The government will soon make it mandatory for all firms involved in clinical research to maintain minimum quality standards and register themselves with the country’s drug regulator, a health ministry official said.
Once the law is implemented, the names of all the approved clinical research organisations (CROs) in the country will be uploaded on the website of Drug Controller General of India (DCGI). A violation of the norms could lead to the firm being barred from conducting clinical studies in India.
“It will weed out fly-by-night CROs,” said the official requesting anonymity. The health ministry will notify the amendment soon and the government inspectors then will start random audits to ensure the requisite standards are maintained, he said.
Several inspectors at the DCGI have been trained by the US Foods and Drug Administration to audit CROs.
The country’s highest technical body on medicines, Drug Technical Advisory Board, has approved an amendment to the Drugs and Cosmetics Act to make CRO registrations compulsory.
According to consultancy firm KPMG’s pharma analyst Hitesh Gajaria, the move is a step in the right direction but it must be effectively implemented. “This will regulate the entire clinical protocols, ethical norms and other practises,” he said. At present, there are 40-50 CROs in the country, a number that is increasing steadily.
CROs typically provide research services to drug companies in developing medicines, especially the clinical trials. They also liaison with hundreds of hospitals and clinics in the country who conduct clinical trials for Indian and global pharma companies.
India’s clinical research market is estimated at $300 million and growing at over 30% annually, thanks to the diversified gene pool and lower cost of clinical studies compared to developed markets. Although, Indian CROs are regarded highly in the global pharma industry, the local industry has remained largely unregulated.
Social groups have also occasionally raised concern about mandatory protocols not being followed during clinical trials and Indian patients being used as cheap targets.
The government’s move comes within weeks of Parliament passing the Clinical Establishments Bill, 2010 making registrations of all clinical establishments in the country, such as hospitals and clinics, mandatory.
Once the law is implemented, the names of all the approved clinical research organisations (CROs) in the country will be uploaded on the website of Drug Controller General of India (DCGI). A violation of the norms could lead to the firm being barred from conducting clinical studies in India.
“It will weed out fly-by-night CROs,” said the official requesting anonymity. The health ministry will notify the amendment soon and the government inspectors then will start random audits to ensure the requisite standards are maintained, he said.
Several inspectors at the DCGI have been trained by the US Foods and Drug Administration to audit CROs.
The country’s highest technical body on medicines, Drug Technical Advisory Board, has approved an amendment to the Drugs and Cosmetics Act to make CRO registrations compulsory.
According to consultancy firm KPMG’s pharma analyst Hitesh Gajaria, the move is a step in the right direction but it must be effectively implemented. “This will regulate the entire clinical protocols, ethical norms and other practises,” he said. At present, there are 40-50 CROs in the country, a number that is increasing steadily.
CROs typically provide research services to drug companies in developing medicines, especially the clinical trials. They also liaison with hundreds of hospitals and clinics in the country who conduct clinical trials for Indian and global pharma companies.
India’s clinical research market is estimated at $300 million and growing at over 30% annually, thanks to the diversified gene pool and lower cost of clinical studies compared to developed markets. Although, Indian CROs are regarded highly in the global pharma industry, the local industry has remained largely unregulated.
Social groups have also occasionally raised concern about mandatory protocols not being followed during clinical trials and Indian patients being used as cheap targets.
The government’s move comes within weeks of Parliament passing the Clinical Establishments Bill, 2010 making registrations of all clinical establishments in the country, such as hospitals and clinics, mandatory.
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