India’s Drug Pricing Policy Focuses on Essentiality and Market-Based Mechanisms
The policy emphasizes several key principles, including regulating prices based on the essentiality of drugs, focusing price controls on consumer-level formulations (medicines) rather than bulk drugs or intermediates, and using market-based pricing mechanisms instead of cost-based pricing.
Government Issues Uniform Code to Regulate Pharmaceutical Marketing Practices
The Department of Pharmaceuticals has released the Uniform Code of Pharmaceutical Marketing Practices 2024, effective March 12, 2024, to curb unethical marketing and promote responsible pharmaceutical product promotion. The code focuses on regulating interactions between doctors/registered medical practitioners (RMPs) and pharmaceutical company representatives.
ICMR & CDSCO Seek Input On HMPV Real-Time PCR Evaluation Protocol
The current draft focuses specifically on laboratory performance evaluation of HMPV real-time PCR kits, with all clinical samples tested according to the candidate test’s instructions for use. The primary purpose is to evaluate the performance characteristics of these kits in diagnosing HMPV infection/disease.
Madhya Pradesh Registration of Births and Deaths Rules 2024
Govt of MP notified the MP Registration of Births and Deaths Rules 2024 under the powers conferred by Section 30 of the Registration of Births and Deaths Act, 1969
CDSCO Publishes Not Of Standard Quality And Spurious Alert For December 2024
The NSQ drug list specifies a total of 84 drugs that were detected to be deficient by State Lab Drugs Control Laboratories. The NSQ drug list for central CDSCO laboratories specifies a total of 51 drugs that were detected to be deficient.
Ministry of Finance Announces Amendments to NDPS Regulations
The Ministry of Finance issued the NDPS (Regulation of Controlled Substances) Amendment Order to amend the NDPS (Regulation of Controlled Substances) Order,2013
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.
