Dear Readers, we are happy to share the most interesting legal and policy updates concerning health industry that we read today. We hope you enjoy reading it.
1. India’s central drug authority has released guidance to identify spurious drugs under the Drugs Rules, 1945. Earlier, the rules mandated QR codes on all APIs from January 2023 and barcodes or QR codes on the top 300 drug brands from August 2023. The authority has now issued a process flow to verify drug authenticity.
Source : https://short-url.org/1gVQq
2. India’s Central Drug Regulator has allowed manufacturers to apply for Certificate of Pharmaceutical Product/World Health Organization – Good Manufacturing Practices (COPP/WHO-GMP) certificates while product license applications are under review by the State Licensing Authority. Final COPP/WHO-GMP certificate will be issued after product approval.
Source: https://short-url.org/1gVUB
3. India’s central government has proposed the Assistive Technology (Standards and Accessibility) Rules, 2025, requiring all assistive devices to meet Bureau of Indian Standards quality standards. The draft ensures transparent procurement, financial aid, repair support, and a toll-free helpline, with an online Assistive Technology Portal for device certification, supply tracking, and grievance redressal.
Source: https://short-url.org/1ceKb
4. The Food Safety and Standards Authority of India has kept the spice enforcement drive (whole & powder) in abeyance until further orders. All state food safety commissioners and regional directors have been instructed not to initiate any action under the earlier directive until further instructions.
Source:
https://short-url.org/1ceKS
https://short-url.org/1gVSp
5. The US Food and Drug Administration (FDA) is seeking public input on evaluating AI-enabled medical devices, including generative AI tools. The aim is to enhance patient outcomes, public health, and accelerate medical innovation, while regulating these advanced technologies
Source: https://short-url.org/1ceLs