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.
Restrictions on Naproxen IP In Fixed Dose Combinations
The Central Government has restricted the manufacture, sale, and distribution of two fixed dose combinations (FDCs) containing Naproxen and either Esomeprazole Magnesium Trihydrate or Pantoprazole. The sale of these FDCs will be permitted only subject to specified conditions.
Prohibition of Manufacture, Sale and Distribution Of S(+)Etodolac + Paracetamol
The Drugs Technical Advisory Board (DTAB) was tasked with examining the necessity of prohibition of the FDC. After careful deliberation and considering the scientific evidence, the DTAB concluded that the FDC lacked therapeutic justification and posed potential risks to human health. This finding was instrumental in the government’s decision to impose a complete ban on the drug.
Government Seeks Public Feedback on Drug Distribution Practices
The Central Drugs Standard Organisation (CDSCO) is seeking public feedback on draft guidelines for Good Distribution Practices (GDP) for pharmaceutical products. These guidelines aim to ensure proper storage and handling of medicines throughout the supply chain, from manufacturers to retailers.
India Makes Strides in Bulk Drug Manufacturing
The Production Linked Incentive (PLI) scheme for promoting domestic manufacturing of key starting materials (KSMs), drug intermediates, and active pharmaceutical ingredients (APIs) was launched in 2022. A press release on the progress of the scheme was issued on August 9, 2024.
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.
