CDSCO Requires Registration Of Clinical Research Organizations
The Central Drugs Standard Control Organization (CDSCO) has announced amendments to the New Drugs and Clinical Trials Rules, 2019. These amendments aim to strengthen the regulatory framework for clinical research organizations (CROs) in India. CROs are now required to register with the Central Licensing Authority before conducting clinical trials.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For August 2024
The NSQ drug list specifies a total of 11 drugs that were detected to be deficient by State Lab Drugs Control Laboratory, Telangana. All of these 11 drugs were declared to be not of standard quality. The NSQ drug list for central CDSCO laboratories specifies a total of 48 drugs that were detected to be deficient. Additionally, CDSCO has also identified 5 drugs to be spurious.
Vaccine Samples Declared Not of Standard Quality 2017-2023
The Central Drugs Standard Control Organization (CDSCO) has released a report detailing various instances of substandard vaccines identified in India over the past six years, i.e. from 2017-2023. The report identified substandard vaccines across various categories, including typhoid, tetanus, polio, and COVID-19 vaccines.
Online Applications Now Mandatory for New Veterinary Drug Permissions and Field Trials
The Central Drugs Standard Control Organization (CDSCO) has announced a shift to online applications for all new drug permissions and field trials related to veterinary medicine. All new applications for new drug permissions and field trials concerning veterinary products must be submitted electronically through the SUGAM Portal.
NPPA Fixes Retail Prices For 62 Formulations
The order specifies the retail prices for a total of 62 new drugs for specified strengths and manufacturers. These prices are exclusive of Goods and Services Tax, if applicable. 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 Chloroquine
NPPA has further increased the ceiling price of 1 Tablet of Chloroquine 150 mg from Rs. 1.17 to Rs. 1.33. The new prices take into account a minimal increase based on the Wholesale Price Index (WPI).
India Unveils Shorter, More Effective Treatment for Drug-Resistant Tuberculosis
The BPaLM regimen, a four-drug combination, offers a dramatic improvement over traditional MDR-TB treatments. While older methods can last up to 20 months with harsh side effects, the BPaLM regimen can cure drug-resistant TB in just six months with a high success rate.
Voluntary Recall Of Tisseel LYO Fibrin Sealant Kits
Healthcare providers may continue to safely use the products if the fibrin sealant is prepared in advance to ensure it is fully dissolved and ready to be used when needed. If the Sealer Protein Concentrate has not fully dissolved, discard the vial, and prepare a fresh kit. If a customer has unused Tisseel Fibrin Sealant Kits that they would like to return, they are requested to contact Baxter Healthcare Center for Service to arrange for return and credit.
Ayurveda Practitioners Warned Against Misleading Cannabis Claims
The National Commission for Indian Medicine (NCISM) has emphasized that registered medical practitioners should refrain from promoting themselves as cannabis specialists. Such claims can be misleading and could lead to the misuse of cannabis-containing drugs. It also observed that these drugs are being falsely advertised and prescribed for various ailments on online platforms.
CDSCO Publishes Not Of Standard Quality Alert For July 2024
The NSQ drug list specifies a total of 13 drugs that were detected to be deficient by State Lab Drugs Control Laboratory, Telangana. All of these 30 drugs were declared to be not of standard quality. The NSQ drug list for central CDSCO laboratories specifies a total of 57 drugs that were detected to be deficient.
