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Regulation/Guidelines

Health Ministry Draft Notification To Add 16 Drugs as OTC Under Schedule K of Drugs Rules, 1945

Ministry of Health and Family Welfare released a draft notification to add 16 drugs as OTC under schedule k of drugs 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

CDSCO releases the timeline for Regularization of Rational Fixed Dose Combination in India

To put regulations on this matter, Central Drugs Standard Control Organisation (CDSCO) made a list of 294 FDCs, and directions are given to all State/UT Drug Controllers of India to withdraw 294 FDCs from the licensed market the consent of DCGI. Court then got it to stay order in favour of the Manufacturers Association

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Regulation/Guidelines

CDSCO GUIDELINES FOR REGULARISATION OF RATIONAL FIXED DOSE COMBINATIONS

Rational fixed dose combinations (FDCs), also known as combination products, are the integration of two or more drugs in a single dosage form. The Food and Drug Administration (FDA), USA defines a combination product as 'a product composed of any combination or integration of a drug and a device or a biological product, or a device.

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Regulation/Guidelines

CDSCO Releases Draft Regulatory Guidelines For The Development Of Vaccines In COVID-19 Pandemic

The Central Drugs Standard Control Organisation (CDSCO) released draft guidelines for developing vaccines in the grave situation of COVID-19, taking it as a special case. The Central Drug Authority came with the guidelines considering the Drug and Cosmetics Rules, 1940 and New Drugs and Clinical Trials Rules, 2019, and the international perspectives of World Health Organization (WHO), United States Food and Drug Administration (USFDA), European Medicines Agency (EMA) guidelines, and other applicable guidelines of CDSCO.

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Regulation/Guidelines

Relaxation Of Drug License For Selling And Stocking Hand Sanitizers

After the outbreak of COVID-19, the World Health Organization (WHO) has said that hand hygiene is important to prevent the virus's spread. Hand hygiene guidelines of WHO recommends the use of an alcohol-based hand rub for 20-30 seconds when hands are not dirty.

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Regulation/Guidelines

How To Get Wholesale Drug Licenses In India?

A step-by-step process to obtain a wholesale drug license for manufacturers – eligibility criteria, required document, validity and process.

Regulation/Guidelines

What Are The Benefits Of Having A Wholesale Drug License In Form 20B & 21B?

A wholesale drug license in Form 20B / 21B has numerous benefits for wholesalers despite the strict rules and regulations of CDSCO and SLA. Since wholesale drug license has a Indian reorganization, so it opens up endless possibilities for businesses.

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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