It took five months for the Directorate General of Health Services (DGHS) to reply to Hisar-based RTI activist Ramesh Verma to tell him the gory truth about how multinational pharmaceutical companies play with the lives of Indians during clinical trials and almost never bother to pay compensation
Here are a few shocking facts that will expose the extent of the rot in the Indian pharma industry, and more important, how multinational (MNC) pharma companies toy around with the lives of Indians.
Here are a few shocking facts that will expose the extent of the rot in the Indian pharma industry, and more important, how multinational (MNC) pharma companies toy around with the lives of Indians.
- Number of dead between the year 2008 and 2010 due to clinical trials of various drugs by multinational companies in India is 1,600!
- The compensation paid by pharmaceutical companies including Merck, Wyeth, Bayer, Pfizer, Amgen, Lilly, Sanofi, PPD, Quintiles and Bristol Myers is for only 22 of the 1,600 who died (as per information, all these 22 people died in 2010). The compensation together, totals to a mere Rs53.30 lakh (at an average of Rs.1.50 lakh to Rs2 lakh. One company by the name of PPD has paid Rs10 lakh—perhaps for the death of more than one person (and this is only an estimate).
- 288 people lost their lives in 2008; 637 people died in 2009 and 668 died in 2010.
- No of registered trials: 11 between July and December 2007; 137 between January and December 2008; 548 between January and December 2009; 806 between January and December 2010 (note the increase in the number of people volunteering for clinical trials over the last three years).
This shocking information was revealed by the Directorate General of Health Services (DGHS) to Hisar-based RTI (Right to Information) activist Ramesh Verma, who has filed more than 500 RTI applications, most of them pertaining to health issues.
It took five months for the DGHS to finally bow down to transparency after the Central Information Commission (CIC) slammed it for not providing the required information by its PIO (Public Information Officer). Besides giving the PIO a show-cause notice for penalty under Section 20 (1) and (2) of the RTI Act, the CIC ordered that information be given to Mr Verma before 25 September 2011. Accordingly, he was provided information on 23rd September. However, he has still not received complete information and is now filing his complaint again to CIC Shailesh Gandhi.
Verma asked the following queries in his RTI application:
1. In the past 10 years, approvals for clinical trials have been given for which drugs... Please give names of the drugs, name of the pharmaceutical company, name of the research organisation conducting trials, conditions on which such trials have been approved.
2. What are the mandatory requirements for the organisation which conducts such clinical trials?
3. Sample copy of written approval by the member of the family of the person who would be undergoing the clinical trial of the drug.
4. Details of the compensation paid in case of harm caused to the person during the course of trials. How many people have received how much compensation in the last 10 years?
5. How many complaints have been received in the last 10 years regarding clinical trials and copy of action taken against such complaints.
6. How many deaths have occurred during such clinical trials and details of compensation given—along with names of the companies.
But the shocking fact is that there is no basic figure of financial compensation fixed for monetary compensation for these pharma companies despite the fact that they are playing with the lives and health of people.
Regarding details of compensation, the DGHS in its reply quoted from the Good Clinical Practices Guidelines (GCP) recognised under Schedule Y to the Drugs and Cosmetics Rules issued by the DGHS, Ministry of Health and Family Welfare, which prescribes:
"The compensation for accidental injury for Research subjects who suffer physical injury as a result of their participation in clinical trial... are entitled to financial or other assistance to compensate them equitably for any temporary or permanent or disability subject to confirmation from IEC. In case of death, their dependents are entitled to material compensation.
" Obligations of the sponsor to pay: The sponsor whether a pharmaceutical company, a government or an institution should agree, before the research begins, to provide compensation for any serious physical or mental injury for which subjects are entitled to compensation or agree to provide insurance coverage for an unforeseen injury whenever possible.''
Regarding complaints received from those adversely affected by clinical trials, DGHS replied: "As per available records, one complaint was received from R Rajendran, Sivakasi, regarding clinical trial of Vitreosolve injection in patients with non-proliferative Diabetic Retinopathy. The matter is sub-judice in the High Court of Judicature of Madras at Madurai Bench in Writ Petition (MD) No 9894 of 2010 filed by R Rajendran, son of A Raju…"
Regarding deaths due to clinical trials, the DGHS provided information only of the past three years and not 10 years as asked by Mr Verma, stating: "Serious adverse events of deaths may occur during clinical trials due to various reasons. These could be disease related deaths like cancer etc or administration to critical or terminally ill patients or side effects or unrelated causes. Such deaths are investigated for causal relationship by investigator and by Medical Monitor of sponsor. The information collated revealed that there were 288 deaths in 2008, 637 in 2009 and 668 in 2010... There were 22 cases of deaths which were related to clinical trial in the year 2010 where compensation has been provided by company."
Regarding the norms of clinical trials, DGHS replies: "[The] number of clinical trials actually conducted in government hospitals/private hospitals is not available with Central Drugs Standard Control Organisations (CDSCO) as prior to 17.11.2008 registration of clinical trial was voluntary. For all clinical trials, permission of which was granted between 17.11.2008 to 14.05.2009, applicants were advised to get the trials registered at ICMR registry at www.ctri.in.
"However, for all clinical trials permitted on or after 15.06.2009, applicants are being informed that it is now mandatory to register the trial at the said ICMR site before enrolling first patient in the study."
It took five months for the DGHS to finally bow down to transparency after the Central Information Commission (CIC) slammed it for not providing the required information by its PIO (Public Information Officer). Besides giving the PIO a show-cause notice for penalty under Section 20 (1) and (2) of the RTI Act, the CIC ordered that information be given to Mr Verma before 25 September 2011. Accordingly, he was provided information on 23rd September. However, he has still not received complete information and is now filing his complaint again to CIC Shailesh Gandhi.
Verma asked the following queries in his RTI application:
1. In the past 10 years, approvals for clinical trials have been given for which drugs... Please give names of the drugs, name of the pharmaceutical company, name of the research organisation conducting trials, conditions on which such trials have been approved.
2. What are the mandatory requirements for the organisation which conducts such clinical trials?
3. Sample copy of written approval by the member of the family of the person who would be undergoing the clinical trial of the drug.
4. Details of the compensation paid in case of harm caused to the person during the course of trials. How many people have received how much compensation in the last 10 years?
5. How many complaints have been received in the last 10 years regarding clinical trials and copy of action taken against such complaints.
6. How many deaths have occurred during such clinical trials and details of compensation given—along with names of the companies.
But the shocking fact is that there is no basic figure of financial compensation fixed for monetary compensation for these pharma companies despite the fact that they are playing with the lives and health of people.
Regarding details of compensation, the DGHS in its reply quoted from the Good Clinical Practices Guidelines (GCP) recognised under Schedule Y to the Drugs and Cosmetics Rules issued by the DGHS, Ministry of Health and Family Welfare, which prescribes:
"The compensation for accidental injury for Research subjects who suffer physical injury as a result of their participation in clinical trial... are entitled to financial or other assistance to compensate them equitably for any temporary or permanent or disability subject to confirmation from IEC. In case of death, their dependents are entitled to material compensation.
" Obligations of the sponsor to pay: The sponsor whether a pharmaceutical company, a government or an institution should agree, before the research begins, to provide compensation for any serious physical or mental injury for which subjects are entitled to compensation or agree to provide insurance coverage for an unforeseen injury whenever possible.''
Regarding complaints received from those adversely affected by clinical trials, DGHS replied: "As per available records, one complaint was received from R Rajendran, Sivakasi, regarding clinical trial of Vitreosolve injection in patients with non-proliferative Diabetic Retinopathy. The matter is sub-judice in the High Court of Judicature of Madras at Madurai Bench in Writ Petition (MD) No 9894 of 2010 filed by R Rajendran, son of A Raju…"
Regarding deaths due to clinical trials, the DGHS provided information only of the past three years and not 10 years as asked by Mr Verma, stating: "Serious adverse events of deaths may occur during clinical trials due to various reasons. These could be disease related deaths like cancer etc or administration to critical or terminally ill patients or side effects or unrelated causes. Such deaths are investigated for causal relationship by investigator and by Medical Monitor of sponsor. The information collated revealed that there were 288 deaths in 2008, 637 in 2009 and 668 in 2010... There were 22 cases of deaths which were related to clinical trial in the year 2010 where compensation has been provided by company."
Regarding the norms of clinical trials, DGHS replies: "[The] number of clinical trials actually conducted in government hospitals/private hospitals is not available with Central Drugs Standard Control Organisations (CDSCO) as prior to 17.11.2008 registration of clinical trial was voluntary. For all clinical trials, permission of which was granted between 17.11.2008 to 14.05.2009, applicants were advised to get the trials registered at ICMR registry at www.ctri.in.
"However, for all clinical trials permitted on or after 15.06.2009, applicants are being informed that it is now mandatory to register the trial at the said ICMR site before enrolling first patient in the study."
