Centre issues guidelines for foreign-made coronavirus vaccines

The Union Health Ministry on Thursday issued the regulatory pathway for foreign-produced coronavirus vaccines. The development comes after DCGI (Drugs Controller General of India) gave its nod to foreign-made and approved COVID-19 vaccines following a massive spike in coronavirus cases.

The decision, according to the ministry, will expedite India's access to foreign jabs, besides boosting "imports 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 total vaccine availability within the country.

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The regulatory pathway has been issued for COVID-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO's Emergency Use Listing (EUL).

The Central Drugs Standards Control Organization (CDSCO), headed by DCGI, laid down the following pathway for such vaccines:

i. CDSCO shall prepare detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on NEGVAC recommendations.

ii. 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.

iii. Applicants for grant of approval for Restricted Use in Emergency situation may be submitted to CDSCO.

iv. Application can be made by the foreign manufacturer through its Indian subsidiary or through its authorised agent in India (in case it does not has an Indian subsidiary).

v. CDSCO will process such applications for restricted use in emergency situation and DCGI will consider and take a decision within 3 working days from the date of submission of complete application by the applicant.

vi. DCGI will issue permission for restricted use in emergency situation with, inter-alia, the following conditions:

a. Vaccine shall be used as per the guidelines prescribed under the National Covid-19 Vaccination Programme.

b. First 100 beneficiaries of such vaccines shall be assessed for 7 days for safety outcomes before it is rolled out for further vaccination programme.

c. Applicant shall initiate conduct of post approval bridging clinical trials within 30 days of such approval.

vii. Applications for restricted use in emergency situation for such vaccines maybe accompanied by bridging trial protocol, application for import registration certificate and import license.

viii. CDSCO will process applications for registration certificate (registration of oversees manufacturing site and product: in this case Covid vaccine) and import license within 3 working days from the date of approval of restricted use in emergency situation.

ix. As per the existing protocol of CDSCO for batch release of vaccines, each batch of the vaccine will be released by the Central Drugs Laboratory (CDL), Kasauli before it can be used as per the guidelines prescribed under the COVID-19 vaccination programme.

x. The applicant will use COVID vaccine, after receipt of CDL approval, initially only on 100 beneficiaries and submit the safety data to CDSCO.

xi. CDSCO will review the safety data submitted by the applicant, and once found satisfactory, will authorise the applicant to use the vaccine.

xii. CDSCO will approve the protocol for the bridging trial in consultation with Subject Expert Committee (SEC) within 7 days of the receipt of the proposal.

xiii. Applicant will conduct the bridging trial within the timelines specified in the approved protocol, and submit data generated in the bridging trial to CDSCO.

xiv. After the receipt of bridging trial results, DCGI will review the permission granted for restricted use in emergency situation.

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