India Elevates Drug Regulation: New Rules Enhance Global Research Standards
Wednesday, 16 October 2024, 16:53 IST
New drug rules and regulatory procedures introduced in India have promoted scientific and ethical research at par with global expectation and international practices, the government said.
Union Minister of State for Health and Family Welfare, Anupriya Singh Patel said in her key-note address that the conference is crucial in sharing knowledge, building partnerships, and working in harmonisation to ensure safe and effective medicines for everyone at the 19th International Conference of Drug Regulatory Authorities (ICDRA) held in the national capital.
According to the minister, "Our efforts can result in better health outcomes for people all over the world. The ICDRA is not merely a conference but an opportunity for us to collaborate and innovate together and support one another in our collective mission towards better health for all".
CDSCO is hosting the conference in India for the first time in collaboration with WHO.
Country has introduced New Drugs and Clinical Trial Rules 2019 and Medical Device Rules 2017.According to the minister, the new medical device rules in India include risk-based classification to bring all devices under regulation through registration, and framing of a regulatory pathway.
There is robust preapproval and postapproval regulatory procedures of all medical devices, diagnostics managing product lifecycle that indicates robust control. We are collaborating with international organizations such as the International Medical Device Regulators Forum (IMDRF), ISO, WHO and regional network like SEARN (South-East Asia Regulatory Network) to harmonise regulatory requirements in the area of medical devices and diagnostics, Patel said during the gathering.
It has now been recognized that India is an affiliate member of IMDRF.
"Recognition of Indian Pharmacopoeia by the Pharmacopoeial Discussion Group (PDG) is another milestone marking the harmonisation and recognition of regulatory standards", the minister informed.
Speaking about the commitment of the Centre towards healthcare, the minister said that programmes like Ayushman Bharat make available quality health care for over 500 million people.
Dr VK Paul, Member (Health), NITI Aayog, said "quality medicines improve the quality of life, human productivity as well as the way of life."
He emphasized that a lot of efforts are being taken on the healthcare sector by the present government. He cited the launch of the world's largest health assurance scheme and a massive effort being taken in the digital health.Dr Paul conveyed that India approved eight vaccines for use during the pandemic through a proper regulatory process.
Dr Rajiv Bahl, Secretary, Department of Health Research and DG, ICMR, in an interview stated that within three months from the "declaration of pandemic," India had developed indigenous tests at one-fortieth of the cost.
"Similarly, within nine months of the pandemic, India approved a Covid-19 vaccine," he said, adding that three diagnostic tests have also been developed for MPox which were approved by CDSCO.
Assistant Director-General, WHO, Dr Yukiko Nakatini noted that one urgent need highlighted by the pandemic was the need for a strong regulatory system.
Dr Yukiko also congratulated India for its achievement of retaining 'Maturity level III' for vaccine regulation.
Union Minister of State for Health and Family Welfare, Anupriya Singh Patel said in her key-note address that the conference is crucial in sharing knowledge, building partnerships, and working in harmonisation to ensure safe and effective medicines for everyone at the 19th International Conference of Drug Regulatory Authorities (ICDRA) held in the national capital.
According to the minister, "Our efforts can result in better health outcomes for people all over the world. The ICDRA is not merely a conference but an opportunity for us to collaborate and innovate together and support one another in our collective mission towards better health for all".
CDSCO is hosting the conference in India for the first time in collaboration with WHO.
Country has introduced New Drugs and Clinical Trial Rules 2019 and Medical Device Rules 2017.According to the minister, the new medical device rules in India include risk-based classification to bring all devices under regulation through registration, and framing of a regulatory pathway.
There is robust preapproval and postapproval regulatory procedures of all medical devices, diagnostics managing product lifecycle that indicates robust control. We are collaborating with international organizations such as the International Medical Device Regulators Forum (IMDRF), ISO, WHO and regional network like SEARN (South-East Asia Regulatory Network) to harmonise regulatory requirements in the area of medical devices and diagnostics, Patel said during the gathering.
It has now been recognized that India is an affiliate member of IMDRF.
"Recognition of Indian Pharmacopoeia by the Pharmacopoeial Discussion Group (PDG) is another milestone marking the harmonisation and recognition of regulatory standards", the minister informed.
Speaking about the commitment of the Centre towards healthcare, the minister said that programmes like Ayushman Bharat make available quality health care for over 500 million people.
Dr VK Paul, Member (Health), NITI Aayog, said "quality medicines improve the quality of life, human productivity as well as the way of life."
He emphasized that a lot of efforts are being taken on the healthcare sector by the present government. He cited the launch of the world's largest health assurance scheme and a massive effort being taken in the digital health.Dr Paul conveyed that India approved eight vaccines for use during the pandemic through a proper regulatory process.
Dr Rajiv Bahl, Secretary, Department of Health Research and DG, ICMR, in an interview stated that within three months from the "declaration of pandemic," India had developed indigenous tests at one-fortieth of the cost.
"Similarly, within nine months of the pandemic, India approved a Covid-19 vaccine," he said, adding that three diagnostic tests have also been developed for MPox which were approved by CDSCO.
Assistant Director-General, WHO, Dr Yukiko Nakatini noted that one urgent need highlighted by the pandemic was the need for a strong regulatory system.
Dr Yukiko also congratulated India for its achievement of retaining 'Maturity level III' for vaccine regulation.
