Lockdown effect: Top drug regulator instructs release of blocked consignment of vaccines, IVDs

In the wake of coronavirus lockdown, the Central Drugs Controller has instructed all port offices of Central Drugs Standard Control Organization (CDCSO) to release the consignments of vaccines and critical in vitro diagnostics (IVDs) in public interest.

A letter written by the top drug regulator stated that it had received presentation from the importers stating that the consignments of vaccines and critical IVDs could not be released from the port offices as the samples could not be sent to the notified laboratories in the view of the lockdown announced by the government due to 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 the larger 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 the release of the batch by the manufactures and satisfactory history of the product, " said the letter, a copy of which is with ANI.

It said sufficient quantity of the vaccines/ IVDs (HIV, HbsAg etc), blood products should be drawn for analysis and stored at the prescribed storage conditions by the importers after mark for security by the port officers of CDCSO and the samples should be sent to the notified laboratories for evaluation at earliest.

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

"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 the public interest due to the situation by COVID19 outbreak lockdown, logistics problems, manpower problem at each level including at labs," said the drug regulator in the letter.

The 21-day countrywide lockdown was announced on March 24 to contain the spread of coronavirus.