI Lucknow, St. Johns Medical College, Bangalore , Fortis group of hospitals, Apollo Group of hospitals, KEM hospital , Mumbai , Narayan Hridayalaya, Bangalore etc., using same protocols , guidelines and budget planning. All these protocols have been approved by Drug Controller General of India(DCGI) , New Delhi and the institutional Ethics Committees of all the participating centers and were monitored and audited by experts in the field.
The published report comments “ in one shocking case , out of the 9 subjects of a trial on the possible use of the drug tadalafil in pulmonary hypertension (otherwise used for male erectile dysfunction) 7 were women and one was 17 year old boy all from poor families “ Please note that the referred study used tadalafil in patients with Group-I pulmonary hypertension which occurs most commonly in young women and tadalafil is the approved therapy of choice for this life threatening disease ( class – I indication) . This is an ongoing legitimate faculty pilot research project with no funding from any outside source and having due approval from institutional ethics and scientific review committee. We do not select participants based on their social status,caste or economic background.
The report also quotes various amounts received by principal investigators as their income but does not indicate that actually the referred amounts are trial budgets provided to the principal investigators by the sponsors to run the research protocol at respective centers and is similar for all the participating centers all over India. This amount is utilized for staff salaries , patient investigators and patient reimbursements and towards honoraria to sub investigators and investigators. The information about the trial budget and other aspects of a planned research protocol is well known to the head of the institution as he is a signatory in the tripartriate clinical trial agreements (CTAs).
Government has constituted a committee to form rules and regulations for conducting clinical trials in a state of Madhya Pradesh and has permitted all the ongoing clinical trials to continue till finish. Autonomous society of M.G. M. Medical College, Indore had permitted clinical trial research in the institution and issued orders to deposit 10% of the research grant in the respective departments (not necessarily college account) to be utilized for improving the existing facilities. We have been following these orders and depositing the above amount in the respective departments, the accounts of which are duly audited.
All the Clinical trials conducted by us are as per ICH-GCP – ICMR guidelines and as per schedule “ Y” of the Drugs and cosmetic act revised 2005. All trial participants have provided well informed written consent in language understood by them i. e. Hindi in majority.
Sir, no Government agency has ever found any misconduct or flouting of clinical trial norms by us nor has any CRO/ Sponsor / institutional Ethics and Scientific Review committee has found any irregularity done by us till now.
Your report alleges about having used children like guine pigs in vaccine trials. In fact vaccine trials carried out by one of us have contributed significantly for helping in developing a vaccine to irradicate existing polio pockets in India and for developing the most wanted affordable swine flu vaccine (H1N1 vaccine) in the country. These achievements were published in TOI with praise at that time . All vaccine trials were conducted following exisiting rules and regulations with high ethical principles .
Sir, we would highly appreciate if the sensitive issues like clinical drug trials that are otherwise imperative for human health are reported without bias and after confirming the facts from all concerned parties and not simply based on false, motivated, unilateral, unconfirmed, unscientific reports from a section of press with vested interests.
Sir,you will realize that it takes decades to build physician’s reputation that may be spoiled with such reports in no time which is unfair, highly injurious and unjustified.
We hope that you will kindly give space to this letter in TOI editions.
Thanking you
शुक्रवार, 10 जून 2011
Letter to Editor, Times of India
Sir,
This refers to news item published in TOI, New Delhi, Lucknow, and Bangalore editions on 3rd June 2011 (Friday) entitled “ Indore DOCS flout clinical trial norms, earn lakhs“ by Rema Nagarajan.
It is very unfortunate and shocking to learn that the most trusted news paper TOI is publishing a totally unconfirmed biased , derogatory unscientific and misleading report on an extremely sensitive issue of clinical drug trials in India.
The published report is based on an entirely baseless, mischievous , biased and motivated propaganda on clinical drug trial research conducted at M.G.M.Medical College, Indore by a section of local press with ulterior motives, fueled by some people with vested interests during last 10 months.
The fact remains that all the clinical drug trials undertaken by us have been multicentre/ multinational endeavors and have been conducted following all the existing rules , regulations and available guidelines in the country. Such studies, as ours , have also been conducted simultaneously all over the country including centers like AIIMS, New Delhi, PGI, Chandigarh, SGPGI Lucknow, St. Johns Medical College, Bangalore , Fortis group of hospitals, Apollo Group of hospitals, KEM hospital , Mumbai , Narayan Hridayalaya, Bangalore etc., using same protocols , guidelines and budget planning. All these protocols have been approved by Drug Controller General of India(DCGI) , New Delhi and the institutional Ethics Committees of all the participating centers and were monitored and audited by experts in the field.
The published report comments “ in one shocking case , out of the 9 subjects of a trial on the possible use of the drug tadalafil in pulmonary hypertension (otherwise used for male erectile dysfunction) 7 were women and one was 17 year old boy all from poor families “ Please note that the referred study used tadalafil in patients with Group-I pulmonary hypertension which occurs most commonly in young women and tadalafil is the approved therapy of choice for this life threatening disease ( class – I indication) . This is an ongoing legitimate faculty pilot research project with no funding from any outside source and having due approval from institutional ethics and scientific review committee. We do not select participants based on their social status,caste or economic background.
The report also quotes various amounts received by principal investigators as their income but does not indicate that actually the referred amounts are trial budgets provided to the principal investigators by the sponsors to run the research protocol at respective centers and is similar for all the participating centers all over India. This amount is utilized for staff salaries , patient investigators and patient reimbursements and towards honoraria to sub investigators and investigators. The information about the trial budget and other aspects of a planned research protocol is well known to the head of the institution as he is a signatory in the tripartriate clinical trial agreements (CTAs).
Government has constituted a committee to form rules and regulations for conducting clinical trials in a state of Madhya Pradesh and has permitted all the ongoing clinical trials to continue till finish. Autonomous society of M.G. M. Medical College, Indore had permitted clinical trial research in the institution and issued orders to deposit 10% of the research grant in the respective departments (not necessarily college account) to be utilized for improving the existing facilities. We have been following these orders and depositing the above amount in the respective departments, the accounts of which are duly audited.
All the Clinical trials conducted by us are as per ICH-GCP – ICMR guidelines and as per schedule “ Y” of the Drugs and cosmetic act revised 2005. All trial participants have provided well informed written consent in language understood by them i. e. Hindi in majority.
Sir, no Government agency has ever found any misconduct or flouting of clinical trial norms by us nor has any CRO/ Sponsor / institutional Ethics and Scientific Review committee has found any irregularity done by us till now.
Your report alleges about having used children like guine pigs in vaccine trials. In fact vaccine trials carried out by one of us have contributed significantly for helping in developing a vaccine to irradicate existing polio pockets in India and for developing the most wanted affordable swine flu vaccine (H1N1 vaccine) in the country. These achievements were published in TOI with praise at that time . All vaccine trials were conducted following exisiting rules and regulations with high ethical principles .
Sir, we would highly appreciate if the sensitive issues like clinical drug trials that are otherwise imperative for human health are reported without bias and after confirming the facts from all concerned parties and not simply based on false, motivated, unilateral, unconfirmed, unscientific reports from a section of press with vested interests.
Sir,you will realize that it takes decades to build physician’s reputation that may be spoiled with such reports in no time which is unfair, highly injurious and unjustified.
We hope that you will kindly give space to this letter in TOI editions.
Thanking you
This refers to news item published in TOI, New Delhi, Lucknow, and Bangalore editions on 3rd June 2011 (Friday) entitled “ Indore DOCS flout clinical trial norms, earn lakhs“ by Rema Nagarajan.
It is very unfortunate and shocking to learn that the most trusted news paper TOI is publishing a totally unconfirmed biased , derogatory unscientific and misleading report on an extremely sensitive issue of clinical drug trials in India.
The published report is based on an entirely baseless, mischievous , biased and motivated propaganda on clinical drug trial research conducted at M.G.M.Medical College, Indore by a section of local press with ulterior motives, fueled by some people with vested interests during last 10 months.
The fact remains that all the clinical drug trials undertaken by us have been multicentre/ multinational endeavors and have been conducted following all the existing rules , regulations and available guidelines in the country. Such studies, as ours , have also been conducted simultaneously all over the country including centers like AIIMS, New Delhi, PGI, Chandigarh, SGPGI Lucknow, St. Johns Medical College, Bangalore , Fortis group of hospitals, Apollo Group of hospitals, KEM hospital , Mumbai , Narayan Hridayalaya, Bangalore etc., using same protocols , guidelines and budget planning. All these protocols have been approved by Drug Controller General of India(DCGI) , New Delhi and the institutional Ethics Committees of all the participating centers and were monitored and audited by experts in the field.
The published report comments “ in one shocking case , out of the 9 subjects of a trial on the possible use of the drug tadalafil in pulmonary hypertension (otherwise used for male erectile dysfunction) 7 were women and one was 17 year old boy all from poor families “ Please note that the referred study used tadalafil in patients with Group-I pulmonary hypertension which occurs most commonly in young women and tadalafil is the approved therapy of choice for this life threatening disease ( class – I indication) . This is an ongoing legitimate faculty pilot research project with no funding from any outside source and having due approval from institutional ethics and scientific review committee. We do not select participants based on their social status,caste or economic background.
The report also quotes various amounts received by principal investigators as their income but does not indicate that actually the referred amounts are trial budgets provided to the principal investigators by the sponsors to run the research protocol at respective centers and is similar for all the participating centers all over India. This amount is utilized for staff salaries , patient investigators and patient reimbursements and towards honoraria to sub investigators and investigators. The information about the trial budget and other aspects of a planned research protocol is well known to the head of the institution as he is a signatory in the tripartriate clinical trial agreements (CTAs).
Government has constituted a committee to form rules and regulations for conducting clinical trials in a state of Madhya Pradesh and has permitted all the ongoing clinical trials to continue till finish. Autonomous society of M.G. M. Medical College, Indore had permitted clinical trial research in the institution and issued orders to deposit 10% of the research grant in the respective departments (not necessarily college account) to be utilized for improving the existing facilities. We have been following these orders and depositing the above amount in the respective departments, the accounts of which are duly audited.
All the Clinical trials conducted by us are as per ICH-GCP – ICMR guidelines and as per schedule “ Y” of the Drugs and cosmetic act revised 2005. All trial participants have provided well informed written consent in language understood by them i. e. Hindi in majority.
Sir, no Government agency has ever found any misconduct or flouting of clinical trial norms by us nor has any CRO/ Sponsor / institutional Ethics and Scientific Review committee has found any irregularity done by us till now.
Your report alleges about having used children like guine pigs in vaccine trials. In fact vaccine trials carried out by one of us have contributed significantly for helping in developing a vaccine to irradicate existing polio pockets in India and for developing the most wanted affordable swine flu vaccine (H1N1 vaccine) in the country. These achievements were published in TOI with praise at that time . All vaccine trials were conducted following exisiting rules and regulations with high ethical principles .
Sir, we would highly appreciate if the sensitive issues like clinical drug trials that are otherwise imperative for human health are reported without bias and after confirming the facts from all concerned parties and not simply based on false, motivated, unilateral, unconfirmed, unscientific reports from a section of press with vested interests.
Sir,you will realize that it takes decades to build physician’s reputation that may be spoiled with such reports in no time which is unfair, highly injurious and unjustified.
We hope that you will kindly give space to this letter in TOI editions.
Thanking you
Letter to Editor, MIMS
Sir,
With reference to the editorial “Chronic clinical investigators : New breed of body hunters “(May 2011), we , the six principal investigators at M.Y.Hospital / M.G.M.Medical College Indore, want to put up with following facts and answers. We demand that our version be given equal space and emphasis but are not sure whether you will follow journalistic ethics, morality and courtesy.
The study on Tadalafil in pulmonary hypertension was not a randomized trial. It was an observational study without any sponsorship. The drug is already approved for and is available in market for this indication. Primary pulmonary hypertension is common in young female, hence there is nothing alarming or unusual about the demographics of study participants.
Similarly there is nothing alarming or unusual about the number of 1521 patients (1170 being children) enrolled between 2005-2010 at Indore. WHO sponsored trial on polio vaccine required large number of children to be recruited. The monitoring and auditing teams from WHO did not find any irregularities. The data uploaded from Indore center were approved and accepted and finally included in a land mark publication in Lancet [Volume 376, issue 9753, pages 1682-1688, 13 Nov 2010]. An accompanying editorial highlighted the importance of this trial in eradicating the remaining stubborn pockets of polio in India.
The various amounts quoted against each principal investigators are gross receipts, 60-80% of which is spent in conduct of trial. That the remainder is a legitimate, taxable, professional (consultancy) income of doctors was even accepted by the minister of Medical Education in M.P. Vidhansabha in reply to a question by one of the members. The medical teachers and other doctors in Madhya Pradesh are permitted private practice and their monthly incomes are much higher than the salaries. The income from clinical trials is relatively minor, considering the time, energy and expertise of senior consultants.
The use of Government infrastructure was minimal. The expenses for staff and office equipments were met from the trial budget. The accreditation of trial budget into personal accounts of principal investigators was done with the knowledge, permission and participation of college authorities including head of departments, hospital superintendent, Dean (s), institutional ethics committee, Executive Council of college ( headed by commissioner) and General Council of college (headed by minister). The Executive Committee and General Council were seized with the matter. Based on the decisions taken in these meetings two subsequent Deans instructed the principal investigators in two different orders to deposit 10% of gross receipts in to a departmental (not institutional ) account, which they have been doing. Over and above the 10% percent contribution, trial budgets have also been used in procuring permanent and temporary assets for the department like civil works, laboratory equipments, computer, printers, fax, internet connections, furniture, air conditioners, refrigerators , stationeries etc.,
All participants in trial were paid for travelling expenses and loss of day’s wages as per ICMR guidelines.
How could a trial on Dopnepezil 23 mg in Alzheimer’s disease be unethical which was approved by institutional ethics committees at 219 centers and Drug Controller Generals in many countries in North America, South America, Europe, Asia, Australia and south Africa. A total of 1467 patients were enrolled all over the world, out of which only six were from Indore. Thirteen deaths were reported during the study or within 30 days of study discontinuation from all over the world. Sheela Geete was not one of them because she died 8 months after the conclusion of the trial. Based on the results of this trial, a new formulation of this “dangerous” high dose of 23 mg donepezil has been approved for marketing not only in India but also in United States of America. There was no case of compensation to be paid because the death or any adverse event was not related to study drug. There were no instances of trial related injury and resultant lost wages in Rotigotine trial in parkinson’s disease.
All clinical trials are not successful or positive. It is a matter of chance. All trials which are successful or positive may not be land mark or pivotal or be “relevant to the country”. Yet the trials at Indore have had a larger share of important contribution. In addition to polio vaccine, others have been swine flu vaccine and polypill for prevention of cardiovascular and cerebrovascular occlusive disease.
Your editorial is extremely biased, one sided, prejudiced , ill informed and malicious. It should be retracted.
With reference to the editorial “Chronic clinical investigators : New breed of body hunters “(May 2011), we , the six principal investigators at M.Y.Hospital / M.G.M.Medical College Indore, want to put up with following facts and answers. We demand that our version be given equal space and emphasis but are not sure whether you will follow journalistic ethics, morality and courtesy.
The study on Tadalafil in pulmonary hypertension was not a randomized trial. It was an observational study without any sponsorship. The drug is already approved for and is available in market for this indication. Primary pulmonary hypertension is common in young female, hence there is nothing alarming or unusual about the demographics of study participants.
Similarly there is nothing alarming or unusual about the number of 1521 patients (1170 being children) enrolled between 2005-2010 at Indore. WHO sponsored trial on polio vaccine required large number of children to be recruited. The monitoring and auditing teams from WHO did not find any irregularities. The data uploaded from Indore center were approved and accepted and finally included in a land mark publication in Lancet [Volume 376, issue 9753, pages 1682-1688, 13 Nov 2010]. An accompanying editorial highlighted the importance of this trial in eradicating the remaining stubborn pockets of polio in India.
The various amounts quoted against each principal investigators are gross receipts, 60-80% of which is spent in conduct of trial. That the remainder is a legitimate, taxable, professional (consultancy) income of doctors was even accepted by the minister of Medical Education in M.P. Vidhansabha in reply to a question by one of the members. The medical teachers and other doctors in Madhya Pradesh are permitted private practice and their monthly incomes are much higher than the salaries. The income from clinical trials is relatively minor, considering the time, energy and expertise of senior consultants.
The use of Government infrastructure was minimal. The expenses for staff and office equipments were met from the trial budget. The accreditation of trial budget into personal accounts of principal investigators was done with the knowledge, permission and participation of college authorities including head of departments, hospital superintendent, Dean (s), institutional ethics committee, Executive Council of college ( headed by commissioner) and General Council of college (headed by minister). The Executive Committee and General Council were seized with the matter. Based on the decisions taken in these meetings two subsequent Deans instructed the principal investigators in two different orders to deposit 10% of gross receipts in to a departmental (not institutional ) account, which they have been doing. Over and above the 10% percent contribution, trial budgets have also been used in procuring permanent and temporary assets for the department like civil works, laboratory equipments, computer, printers, fax, internet connections, furniture, air conditioners, refrigerators , stationeries etc.,
All participants in trial were paid for travelling expenses and loss of day’s wages as per ICMR guidelines.
How could a trial on Dopnepezil 23 mg in Alzheimer’s disease be unethical which was approved by institutional ethics committees at 219 centers and Drug Controller Generals in many countries in North America, South America, Europe, Asia, Australia and south Africa. A total of 1467 patients were enrolled all over the world, out of which only six were from Indore. Thirteen deaths were reported during the study or within 30 days of study discontinuation from all over the world. Sheela Geete was not one of them because she died 8 months after the conclusion of the trial. Based on the results of this trial, a new formulation of this “dangerous” high dose of 23 mg donepezil has been approved for marketing not only in India but also in United States of America. There was no case of compensation to be paid because the death or any adverse event was not related to study drug. There were no instances of trial related injury and resultant lost wages in Rotigotine trial in parkinson’s disease.
All clinical trials are not successful or positive. It is a matter of chance. All trials which are successful or positive may not be land mark or pivotal or be “relevant to the country”. Yet the trials at Indore have had a larger share of important contribution. In addition to polio vaccine, others have been swine flu vaccine and polypill for prevention of cardiovascular and cerebrovascular occlusive disease.
Your editorial is extremely biased, one sided, prejudiced , ill informed and malicious. It should be retracted.
मध्य प्रदेश विधान सभा में चिकित्सा शिक्षा मंत्री का वक्तव्य
ऐलोपैथी दवाओं के विकास और मार्केटिंग की अनुमति प्राप्त करने के लिये ड्रग ट्रायल अनिवार्य है। नई औषधि पर ट्रायल करने के पूर्व ड्रग कन्ट्रोलर जनरल ऑफ इण्डिया की अनुमति औषधि कम्पनी द्वारा ली जाती है। ड्रग ट्रायल के बाद नई दवाईयों का सामान्य चिकित्सकीय उपयोग सम्भव हो पाता है।
भारत सरकार के ड्रग एण्ड कोस्मेटिक एक्ट १९४० तथा इण्डियन काउन्सिल ऑफ मेडिकल रिसर्च (आई.सी.एम.आर.) के दिशा निर्देशों के अनुसार ड्रग ट्रायल संचालित किये जाते हैं । इन निर्देशों के अनुसार प्रत्येक संस्था में किसी ड्रग ट्रायल की अनुमति देने व उस पर निगरानी हेतु एक एथिकल कमेटी गठित की जाती है। एथिक्स कमेटी में विशेषज्ञ चिकित्सकों के अलावा समाज के अन्य वर्गों के प्रतिष्ठित नॉन मेडिकल प्रतिनिधि जैसे न्यायपालिका के पूर्व सदस्य, पत्रकार, सामाजिक कार्यकर्ता आदि शामिल होते हैं। शासकीय चिकित्सा महाविद्यालय इन्दौर में उक्त समिति गठित है, जिसके सदस्यों में माननीय उध न्यायालय के सेवानिवृत्त न्यायाधीश, पद्मश्री उपाधि प्राप्त सामाजिक कार्यकर्ता, एक अधिवक्ता तथा एक वरिष्ठ पत्रकार भी शामिल हैं । वर्ष २००९ से ड्रग ट्रायल प्रारंभ करने के पूर्व क्लीनिकल ड्रग ट्रायल रजिस्ट्री ऑफ इण्डिया में पंजीयन कराना अनिवार्य किया गया है। शासकीय चिकित्सा महाविद्यालयों से संबंधित अस्पतालों में संचालित समस्त ड्रग ट्रायल्स में आई.सी.एम.आर. द्वारा दिये गये दिशानिर्देशों का पूर्णतः पालन किया जा रहा है।
ड्रग ट्रायल के संचालन हेतु प्रायोजित औषधि कम्पनी अन्वेषणकर्ता चिकित्सक तथा कुछ मामलों में संस्था के प्रमुख (अधिष्ठाता) के माध्यम से अनुबंध होता है, जिसकी जानकारी एथिक्स कमेटी के सदस्यों को दी जाती है । गोपनीयता अनुबंध के अनुसार उक्त जानकारी नियामक संस्थाओं के पदाधिकारियों के अलावा किसी अन्य को दिये जाने की अनुमति नहीं है। ट्रायल में भाग लेने में समस्त मरीजों को हिन्दी में विस्तारपूर्वक सहमति व्यक्त करने के बाद ही हस्ताक्षर करवाये जाते हैं। ट्रायल में भाग लेने से होने वाले सम्भावित दुष्परिणामों के बारे में भी मरीज को बताया जाता है।
मरीज पर किसी प्रकार का दुष्प्रभाव होने पर पूर्ण उपचार की व्यवस्था बीमा कम्पनी द्वारा की जाती है। मरीज या उसके परिजनों को स्वतंत्रता होती है कि वे जब भी चाहें ट्रायल में से अपने आपको बाहर कर सकते हैं। अनेक औषधियाँ विदेशों में पहले से ही जांची परखी होती हैं। परन्तु भारत सरकार के एफ.डी.ए. की अनुशंसकों के अनुसार भारत में मार्केटिंग हेतु भारतीय मरीजों में ट्रायल करके उक्त औषधि की उपयोगिता सिद्ध करना अनिवार्य कर दिया गया है।
ड्रग ट्रायल के संचालन हेतु प्रायोजक ड्रग कम्पनी द्वारा अध्ययनकर्ता चिकित्सक को एक बजट आवंटित किया गया है, जो मरीजों की संख्या, उनके द्वारा होने वाली विजिट तथा अन्य खर्चों को ध्यान में रखकर बनाया जाता है। इस बजट का अधिकांश भाग ट्रायल के संचालन में खर्च हो जाता है। यदि कुछ राशि बच जाती है तो वह अध्ययकर्ता चिकित्सक की वैधानिक आय होती है।
शासकीय चिकित्सा महाविद्यालय इन्दौर की कॉलेज काउन्सिल की बैठक दिनांक १ अप्रैल २००८ के निर्णयानुसार कुल प्राप्त बजट का १० अध्ययकर्ता चिकित्सकों द्वारा विभागीय फण्ड में जमा करवाया गया है, जो विभागाध्यक्ष तथा अन्य फैकल्टी की सहमति से विभाग के उन्नयन में खर्च होता है। इसके अतिरिक्त ट्रायल बजट से विभाग की अघोसंरचना के विकास में मदद भी मिलती है। ट्रायल के माध्यम से स्नातकोत्तर छात्रों को शोध की अनेक विधाओं का प्रशिक्षण प्राप्त होता है।
डब्ल्यू. एच.ओ. द्वारा प्रायोजित पोलियो वैक्सीन ट्रायल का संचालन शासकीय चिकित्सा महाविद्यालय इन्दौर में किया गया था, जिसके सफल परिणामों के फलस्वरूप देश से पोलियो के अन्मूलन में मदद मिल रही है। स्वाइन फ्लू वैक्सीन के सस्ते टीकों का सफल ट्रायल भी शासकीय मेडिकल कॉलेज इन्दौर में किया गया तथा इसके फलस्वरूप सस्ती वैक्सीन की उपलब्धता आम जनता के लिये बढ गई है।
अतः यह सत्य नहीं है कि मेडिकल कॉलेज के अस्पतालों में चिकित्सकों द्वारा इस प्रकार मरीजों से खिलवाड किया जाना गम्भीर चिन्ता का विषय है।
भारत सरकार के ड्रग एण्ड कोस्मेटिक एक्ट १९४० तथा इण्डियन काउन्सिल ऑफ मेडिकल रिसर्च (आई.सी.एम.आर.) के दिशा निर्देशों के अनुसार ड्रग ट्रायल संचालित किये जाते हैं । इन निर्देशों के अनुसार प्रत्येक संस्था में किसी ड्रग ट्रायल की अनुमति देने व उस पर निगरानी हेतु एक एथिकल कमेटी गठित की जाती है। एथिक्स कमेटी में विशेषज्ञ चिकित्सकों के अलावा समाज के अन्य वर्गों के प्रतिष्ठित नॉन मेडिकल प्रतिनिधि जैसे न्यायपालिका के पूर्व सदस्य, पत्रकार, सामाजिक कार्यकर्ता आदि शामिल होते हैं। शासकीय चिकित्सा महाविद्यालय इन्दौर में उक्त समिति गठित है, जिसके सदस्यों में माननीय उध न्यायालय के सेवानिवृत्त न्यायाधीश, पद्मश्री उपाधि प्राप्त सामाजिक कार्यकर्ता, एक अधिवक्ता तथा एक वरिष्ठ पत्रकार भी शामिल हैं । वर्ष २००९ से ड्रग ट्रायल प्रारंभ करने के पूर्व क्लीनिकल ड्रग ट्रायल रजिस्ट्री ऑफ इण्डिया में पंजीयन कराना अनिवार्य किया गया है। शासकीय चिकित्सा महाविद्यालयों से संबंधित अस्पतालों में संचालित समस्त ड्रग ट्रायल्स में आई.सी.एम.आर. द्वारा दिये गये दिशानिर्देशों का पूर्णतः पालन किया जा रहा है।
ड्रग ट्रायल के संचालन हेतु प्रायोजित औषधि कम्पनी अन्वेषणकर्ता चिकित्सक तथा कुछ मामलों में संस्था के प्रमुख (अधिष्ठाता) के माध्यम से अनुबंध होता है, जिसकी जानकारी एथिक्स कमेटी के सदस्यों को दी जाती है । गोपनीयता अनुबंध के अनुसार उक्त जानकारी नियामक संस्थाओं के पदाधिकारियों के अलावा किसी अन्य को दिये जाने की अनुमति नहीं है। ट्रायल में भाग लेने में समस्त मरीजों को हिन्दी में विस्तारपूर्वक सहमति व्यक्त करने के बाद ही हस्ताक्षर करवाये जाते हैं। ट्रायल में भाग लेने से होने वाले सम्भावित दुष्परिणामों के बारे में भी मरीज को बताया जाता है।
मरीज पर किसी प्रकार का दुष्प्रभाव होने पर पूर्ण उपचार की व्यवस्था बीमा कम्पनी द्वारा की जाती है। मरीज या उसके परिजनों को स्वतंत्रता होती है कि वे जब भी चाहें ट्रायल में से अपने आपको बाहर कर सकते हैं। अनेक औषधियाँ विदेशों में पहले से ही जांची परखी होती हैं। परन्तु भारत सरकार के एफ.डी.ए. की अनुशंसकों के अनुसार भारत में मार्केटिंग हेतु भारतीय मरीजों में ट्रायल करके उक्त औषधि की उपयोगिता सिद्ध करना अनिवार्य कर दिया गया है।
ड्रग ट्रायल के संचालन हेतु प्रायोजक ड्रग कम्पनी द्वारा अध्ययनकर्ता चिकित्सक को एक बजट आवंटित किया गया है, जो मरीजों की संख्या, उनके द्वारा होने वाली विजिट तथा अन्य खर्चों को ध्यान में रखकर बनाया जाता है। इस बजट का अधिकांश भाग ट्रायल के संचालन में खर्च हो जाता है। यदि कुछ राशि बच जाती है तो वह अध्ययकर्ता चिकित्सक की वैधानिक आय होती है।
शासकीय चिकित्सा महाविद्यालय इन्दौर की कॉलेज काउन्सिल की बैठक दिनांक १ अप्रैल २००८ के निर्णयानुसार कुल प्राप्त बजट का १० अध्ययकर्ता चिकित्सकों द्वारा विभागीय फण्ड में जमा करवाया गया है, जो विभागाध्यक्ष तथा अन्य फैकल्टी की सहमति से विभाग के उन्नयन में खर्च होता है। इसके अतिरिक्त ट्रायल बजट से विभाग की अघोसंरचना के विकास में मदद भी मिलती है। ट्रायल के माध्यम से स्नातकोत्तर छात्रों को शोध की अनेक विधाओं का प्रशिक्षण प्राप्त होता है।
डब्ल्यू. एच.ओ. द्वारा प्रायोजित पोलियो वैक्सीन ट्रायल का संचालन शासकीय चिकित्सा महाविद्यालय इन्दौर में किया गया था, जिसके सफल परिणामों के फलस्वरूप देश से पोलियो के अन्मूलन में मदद मिल रही है। स्वाइन फ्लू वैक्सीन के सस्ते टीकों का सफल ट्रायल भी शासकीय मेडिकल कॉलेज इन्दौर में किया गया तथा इसके फलस्वरूप सस्ती वैक्सीन की उपलब्धता आम जनता के लिये बढ गई है।
अतः यह सत्य नहीं है कि मेडिकल कॉलेज के अस्पतालों में चिकित्सकों द्वारा इस प्रकार मरीजों से खिलवाड किया जाना गम्भीर चिन्ता का विषय है।
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संदेश (Atom)
