LAHORE - Delay in quota allocation of controlled substances to pharmaceutical companies is likely to cause shortage of important drugs, TheNation has learnt.
The 59th meeting of CAQCS (Committee for Allocation of Quota of Controlled Substance) held last week proved a futile exercise, raising concerns among manufacturers who are seeing shortage of important medicines in near future.
The meeting was held at the Ministry of Narcotic Control under the Chairmanship of the Secretary Narcotic Control and was attended by the MoNC, ANF and officials of the Controlled Division of DRAP.
Despite the invitation to Industry Associations from the Controlled Division of the DRAP to discuss concerns on SOP for allocation of quota of Controlled Substance, they were not given a chance to explain the issues they face in ensuring availability of medicines to the patients.
The manufacturers believe that the scenario will result in severe shortage of medicines across the country. It may also affect the supply of medicines treating anxiety, depression, and other psychiatric ailments in the near future.
“It also includes tablets and syrups for cold and cough,” they said, adding that the shortage is creating room for smuggling and counterfeit drugs. They added that the shortage is often created due to flaws in the release mechanism of controlled substance as the policy of allocating quota to pharmaceutical companies is causing delays in production of certain drugs.
“The companies are demanding rectification of process by adopting a transparent and pragmatic mechanism as per global norms and practices,” said Amjad Ali Jawa, former Chairman Pakistan Pharmaceutical Manufacturers Association (PPMA) and former Senior Vice President Lahore Chamber of Commerce and Industry (LCCI).
“The quota allocation is granted annually and it takes around three to four months to import APIs due to red-tapism in the concerned departments,” he said, adding, the Ministry and Controlled Division-DRAP were not ready to understand the importance of timely issuance of quota along with increase as per market needs.
He said the process of importing controlled APIs for psychotropic drugs starts with application for quota allocation in January after the exhaustion of previously allocated raw material.
And then after scrutiny of applications and meetings which takes almost a month, an allocation letter is issued followed by permit to import, he said, adding that to ensure global safety standards pharmaceutical companies are bound to send original hard copies of allocation letters and import permit to sourcing countries.
Only then the production of APIs start abroad, he added. “Almost by April, APIs for psychotropic drugs reach Pakistan, clearing certificates are issued and drugs are being manufactured, followed by distribution. Hence, the process that initiates in January results in the availability of such crucial drugs by April/May,” said Mr Jawa, proprietor of Wilshire Laboratory in Lahore.
“It’s already December and we are left with minimum stocks. We won’t be able to meet the market demand until the new batch is available,” he said, adding, this situation will only create a room for counterfeits, posing serious threats to life of millions of patients.
He claimed that matters are being run on the whims of bureaucracy and there is dire lack of professionalism.
“We need systems and mechanisms in place to address such crisis and ensure smooth running of affairs to help both the industry and the patient,” he said.