Improvements in India’s Public Health
India’s National Health Mission (NHM) has made substantial strides in improving public health outcomes over the past three years, focusing on expanding healthcare human resources, addressing critical health challenges, and strengthening the healthcare system’s response to emergencies like the COVID-19 pandemic.
Draft Guidelines For The Pharmaceutical Industry In India
The Central Pollution Control Board (CPCB) has issued draft guidelines for the pharmaceutical industry aiming to regulate and mitigate its environmental impact. Stakeholders and the general public have until February 5, 2025, to provide their feedback on the proposed guidelines. Suggestions can be submitted via email to designated CPCB officials or sent to the IPC-I Division of CPCB in Delhi.
Guidance Document Validation Of Rapid Diagnostics For Pathogen Identification And Antimicrobial Susceptibility Testing, 2025
The Indian Council of Medical Research (ICMR) has released a comprehensive guidance document for the validation of rapid diagnostics aimed at pathogen identification and antimicrobial susceptibility testing (AST). This document bridges existing gaps in the validation process and provides a framework for innovators and developers to ensure their diagnostic tools meet regulatory standards.
New Drug Rules Allow Nasal Sprays for Ayurveda, Siddha, and Unani Medicine
The National Licensing Authority will grant licenses for nasal spray products based on specific guidelines outlined in a new Schedule TB. Only ingredients defined as Ayurvedic, Siddha, or Unani drugs under the Drugs and Cosmetics Act can be used. The rules also detail specifications for the device (pump, bottle, actuator) and the finished product.
CDSCO Sub-Zonal Office in Uttarakhand Relocates to Dehradun
The Central Drugs Standard Control Organization (CDSCO) has announced the relocation of its Sub-Zonal Office in Uttarakhand. All official submissions and communications should now be directed to its new address at CDSCO, Sub-Zonal Office The Survey of India, Survey Chowk Campus Plot No. 68, 17 EC Road Dehradun-248001 Uttarakhand.
Government Updates Medical Device Classification Lists, Seeks Public Feedback
Drafts of the revised classification lists are available for public review. Stakeholders, including industry associations and medical professionals, are encouraged to provide feedback through the dedicated Google Form by February 5, 2025. Following the feedback period, the CLA will finalize and publish the updated classification lists.
National Workshop Focuses on Combating India’s Rising NCD Burden
The Union Health Secretary emphasized the need for inter-sectoral collaboration, enhanced research, and innovative practices to combat the growing NCD burden. The importance of community-level initiatives like Fit India and Eat Right India was highlighted. Best practices from Nagaland (tobacco cessation) and Telangana (yoga and wellness) were also showcased. Programs from Assam (hypertension control), Tamil Nadu (NCD screenings), and Andhra Pradesh (cancer care) were presented as successful models for other states.
ESIC Issues Notification on Revision of Pharmaceuticals Purchase Policy (PPP) Products
Employees’ State Insurance Corporation (ESIC) issued an important notification regarding the revision of its Pharmaceuticals Purchase Policy (PPP)
Government Extends Compliance Deadline for Small Drug Manufacturers
The Ministry of Health and Family Welfare has announced a proposed extension for small and medium drug manufacturers to comply with the revised Schedule M of the Drugs Rules, 1945. Following industry representations, the government has decided to extend the compliance deadline for manufacturers with a turnover of ₹250 crore or less. These companies can now apply for an extension until December 31, 2025. To avail of the extension, manufacturers must submit an application to the Central Licensing Approving Authority (CLAA) by April 4, 2025.
ICMR and CDSCO Seek Public Input on Draft Protocols For Standardizing IVD Testing
ICMR and CDSCO have developed a series of draft standard evaluation protocols for specific IVDs. These protocols outline the methodologies and criteria for testing the quality and performance of these diagnostic tools. ICMR and CDSCO are now inviting comments from all interested stakeholders on these draft protocols. This window for public input closes on February 15, 2025.
