462 deaths related to testing of experimental drugs on patients in India till mid-2010 alone, show health ministry figures
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Apta
Aug 31, 2010, 6:05:38 AM8/31/10
to India Clinical Research
462 deaths related to testing of experimental drugs on patients in
India till mid-2010 alone, show health ministry figures
Deaths related to drug testing in humans are going exponentially high
in India as the country is becoming a choice destination for
pharmaceutical giants to conducts clinical studies of experimental
drugs on real-time patients.
The number of deaths during clinical studies has been steadily
increasing and as many as 462 people, who were a part of clinical
trials, died in the year 2010 alone till June, according to figures
available with the Union Health Ministry.
There were 132 deaths in year 2007, 288 deaths in the year 2008 and
637 deaths in year 2009 , say the data.
In April, Indian government suspended Merck’s cervical cancer vaccine
Gardasil study in two states following reports of deaths of 4 girls
and several complications.
Gardasil was to be tested for its “acceptability and service delivery
issues” in about 32,000 girls aged 10-14 in the southern Indian state
of Andhra Pradesh and Western state of Gujarat.
Gardasil vaccination programme is being conducted jointly with PATH, a
Seattle-based NGO, the Indian Council of Medical Research (ICMR) and
the two state governments. The vaccination drive is funded by the Bill
and Melinda Gates Foundation
PATH-International, which is conducting the study for the maker of
Gardasil Merck, an American pharmaceutical company since July 2009,
has described the study as a “demonstration project.”
The human papilloma virus (HP) vaccine HPV vaccine Gardasil, meant to
prevent cervical cancer among women, has been alleged to have led to
the death of the four girls who were administered the dose in Khammam
district of Andhra Pradesh.
Besides the death, more than 120 girls, who were given the
vaccination, have complained severe adverse reactions of stomach
disorders, epilepsy, headaches and early menarche.
Though officials say that deaths occurring due to negligence of the
company during trials is rare, such instances have come to light. The
most recent case being the trial of a human papilloma virus (HPV)
vaccine in Andhra Pradesh, where four girls died after being
vaccinated. While, the Indian Council of Medical Research (ICMR)
halted the trials, experts are still investigating the cause of the
deaths.
New laws to prevent pharmaceutical companies from conducting clinical
studies of medicines involving humans without obtaining permission
from accredited ethical committees may soon come into force in India.
The proposed legislations will form part of a new Bill which the
government is going to introduce in the country to restrict unethical
practices and streamline the fast-growing clinical research industry
in India.
The Union Health Ministry, under the government of India is reportedly
finalizing a statute for the biomedical research.
The Indian Council of Medical Research (ICMR), the apex body advising
the government on medical research is reportedly working on a draft
Bill which proposes the restriction.
The Bill titled ‘Biomedical Research Human Subjects Promotion and
Regulation Bill’ may soon be introduced in the parliament.
Presently, there is no apex body to accredit investigators to clinical
trials.
Prior to November 17, 2008 the number of clinical trials actually
conducted in government/private hospitals are not available with the
Central drugs Standard and Control Organization (CDSCO), as
registration of clinical trial was voluntary.
CDSCO has granted permissions to about 2000 clinical studies from the
year 2004 till December 2009, reports said quoting official sources.
Indian government has made registration of all clinical trials
conducted in the country mandatory from 15th June 2009.
Registration of clinical trials in a publicly accessible registry is
very important as it improves the accountability of the stake-holders
and also ensures that key information is made available to the
public,’’ stated the notification dated 1st of June, 2009.
The Clinical Trials Registry- India (CTRI) has been set up by the
ICMR’s National Institute of Medical Statistics (NIMS) and is funded
by the Department of Science and Technology (DST) through the Indian
Council of Medical Research (ICMR).
The idea behind setting up of the Clinical Trials Registry-India
(CTRI) is to encourage all clinical trials conducted in India to be
prospectively registered before the enrollment of the first
participant and to disclose details of the 20 mandatory items of the
WHO International Clinical Trials Registry Platform (ICTRP) dataset.
Clinical trial outsourcing market in India is forecasted to grow at a
CAGR of over 30% during 2010-2012 to around US$ 600 million by 2012,
says new report by RNCOS.
India will become one of the highest growing clinical trial
destinations in the world, with this kind of growth, according to the
study titled “Booming Clinical Trials Market in India”.
India is becoming a major hub for clinical studies because all the
major pharmaceutical and biotech players as well as major CROs are
making India their base for conducting global clinical trials.
Finding and recruiting patients – the most crucial part of the
clinical research — who can qualify for a clinical trial, is
relatively much easier in India as compared to the Western countries.
Increasing prevalence of diseases and low cost of clinical trials are
other factors promoting this market. Syngene and Quintiles are right
on top in terms of market share in a market which are rather crowd
with more than 100 firms working in India in the clinical trial
market.
There has been a dramatic increase in the number of trials that have
got officially registered in Clinical Trials Registry-India (CTRI).
According to records collected by the Indian Council of Medical
Research and the Drug Controller General’s office, between July-
December 2007, only 11 trials were registered. The number increased to
137 between Jan-Dec 2008 and then to an all-time high of 546 between
Jan-Dec 2009. This year, while January saw 58 trials registered,
February recorded 60.
India till mid-2010 alone, show health ministry figures
Deaths related to drug testing in humans are going exponentially high
in India as the country is becoming a choice destination for
pharmaceutical giants to conducts clinical studies of experimental
drugs on real-time patients.
The number of deaths during clinical studies has been steadily
increasing and as many as 462 people, who were a part of clinical
trials, died in the year 2010 alone till June, according to figures
available with the Union Health Ministry.
There were 132 deaths in year 2007, 288 deaths in the year 2008 and
637 deaths in year 2009 , say the data.
In April, Indian government suspended Merck’s cervical cancer vaccine
Gardasil study in two states following reports of deaths of 4 girls
and several complications.
Gardasil was to be tested for its “acceptability and service delivery
issues” in about 32,000 girls aged 10-14 in the southern Indian state
of Andhra Pradesh and Western state of Gujarat.
Gardasil vaccination programme is being conducted jointly with PATH, a
Seattle-based NGO, the Indian Council of Medical Research (ICMR) and
the two state governments. The vaccination drive is funded by the Bill
and Melinda Gates Foundation
PATH-International, which is conducting the study for the maker of
Gardasil Merck, an American pharmaceutical company since July 2009,
has described the study as a “demonstration project.”
The human papilloma virus (HP) vaccine HPV vaccine Gardasil, meant to
prevent cervical cancer among women, has been alleged to have led to
the death of the four girls who were administered the dose in Khammam
district of Andhra Pradesh.
Besides the death, more than 120 girls, who were given the
vaccination, have complained severe adverse reactions of stomach
disorders, epilepsy, headaches and early menarche.
Though officials say that deaths occurring due to negligence of the
company during trials is rare, such instances have come to light. The
most recent case being the trial of a human papilloma virus (HPV)
vaccine in Andhra Pradesh, where four girls died after being
vaccinated. While, the Indian Council of Medical Research (ICMR)
halted the trials, experts are still investigating the cause of the
deaths.
New laws to prevent pharmaceutical companies from conducting clinical
studies of medicines involving humans without obtaining permission
from accredited ethical committees may soon come into force in India.
The proposed legislations will form part of a new Bill which the
government is going to introduce in the country to restrict unethical
practices and streamline the fast-growing clinical research industry
in India.
The Union Health Ministry, under the government of India is reportedly
finalizing a statute for the biomedical research.
The Indian Council of Medical Research (ICMR), the apex body advising
the government on medical research is reportedly working on a draft
Bill which proposes the restriction.
The Bill titled ‘Biomedical Research Human Subjects Promotion and
Regulation Bill’ may soon be introduced in the parliament.
Presently, there is no apex body to accredit investigators to clinical
trials.
Prior to November 17, 2008 the number of clinical trials actually
conducted in government/private hospitals are not available with the
Central drugs Standard and Control Organization (CDSCO), as
registration of clinical trial was voluntary.
CDSCO has granted permissions to about 2000 clinical studies from the
year 2004 till December 2009, reports said quoting official sources.
Indian government has made registration of all clinical trials
conducted in the country mandatory from 15th June 2009.
Registration of clinical trials in a publicly accessible registry is
very important as it improves the accountability of the stake-holders
and also ensures that key information is made available to the
public,’’ stated the notification dated 1st of June, 2009.
The Clinical Trials Registry- India (CTRI) has been set up by the
ICMR’s National Institute of Medical Statistics (NIMS) and is funded
by the Department of Science and Technology (DST) through the Indian
Council of Medical Research (ICMR).
The idea behind setting up of the Clinical Trials Registry-India
(CTRI) is to encourage all clinical trials conducted in India to be
prospectively registered before the enrollment of the first
participant and to disclose details of the 20 mandatory items of the
WHO International Clinical Trials Registry Platform (ICTRP) dataset.
Clinical trial outsourcing market in India is forecasted to grow at a
CAGR of over 30% during 2010-2012 to around US$ 600 million by 2012,
says new report by RNCOS.
India will become one of the highest growing clinical trial
destinations in the world, with this kind of growth, according to the
study titled “Booming Clinical Trials Market in India”.
India is becoming a major hub for clinical studies because all the
major pharmaceutical and biotech players as well as major CROs are
making India their base for conducting global clinical trials.
Finding and recruiting patients – the most crucial part of the
clinical research — who can qualify for a clinical trial, is
relatively much easier in India as compared to the Western countries.
Increasing prevalence of diseases and low cost of clinical trials are
other factors promoting this market. Syngene and Quintiles are right
on top in terms of market share in a market which are rather crowd
with more than 100 firms working in India in the clinical trial
market.
There has been a dramatic increase in the number of trials that have
got officially registered in Clinical Trials Registry-India (CTRI).
According to records collected by the Indian Council of Medical
Research and the Drug Controller General’s office, between July-
December 2007, only 11 trials were registered. The number increased to
137 between Jan-Dec 2008 and then to an all-time high of 546 between
Jan-Dec 2009. This year, while January saw 58 trials registered,
February recorded 60.
sreekanth gattu
Aug 31, 2010, 7:03:18 AM8/31/10
to indiaclinic...@googlegroups.com
Can you please provide us with the source of this information?
Thanks,
Dr Sreekanth Gattu, MD, CPI (ACRP)
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Mohd. Arif Mansuri
Aug 31, 2010, 8:22:54 AM8/31/10
to indiaclinic...@googlegroups.com, sreekanthgattu
yes sir sure, please check the following URL.
http://www.dancewithshadows.com/pillscribe/462-deaths-related-to-testing-of-experimental-drugs-on-patients-in-india-till-mid-2010-alone-show-health-ministry-figures/
Regads,
Aarif
Manager Site Identification and Study Start Up
Cosmos Clinical Research
+91 9978770715--
Best Regards
M. Aarif Mansuri
M.Sc. in Clinical Research
Site Identification Executive
Cosmos Clinical Research
+91 99787 70715
http://www.dancewithshadows.com/pillscribe/462-deaths-related-to-testing-of-experimental-drugs-on-patients-in-india-till-mid-2010-alone-show-health-ministry-figures/
Regads,
Aarif
Manager Site Identification and Study Start Up
Cosmos Clinical Research
+91 9978770715
Best Regards
M. Aarif Mansuri
M.Sc. in Clinical Research
Site Identification Executive
Cosmos Clinical Research
+91 99787 70715
Pratik Shah
Sep 1, 2010, 7:12:55 AM9/1/10
to indiaclinic...@googlegroups.com
Dear All,
Does anyone know how many people died in India due to road accidents? Cardiovascualar disorders? Tuberculosis? HIV? etc etc....Why not? I think death is same if it is due to clincal trial or due to any other illness. Why nobody wants to pay any attention to other causes of death.
I believe at least people related to the industry should learn to avoid this negative publicity showered on to clinical trial industry.
Regards,
Dr. Pratik Shah, MD
Head-Medical & Clinical Research
Astellas Pharma India Pvt Ltd.
Mohd. Arif Mansuri
Sep 1, 2010, 9:02:30 PM9/1/10
to indiaclinic...@googlegroups.com, drpra...@gmail.com
Dear Dr Pratik,
It was pleasure seeing your reply with bit of some negative points reflecting in your reply. My intention was to make aware the clinical research fraternity about the facts. This mail is already there in media since last month So, By spreading the information to few of the people who are in India "Clinical Research Group" Nobody can say that I am spreading Negativity.
Another point is....The Mail contain some Positive points like Government going to Introduce new laws to prevent pharma companies conducting clinical trials without obtaining permission from accredited ethics committees. As everybody knows that there are mushrooming of commercial ethics committees in India which are giving permission just for the sake of money by keeping patients on Big Risk. So, In my view it is very positive move by the government that would further promote this industry.
There are some other points Like ....Government is drafting the bill on Biomedical research, etc.
So, Dear Dr Pratik....From your reply it seems that you have just read the title of this mail and not the entire mail.
My intention was to save Indian population by making Clinical Research fraternity with the facts otherwise this mail is already there in media. And anybody can get the information from ministry of health by using your "Right to information act, 2005"
It is necessary to make aware the clinical research fraternity with the facts otherwise another Jamnagar incidents, Aims Incidents, Tuskgee incidents will occur and nobody will be able to save this industry in India then.
Even though if you feel I have done anything wrong then I sincerely apologize for that. You are very experienced person and like my mentor. I am very new to this industry.
Regards,
Aarif
It was pleasure seeing your reply with bit of some negative points reflecting in your reply. My intention was to make aware the clinical research fraternity about the facts. This mail is already there in media since last month So, By spreading the information to few of the people who are in India "Clinical Research Group" Nobody can say that I am spreading Negativity.
Another point is....The Mail contain some Positive points like Government going to Introduce new laws to prevent pharma companies conducting clinical trials without obtaining permission from accredited ethics committees. As everybody knows that there are mushrooming of commercial ethics committees in India which are giving permission just for the sake of money by keeping patients on Big Risk. So, In my view it is very positive move by the government that would further promote this industry.
There are some other points Like ....Government is drafting the bill on Biomedical research, etc.
So, Dear Dr Pratik....From your reply it seems that you have just read the title of this mail and not the entire mail.
My intention was to save Indian population by making Clinical Research fraternity with the facts otherwise this mail is already there in media. And anybody can get the information from ministry of health by using your "Right to information act, 2005"
It is necessary to make aware the clinical research fraternity with the facts otherwise another Jamnagar incidents, Aims Incidents, Tuskgee incidents will occur and nobody will be able to save this industry in India then.
Even though if you feel I have done anything wrong then I sincerely apologize for that. You are very experienced person and like my mentor. I am very new to this industry.
Regards,
Aarif
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