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Regulation of 4 Medical Devices as Drugs

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...

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

Indian pharma market is flooded with irrational Fixed Dose Combination (FDCs) and is an important topic for critical and scientific analysis. The country needs some regulatory laws for FDCs after analysing whether...

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CDSCO releases Draft Regulatory Guidelines for the development of vaccines in COVID-19 Pandemic

Coronavirus still poses a potential threat to the global population, but no vaccines protect the body against the virus, causing COVID-19. The coronavirus spreads quickly, and majority of the world's population is...

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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...

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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...

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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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What should you know about manufacturing licenses for new API and formulations in India

Manufacturing Licenses For New API (Active Pharmaceutical Ingredients) And Formulations There is a constant demand from customers and global competitive pressure to produce active pharmaceutical ingredients (API) on the pharmaceutical manufacturers in...

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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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