Quota allocation for controlled substance/narcotics: Pharma Bureau urges DRAP to revise SOP

The Pharma Bureau has urged the Drug Regulatory Authority of Pakistan to revise the SOP for controlled substance 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 a spokesman of Pharma Bureau.
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 DRAP.
"DRAP's efforts to curb the shortages are commendable but a breakthrough development in this regard could be just the change of quota allocation dates, which could be before the year ends so that new allocations are acquired well in advance and consumers do not have to suffer on this pretext.
This year announcement of quota was due in November 2015 which was ultimately announced in March, 2016, which has created severe shortage of important drugs in the market," he said. "The controlled API is allocated but except for the pseudoephedrine (cough/cold) rest of the raw materials are procured from overseas, 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.
Therefore it is imperative that SOP is revised after which it can be ensured that there will be no shortages in future. "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 last seven years and investing around 3.2 million dollars every year on a single manufacturing facility in Pakistan. We will always be playing our role in betterment of industry and patients in Pakistan," said the spokesman of Pharma Bureau.-PR