In order to strengthen the regulatory provisions and the monitoring mechanism of clinical trials in the country, Drugs and Cosmetics Rules, 1945 have been amended as follows:-
A. Amendment vide Gazette Notification G.S.R. 53 (E) dated 30-01-2013 specifying procedures to analyze the reports of Serious Adverse Events occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death as per prescribed timelines.
B. Amendment vide Gazette Notification G.S.R. 63(E) dated 01-02-2013 specifying various conditions for conduct of clinical trials, authority for conducting clinical trial inspections and actions in case of non-compliance.
C. Amendment vide Gazette Notification G.S.R No. 72(E) dated 08.02.13 specifying requirements and guidelines for mandatory registration of Ethics Committee.
The National Institutes of Health (NIH), have raised concerns about how these new requirements will be implemented, particularly the specific provision related to compensation.NIH have suspended enrolment of participants in 35 interventional trials in India. This will, however, not affect this country’s health programme and domestic pharma industry.
The drug trial policy has been evolving in course of time. Government has been trying to strengthen the regulatory mechanism to ensure proper drug trials.
This information was given by the Union Minister of Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the Rajya Sabha yesterday.
Clinical trials of untested drugs on humans require certain mandatory standards to be followed, the Supreme Court said on Friday while directing the government to put in place a mechanism to monitor them.
The apex court directed the Centre to convene a meeting of Chief Secretaries or Health Secretaries of all the states to frame a law for regulation of clinical trials of drugs by multinational pharma companies.
A bench of justices R.M. Lodha and Madan B. Lokur granted four weeks time to the Centre to convene the meeting and for framing rules.
“Certain standards and protocol should be followed while conducting clinical trials of drugs on humans. We are concerned about human life,” the bench said, asking the Centre to consider suggestions of the National Human Rights Commission on the issue.
“How do you monitor that clinical trial does not result in death and there are no side effects. There should also be proper compensation,” it said.
It said that there should be an oversight committee to monitor such trials and directed the Centre to file an affidavit by September 24 after consulting state governments.
Additional Solicitor General Siddharth Luthra submitted that the Centre is considering making amendments in the Drugs and Cosmetics Act by introducing penal provision for any violation.
Earlier, the apex court had said that uncontrolled clinical trial of drugs by multinational companies was creating “havoc” and slammed the Centre for failing to stop the “rackets” which caused deaths.
Observing that the Government has slipped into “deep slumber” in addressing this “menace”, the court had earlier ordered that all drug trials will be done under the supervision of the Union Health Secretary.
In an affidavit, the Centre had admitted that 2,644 people died during clinical trials of 475 new drugs between 2005 to 2012.
“Serious adverse events of deaths during the clinical trials during the said period were 2,644, out of which 80 deaths were found to be attributable to the clinical trials,” the affidavit had said.
Additional inputs curtsy The Hindu Dated July 26, 2013
A. Amendment vide Gazette Notification G.S.R. 53 (E) dated 30-01-2013 specifying procedures to analyze the reports of Serious Adverse Events occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death as per prescribed timelines.
B. Amendment vide Gazette Notification G.S.R. 63(E) dated 01-02-2013 specifying various conditions for conduct of clinical trials, authority for conducting clinical trial inspections and actions in case of non-compliance.
C. Amendment vide Gazette Notification G.S.R No. 72(E) dated 08.02.13 specifying requirements and guidelines for mandatory registration of Ethics Committee.
The National Institutes of Health (NIH), have raised concerns about how these new requirements will be implemented, particularly the specific provision related to compensation.NIH have suspended enrolment of participants in 35 interventional trials in India. This will, however, not affect this country’s health programme and domestic pharma industry.
The drug trial policy has been evolving in course of time. Government has been trying to strengthen the regulatory mechanism to ensure proper drug trials.
This information was given by the Union Minister of Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the Rajya Sabha yesterday.
Clinical trials of untested drugs on humans require certain mandatory standards to be followed, the Supreme Court said on Friday while directing the government to put in place a mechanism to monitor them.
The apex court directed the Centre to convene a meeting of Chief Secretaries or Health Secretaries of all the states to frame a law for regulation of clinical trials of drugs by multinational pharma companies.
A bench of justices R.M. Lodha and Madan B. Lokur granted four weeks time to the Centre to convene the meeting and for framing rules.
“Certain standards and protocol should be followed while conducting clinical trials of drugs on humans. We are concerned about human life,” the bench said, asking the Centre to consider suggestions of the National Human Rights Commission on the issue.
“How do you monitor that clinical trial does not result in death and there are no side effects. There should also be proper compensation,” it said.
It said that there should be an oversight committee to monitor such trials and directed the Centre to file an affidavit by September 24 after consulting state governments.
Additional Solicitor General Siddharth Luthra submitted that the Centre is considering making amendments in the Drugs and Cosmetics Act by introducing penal provision for any violation.
Earlier, the apex court had said that uncontrolled clinical trial of drugs by multinational companies was creating “havoc” and slammed the Centre for failing to stop the “rackets” which caused deaths.
Observing that the Government has slipped into “deep slumber” in addressing this “menace”, the court had earlier ordered that all drug trials will be done under the supervision of the Union Health Secretary.
In an affidavit, the Centre had admitted that 2,644 people died during clinical trials of 475 new drugs between 2005 to 2012.
“Serious adverse events of deaths during the clinical trials during the said period were 2,644, out of which 80 deaths were found to be attributable to the clinical trials,” the affidavit had said.
Additional inputs curtsy The Hindu Dated July 26, 2013
