Pharma Bureau insists on revising SOPs

Says delay in allocation dates could mean shortage of life saving drugs

KARACHI: The Pharma Bureau has urged the Drug Regulatory Authority of Pakistan (DRAP) to revise the standard operating procedures (SOPs) for controlled substance and narcotic quota allocation to pharmaceutical companies.

“Every year the quota allocation for raw materials which contains controlled substances such as ephedrine gets delayed and every year patients face shortage of multiple medicines since companies are unable to produce them,” according to a Pharma Bureau press release on Tuesday.

“For instance this year’s announcement of quota was due in November 2015 but it was announced in March 2016, causing a severe shortage of important drugs in the market.

All controlled active pharmaceutical ingredients (API) are allocated, except for pseudoephedrine (used to treat cold and cough). Since the raw materials are procured from overseas, it takes two months for them to make it to the shelf. Consequently, when quotas are allocated this year, the products containing imported API would not be available till May.”

The bureau appreciated DRAP’s efforts to curb the shortages, however, it insisted that a mere change in quota allocation dates could be the breakthrough development that was needed. The bureau pushed for the allocations to be made before the year’s end, which would ensure that the new allocations are acquired well in advance, circumventing any possible shortages.

Pharma Bureau is a representative body of multinational pharmaceuticals operating in Pakistan.

Published in The Express Tribune, April 6^th,  2016.

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