NPPA Retail Price Fixation for Pharmaceutical Formulations
The National Pharmaceutical Pricing Authority (NPPA), under the Ministry of Chemicals and Fertilizers, has issued an order dated November 28, 2025 fixing the retail price (exclusive of Goods and Services Tax, GST) for several drug formulations.
CDSCO Mandates Display of QR Code and Toll-Free Number for Adverse Drug Reaction Reporting
The Central Drugs Standard Control Organization (CDSCO) has issued a Circular directing all retail and wholesale pharmacy stores across the country to prominently display a designated Pharmacovigilance Programme of India (PvPI) QR Code and a Toll-Free Number for reporting Adverse Drug Reactions (ADRs).
Updated National Action Plan on Antimicrobial Resistance 2.0
Union Minister of Health and Family Welfare launched the second version of the National Action Plan on Antimicrobial Resistance (NAP-AMR 2.0) (2025–29) on November 18, 2025, which also marked the first day of the WHO’s World AMR Awareness Week (November 18–24). The Minister emphasized that Antimicrobial Resistance (AMR) is a major public health concern that demands collective action.
PCIM&H Clarifies on Pharmacopoeial Parameters of ASU&H Drugs
The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) organized a one-day Awareness Programme on “Pharmacopoeial Parameters of ASU&H” on November 18, 2025. The program focused on the critical role of raw drug quality in ensuring the safety and efficacy of Ayurveda, Siddha, Unani, and Homoeopathy (ASU&H) systems.
NPPA Adds Manufacturers to Ceiling Price Order for IV Fluids
The National Pharmaceutical Pricing Authority (NPPA) has issued an addendum, dated November 4, 2025, to its previous orders (No. 1486(E) dated March 27, 2025, and No. 3976(E) dated August 29, 2025) concerning the ceiling price fixation of scheduled intravenous (I.V.) fluid packs (specifically non-Glass with special features).
NPPA Fixes Retail Prices for 28 Formulations, Including Diabetes and Hypertension Drugs
The National Pharmaceutical Pricing Authority (NPPA) has issued an order to fix the retail prices for 28 specific drug formulations under the powers conferred by the Drugs (Prices Control) Order, 2013 (DPCO, 2013). This order, dated November 4, 2025, sets the maximum retail price, exclusive of Goods and Services Tax (GST), for each formulation manufactured by the specified companies.
Ministry of Health Issues Corrigendum on Drug Testing Sample Size
The Ministry of Health and Family Welfare (MoHFW), under the Department of Health and Family Welfare, has issued a corrigendum to amend a condition regarding the sample size for drug testing in a previously published draft notification.
Government Proposes Strict Debarment Rules for Submitting False Information Under Drugs Act
The Ministry of Health and Family Welfare has published draft rules proposing stringent penalties, including the debarment of applicants, found guilty of submitting misleading, fake, or fabricated documents and information across various regulatory parts of the Drugs Rules, 1945.
CDSCO Withdraws COVID-19 Indications for Baricitinib Tablets
The Central Drugs Standard Control Organization (CDSCO) has formally acknowledged the withdrawal of the approved indications of Baricitinib Tablets (2mg & 4mg) for the treatment of COVID-19, effective October 23, 2025.
State Lab Issues Alert for Spurious Dry Cough Formula
The State Drug Testing Laboratory (SDTL) in Raipur, Chhattisgarh, has flagged a batch of the product Besto-Cof DRY COUGH FORMULA as purported to be spurious. The actual manufacturer, as per the label claim, has officially stated that the impugned batch was not manufactured by them, confirming the product’s status as spurious and subject to the outcome of an ongoing investigation.
Nationwide Alert Issued as 112 Drug Batches Declared Not of Standard Quality in September 2025
The Central Drugs Standard Control Organisation (CDSCO) and various State Drug Testing Laboratories have issued a comprehensive alert identifying numerous drug batches that failed quality testing in September 2025. The consolidated list comprises 112 instances of drug products—including antibiotics, cardiovascular medications, supplements, and specialized injections—that were declared Not of Standard Quality (NSQ).
CDSCO Launches Digital Monitoring System for High-Risk Solvents on ONDLS Portal
The Central Drugs Standard Control Organisation (CDSCO) has launched a Digital Monitoring System on its Online National Drug Licensing System (ONDLS) portal to enhance surveillance over the supply chain and quality of high-risk pharmaceutical solvents.