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Drug Controller to Accelerate Foreign-Made Vaccine Applications | India News


NEW DELHI: In order to accelerate the availability of Covid vaccines in the country, the drug controller will process import licenses and applications for registration certificates of jabs manufactured abroad within three business days after the granting of the approval of emergency use, according to the guidelines issued by the Ministry of Health on Thursday.
“CDSCO (the Central Organization for the Control of Medicines Standards) will process the applications for the registration certificate (registration of supervises the manufacturing site and the product: in this case, Covid vaccine) and the Import License, within three days working from the date of approval of the Restricted Use in Emergency Situation ”, Said the Ministry of Health.
On Tuesday, the government waived the precondition of bridging studies in the local population for the US grant for foreign-manufactured vaccines that have already been approved for use in the US, UK, European Union and Japan. or they are on the WHO lists.
However, these vaccines will need to undergo parallel bridging studies once they are launched in India.
“Applications for restricted use in emergency situations for such vaccines may be accompanied by a bridge test protocol, an import registration certificate application and an import license application,” the ministry said.
A foreign manufacturer can apply through its Indian subsidiary. It can also be filed through an authorized agent in India in case a company does not have an Indian subsidiary.
“The Controller General of Medicines of India (DCGI) will issue a permit for restricted use with the following conditions: The vaccine will be used according to the guidelines prescribed in the National Covid-19 Vaccination Program. The first 100 beneficiaries of said vaccines will be evaluated for 7 days … The applicant must begin conducting bridging clinical trials after approval within 30 days after approval, ”the guidelines stated.
Each batch of vaccine will be released by the Central Drug Laboratory (CDL), Kasauli, before it can be used according to the guidelines prescribed in the National Covid-19 Vaccination Program.
After receiving CDL approval, an applicant will use the Covid-19 vaccine on only 100 beneficiaries initially and submit the safety data to CDSCO. The company in question will be able to use the vaccine only after CDSCO’s subject matter experts review the safety data of 100 beneficiaries submitted by it and find it satisfactory.
The regulator will approve the protocol for the bridge trial in consultation with its panel of subject matter experts within seven days of receiving the proposal, the guidelines say.
The government hopes the measure will facilitate faster access to foreign vaccines by India and encourage imports, including bulk pharmaceutical material, optimal utilization of domestic filling and finishing capacity, etc., which , in turn, will provide a change to vaccine manufacturing capacity and the total vaccine. availability within the country.

Times of India