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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

Regulations for Hand sanitizers and home drug deliveries by CDSCO in India

Regulations regarding hand sanitisers and home deliveries of the drugs, along with the list of approved formulations for hand sanitisers

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Regulation/Guidelines

What Should You Know About Manufacturing Licenses For New API And Formulations In India?

There is a constant demand from customers and global competitive pressure to produce active pharmaceutical ingredients (API) on the pharmaceutical manufacturers in India. The coronavirus pandemic has created the need for an API manufacturing hot-spot other than China as India has the potential to manufacture new API and formulations. To manufacture or import Active Pharmaceutical Ingredient (API)/drugs to India, the company or the organization should seek prior approval from the Drugs Controller General of India (DCGI) for licensing and distribution in the country.

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Regulation/Guidelines

CDSCO Announced Clinical Trials Conduct Rules During COVID-19 Outbreak

This guidance document covers the actions that sponsors of ongoing clinical trials affected by the present pandemic should take to ensure the integrity of the research studies and interpretation of study results while safeguarding the safety of clinical trial participants as a priority

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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

New Regulatory Guidance to Facilitate Drug & Vaccine Approval for COVID-19

The SARS-CoV-2 virus started in December 2019 and then spread at an alarming rate, mainly to China, Italy, the USA, Iran, Japan, and South Korea and even India. There is no drug or vaccine yet approved by the FDA for COVID-19. Presently, there is not any evidence from randomized clinical […]

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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.

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.

Regulation/Guidelines

CDSCO Extends Timeline For Import Of Drugs With Residual Shelf Life Less Than 60 Percent Till Oct 31

COVID-19 is disrupting global distribution on a scale unseen in recent times, creating extreme challenges for the supply chain of imported drugs and healthcare products. Increased border controls and customs regulations resulting in longer wait times and lack of capacity for long-haul and last-mile fulfillment create extreme challenges for the pharmaceutical industry.The Central Drugs Standard Control Organisation (CDSCO) has extended permission to three months to import drugs whose residual shelf life is less than 60 percent.

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