Pharma Bureau urges DRAP to revise SOPs

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

“Every year, the quota allocation for raw materials, which contain controlled substances such as ephedrine, gets delayed and patients face shortage of multiple medicines as companies are not able to produce the same,” said Pharma Bureau spokesman on Tuesday.

The narcotics based raw materials both imported and acquired locally are used for many life-saving therapies, anti-depressants, cough and cold syrups and tablets, etc, of which a special permission is granted by Ministry of Narcotics Control in consultation with the Drug Regulatory Authority Pakistan.

“Drap’s efforts to curb the shortages are commendable, but a breakthrough development in this regard can be just the change of quota allocation dates, which should be before the year ends so
that new allocations are acquired well in advance and consumers do not have to
suffer.

This year’s announcement of the quota was expected in November 2015, which was ultimately announced in March 2016, which has created severe shortage of important drugs in the market,” he said.

He said the controlled active pharmaceutical ingredient (API) was allocated but except for the pseudoephedrine (cough/cold) rest of the raw materials were procured from abroad.

“It takes two months before the products actually make it to the shelf.

Hence this year, even when the quota allocation is done, the products containing imported API would not be available till May,” he said.

“Pharma Bureau is the representative body of research based multinational pharma companies in Pakistan.”

“We have invested in excess of 0.5 billion dollars in the last seven years, and invest around 3.2 million dollars every year on a single manufacturing facility in Pakistan,” said the spokesman of the bureau.