Draft of Punjab Drugs (Amendment) Act 2017 to be tabled in PA

LAHORE: Punjab Law Minister Rana Sanaullah has said the Punjab government will table the consensus draft of Punjab Drugs (Amendment) Act 2017, prepared in consultation with the representatives of all stakeholders, in the next session of Punjab Assembly to be held in August, which aims at providing not only business-friendly environment to the pharma industry but would also ensure quality and cost-effective medicines to the patients in the country.

“The new consensus draft of amendment bill will not only allay concerns of the stakeholders, but also tighten its noose around producers of counterfeit medicines to curb this menace,” he said.

He was addressing the concluding session of the 3rd Pakistan Pharma Summit organised by Pakistan Pharmaceutical Manufacturers’ Association (PPMA) here at a local hotel on Monday.

After hue and cry was raised upon passage of the Punjab Drugs (Amendment) Act 2017, he informed that Chief Minister Shahbaz Sharif constituted a Cabinet Committee, headed by Law Minister Rana Sanaullah, which held consultations with the representatives of pharmaceutical industry, manufacturers, distributors, retailers and wholesalers for three months to identify seven contentious points, which were further narrowed down to two points to make them acceptable for the both the government and pharmaceutical industry for the ultimately benefit of the patients in the country.

He said the Punjab government wanted to abolish the system of drug inspectors, which had become a mafia like police inspectors, excise inspectors, food inspectors and patwaris, but on the insistence of pharma industry, the Punjab government agreed to gradually abolish the system of drug inspectors, which would be ultimately replaced with audit by renowned private firms. Secondly, he said, the Punjab government agreed to industry’s demand of confirming the status of substandard or fake drugs from two or three available options of private firms. “We do not want to impose anything forcefully on the pharmaceutical industry, but will gradually implement the international standards in vogue in developed countries of the world.

Earlier, Punjab Information, Excise and Taxation Minister Mian Mujtaba Shuja-ur-Rehman informed 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 a committee with Punjab Law Minister Rana Sanaullah in the chair and having representation of Pharma industry, pharmacy owners, and the government authorities had finalised 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 its implementation in accordance with the demand of the industry.

The Drug Regulatory Authority of Pakistan (DRAP) Chief Executive Officer Dr Muhammad 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 modernise 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.

Earlier, speaking at the inaugural session of the Summit, the pharmaceutical industry representatives called upon the Drug Regulatory Authority of Pakistan (DRAP) to review its directive giving just six months to the medicine manufacturers to adopt systems of “Serialisation 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.

In June 2017, the DRAP had issued a directive making it binding upon the Pharma industry to adopt within six months the system of Serialisation, 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 serialisation in their systems by the year 2020/2021 in order to protect patients from the menace of counterfeit drugs. Learning that the DRAP has planned to employ serialisation 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 than confronting and issuing SROs (statutory regulatory orders),” said Haroon Qassim.

“By the year 2020/21, it is expected that 75 percent 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.

He said that industry and regulatory agencies should work together to ensure maximum benefit to patients while minimising 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 situation”.

Former chairman of PPMA Jawed Akhai said that six months given by the DRAP to adopt systems of serialisation 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 percent of their gross profits towards the Central Research Fund (CRF) being maintained by the federal government as funds available with the CRF should be used to help out Pharma industry to adopt modern systems like serialisation 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 10 years such just demands of the industry remained unheeded as in the meantime similar smuggled and unauthorised 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 issuance of licences and registration for manufacturing and introducing new medicines in Pakistani market for the maximum benefit of ailing citizenry.

He said that such matters should be handled by the DRAP and other authorities concerned of the 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 and such careless attitude should not be shown again,”

Other medicine manufacturers speaking on the occasion also urged the government to liberalise 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.