Small and Medium Pharma Companies Get Schedule M Deadline Extension
The Ministry has granted the extension with a condition: small and medium manufacturers must submit their upgradation plan (Form A) to the Central License Approving Authority within three months from February 11, 2025. Those who meet this requirement will have until December 31, 2025, to fully implement the revised Schedule M.
NPPA Fixes Retail Price for Cilnidipine & Telmisartan Tablets
Each film coated Cilnidipine & Telmisartan Tablet shall bear the retail price of Rs. 14.15. This price applies to tablets manufactured by M/s Akums Drugs & Pharmaceuticals Ltd. and marketed by M/s Glenmark Pharmaceuticals Limited.
NPPA Revises Ceiling Prices of Azithromycin & Amoxicillin + Clavulanic Acid
Manufacturers selling these formulations (branded or generic) above the revised ceiling price (plus applicable GST) must immediately revise their prices downwards to comply. Retailers and dealers must prominently display the price list provided by the manufacturer.
NPPA Fixes Retail Prices For 42 Formulations
The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices for 42 pharmaceutical formulations. These prices are exclusive of Goods and Services Tax, if applicable. These prices were notified on February 7, 2025.
Drug Price Display Mandatory for Online and On-Site Pharmacies
Online pharmacies operating through websites, portals, mobile apps, e-commerce platforms, or any other online mode are equally obligated to display the current price list of drugs as brick-and-mortar stores.
CDSCO Updates List of Approved FDCs
The CDSCO has now identified and corrected typographical errors in the earlier list of FDCs (Annexure-A) for which manufacturing licenses could be obtained directly from State Licensing Authorities.
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.
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.
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.
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.
