CDSCO notifies online application for issuance of Form 41 and Form 10 for Veterinary vaccines.
The Applicant seeking such certificate/license shall apply online as per the checklist in the developed modules and the submission of applications in hard copy may not be available after 25th March 2021 for processing.
MoHFW issues FAQs for Healthcare Workers and Front line workers on COVID-19 vaccination.
The Centre has approved the use of Covishield and Covaxin vaccines for emergency use authorization by the Central Drugs Standard Control Organization.
CDSCO clarification on online submission of SAE reports
CDSCO clarifies that follow up reports of the already submitted SAE reports shall be continued to be submitted in offline mode. User manual and video tutorial for SAE reporting on SUGAM portal is available on CDSCO website.
MoHFW issues SOP on preventive measures in Hotels and other Hospitality Units to contain spread of COVID-19.
The SOP aims to minimize all possible physical contacts between Staff and Guests and maintain physical distancing and other preventive and safety measures against COVID-19.
The Drugs and Cosmetics (Amendment) Rules, 2021.
The Amendment is brought under schedule K to the Drugs and Cosmetics Rules, 1945 in which serial number 23 prescribes the drugs supplied by Multipurpose Workers attached to Primary Health Centres/Sub-Centres.
Guidelines for the integration of Non-Alcoholic fatty liver disease into National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular diseases and Stroke
Broad activities permissible under NPCDCS are as follows:
Health promotion
Screening and Case detection
Monitoring and evaluation
Capacity building
Public-private partnership
Citizen Registration and Appointment for Vaccination User Manual
The CO-WIN application will facilitate the citizen with an option to register and schedule the vaccination session online in Centers of their choice. The Co-WIN application facilitates multiple role creations for orchestrating vaccination drive at various levels.
Guidance note for COWIN 2.0
The next phase of vaccination is due for citizens of age appropriate categories, including initially the people above 60 years of age and those aged from 45 years to 60 years and have the comorbidities. To augment and simplify the process of registration for vaccination, the MoHFW is coming with COWIN 2.0, based on the feedbacks received during the implementation of Phase 1 of Covid-19 vaccination drive.
Drugs and Cosmetics (Amendment) Rules, 2021
Drugs supplied by Community Health Officers at Ayushman Bharat Health and Wellness Centers is exempted from the requirement to be covered by a sale license.
The Report of all Serious Adverse Events shall be filed through SUGAM portal from 14th March 2021.
As per “The New Drugs and Clinical Trials Rules, 2019”, Investigator, Sponsor/CT-NOC Holder and Ethics Committee shall report all Serious Adverse Events (SAE’s)to the Central Licensing Authority within a prescribed time bound manner as specified in Rule 42 of the said rules.