BIS Invests in R&D to Drive Standardisation
The Bureau of Indian Standards (BIS) has announced the sanction of 82 research and development (R&D) projects to bolster its standardisation efforts. These projects, awarded to faculty members from institutions like IITs and NITs, will focus on cutting-edge domains such as artificial intelligence, blockchain technology, medical devices, renewable energy, and sustainability.
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.
MoHFW Notifies New Draft Drug Rules (….Amendment),2024
On July 10, 2024, the Ministry of Health and Family Welfare proposed amendments to the Drugs and Cosmetics Rules, 1945, focusing on Schedule G drugs:
Rule 74: Includes Schedule G drugs in specific regulatory requirements.
Rule 74A: Adds guidelines for manufacturing and distribution of Schedule G drugs.
Rule 74B: Specifies safety measures for Schedule G drugs.
Rule 78: Strengthens oversight in licensing and registration for Schedule G drugs.
Rule 78A: Details responsibilities for manufacturers and distributors of Schedule G drugs.
India Mandates Polio Vaccination for Travelers Entering The Country
Travelers must obtain a valid OPV (Oral Polio Vaccine) or IPV (Inactivated Polio Vaccine) certificate issued by a designated health officer in their home country. The advisory is effective for travel since May 1, 2024. However, due to limited OPV availability in some listed countries, it is revised to now accept IPV vaccination.
BIS Revises Standards On Surgical Instruments And Dentistry
The Bureau of Indian Standards (BIS) has revised certain standards on Thoracic Surgery Instruments And Dentistry. These notifications were published on June 26, 2024. All these standards were established on June 6, 2024 and their previous versions will be withdrawn from September 6, 2024.
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.
Guidelines For Ethical Use Of Biological Samples For Commercial Purpose
Human biological samples, often collected during diagnosis or treatment, can be a valuable resource for therapeutic advancements and improving patient outcomes and diagnostic accuracy. These guidelines aim to ensure this process is conducted ethically and transparently.
NPPA Approves 15% Price Increase for Ciprofloxacin Injection by Aculife Healthcare
The National Pharmaceutical Pricing Authority (NPPA) has approved a 15% increase in the ceiling price of Ciprofloxacin Injection 200mg/100ml for M/s Aculife Healthcare Pvt. Ltd., due to the special features of their packaging. The ceiling price has been fixed as Rs. 0.23/ ml (plus applicable Goods and Services Tax). Prices for all such formulations must be revised downward if they exceed the set ceiling price plus local taxes.
NPPA Revises Retail Prices for 54 New Drug Formulations
The retail price for these specified formulations must match the specified price. 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. Retailers and dealers must clearly display the price list provided by manufacturers to ensure it is easily accessible to customers.
