Dr. Rajeev Singh Raghuvanshi, Drug Controller General of India, Head of CDSCO
While speaking at the 19th International Conference of Drug Regulatory Authorities, the Drug Controller General of India, Dr. Rajeev Singh Raghuvanshi, spoke at length on how India is playing a significant role in the global healthcare ecosystem, how it is evolving in regulatory systems, clinical trials, and commitments to supplying high-quality, affordable medicines to more than 200 countries. Following are the key insights from his address.
India holds an important position in the global healthcare market by exporting drugs, vaccines, and medical devices to over 200 countries. Building international partnerships and maintaining trust are the most important factors in the global healthcare value chain. Based on a commitment to providing support to public health throughout the world, India is a reliable partner with its healthcare contributions. This global reach also means we need to live up to the highest standards of quality and safety and India has risen to the responsibility of improving its regulatory frameworks and healthcare capabilities over time. This ongoing dedication by the country ensures that it plays an integral role in the global public health landscape.
Recent progress in India’s drug regulatory system has been marked by its MF3 designation after the National Regulatory Authority (NRA) gave it the nod. This recognition by international regulatory bodies is an acknowledgment of how India has taken strides in regulatory reforms and its adherence to stringent global standards. The process was difficult, but India came out victorious, meeting international expectations. The nation’s determination to safeguard the safety, efficacy, and quality of its healthcare products reflects the nation’s global credibility. Additionally, the continued improvements to India’s regulatory system are a reflection of how it continues to develop its world-class healthcare solutions.
As a big milestone for India’s growing medical device industry, India gained associate membership in the International Medical Device Regulators Forum (IMDRF). This is important to the medical device sector of the country which is still in its infancy and has huge potential. IMDRF recognition of Indian commitment to aligning its medical device regulation to international standards is welcome news that will open the door to further collaboration and market expansion. The validation of the progress made in India’s regulatory landscape as well as the importance of the role India plays in the global medical device industry also comes through this membership.
India’s pharmaceutical sector has achieved a major feat with the induction of the Indian Pharmacopeia into the prestigious Pharmaceutical Discussion Group along with United States Pharmacopeia (USP), European Pharmacopeia, and Japanese Pharmacopeia. India has become one of the leaders in global pharmaceutical standards, and the inclusion of India in the list shows how much influence India is growing. A testament to the growing standing of the Indian Pharmacopeia is that it has already been adopted as the standard by eleven countries. This achievement marks India’s stepping out of the role of a cost-effective medicines supplier to become a driver of pharmaceutical standards development and regulation. The recognition provides India the credibility to continue as a global player in quality healthcare.
We are witnessing growing confidence from the international research organizations in India’s clinical trial ecosystem, approving around 100 local clinical trials a year. This trust in India’s regulatory processes is growing and reflects the strength of that framework and its ability to process complicated and cutting-edge medical research. In this regard, the National Regulatory Authority (NRA) has acted proactively in approving advanced technology-based products such as CAR T-cell therapy, mRNA vaccines, and software as medical devices. The approvals indicate that India is not just a part of the global healthcare industry but is also leading the development and regulation of next-generation medical therapies.
Recently, India implemented a pioneering policy that streamlines the country’s medical product approval system for approved products from six designated countries. India will not require separate clinical trials for approvals of products from five specific categories if the regulatory authorities of these countries approve them. It represents a big step toward faster and more efficient approvals for innovative therapies. This shows India’s resolve to speed up the introduction of the best available advanced treatments for its people while abiding by global best practices. India is saving resources by rationalizing its regulatory approach and is focusing its efforts on high-value work.
The evolution of India’s healthcare has been from being a provider of cheap medicines to being a leader in setting quality standards globally. Today, India not only provides medicines at prices that are affordable for everyone but also reference materials and standards of the highest quality for the global healthcare community. Now the country's contributions include capacity building in areas such as pharmacovigilance and quality management besides drug production. India also boasts some of the most highly trained healthcare professionals in the world, who are now highly sought after around the globe, acting as a prime example of the nation’s future role in shaping global healthcare. This is an expansion of expertise that points out India’s continued pledge to raise the bar in healthcare quality and safety.
While India is still at the developing stage, it has done the groundwork for the future of global healthcare, where India’s continued advancements in regulatory policies and healthcare standards are evident. India, with streamlined regulatory processes, skilled upgradation, and being a partner in international collaborations, is well poised to contribute substantially towards shaping the future of the global supply chain for healthcare. With its long-term vision of contributing to more sustainable global healthcare, its efforts are aimed at providing high-quality medicines, materials, and training services all over the world. With these successes in India, the country will likely continue to be an integral player in global healthcare, giving India and its international partners a significant benefit.
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