India’s drug regulator has cleared the way for import of Covid-19 vaccines into India.
According to the drug regulator any private entity can procure the vaccine from the importer for its use if the vaccine to be imported is approved by the drug regulatory authority and import license has been obtained from it.
If the vaccine is not yet approved or licensed, the importer or the authorised agent of the manufacture of the vaccine will have to obtain permission license from the regulatory authority which includes the New Drug Permission under New Drugs & clinical Trials Rules, 2019, import registration under Drugs Rules, 1945 and Import licence under Drugs Rules, 1945.
With import licence, vaccine can be imported for supply to state governments and private entities, the regulator has said in a set of guidance released for import of vaccines by private sector and state governments.
According to the drug regulator any private entity can procure the vaccine from the importer for its use if the vaccine to be imported is approved by the drug regulatory authority and import license has been obtained from it.
If the vaccine is not yet approved or licensed, the importer or the authorised agent of the manufacture of the vaccine will have to obtain permission license from the regulatory authority which includes the New Drug Permission under New Drugs & clinical Trials Rules, 2019, import registration under Drugs Rules, 1945 and Import licence under Drugs Rules, 1945.
With import licence, vaccine can be imported for supply to state governments and private entities, the regulator has said in a set of guidance released for import of vaccines by private sector and state governments.
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