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.
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.
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)
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.
CDSCO Adds To Functionality Of Online Applications For Clinical Trials
The Central Drugs Standard Control Organisation (CDSCO) has announced a shift towards online applications for adding clinical trial sites and changing Principal Investigators. CDSCO is now accepting these submissions through the SUGAM portal. The CDSCO has also implemented a “deemed approval” system for applications submitted through SUGAM.
ESIC Issues Warning on “Not of Standard Quality” Drug
Employees’ State Insurance Corporation (ESIC) issued a critical notification regarding the testing of a drug found to be “Not of Standard Quality”
Government Seeks Public Input on New Standards for Clinical Electrical Thermometers
The proposed rules mandate verification and stamping of clinical electrical thermometers to ensure compliance with the new standards. These thermometers, used in homes, hospitals, and various industries, play a vital role in diagnosing fevers, hypothermia, and other temperature-related conditions. This additional measure strengthens consumer protection and promotes trust in the devices.
Government Ramps Up Production of Pharmaceuticals and Medical Devices in India
The PLI scheme for Bulk Drugs, with a financial outlay of Rs. 6,940 crore, incentivizes the manufacturing of essential Key Starting Materials (KSMs), Drug Intermediates (DIs), and Active Pharmaceutical Ingredients (APIs). With a budget of Rs. 15,000 crore, the PLI Scheme for Pharmaceuticals focuses on high-value products like patented/off-patented drugs, biopharmaceuticals, complex generics, and anti-cancer drugs. The PLI Scheme for Promoting Domestic Manufacturing of Medical Devices targets high-end medical devices previously imported into India.
