KARACHI: The Pharmaceutical industry representatives have called upon the Drug Regulatory of Pakistan (Drap) to review its directive giving just six months to the medicine manufacturers to adopt systems of “Serialization and barcode” for the medicinal products in the country as this deadline is even shorter than the timelines prescribed by regulatory bodies in the developed world for adopting similar technological mechanisms.
This was one of the main demands made by speakers at the inauguration of 3rd Pakistan Pharma Summit organized by Pakistan Pharmaceutical Manufacturers’ Association (PPMA) here at a hotel on Monday.
Audience of the summit were reminded by the speakers that in June this year the Drap had issued a directive making it binding upon the Pharma industry to adopt within six months the system of Serialization, which includes barcodes for medicines in order to ensure authenticity and quality of drug products being sold in the market.
“The regulatory bodies from across the globe are planning to implement the process of serialization in their systems by the year 2020/2021 in order to protect patients from the menace of counterfeit drugs. Learning that the Drap has plans to employ serialization process a lot quicker than the USA and Europe is encouraging but it comes with a word of caution,” said Haroon Qassim in his introductory remarks for the moot being chairman of the Pharma Summit on behalf of the PPMA.
“We believe that an entire ecosystem has to be built before venturing into the complexities of this magnificent tool as being over ambitious sometimes carries undesirable consequences. We appreciate the Drap for its futuristic approach but it should work as a partner with the industry rather confronting and issuing SROs (statutory regulatory orders),” said Mr. Qassim.
“By the year 2020/21, it is expected that 75 per cent of the world’s pharmaceutical supply chain will be covered under various regulatory mandates. Compliance with these regulations will require companies to invest in new technology, make major process changes, and potentially restructure their supply chains. This is a tall order, are we ready for that,” he said.
The summit chairman said that industry and regulatory agencies should work together to ensure maximum benefit to patients whilst minimizing risks. “There is also a need for objective dialogue on regular basis between regulators and the industry to resolve and dissolve all emerging challenges and issues for a win-win scenario”.
Former chairman of PPMA Jawed Akhai said on the occasion that six months given by the Drap to adopt systems of serialization and barcode for medicinal products was too less as only such Pharma companies would be able to abide by this deadline, which had been working on such technological innovations for last several years.
He said that pharmaceutical companies for last several decades had been contributing one per cent of their gross profits towards the Central Research Fund (CRF) being maintained by federal government as funds available with the CRF should be used to help out Pharma industry to adopt modern systems like serialization and barcode systems for medicinal products.
He said that Pharma industry of the country had been urging the government to adopt policy for introducing Vitamin products in the market but for last ten years such just demands of the industry remained unheeded as in the meantime similar smuggled and unauthorized medicinal products were openly being sold in the market without any check.
He said the Drap should not delay any more decisions on important affairs related to industry including grant of licenses and doing registration for manufacturing and introducing new medicines in Pakistani market for the maximum benefit of ailing citizenry.
He said that such matters should be dealt by the Drap and other concerned authorities of federal government on a priority basis what had been the norm of Pharma sector regulators in the developed world. “During the time I served as the PPMA chairman I happened to deal with cases where Drap officials had simply lost files containing registration applications for new medicines to be introduced in the market as such careless attitude should not be shown again,”
Other medicine manufacturers speaking on the occasion also urged the government to liberalize the drug pricing mechanism as was done by India and China to harness huge potential of the Pharma industry of Pakistan and to get its exports accelerated. Drap Chief Executive Officer Dr. Mohammad Aslam urged the Pharma industry to adopt a fresh strategic plan to adopt technological advancements and do compliance with regulatory requirements to match with the highest quality standards being maintained by Pharma industry in the developed part of the world.
In his welcome speech, Central PPMA Chairman Dr. Kaiser Waheed said that Pharma industry of the country had been actively thinking to modernize and change its system of manufacturing and running other systems of business to meet regulatory requirements of modern day and to extend maximum benefit to people suffering from various contagious and congenital diseases.
AMENDMENT IN PUNJAB DRUGS ACT: Speaking as the chief guest of inaugural session, Punjab Information, Excise and Taxation Minister Mian Mujtaba Shuja-ur-Rehman informed audience of the summit that the bill to duly amend Punjab Drugs (Amendment) Act-2017 in accordance with demands of Pharma industry and pharmacy owners would be tabled in next session of Punjab Assembly. He said that a committee with Punjab Law Minister Rana Sanaullah in chair and having representation of Pharma industry, pharmacy owners, and the govt authorities had finalized its proposals to duly amend the Punjab Drugs (Amendment) Act. He said despite that the law passed by Punjab Assembly in January, 2017 had become an Act after assent of the governor but the Punjab chief minister had stopped implementation on it in accordance with demand of the industry.[related_post themes="text" id="317841"]