India plans to audit clinical trials
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《英国医生杂志》
The Indian government has announced a plan to set up a registry and to audit some clinical trials after being dogged for years by controversies over illegal and unethical trials.
The Indian Council of Medical Research will establish a registry of clinical trials conducted in the country, and drug regulators will scrutinise trials to ensure compliance with ethical guidelines and good clinical practice, officials said last week.
The health ministry has begun training drug inspectors to audit trials, Ashwini Kumar, the Drugs Controller General of India, said.
"But it won't be easy, because we don't have a culture of policing doctors," Mr Kumar said after a two day, closed conference of government officials, industry representatives, and doctors that was called to consider India's capacity for clinical trials.
Nearly 100 trials are currently under way in India as part of international multicentre studies to evaluate drugs, Mr Kumar said. Although India's large numbers of patients and doctors make it an attractive site for trials, experts at the conference warned that the country is largely unprepared for the expected expansion of trials.
"Given the vulnerability of uneducated and poor patients, India has a long way to go in ensuring adequate protection to human subjects," said Falguni Sen, professor of business at Fordham University, New York, who has studied India's clinical trials environment.
A paper circulated by Professor Sen at the conference indicated that India has to strengthen its regulatory mechanisms and infrastructure as well as its human resources if it is to expand clinical trial activities. The industry estimates that India earned about $17m (￡10m; 14m) in revenue through clinical trials in 2003.
A survey by the Indian Council of Medical Research earlier this year showed that one in two institutional ethical committees had a chairman or chairwoman from the parent institution, creating potential for a conflict of interest. Only 40 of 179 committees follow prescribed guidelines.
The council had drafted ethical guidelines for medical research more than five years ago. "But legislation to enforce guidelines and introduce penalties for violation is pending," said Vasantha Muthuswamy, the council's deputy director general.
Over the past decade public sector and private doctors in India have conducted several clinical trials without regulatory approvals.
Between 1998 and 2000 surgeons in a north Indian city injected vascular endothelial growth factor in patients with heart disease ( BMJ 2001;322: 1142). Four years ago government doctors teamed up with a researcher at Johns Hopkins University, Baltimore, Maryland, in an illegal trial of a cancer drug ( BMJ 2001;323: 299).(Ganapati Mudur)
The Indian Council of Medical Research will establish a registry of clinical trials conducted in the country, and drug regulators will scrutinise trials to ensure compliance with ethical guidelines and good clinical practice, officials said last week.
The health ministry has begun training drug inspectors to audit trials, Ashwini Kumar, the Drugs Controller General of India, said.
"But it won't be easy, because we don't have a culture of policing doctors," Mr Kumar said after a two day, closed conference of government officials, industry representatives, and doctors that was called to consider India's capacity for clinical trials.
Nearly 100 trials are currently under way in India as part of international multicentre studies to evaluate drugs, Mr Kumar said. Although India's large numbers of patients and doctors make it an attractive site for trials, experts at the conference warned that the country is largely unprepared for the expected expansion of trials.
"Given the vulnerability of uneducated and poor patients, India has a long way to go in ensuring adequate protection to human subjects," said Falguni Sen, professor of business at Fordham University, New York, who has studied India's clinical trials environment.
A paper circulated by Professor Sen at the conference indicated that India has to strengthen its regulatory mechanisms and infrastructure as well as its human resources if it is to expand clinical trial activities. The industry estimates that India earned about $17m (￡10m; 14m) in revenue through clinical trials in 2003.
A survey by the Indian Council of Medical Research earlier this year showed that one in two institutional ethical committees had a chairman or chairwoman from the parent institution, creating potential for a conflict of interest. Only 40 of 179 committees follow prescribed guidelines.
The council had drafted ethical guidelines for medical research more than five years ago. "But legislation to enforce guidelines and introduce penalties for violation is pending," said Vasantha Muthuswamy, the council's deputy director general.
Over the past decade public sector and private doctors in India have conducted several clinical trials without regulatory approvals.
Between 1998 and 2000 surgeons in a north Indian city injected vascular endothelial growth factor in patients with heart disease ( BMJ 2001;322: 1142). Four years ago government doctors teamed up with a researcher at Johns Hopkins University, Baltimore, Maryland, in an illegal trial of a cancer drug ( BMJ 2001;323: 299).(Ganapati Mudur)