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.
Drug Alert List for October 2023
A total of 1105 samples were tested by the CDSCO. Based on the samples tested, CDSCO has found a total of 61 drugs, medical devices and cosmetics that are identified as being deficient.
India and Netherlands Collaborate on Medical Product Regulation
India and Netherlands have formalized their commitment to enhance medical product regulation and elevate the quality of healthcare services through a Memorandum of Intent (MoI). The collaboration aims to foster cooperation in pharmaceutical and medical technology industries, a significant stride towards global health goals.
CDSCO invites Proposals for Development of Digital Drugs Regulatory System
The aim of this project is to develop the DDRS as a unified digital ecosystem that will replace existing portals. DDRS is envisioned to be a Single Window, Single Sign On, and Unified Portal for all regulatory activities in the field of pharmaceuticals. The development of DDRS represents a significant step towards enhancing regulatory systems in India, ensuring the availability of quality medicines for the country and the world.
CDSCO Grants Approval to Private Testing Laboratories to test Cough Syrups to be Exported
Central Drugs Standard Control Organisation (CDSCO) has granted approval to 3 NABL Accredited Private Testing Laboratories to test cough syrups to be exported by manufacturers and authorised persons of manufacturers/ exporters. This notice was issued on 13th September, 2023.
