Summary: The CDSCO’s Draft Guidance on Medical Device Software only clarifies how the existing Medical Devices Rules apply to software across its lifecycle, but does not create any new regulatory requirements. Its significance lies in signalling a more structured, risk-based and lifecycle-oriented approach to regulating software-driven healthcare products in India.Continue Reading Medical Device As Software: Has CDSCO Guidance Changed The Rules?
In Part 1 of the CRISPR blogpost series, we outlined the science behind CRISPR technology and also illustrated its current and potential uses in India. As previously discussed, CRISPR technology, being a genetic engineering method, poses some serious concerns. These concerns are largely ethical, social, and safety related. Hence, it is pertinent to understand the regulatory regime for CRISPR in India. In this blog post, we have outlined the regulatory regime for genetic engineering in India, with special focus on CRISPR technology.Continue Reading CRISPR, The New Gold Standard?Understanding The Rise Of Genetic Engineering In India – Part 2
In the intricate ecosystem of global healthcare, the trust between doctors and patients forms the bedrock of ethical practice. A growing number of Indian healthcare service providers are integrating digital health technologies into their business development initiatives and operational framework, leading to an unsettling trend. Several such healthcare providers now deploy offline and online resources to set up and maintain incentive-driven patient referral networks through collaboration and partnership arrangements with healthcare institutions and practicing doctors. These arrangements are designed to attract new patients through referrals from doctors, pharmacists, and healthcare workers, who are then adequately compensated with merchandise, coupons, gifts, travel facilities and grants. This intersection of medicine and commerce raises profound ethical and legal questions, challenging the integrity of the medical profession and the sanctity of patient care.Continue Reading Rx for Referrals: Navigating the Ethical Considerations in India’s Medical Landscape