Anti-Cancer Drugs to Become More Affordable
The National Pharmaceutical Pricing Authority (NPPA) has directed manufacturers to reduce the Maximum Retail Price (MRP) of Trastuzumab, Osimertinib, and Durvalumab. This reduction in MRP is a result of the government’s initiative to exempt these drugs from customs duty and reduce GST rates.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For September 2024
The NSQ drug list specifies a total of 18 drugs that were detected to be deficient by State Lab Drugs Control Laboratories. All of these 18 drugs were declared to be not of standard quality. The NSQ drug list for central CDSCO laboratories specifies a total of 49 drugs that were detected to be deficient. Additionally, CDSCO has also identified 4 drugs to be spurious.
Important Update: Amendments to Cough Syrup Export Policy
The Ministry of Commerce and Industry in on October 18, 2024 announced significant changes to the export policy for cough syrups under Chapter 30 of the ITC (HS) 2022.
India Calls for Global Cooperation to Combat Antimicrobial Resistance
Addressing the gathering, the minister stressed on the critical threat AMR poses to global public health, undermining decades of progress in modern medicine. She called for the integration of AMR containment strategies into various health programs, including pandemic preparedness, health system strengthening, and universal health coverage.
CDSCO Requires Registration Of Clinical Research Organizations
The Central Drugs Standard Control Organization (CDSCO) has announced amendments to the New Drugs and Clinical Trials Rules, 2019. These amendments aim to strengthen the regulatory framework for clinical research organizations (CROs) in India. CROs are now required to register with the Central Licensing Authority before conducting clinical trials.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For August 2024
The NSQ drug list specifies a total of 11 drugs that were detected to be deficient by State Lab Drugs Control Laboratory, Telangana. All of these 11 drugs were declared to be not of standard quality. The NSQ drug list for central CDSCO laboratories specifies a total of 48 drugs that were detected to be deficient. Additionally, CDSCO has also identified 5 drugs to be spurious.
Vaccine Samples Declared Not of Standard Quality 2017-2023
The Central Drugs Standard Control Organization (CDSCO) has released a report detailing various instances of substandard vaccines identified in India over the past six years, i.e. from 2017-2023. The report identified substandard vaccines across various categories, including typhoid, tetanus, polio, and COVID-19 vaccines.
Online Applications Now Mandatory for New Veterinary Drug Permissions and Field Trials
The Central Drugs Standard Control Organization (CDSCO) has announced a shift to online applications for all new drug permissions and field trials related to veterinary medicine. All new applications for new drug permissions and field trials concerning veterinary products must be submitted electronically through the SUGAM Portal.
CDSCO Seeks Public Input on Revised Good Clinical Practices Guidelines
Good Clinical Practice is a set of guidelines for biomedical studies which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human participants. Stakeholders are encouraged to submit their comments and suggestions on the draft guidelines. Comments can be submitted electronically within by October 12, 2024 to dci@nic.in.
NPPA Extends Ceiling Prices for Orthopaedic Knee Implants
The NPPA has decided to continue the current ceiling prices for primary and secondary knee replacement systems. The specific ceiling prices for primary and secondary knee replacement systems will remain unchanged for another year, i.e. from September 16, 2024 to September 15, 2025, or until the next revision.
