Central drug regulator orders release of vaccine, IVD consignments from port offices amid lockdown

The central drug regulator has directed its port offices to release consignments of vaccines and critical in vitro diagnostics (IVDs) "in public interest" amid a 21-day nationwide lockdown.

In a letter to Central Drugs Standard Control Organization (CDSCO) port offices, the drug controller said his office had received representations from importers about consignments of vaccines and critical IVDs not being released in view of the ongoing lockdown announced by the government to combat the COVID-19 pandemic.

"This matter has been examined carefully by the committee and in the view of the criticality of these products it has been decided in large public interest, till further orders that the consignments of the vaccines and critical IVDs and blood products (which are usually sampled 100 per cent for testing) may be released by all the port offices based on the review of documents, protocol, certificates of release of batch by the manufactures and satisfactory history of the product, subject to the following conditions," it said.

It stated that sufficient quantity of the vaccines/IVDs, blood products should be drawn for analysis and stored at the prescribed storage conditions by the importers after putting mark for the security by the port officers of CDCSO and the samples should be sent to the notified laboratories for evaluation at earliest when the logistics are reported.

The importers should submit an undertaking stating that their product released in this circumstance will be recalled in case the samples does into clear the evaluation by laboratories, the letter stated.

"The port officers are hereby requested to follow the aforesaid procedures in order not to hamper the supplies of essential vaccine, diagnostics and blood products in public interest due to the situation arisen by COVID-19 outbreak lockdown, logistics problems, manpower problem at the each level including at labs," it said.