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Regulation/Guidelines

DCGI Enlists New Regulation For The Classification Of Medical Devices Pertaining To Anesthesiology

The Drugs Controller General (India) has listed a new classification of medical devices pertaining to anaesthesiology based on the device’s intended use and risk and other parameters.

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Regulation/Guidelines

CDSCO Orders Regulation Of CT Scan Equipment, All Implantable Devices, Medical Equipment As Drugs

The Government of India has ordered to regulate the equipment for CT scan, MRI, defibrillators, PET, dialysis, X-ray, etc. as drugs from April 01, 2021.

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Regulation/Guidelines

CDSCO Notifies To Update The Product Insert Of 4th Generation HIV In-Vitro Diagnostics Kit

NIB Noida is evaluating samples of in-vitro Diagnostics of 4th generation HIV kits for QC evaluation. While evaluating NIB, Noida noticed that many manufacturers of such Kits are not mentioning sensitivity for HIV P-24 antigen in the product insert. All the manufacturers or licensees are requested to update the product insert of these 4th generations HIV In-vitro diagnostic kits for inclusion of analytical sensitivity for HIV P-24 antigen so that there is no unnecessary delay in evaluation

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Regulation/Guidelines

Regulatory Updates on Disinfectants

Alcohol-based hand sanitizers (gel) and hand rubs (liquid) together referred to as “ABHR’s”are simple formulations used to disinfect mainly the hands and get rid of bacteria, viruses, fungi etc. to prevent further transmission.A good sanitizer should destroy 99.99% microbes in ~20-30 seconds4,5 should be safe on skin over long-term use and optionally have a light non-overpowering fragrance.

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Regulation/Guidelines

CDSCO codifies New Cosmetics Rules,2020

The Ministry of Health and Family Welfare (MoHFW) has notified the Cosmetics Rules, 2020 under the Drugs and Cosmetics Act, 1940. This move is to streamline all functions and bring effective compliance in the cosmetic sector of India. The notification came to separately codify and update the rules relating to import, manufacture, labeling, sale, and distribution of cosmetics in India, which were earlier set out under the Drugs and Cosmetics Rules, 1945.

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Regulation/Guidelines

Regulation of 4 Medical Devices as Drugs by CDSCO: A new Notification

CDSCO has notified four medical devices, i.e., nebulizer, blood pressure monitoring devices, digital thermometer, and glucometer as drugs. The importers and manufacturers of these 4 medical devices need to take import and manufacturing licenses from the Central Licensing Authority or State Licensing Authority effectively from 1st January 2021.

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Regulation/Guidelines

COVID-19 Home Testing Using Rapid Antigen Tests (RATs)

Rapid Antigen tests aim to confirm positive test results of covid-19 infection in people possessing potential symptoms related to the disease. The rapid antigen home tests are accessible as they can be used wherever the patient is and can provide the test results quickly.

Regulation/Guidelines

CDSCO Provides Guidelines For Approval Of COVID-19 Vaccines For Restricted Use In An Emergency Situation In India And For The Import Of Vaccine By The Private Sector

The Government of India has laid out guidelines for the Restricted use of vaccines in Emergency situations. The guidelines also allow the ready-to-use vaccine to be fully utilized from 1st May.

Regulation/Guidelines

Extended Timelines For Submission Of Notarized/ Apostilled Documents For Import And Registration Of Cosmetics

Drugs Controller General of India (DCGI) has further extended the deadline by four months to submit notarized or apostilled regulatory documents for import and registration of cosmetics such as Authorisation from Manufacturer, free sale certificate (FSC) with legal signatures. This is in continuation to the notices given on April 20, 2020, August 19, 2020, and December 18, 2020.

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