Indian pharmaceuticals have grown exponentially to become the world’s third largest by volume, exporting to over 200 countries. With a market value of $50 billion, it’s projected to grow to $120-130 billion within the next decade. Amidst this growth, the importance of quality assurance (QA) cannot be overstated.

To provide high-quality pharmaceuticals to international markets, our quality standards must ensure product safety, efficacy, and compliance at par with global standards.

India has made notable breakthroughs in vaccine research, innovative cancer treatment, GLP-1 drugs for obesity, gene therapy for rare diseases, and new Alzheimer’s treatments. However, challenges remain.

Inadequate regulatory supervision can lead to oversight lapses, and combating counterfeit pharmaceuticals requires government and industry cooperation. Addressing these issues and focusing on advanced quality control can firmly establish India as a reliable supplier of affordable, quality medicines.

Pharmaceutical quality assurance in India is undergoing a transformation driven by regulatory support, technological advancements, and a growing focus on sustainability. The revised Schedule M requires a Pharmaceutical Quality System (PQS) and mandates WHO-GMP certification.

In response to Revised Schedule M and WHO-GMP, the Department of Pharmaceuticals (DoP) announced the Revamped Pharmaceuticals Technology Upgradation Assistance (RPTUAS).

Facility upgrades

This scheme incentivises facility upgrades for smaller players with turnovers of less than ₹50 crore, providing higher incentives, while those with higher turnovers receive slightly lesser percentages.

Upgradation of testing labs is also covered under this scheme. State governments can further incentivise with top-ups to enhance the viability of their industrial areas/SEZs.

Cutting-edge technologies like smart sensors, advanced analytics, and automation are making quality assurance more efficient and effective. Cybersecurity and sustainability have become integral components of robust QA practices, ensuring the security of digital systems and minimizing the environmental impact of production processes. Collaborative research partnerships between academia and industry are fostering innovation in QA practices. Government initiatives such as the Production Linked Incentive Scheme (PLI), MedTech Policy, and Pharmaceutical Research and Innovation Platform (PRIP) are pivotal in this transformation.

Continuous monitoring and rigorous testing ensure accuracy and efficiency in QA. Big data and advanced analytics enable real-time monitoring and early issue detection.

The pharmaceutical industry must uphold high QA standards while adapting to new technologies, workforce trends, globalization, and growing healthcare demands, ensuring consistent quality across diverse markets for long-term success.

Future Perspectives

Ongoing technological advancements significantly influence the future of quality assurance (QA) within the pharmaceutical industry. Cloud-based solutions, AI, automation, and predictive analytics will continue reshaping QA processes, progressively enhancing efficiency and efficacy. Industry stakeholders must integrate emerging technologies, emphasizing scalability and compliance.

Collaborative endeavours between governmental bodies and industry entities are poised to play a pivotal role in this integration, providing support and resources to foster continued innovation. Cooperative research and development initiatives and cloud-based solutions will propel QA growth, ensuring its resilience and adaptability to the evolving demands of the pharmaceutical sector.

The writer is Director, NIPER, Raebareli