CDSCO releases procedure for lot release of Human vaccine in view of prevailing COVID-19 pandemic

New Delhi: Through the recent circular Central Drugs Standard Control Organisation(CDSCO), Directorate General of Health Services has stated the procedure for lot release of Human vaccine in view of prevailing COVID-19 pandemic.

The procedural details were given by Dr V. G. Somani, Drugs Controller General (India) to The Director, Central Drugs Laboratory (CDL), Kasauli. Himachal Pradesh-173204, all Zone/Sub Zone offices of CDSCO and State Licensing Authorities, all Human Vaccine manufacturers and copy for the same was provided to PPS to Directorate General of Health Services, Ministry of Health and Family Welfare, PPS to the Joint Secretary (R), Ministry of Health and Family Welfare.

The directions came after Directorate General of Health Services received a representation from the domestic manufacturer of Human Vaccine wherein it has been requested to grant permission for testing and lot release of Human vaccine on the basis of the internal quality system and approval of the batch summary protocol by Central Drugs Laboratory (CDL), Kasauli due to current situation of lock-down and constraints in the supply management due to COVID-19 pandemic situation in the country.

In this regard, the matter has been examined in light of requirements & availability of essential Human vaccines in the country and it is decided that the manufacturer shall send the samples as per usual procedures to CDL, Kasauli for evaluation when logistics are restored. Till such time, CDL, Kasauli may carry out lot release activity for Human vaccines manufactured domestically by review of summary lot protocol on a case by case basis.

The lot release is subject to the condition that manufacturer shall forward summary lot protocol of each batch/lot to CDL, Kasauli through e-mail along with a certificate of analysis and an undertaking that Human Vaccine released in the market shall be recalled in case of quality failures. However CDL.

Kasauli may not issue a lot release certificate wherever it is of the opinion that data is insufficient to take the decision. This procedure may be followed till the situation returns to normal.

In order to ensure continued availability of vaccines, being an essential drug, and due to the prevailing outbreak of COV1D-19, lockdown announced by Government of India, logistic problem, manpower problem at each level including laboratory, this order is being issued in the public interest.

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