Hikes In Ceiling Prices For Scheduled Formulations
The National Pharmaceutical Pricing Authority (NPPA) has issued a notification revising the ceiling prices for scheduled formulations. This action aims to regulate drug prices in the country and it takes into consideration the Wholesale Price Index (WPI) impact @0.00551% for the year 2024. These notifications were issued on August 7, 2024.
NPPA Revises Retail Prices for 70 New Drug Formulations
The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices for 58 + 12 pharmaceutical formulations. These prices are exclusive of Goods and Services Tax, if applicable. These prices were notified on August 6, 2024.
India Exempts Local Clinical Trials For New Foreign Drugs
The Indian government has announced a streamlined approval process for certain categories of new drugs recognizing approvals from key global regulatory authorities. CDSCO has specified a waiver from local clinical trials for USA, UK, Japan, Australia, Canada, and the European Union (EU).
CDSCO Urges Manufacturers To Implement New Drug Manufacturing Rules
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. The CDSCO has also advocated for manufacturers to comply particularly with WHO good manufacturing practices for sterile pharmaceutical products.
Relaxing Norms for Toxicity Studies in Drug Approval
The CDSCO aims to streamline the drug approval process without compromising safety. The New Drugs and Clinical Trials Rules, 2019 allow for the acceptance of preclinical toxicity data generated in other countries, provided the data is of high quality and meets specified standards.
CDSCO Publishes List Of Drugs Declared As Not Of Standard Quality And Spurious For June 2024
The NSQ drug list specifies a total of 30 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 and 2 were also found to be misbranded. The NSQ drug list for central CDSCO laboratories specifies a total of 31 drugs that were detected to be deficient.
Government Proposes New Labeling Requirements for Drugs
These draft rules propose the inclusion of “details of excipients” on all drug labels. The amendment also proposes replacing semicolons with full stops (periods) after “date of expiry” and “manufacturing license number” to improve clarity and separation of information.
CDSCO Publishes List Of Drugs Declared As Not Of Standard Quality And Spurious For May 2024
The NSQ drug list specifies a total of 13 drugs that were detected to be deficient by State Lab Drugs Control Laboratory, Telangana. Out of these 23 drugs, 8 were declared to be not of standard quality and the remaining 5 were misbranded. The NSQ drug list for central CDSCO laboratories specifies a total of 39 drugs that were detected to be deficient.
MoHFW Permits Import of Drugs Through Cochin and Thiruvananthapuram Airports
The Ministry of Health and Family Welfare (MoHFW) has sanctioned Cochin and Thiruvananthapuram airports for the import of drugs into the country. Prior to this amendment, drugs could be imported only through airports located at Chennai, Kolkata, Mumbai, Delhi, Ahmedabad, Hyderabad, Goa, Bengaluru and Visakhapatnam.
Updates On Use of Olaparib Tablets for Ovarian Cancer Treatment
The initially approved use of Olaparib for advanced ovarian cancer in patients with a gBRCA mutation and who have received three or more prior chemotherapy treatments is being withdrawn.
