Import licences for foreign vaccine in 3 days, says government - Times of India
NEW DELHI: In order to fast track availability of Covid-19 vaccines in the country, the drug controller will process import licences and registration certificate applications of foreign-made jabs in three working days after grant of emergency use approval
NEW DELHI: In order to fast track availability of Covid-19 vaccines in the country, the drug controller will process import licences and registration certificate applications of foreign-made jabs in three working days after grant of emergency use approval, according to guidelines issued by the health ministry on Thursday.
“The CDSCO (Central Drugs Standard Control Organisation) will process applications for registration certificate (registration of oversees manufacturing site and product: in this case Covid-19 vaccine) and import licence, within three working days from the date of approval of restricted use in emergency situation,” the ministry said.
The government on Tuesday waived the pre-condition of bridging studies in local population for grant of EUA for foreign-made vaccines that have already been approved for use in the US, the UK, the European Union and Japan or are on WHO lists.
However, such vaccines will be required to carry out parallel bridging studies once launched in India.
“Applications for restricted use in emergency situation for such vaccines may be accompanied by bridging trial protocol, application for import registration certificate and application for import licence,” the ministry said.
An application can be made by a foreign manufacturer through its Indian subsidiary. It can also be filed through an authorised agent in India in case a company does not have an Indian subsidiary.
“The Drugs Controller General of India (DCGI) will issue permission for restricted use with following conditions: vaccine shall be used as per the guidelines prescribed under National Covid-19 Vaccination Programme; first 100 beneficiaries of such vaccines shall be assessed for seven days; and applicant shall initiate conduct of post-approval bridging clinical trials within 30 days of such approval,” the guidelines said.
Each vaccine batch will be released by the Central Drugs Laboratory (CDL), Kasauli, before it can be used as per guidelines prescribed under the National Covid-19 Vaccination Programme.
After receiving approval from the CDL, an applicant will use the Covid-19 vaccine only on 100 people initially and submit the safety data to CDSCO. The company concerned will be allowed to use the vaccine only after the safety data of the 100 recipients submitted by it is reviewed by subject experts in the CDSCO and found to be satisfactory.
The regulator will approve the protocol for the bridging trial in consultation with its subject expert panel within seven days of the receipt of the proposal, the guidelines said.
The government expects the move to facilitate quicker access to foreign vaccines by India and encourage imports, including that of bulk drug material, optimal utilisation of domestic fill-and-finish capacity etc, which will, in turn, provide a fillip to vaccine manufacturing capacity and vaccine availability within the country.