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RCGM and CDSCO recommends Fast Track Processing of Recombinant Vaccines Applications for COVID-19

All over the world, scientists are working around the clock to find a vaccine against COVID-19. Global experts estimate that a fast-tracked vaccine can bring a vaccine to market in approximately 12-18...

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Ethics Committee Guidance amid COVID-19 Pandemic in India

As COVID-19 spreads across the globe, scientists are constantly trying to make effective and efficient drugs and vaccines and fast-track the development of diagnostic tools with better outcomes. The present situation demands research...

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Release of consignments of vaccines and in-vitro diagnostic kits in COVID- 19 pandemic

Currently, the COVID-19 outbreak is affecting the logistics and transportation of essential commodities, including vaccines and In-vitro Diagnostics(IVDs). Recently importers approached the Central Drug and Standards Control Organization (CDSCO) and shared with...

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Guidance to help conduct clinical trials during the COVID-19 pandemic in India

The Central Drugs Standard Control Organization (CDSCO) acknowledges the potential impact of COVID-19 pandemic on the healthcare system and broader society, and the impact it may have on clinical trials and subjects....

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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...

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Marketing Authorization of Biological Products in India

What are Biological Products? Biological products are used for diagnosis, prevention, treatment and cure of diseases and certain medical conditions and are regulated by the Food and Drug Administration of India. They...

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The Indian government has brought about some major changes with regards to the rules and regulations governing the manufacturing to enhance the quality of products used in the healthcare industry. As India...

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BIOLOGICS AND BIOSIMILARS Biologics are medicinal products which are mainly composed of living tissues or cells. Sometimes, they are living entity- derived products used for the treatment or prevention of a disease....

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