ISLAMABAD: Pharmaceutical companies have blamed the Drug Regulatory Authority of Pakistan (Drap) for the current shortage of certain medicines in the country.

Their representative body, the Pharma Bureau, urged the Drap in a statement on Tuesday to revise its mechanism for controlling the supply of Ephedrine, Pseudoephedrine and other Active Pharmaceutical Ingredients (API) that are used in manufacturing cough and cold syrups, psychotherapeutic drugs and other medicines. Supply of the opiates was tightened in 2012 after a scandal rocked the industry and the country’s political establishment over the drug manufacturers’ allegedly oversized demands for the opiates.

Drap CEO Dr Mohammad Aslam, therefore, finds it “natural” for the new, strict Standard Operating Procedure (SOP) devised in 2013 for regulating the supplies of APIs to continue unchanged. The SOP was framed after the Supreme Court took up the matter and questioned political personalities involved and sent several bureaucrats to jail.

However, the Pharma Bureau statement claimed that Drap delays the yearly allocation of quota for raw materials, which contain controlled substances like ephedrine, causing shortage of multiple medicines to the discomfort of patients.

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 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,” said the statement.

Executive Director Pharma Bureau Ayesha Tammy Haq told Dawn that this year’s quota was due in January but was actually announced in March. That created severe shortage of important drugs in the market, she said.

Ms Haq explained: “While the controlled API is allocated, rest of the raw materials – except the pseudoephedrine (for cough/cold medicines) - is 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.”

She insisted it was imperative that Drap needed to revise its SOP to ensure that there are no shortages in future.

She noted that though the medicines disappeared from the market because of unavailability of raw material, pharmaceutical companies are accused of deliberately creating the shortage to increase prices.

“We demand that the allocation of API should be confirmed in November every year so that the medicine would be available by January next year,” she said.

An official of Ministry of National Health Services, however, disagreed with her arguments. Requesting anonymity, he said: “Normally, the last batch of the API-based medicines, which comes in December, should last till March. The fact is that the companies increased prices of medicines and then they withdrew medicine from the market to change the prices. It created shortage of medicine,” he claimed.

“Another problem is that every year companies demand increase in their quota so it takes time to analyse the cases. It has to be ensured that the quota will not be misused,” he said.

Drap CEO Dr Aslam while talking to Dawn said the issue was very sensitive as it was directly related with the Narcotics Control Board.

“The year ends on December 31 and the companies have to report by January 7 if they had consumed their quota and how much more APIs they require. This year we requested the companies to provide information on first working day after December 31 but some of them stuck to the last date and others took even longer,” he said.

“Next year we will try to process the cases quicker,” he added.

Published in Dawn, April 6th, 2016