Fortifying Biologics: India’s Regulatory Drive for Manufacturing Integrity

Published March. 1. 2024

India’s health regulator is instituting stringent measures to ensure the integrity of biologic manufacturing processes following their approval. Biologics, essential components of India’s pharmaceutical market and public health strategy, are receiving heightened scrutiny from the Drug Controller General of India (DCGI). The DCGI, in coordination with industry stakeholders, is striving to elevate production standards in line with globally recognized best practices, particularly those endorsed by the World Health Organization (WHO). This move comes as India acknowledges the pivotal role of biologics in addressing healthcare needs and seeks to reinforce its position as a leader in pharmaceutical innovation.

In a recent announcement dated February 28, DCGI Rajeev Raghuvanshi unveiled draft guidelines aimed at aligning India’s biologics industry with international standards. The proposed guidelines, developed through extensive consultation, emphasize adherence to WHO guidelines and prevailing global regulatory frameworks. Stakeholders are encouraged to provide feedback within a specified timeframe, with the DCGI committed to integrating industry input into the final guidance document. This collaborative approach underscores India’s commitment to transparency and excellence in biologic manufacturing.

One significant aspect of the draft guidelines is the introduction of a new category termed “change registration,” signalling a more meticulous approach to oversight. This category mandates the recording of even minor alterations in manufacturing processes, reflecting the regulator’s dedication to ensuring product quality and safety. From adjustments in formulation to facility upgrades, any changes that could potentially impact biologic integrity must be thoroughly documented. Such stringent measures underscore India’s proactive stance in upholding global standards and safeguarding patient welfare in the biologics sector.

The draft guidelines, updated to align with revised Schedule M and global regulatory norms, emphasize the importance of maintaining robust manufacturing practices. By meticulously documenting changes and adhering to stringent quality standards, India aims to bolster confidence in its biologics industry and foster innovation. This initiative not only reinforces India’s commitment to excellence in pharmaceutical manufacturing but also positions the country as a reliable partner in the global healthcare ecosystem. As India continues to evolve its regulatory framework, stakeholders can anticipate a heightened emphasis on quality assurance and patient-centric practices in the biologics sector.

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