Why do space-manufactured therapeutics require a harmonised international regulatory framework? How can India’s CDSCO adapt to these emerging biotechnology challenges?

Space-manufactured therapeutics are made in microgravity, where proteins may crystallise better and cell growth can differ from Earth. But these products also face unclear rules on quality, safety, shelf-life and legal jurisdiction.

• Why harmonised rules are needed: terrestrial drug laws do not fully cover microgravity, radiation exposure, remote manufacturing and cross-border launch-sale chains.
• Quality assurance: shared standards are needed for validation, reproducibility, potency and impurity control.
• Jurisdiction: clarity is required on which country regulates manufacture, trial, approval and post-market surveillance.
• Global confidence: common norms will support collaboration, faster approvals and acceptance of products across markets.

India’s CDSCO can adapt by creating a dedicated pathway for space and other advanced biologics, using a risk-based approach, and issuing clear guidance on microgravity-specific data requirements. It should build expertise in regulatory science, work closely with DBT, ICMR and global forums, and strengthen long-term safety follow-up, ethics review and manufacturing oversight.

A flexible but strict framework will protect patients while encouraging innovation in next-generation therapeutics.