India’s Drug Regulatory Framework Meets Global Standards

The Drugs Controller General of India (DCGI) leads the Central Drugs Standard Control Organisation (CDSCO), the Drug Regulatory Authority under the Ministry of Health & Family Welfare (MoHFW), Government of India. Tasked with ensuring the safety, efficacy, and quality of medicinal products, the CDSCO oversees drug approvals, clinical trials, and coordination with state drug control organisations under the Drugs and Cosmetics Act, 1940.

In an exclusive conversation with Double Helical, Dr Rajeev Raghuvanshi, the DCGI, delves into the strides made in enhancing the quality of Indian medicines, the collaborative role of regulatory bodies, and initiatives aimed at aligning Indian pharmaceutical standards with global benchmarks.

Excerpts from the Interview:

How do you ensure the quality and safety of Indian medicines?
At CDSCO, quality and safety are at the core of our regulatory framework. We rigorously review clinical trial applications for new drugs, investigational new drugs, and imported drugs. Standards for manufacturing, sale, import, and distribution are established under the Drugs and Cosmetics Act, 1940 and monitored stringently.
We conduct monthly testing of 2,000 to 3,000 drug samples from the market. Medicines failing any quality parameter are flagged and listed on our official website. This ensures transparency and accountability. Furthermore, we adhere to the quality standards outlined in the Indian Pharmacopoeia (IP), which is regularly updated to meet international norms.
India’s contribution as the world’s largest supplier of generic drugs and vaccines reflects our adherence to these standards. Over 50 per cent of the global vaccine demand is met by India, underscoring the robustness of our regulatory mechanisms. However, maintaining such high standards requires continuous collaboration between the CDSCO and state-level regulatory agencies, along with periodic training and capacity-building efforts.

Q: Could you explain the structure of India’s drug regulatory system?
India’s drug regulatory framework operates through a dual structure: the CDSCO and 36 state-level regulatory agencies.
The CDSCO primarily handles new drug approvals, clinical trials, and the regulation of imported medicines. Meanwhile, state authorities oversee the licensing for manufacturing, sale, and distribution of drugs. A critical role of these state bodies is conducting regular inspections to prevent the production and distribution of spurious or adulterated drugs. This two-tiered system ensures checks and balances across the pharmaceutical supply chain.
Additionally, efforts are underway to enhance collaboration between central and state agencies to strengthen the monitoring of drug quality and compliance with regulatory norms.

The International Conference of Drug Regulatory Authorities (ICDRA) was successfully held under your leadership. What were the key outcomes?
The recent ICDRA, themed “Smart Regulation: Delivering Quality Assured Medical Products for All,” was a milestone event. It brought together regulatory authorities from most of the World Health Organization (WHO) member states, fostering collaboration and building international consensus on key regulatory priorities.
The conference provided a unique platform to exchange best practices, promote regulatory reliance, and harmonise practices across nations. Union Health and Family Welfare Minister, Shri J P Nadda who inaugurated the event, highlighted the importance of such events in ensuring the timely availability of safe, effective, and affordable medical products.
One of the significant outcomes was the emphasis on capacity building and trust among regulatory authorities to enable regulatory convergence. This is essential for ensuring quality healthcare worldwide, especially in today’s dynamic and innovation-driven pharmaceutical sector.

With India being a global leader in pharmaceuticals, what are your priorities for the future?
Our primary focus is on ensuring that Indian pharmaceuticals meet global standards consistently. This includes capacity building among regulators and manufacturers, promoting innovation in dosage form design, and enhancing audit processes.
We also aim to strengthen pharmacovigilance, foster research and development, and streamline clinical trial approvals. By integrating advanced technologies and fostering collaboration at both domestic and international levels, we can maintain India’s position as a trusted global supplier while addressing emerging challenges in the pharmaceutical sector.
India’s pharmaceutical industry stands at a pivotal moment. The initiatives we are undertaking today will ensure a safer, more efficient, and globally competitive future for Indian healthcare

What was the role of the DGCI during Covid-19?
During the Covid-19 pandemic, MoHFW, the Directorate General of Health Services (DGHS) and the regulatory ecosystem, including the DCGI, faced the enormous challenge of ensuring the timely availability of safe and effective medicines to patients amidst global disruptions. The healthcare system encountered significant difficulties in maintaining a consistent supply of Covid-19-related drugs, which necessitated innovative measures to address the crisis.
The Indian Pharmacopoeia Commission (IPC), a critical partner in this effort, introduced an important general chapter titled ‘Approach to Alternative Microbiological Methods’. This guidance document provided stakeholders with the framework to adopt alternatives to traditional microbiological methods, enabling faster batch releases of critical Covid-19 medicines while maintaining quality standards.

You mentioned Pharmacopoeia. Could you elaborate?
A pharmacopoeia is an authoritative compendium of drug quality standards, providing detailed information about medicines’ quality specifications including their identification, limits of quality parameters, method of analysis etc. Typically revised every four years, it serves as a legally enforceable document to ensure the quality of medicines.
The IP is the official standard for medicines sold in India. Its ninth edition, published in 2022, became effective from December 1, 2022, and has been lauded globally as one of the most comprehensive editions to date. This edition introduced 92 new monographs, encompassing 60 chemical monographs, 21 monographs on vitamins, minerals, amino acids, and fatty acids, among others. Furthermore, it added 12 new general chapters, including critical updates on dosage uniformity and clarification of key methodologies such as IP General Chapter 2.5.4(i).
The 2022 edition reflects India’s commitment to aligning with global standards while addressing unique domestic pharmaceutical challenges. It has been widely appreciated for its detailed guidelines, which bolster the safety, efficacy, and quality of medicines in the Indian market.
Additionally, the IPC introduced a general requirement for ‘Phytopharmaceuticals’, providing much-needed operational clarity for defining this unique class of drugs in the context of modern pharmacology.

Further advancements included a new general chapter on ‘Elemental Impurities,’ designed to guide stakeholders on the detection and management of such impurities in pharmaceutical products. While this chapter was not immediately made mandatory for individual monographs, it served as an alternative to traditional heavy metal tests under the provisions of the IP General Notices. The IPC aims to progressively integrate these standards, making them mandatory in future editions of the IP. Another significant addition was the general chapter on ‘Nitrosamine Impurities,’ offering critical guidance for detecting and addressing these impurities in marketed pharmaceutical products, thereby enhancing drug safety.

The Indian pharmaceutical market has faced criticism for quality issues recently. How is this being addressed?
The regulatory framework in India is robust, and stringent measures are undertaken to address instances of non-compliance. When manufacturers fail to meet the quality and regulatory parameters established by the CDSCO, immediate corrective actions are implemented.
These actions include recalling substandard drugs from the market, conducting comprehensive mapping of the supply chain to trace affected products, and initiating show-cause notices to manufacturers. Depending on the severity of non-compliance, regulatory authorities may also recommend further punitive measures. Such proactive interventions aim to uphold public trust in the pharmaceutical system while ensuring patient safety. The commitment to enforcing quality standards underscores the regulators’ dedication to maintaining the integrity of the Indian pharmaceutical industry, even amidst challenges.

From Research to Industry Leadership

Dr Rajeev Singh Raghuvanshi’s illustrious career reflects a seamless blend of academic excellence, innovative research, and impactful leadership in the pharmaceutical industry. A graduate of the prestigious IIT-BHU, Varanasi, he earned his bachelor’s and master’s degrees before pursuing a PhD at the National Institute of Immunology, New Delhi. His doctoral research focused on the development of Extended Release Vaccine Formulations, an innovative approach aimed at reducing the number of injections required for complete immunisation—a significant step toward improving vaccine compliance and accessibility.

After completing his PhD, Dr Raghuvanshi served at the National Institute of Immunology for seven years, contributing to cutting-edge research. He then transitioned to the private sector, joining Ranbaxy Laboratories Ltd., one of India’s leading multinational pharmaceutical companies. Over the course of twelve years at Ranbaxy, he played a significant role in the development, registration, and launch of Novel Drug Delivery Systems (NDDS), generics, and branded generics across multiple global markets. His tenure at Ranbaxy not only underscored his technical expertise but also showcased his ability to navigate the regulatory landscapes of various countries, enabling successful market entries.

Building on this success, Dr Raghuvanshi moved to Dr Reddy’s Laboratories Ltd., Hyderabad, where he spent the next eleven years in diverse roles. For the first eight years, he led the Chemistry, Manufacturing, and Controls (CMC) teams in the development of 505(b)(2) NDA products for the US market. Under his leadership, the company achieved first-cycle approvals for six products by the USFDA, an exceptional feat in the highly competitive pharmaceutical sector. These accomplishments required not only scientific rigor but also strategic coordination with regulatory agencies such as the USFDA, with whom he had multiple face-to-face interactions. Additionally, he engaged with regulatory bodies from countries like the UK, South Korea, Sweden, and Romania, further solidifying his global credentials.

The latter part of his tenure at Dr Reddy’s Laboratories marked a shift in focus, as he spearheaded the establishment of an R&D team dedicated to emerging markets, including India, China, and Russia. This role demanded an acute understanding of the unique pharmaceutical landscapes of these regions and involved innovation in product differentiation, regulatory registrations, and successful launches. His efforts ensured that the company maintained a competitive edge in markets characterised by distinct regulatory and consumer dynamics.

Dr Raghuvanshi’s contributions extend far beyond corporate achievements. He has been instrumental in the development of more than 200 pharmaceutical products, many of which are currently being marketed in India, the US, Europe, and other emerging economies. His ingenuity is further reflected in his intellectual property portfolio, which includes 19 granted US patents and over 250 published patents across PCTs and Indian filings. In addition to his contributions to product development, he has co-authored six book chapters and published more than 60 articles in peer-reviewed journals, thereby enriching the scientific literature in his field.

A passionate advocate for leadership development, Dr Raghuvanshi has mentored numerous professionals who now hold senior positions in leading pharmaceutical companies worldwide. His commitment to knowledge sharing is evident in his role as a visiting faculty member at esteemed institutions such as NIPER-Hyderabad and IIT-BHU, as well as his engagements at NIPER-Mohali, where he has taught and inspired future industry leaders. He is also a sought-after speaker at international and national conferences, where his insights on pharmaceutical innovation and regulatory science have earned widespread acclaim.

For his outstanding contributions to the pharmaceutical industry, Dr Raghuvanshi has been recognised with numerous accolades, including the prestigious Dr Reddy’s Excellence Award, which he received twice.

After a very successful career with corporate pharma, he decided to do something completely different which is socially more impactful. Of many possibilities, he chose to work with the Government of India and joined the MoHFW as Secretary-cum-Scientific Director of Indian Pharmacopoeia Commission on 16 February 2021. In a short stint of two years, he changed the face of IPC and bought multiple long lasting changes impacting quality standards for medicines being sold in India. Cultural shift to more open and receptive organisation scaling up the Impurity Standards inventory, harmonisation of quality specification with ICH and other global standards, increasing user base for IP and IPRS, PDG membership for IP, international recognitions and scaling up of Pharmacovigilance and Materiovigilance program of India are some of them. Dr Raghuvanshi’s vision, expertise, and leadership continue to shape the pharmaceutical landscape, both in India and globally, reinforcing his status as a transformative figure in the sector.