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CDL to allow vaccine makers to release product after evaluating summary lot protocol of each batch

Laxmi Yadav, Mumbai
Monday, April 13, 2020, 08:00 Hrs  [IST]

To ensure hassle-free supply of vaccines during the lockdown announced by the government to prevent coronavirus transmission, the Drugs Controller General of India (DCGI) has directed Central Drugs Laboratory (CDL), Kasauli to issue lot release certificate to vaccine manufacturers after going through summary lot protocol of each lot of the vaccine and its analysis report sent by them.

However, the manufacturers are required to give undertaking that the vaccine will be recalled by them in case of failure of sample test.

Considering the outbreak of COVID-19 and the subsequent lockdown announced by the government, logistic problems and manpower problems at each level including laboratory, the DCGI has exempted vaccine manufacturers from dispatching the product sample to CDL, Kasauli for testing.

Earlier domestic manufacturers of vaccine had made representation to DCGI VG Somani urging him to grant permission for testing and lot release of vaccine on the basis of internal quality system and approval of batch summary protocol by CDL, Kasauli due to current situation of lockdown and constraints in supply management due to COVID-19 pandemic in the country.

“Vaccine manufacturers are facing several challenges during this lockdown period which is impacting their ability to run their plants as normal. These include – inability of manpower to reach manufacturing and distribution sites, interruption in delivery of product due to flight cancellations and interruption in trucking activity to move raw materials and finished products on time. The flight cancellations have especially affected the import of key raw materials from China as well as export of finished products to various countries,” said Dr Prasanna Deshpande, deputy managing director, Indian Immunologicals Limited.

Taking serious note of logistic challenges faced by the vaccine manufacturers, DCGI has asked them to forward summary lot protocol of each batch/lot to CDL, Kasauli through email along with certificate of analysis and an undertaking that vaccine released in the market shall be recalled in case of quality failures.

CDL, Kasauli will carry out lot release activity for vaccines manufactured domestically by review of summary lot protocol on case by case basis, stated Somani.

However CDL, Kasauli may not issue 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, he clarified.

The DCGI directed vaccine manufacturers to send the samples as per usual procedures to CDL, Kasauli for evaluation when logistics are restored.

The DCGI has issued a letter to all zonal offices of Central Drugs Standard Control Organisation (CDSCO) and state licensing authorities in this regard.

This is a welcome step taken by CDSCO and CDL. It will address a significant uncertainty for delivery of vaccines during this lockdown period, said Dr Deshpande.

In order to ensure smooth supplies of essential vaccines, diagnostics and blood products during the lockdown, CDSCO had earlier directed its port offices to release consignments of vaccines and critical in-vitro diagnostics (IVDs) after importers setting samples for testing aside and giving the undertaking that they will recall the product in case of failure of sample test.


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