NEW DELHI: The Central government on Thursday issued the regulatory pathway in India for Covid-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL), said the Union health ministry. The Central Drugs Standards Control Organisation (CDSCO) headed by Drugs Controller General of India (DCGI) has explained that it prepare detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on NEGVAC recommendations. These guidelines have since been prepared and posted by CDSCO on its website. CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders, the ministry said.
Regulatory pathway for foreign vaccines issued
April 15, 2021
CDSCO will widely disseminate these guidelines to the concerned stakeholders
The government, on Thursday, issued regulatory pathway related to Covid-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL). The Central Drugs Standards Control Organisation (CDSCO), headed by Drugs Controller General of India or DCGI, has laid out the pathway according to which the former will prepare detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on NEGVAC recommendations.
CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders. Applicants for grant of approval for restricted use in emergency situation may be submitted to CDSCO. Application can be made by the foreign manufacturer through its Indian subsidiary or through its authorised agent in India in case it does not hav
Health Ministry issues regulatory pathways for foreign-produced COVID-19 vaccines ANI | Updated: Apr 15, 2021 14:35 IST
New Delhi [India], April 15 (ANI): The Central Government on Thursday issued the regulatory pathway in India for COVID-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL), said the Union Health Ministry.
The Central Drugs Standards Control Organisation (CDSCO) headed by Drugs Controller General of India (DCGI) has explained that it prepare detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on NEGVAC recommendations. These guidelines have since been prepared and posted by CDSCO on its website. CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders, the ministry said.
AYUSH Ministry s manufacturing unit IMPCL achieves highest ever turnover ANI | Updated: Apr 14, 2021 16:43 IST
New Delhi [India], April 14 (ANI): The public sector manufacturing unit of the Ministry of AYUSH, Indian Medicines Pharmaceutical Corporation Limited (IMPCL) has recorded its highest-ever turnover of Rs 164 crore in 2020-21.
According to a statement issued by the Ministry of AYUSH, this is the highest number achieved in the company s history and an all-time high profit of approximately Rs 12 crore is reported for the year. In the previous year, 2019-20 best revenue figures of the company was Rs 97 Crore. This growth is reflective of the fast-growing adoption of AYUSH products and services by the public in the wake of the COVID-19 pandemic, the statement said.
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