Drap delay

April 04, 2020

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IT is distressing to learn that the country’s lead regulator for the pharmaceutical sector, the Drug Regulatory Authority of Pakistan, was largely dysfunctional between Feb 25 and March 31 when the fight against Covid-19 had begun in earnest. During that period, 10 critical appointments were pending, and since these were posts where all important decisions are made, the authority was unable to respond to any requests from the pharmaceutical sector, whether on pricing or permission to introduce new drugs or approve basic things necessary for the fight against the coronavirus such as hand sanitisers. The result is that a large number of players have entered the hand sanitiser market, and the majority of what they are selling are substandard products that would be ineffective against the virus since a test conducted by the Pakistan Standard and Quality Control Authority shows they have alcohol content below 60pc, which is the minimum required threshold for effectiveness against the virus.

In addition, manufacturers have not been able to place orders for many medicines that may be essential for the fight, such as chloroquine, because crucial price adjustments are required before orders for raw material can be placed due to large fluctuations in the global markets. Since nobody had been appointed to the posts where such price adjustments are usually discussed, the manufacturers emptied their stock without placing new orders while they waited for the position to be filled. As it turns out, Drap filled those positions in a hurry on the evening of March 31 once the media queries began to come in. This action demonstrated that the delay had been entirely unnecessary and the positions need not have been vacant all this time. This is nothing short of a travesty. Our front-line professionals in the health sector are making enormous sacrifices in this fight and it is surely distressing for them to learn of the level of ineptitude that rendered the lead drug regulator dysfunctional at a crucial time.

Published in Dawn, April 4th, 2020