CDSCO Launches Additional Forms on National Single Window System (NSWS Portal)
CDSCO has made the applications for grant of permission/ licence in Forms CT-10, CT-12, CT-13 live on the NSWS Portal from January 16, 2024. Form 12 will be live from January 24, 2024. All concerned stakeholders shall submit the above applications only through the NSWS Portal. The existing SUGAM online portal for these activities will be disabled from February 10, 2024.
CDSCO Notifies New Pathway For Clearance or Grant of Product Licence for Specified FDCs
The Central Drug Standard Control Organisation (CDSCO) has notified a new pathway for clearance or grant of product licence for specified FDCs. Moreover, all manufacturers must comply with the specified recommendations of the expert committee for revision of the prescribing information/ label.
New Drug Manufacturing Rules Introduced to Strengthen Quality Standards
The Amendment Rules introduce a new set of guidelines titled “GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS” in Schedule M. The guidelines outline several key principles to be adhered to by pharmaceutical manufacturers, focusing on pharmaceutical quality systems, quality risk management, sanitation and hygiene, qualification and validation, complaints and adverse reactions, product recalls, and change control.
Union Health Minister Inaugurates CDSCO Sub Zonal office & CDTL in Indore
The Central Drug Testing Laboratory, equipped with high-quality laboratory services, will play a crucial role in testing drugs, ensuring the availability of essential and high-quality medicines to improve the health of citizens. The facility is equipped with advanced instruments, including 12 HPLCs, 1 GLC, and 1 UV Spectrophotometer.
CDSCO Revises Drug Alert for May 2022
CDSCO has purported Omeprazole (Delayed-Release) and Domperidone (Sustained Release) Capsules as spurious. This drug is purported to be manufactured by Dr. Reddys Laboratories Ltd., Village Mauja Thana, Baddi173205, Dist. Solan, Himachal Pradesh. However, the actual manufacturer (as per label claim) has stated that the impugned batch of the product has not been manufactured by them and that it is a spurious drug.
Drug Alert List for November 2023
A total of 1197 samples were tested by the CDSCO. Based on the samples tested, CDSCO has found a total of 64 drugs, medical devices and cosmetics that are identified as being deficient.
Ministry of AYUSH Seeks to Introduce License for Nasal Spray Drugs
The proposed draft rules aim to regulate the development and quality of AYUSH nasal spray formulations, ensuring safety, efficacy, and adherence to traditional practices. Stakeholders and the public are invited to provide feedback on the draft before January 12, 2024.
New Label Warning for FDC of Chlorpheniramine Maleate IP 2mg And Phenylephrine HCI IP 5mg drop/ml
CDSCO has emphasised that all manufacturers of FDC of of Chlorpheniramine Maleate IP 2mg And Phenylephrine HCI IP 5mg drop/ml should mention a warning that ‘FDC should not be used in children below 4 years of age’. This should be included in the label and the package insert/ promotional literature of the drug.
NPPA Takes Measures to Ensure Price Transparency in Pharmaceutical Market
As per existing regulations, every manufacturer producing a scheduled or non-scheduled formulation for sale must prominently display the maximum retail price (MRP) on the label of the container, along with the words “Maximum Retail Price” and “inclusive of all taxes.” Additionally, manufacturers are required to issue a price list to dealers, who must prominently display it on their business premises.
Cough Syrup Manufacturers To Ensure Use of Quality Excipients
The Central Drugs Standard Control Organization (CDSCO) has issued an advisory to all cough syrup manufacturers to ensure the use of quality excipients in the manufacture of cough syrups. This advisory was issued on December 5, 2023.
