SEC of CDSCO makes recommendations in respect of Accelerated Approval Process request of Serum Institute of India & Bharat Biotech International Ltd as well as about Phase-III Trials of Cadila Healthcare Ltd

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Central Drugs Standard Control Organization (CDSCO)
Central Drugs Standard Control Organization (CDSCO)

PIB News Update: The Subject Expert Committee of CDSCO met on 1st and 2nd January, 2021 and made the following recommendations for the consideration and final decision of the Drugs Controller General of India :-

1) Grant of permission for restricted emergency use of vaccine, subject to multiple regulatory conditionalities, to M/s Serum Institute of India, Pune.

2) Grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains, to M/s Bharat Biotech International Ltd., Hyderabad.

3) Grant of permission for conduct of Phase-III Clinical Trial Protocol to M/s Cadila Healthcare Ltd, Ahmedabad.

 

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Saurabh
Saurabh
Saurabh Sinha, Editor of IndianBureaucracy.com, is known for his credible, precise and insightful coverage of governance, civil services and administrative developments in India. Under his leadership, the portal has grown into a trusted national platform for accurate updates, appointments and policy movements within the bureaucratic ecosystem. Saurabh’s strong professional networking and deep understanding of government functioning enable him to present timely, reliable and well-contextualised information to readers across sectors. As a thought-driven editor, he promotes informed dialogue on governance reforms while maintaining high editorial standards. His calm, consistent and detail-oriented approach continues to strengthen the portal’s reputation. इंडियनब्यूरोक्रेसी.कॉम के संपादक सौरभ सिन्हा देश की नौकरशाही, शासन व्यवस्था और प्रशासनिक गतिविधियों की विश्वसनीय तथा संतुलित रिपोर्टिंग के लिए जाने जाते हैं। उनके नेतृत्व में यह पोर्टल नियुक्तियों, नीतिगत बदलावों और प्रशासनिक खबरों का एक भरोसेमंद राष्ट्रीय स्रोत बन चुका है। शासन तंत्र की गहरी समझ और मजबूत पेशेवर नेटवर्क के कारण सौरभ पाठकों को समयबद्ध, सटीक और संदर्भित जानकारी प्रदान करते हैं। एक विचारशील संपादक के रूप में वे सुशासन, पारदर्शिता और सुधारों पर सकारात्मक संवाद को बढ़ावा देते हैं। उनकी शांत, सूक्ष्म और पेशेवर संपादकीय शैली पोर्टल की प्रतिष्ठा को लगातार मजबूत कर रही है।
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