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.
Central Government Prohibits Nimesulide Formulations for Animal Use
According to an official notification, the Central Government has determined that Nimesulide formulations are likely to involve risks to animals and that safer alternatives are readily available. After consulting the Drugs Technical Advisory Board, the government has concluded that it is necessary and expedient to impose this ban in the public interest.
Massive Drug Raid in Kolkata Uncovers Rs. 6.60 Crore Worth of Spurious Medicines
The raid targeted a wholesale premises located in Kolkata, and led to the seizure of a substantial quantity of suspected spurious drugs, including anti-cancer and anti-diabetic medications. Additionally, investigators discovered empty packing materials at the site, further raising concerns about the authenticity of the products.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For November 2024
The NSQ drug list specifies a total of 70 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 41 drugs that were detected to be deficient. Additionally, CDSCO has also identified 2 drugs to be spurious.
NPPA Approves Separate Pricing for Cipla’s Synchrobreathe Inhaler Device
The National Pharmaceutical Pricing Authority (NPPA) has approved separate pricing for Cipla Ltd.’s “Synchrobreathe Inhaler Device” when used with specific Budesonide and Formoterol formulations. This decision follows recommendations from a Multidisciplinary Committee of Experts and aims to promote incremental innovation in drug delivery.
NPPA Fixes Retail Prices For 65 Formulations
The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices for 65 pharmaceutical formulations. The retail price for these specified formulations must match the specified price. Manufacturers are required to submit a price list in Form–V via IPDMS to the National Pharmaceutical Pricing Authority (NPPA) and provide copies to State Drug Controllers and dealers.
NPPA Revises Ceiling Prices for Scheduled Formulations
The National Pharmaceutical Pricing Authority (NPPA) has issued an order fixing ceiling prices for several essential medicines and revising prices for others based on a review order. The new prices, effective from December 19, 2024, aim to ensure affordability and accessibility of essential drugs.
India’s Pharmaceutical Industry With Ambitious Growth Plans
India’s pharmaceutical industry is a significant force in the global market, boasting a strong domestic presence and a rapidly growing export sector. National Institutes of Pharmaceutical Education & Research (NIPERs) spearhead research efforts.
Inclusion Of Homoeopathic And Sowa-Rigpa Systems Authoritative Books In Drugs and Cosmetics Act
The Central Government, in consultation with the Ayurveda, Siddha, Unani Drugs Technical Advisory Board, has introduced an amendment to the Drugs and Cosmetics Act, 1940. The amendment aims to modify the First and Second Schedules of the Act. This amendment was published on December 9, 2024.
