NEW DELHI: Union Health Minister JP Nadda on Monday inaugurated the 19th International Conference of Drug Regulatory Authorities and said that the ICDRA platform provides a space to share knowledge, foster partnerships and develop regulatory frameworks that ensure quality of medical products worldwide.
The event, being hosted for the first time in India, is being held from October 14 to 18 by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, in collaboration with the World Health Organization (WHO). It has brought together regulatory authorities, policymakers, and health officials from over 194 WHO member states.
Addressing the gathering, Nadda emphasized on the shared commitment for enhancing global healthcare standards and safeguarding public health.
He highlighted that during the unprecedented COVID 19 pandemic, India emerged not only as a global leader in health resilience and innovation but also reaffirmed its role as the pharmacy of the World.
"India rapidly expanded its healthcare infrastructure and scaled up vaccine production to meet both domestic and global demands. The successful rollout of the COVID-19 vaccination program, covering over a billion people, is a testament to the robustness of our healthcare system, the dedication of our health workers, and the soundness of our policies," he said.
The Union Health Minister highlighted that India played a crucial role in ensuring affordable access to essential medicines, vaccines, and medical supplies for nations across the globe.
"Guided by the principle of ' Vasudhaiva Kutumbakam ' - the world is one family, we extended our support to more than 150 countries, providing life-saving drugs and vaccines during the pandemic. This spirit of international solidarity is at the heart of India's approach to global health. We believe that our progress is inseparable from the progress of the world, and as such, we remain committed to contributing to global health security and sustainability," he said.
"ICDRA platform provides a space to share knowledge, foster partnerships, and develop regulatory frameworks that ensure the safety, efficacy, and quality of medical products worldwide," he added.
Highlighting the achievements of CDSCO, Nadda said that "it has developed robust systems for approving safe and efficacious drugs and medical devices in the country and for export to more than 200 countries in the world".
Availability of Quality medicine at affordable price is at the core, he said.
He said eight mini testing labs are operational at different ports for quick testing and release of drugs and raw material being imported.
In addition, 38 State Drug Regulator's Testing Labs are operational. Altogether, more than a hundred thousand samples are being tested every year under regulatory surveillance mechanism, he said.
The Union Minister also stated that more than 95 per cent regulatory processes currently have been digitized at CDSCO, bringing transparency and increasing trust among stakeholders.
"Considering the importance of medical devices in health care delivery, Medical Device industry in India is also being regulated. Drugs Rules have been amended to make Good Manufacturing Practice Guidelines more comprehensive and at par with the WHO-GMP guidelines."
It was also pointed out that in order to make drug supply chain robust, it has been made mandatory to provide Bar Code or Quick Response Code (QR Code) on top 300 brands of drug products. Similarly, QR Code is mandatory on all API packs, either being imported or manufactured in India.
The Union Minister concluded his address by underscoring India's full committed to advancing global health.
"We believe in 3 Ss i.e. "Skill, Speed and Scale" and by focusing on these three aspects, we have been able to meet the increasing demand for pharma products while adhering to global quality standards without any compromise. We are prepared to address pressing challenges, from antimicrobial resistance to ensuring equitable access to life-saving treatments. We are not just participants in this dialogue; we are partners in building a healthier, safer and more resilient world," he said.
Dr Tedros Adhanom Ghebreyesus , Director-General of WHO, in his speech, commended India for hosting this crucial global regulatory forum and highlighted the importance of global cooperation in drug regulation, particularly in light of challenges such as antimicrobial resistance, the post-pandemic world, and the safe use of AI in healthcare.
Dr Saima Wazed, Regional Director, WHO Southeast Asia Region stated that India is the largest provider of generic medicines while the Indian pharmaceutical industry is the third largest in the world.
She noted that India provides over 50 per cent of the world's vaccine demands. She emphasized that a strong regulatory system is crucial to achieving universal health coverage and highlighted the need for strengthened regulatory convergence and information sharing between national regulatory authorities.
Union Health Secretary Punya Salila Srivastava stated that the Indian pharmaceutical industry has recently become the fourth largest export sector of India, exemplifying the level of our integration into the global pharmaceutical supply chain.
"India is the third largest producer of pharmaceuticals in the world, and has the largest number of US FDA-approved plants outside the USA."
She also highlighted that India supplies 50 per cent of the world's vaccines, most of them going to UN agencies like WHO, UNICEF and the Pan American Health Organization (PAHO) and to organisations like GAVI.
Malebona Precious Matsoso, Co-Chair, WHO Intergovernmental Negotiation Body, South Africa, said that regulation of medical products is one of the most crucial aspects today.
"The impact of regulatory decisions is found not only at the national or global level but also in the hospital rooms."
Public health interventions and response can be shortened through efficient regulation and oversight, she said.
Highlighting India as the pharmacy of the world, she said that this tag comes with certain expectations and capacities about India.
She concluded her address by emphasising on smart regulation as opposed to under-regulation and over-regulation.
Dr Rajeev Singh Raghuvanshi , Drugs Controller General of India, highlighted India's achievements in drugs control and medical devices sector, including the approval of India's first CAR T-cell therapy.
"We are continuously upgrading our skills and capacities in our systems and are on a path towards low regulation and high execution," he said.
As a precursor to the main conference, an exhibition was also held which showcased India's innovation, capabilities, and leadership in the pharmaceutical, medical devices, and clinical research sectors. Key industry players, including pharmaceutical giants, medical device manufacturers, and healthcare innovators, presented their advancements and breakthroughs to an international audience of regulators and stakeholders. This exhibition served as a testament to India's standing as the "Pharmacy of the World" and its growing influence in global healthcare, an official release said.
In addition to the main conference sessions, several side meetings will take place, where representatives from various countries will engage in focused discussions on specific regulatory challenges and opportunities.
These meetings will facilitate bilateral and multilateral dialogues on strengthening regulatory systems, promoting innovation, and fostering collaboration to address global health needs.
The event, being hosted for the first time in India, is being held from October 14 to 18 by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, in collaboration with the World Health Organization (WHO). It has brought together regulatory authorities, policymakers, and health officials from over 194 WHO member states.
Addressing the gathering, Nadda emphasized on the shared commitment for enhancing global healthcare standards and safeguarding public health.
He highlighted that during the unprecedented COVID 19 pandemic, India emerged not only as a global leader in health resilience and innovation but also reaffirmed its role as the pharmacy of the World.
"India rapidly expanded its healthcare infrastructure and scaled up vaccine production to meet both domestic and global demands. The successful rollout of the COVID-19 vaccination program, covering over a billion people, is a testament to the robustness of our healthcare system, the dedication of our health workers, and the soundness of our policies," he said.
The Union Health Minister highlighted that India played a crucial role in ensuring affordable access to essential medicines, vaccines, and medical supplies for nations across the globe.
"Guided by the principle of ' Vasudhaiva Kutumbakam ' - the world is one family, we extended our support to more than 150 countries, providing life-saving drugs and vaccines during the pandemic. This spirit of international solidarity is at the heart of India's approach to global health. We believe that our progress is inseparable from the progress of the world, and as such, we remain committed to contributing to global health security and sustainability," he said.
"ICDRA platform provides a space to share knowledge, foster partnerships, and develop regulatory frameworks that ensure the safety, efficacy, and quality of medical products worldwide," he added.
Highlighting the achievements of CDSCO, Nadda said that "it has developed robust systems for approving safe and efficacious drugs and medical devices in the country and for export to more than 200 countries in the world".
Availability of Quality medicine at affordable price is at the core, he said.
He said eight mini testing labs are operational at different ports for quick testing and release of drugs and raw material being imported.
In addition, 38 State Drug Regulator's Testing Labs are operational. Altogether, more than a hundred thousand samples are being tested every year under regulatory surveillance mechanism, he said.
The Union Minister also stated that more than 95 per cent regulatory processes currently have been digitized at CDSCO, bringing transparency and increasing trust among stakeholders.
"Considering the importance of medical devices in health care delivery, Medical Device industry in India is also being regulated. Drugs Rules have been amended to make Good Manufacturing Practice Guidelines more comprehensive and at par with the WHO-GMP guidelines."
It was also pointed out that in order to make drug supply chain robust, it has been made mandatory to provide Bar Code or Quick Response Code (QR Code) on top 300 brands of drug products. Similarly, QR Code is mandatory on all API packs, either being imported or manufactured in India.
The Union Minister concluded his address by underscoring India's full committed to advancing global health.
"We believe in 3 Ss i.e. "Skill, Speed and Scale" and by focusing on these three aspects, we have been able to meet the increasing demand for pharma products while adhering to global quality standards without any compromise. We are prepared to address pressing challenges, from antimicrobial resistance to ensuring equitable access to life-saving treatments. We are not just participants in this dialogue; we are partners in building a healthier, safer and more resilient world," he said.
Dr Tedros Adhanom Ghebreyesus , Director-General of WHO, in his speech, commended India for hosting this crucial global regulatory forum and highlighted the importance of global cooperation in drug regulation, particularly in light of challenges such as antimicrobial resistance, the post-pandemic world, and the safe use of AI in healthcare.
Dr Saima Wazed, Regional Director, WHO Southeast Asia Region stated that India is the largest provider of generic medicines while the Indian pharmaceutical industry is the third largest in the world.
She noted that India provides over 50 per cent of the world's vaccine demands. She emphasized that a strong regulatory system is crucial to achieving universal health coverage and highlighted the need for strengthened regulatory convergence and information sharing between national regulatory authorities.
Union Health Secretary Punya Salila Srivastava stated that the Indian pharmaceutical industry has recently become the fourth largest export sector of India, exemplifying the level of our integration into the global pharmaceutical supply chain.
"India is the third largest producer of pharmaceuticals in the world, and has the largest number of US FDA-approved plants outside the USA."
She also highlighted that India supplies 50 per cent of the world's vaccines, most of them going to UN agencies like WHO, UNICEF and the Pan American Health Organization (PAHO) and to organisations like GAVI.
Malebona Precious Matsoso, Co-Chair, WHO Intergovernmental Negotiation Body, South Africa, said that regulation of medical products is one of the most crucial aspects today.
"The impact of regulatory decisions is found not only at the national or global level but also in the hospital rooms."
Public health interventions and response can be shortened through efficient regulation and oversight, she said.
Highlighting India as the pharmacy of the world, she said that this tag comes with certain expectations and capacities about India.
She concluded her address by emphasising on smart regulation as opposed to under-regulation and over-regulation.
Dr Rajeev Singh Raghuvanshi , Drugs Controller General of India, highlighted India's achievements in drugs control and medical devices sector, including the approval of India's first CAR T-cell therapy.
"We are continuously upgrading our skills and capacities in our systems and are on a path towards low regulation and high execution," he said.
As a precursor to the main conference, an exhibition was also held which showcased India's innovation, capabilities, and leadership in the pharmaceutical, medical devices, and clinical research sectors. Key industry players, including pharmaceutical giants, medical device manufacturers, and healthcare innovators, presented their advancements and breakthroughs to an international audience of regulators and stakeholders. This exhibition served as a testament to India's standing as the "Pharmacy of the World" and its growing influence in global healthcare, an official release said.
In addition to the main conference sessions, several side meetings will take place, where representatives from various countries will engage in focused discussions on specific regulatory challenges and opportunities.
These meetings will facilitate bilateral and multilateral dialogues on strengthening regulatory systems, promoting innovation, and fostering collaboration to address global health needs.
