Regulatory CDSCO - Articles

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Covid-19 vaccines approved for use in India – What you need to know · Cliniexperts

Covid-19 vaccines approved for use in India – What you need to know Indian, one of the leaders in the pharmaceutical sector, is set to play a vital role in the global COVID-19 vaccination effort.On 03 January 2021, the Drugs Controller General of India (DCGI) granted emergency approval for two COVID-19 vaccines –Covishield and Covaxin.

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Biosimilars in India – Things you need to know · Cliniexperts

Biosimilars in India – Things you need to know Biological agents show significant clinical benefits, but their high cost limits their accessibility. The demand for cost-effective options and the patent expiry of biologics have propelled the development of biosimilars or similar biologics. This article covers the key takeaways from the Indian regulatory guidelines for the

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Conducting clinical trial during COVID-19 · Cliniexperts

Conducting Clinical Trial during COVID-19 COVID-19 has caused a massive shift in how we manage clinical trials. Due to inadequate resources and restrictions placed due to the pandemic, companies are struggling to maintain the safety of study participants and staff while ensuring the continuity of ongoing trials. The pandemic also paved the way for new

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Diagnostic Kits |
Drug |
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Online submission of SAE reports through SUGAM portal · Cliniexperts

Online submission of SAE reports through SUGAM portal The New drugs and clinical trials rules, 2019, requires that the investigator, sponsor / CT-NOC holder and ethics committee report all serious adverse events (SAE’s) to the Central Licensing Authority (CLA) within a specified time-frame. CDSCO, through the SUGAM portal, started the process of electronic submissions of

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COVID-19 Vaccine Development: Key Developments in India · Cliniexperts

  COVID-19 Vaccine Development: Key Developments in India The Covid-19 emergency has propelled a race for preventive vaccines and treatment, with numerous efforts by companies, commercial consortia, and scientific organizations worldwide. India is a hub for vaccine production and produces 60 percent of the world’s vaccines. Indian companies have played a pivotal role in producing


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