Pharmaceutical sector of Pakistan

[ghazi52]

‘Pharmaceutical sector can help Pakistan with its export target’

• It is a low-hanging fruit that can aid the economy achieve sustainable growth, says PBC vice-chairman

Ali Ahmed
02 Jun 2021

Karachi: As the government seeks to find a way to achieve long-term sustainable growth, the pharmaceutical industry has said that it is a low- hanging fruit that can help Pakistan both in terms of exports and industrial progress.

These remarks were given by Muhammad Aurangzeb, vice-chairman of the Pakistan Business Council (PBC), during a webinar held on Wednesday for the launch of the report titled, ‘Unleashing the Potential of Pharmaceuticals in Pakistan’.

The report said exports of the pharmaceutical sector could hit $5 billion in just a few years as Pakistan emphasizes public healthcare.

“In 2020, the value of the pharmaceutical sector of Pakistan was estimated to be around $3.2 billion, doubling from $1.64 billion in 2011,” stated the report. “Its total exports in 2019 stood at $218 million, up from $44.4 million in 2003. Yet exports from the sector accounted for only 0.9 per cent of Pakistan’s total exports to the world in 2019.”

Expressing his views, panellist Dr Ijaz Nabi, chairperson of the Consortium for Development Policy Research (CDPR) and member of the PM’s Economic Advisory Council, said that the pharmaceutical industry has the potential to change Pakistan's image.

He said that much like how the IT industry changed the image of India, and the garments industry changed the image Bangladesh, similar could be the case with the pharmaceutical sector for Pakistan.

“The timing is absolutely right to focus on the pharmaceutical sector,” said Nabi as the government has been able to attain economic stability during its tenure.

The report was of the view that with global pharmaceutical markets in a flux due to major restructuring, there is an opportunity for Pakistan to enter the global off-patent drugs market that will be worth $700 billion in branded generics and $381 billion in generics by 2025.

It said that Pakistan, with a local market of 215 million consumers and more than 700 pharmaceutical companies, is poised well to gain from opportunities provided under these shuffling global patterns of supply and demand.
The PBC report said that Pakistan should acquire vaccine manufacturing capabilities as a first step.
“In phase I, which can begin immediately, local firms having validated biologic production facilities, or that are willing to invest in the required standards will use imported bulk vaccine concentrate to fill-and-finish vaccines into individual doses. The government will provide long-term purchase/buy-back agreements for these locally produced vaccines, under a public private partnership model,” said the report.

However, Pakistan needs to improve its education standard if it is looking to move forward in the pharmaceutical sector, which is a science and technology industry, said Khaild Mehmood, managing director & CEO Getz Pharma, one of the largest exporters of pharmaceuticals in Pakistan.

“The curriculum of pharmaceutical and chemistry in Pakistan is very old and unfortunately, no government has really looked at it,” he said.

On the other hand, Asif Jooma, chief executive at ICI Pakistan Ltd & former CEO of Abbott Pakistan Ltd, called for an overhaul of the Drug Regulatory Authority of Pakistan (DRAP), a view he shared with the PBC report.

“The regulatory environment in Pakistan is unfortunately regressive which actually compromises on patient interest,” said Jooma. He said multiple stakeholders need to sit together and develop a policy that caters to industry growth as well as patient interest.

The report, in its recommendations, said that a sectoral growth strategy and corresponding action plan is urgently needed.

‘Pharmaceutical sector can help Pakistan with its export target’

It is a low-hanging fruit that can aid the economy achieve sustainable growth, says PBC vice-chairman

www.brecorder.com

 

[Mk-313]

you know the problem with you people is that you have an insane amount of natural resoruces that its crazy but everyone goes around just saying oh we have this and that but no one actually gets up and does something

i mean which country has a $3 trillion gold mine just sitting idly by. just working on that mine alone can make you richer than india and its 1.3 billion population

 

[ghazi52]

ISLAMABAD: Pakistan's pandemic efforts have received a "booster shot" as the first batch of locally-produced Covid-19 vaccines is rolling off the line here at a national lab.

As many as 120,000 doses have recently been produced at Pakistan's National Institute of Health (NIH) under rigorous quality control with tech support from Chinese pharmaceutical firm CanSino.

Local health authorities welcomed the vaccines as a major landmark in Pakistan's efforts to attaining vaccine self-sufficiency, a much-needed, yet challenging task that Pakistan had fervently hoped to fulfil within months.

"The cooperation between the two countries also underscores the philosophy that the Covid-19 vaccine is a global good," said Special Assistant to the Pakistani Prime Minister on Health Faisal Sultan at the production ceremony.


Magic in an empty room

CanSino Biologics Vice President Xin Chunlin admitted it initially came to him that the first batch of local production "wouldn't be a tough assignment," given the NIH's rich experience in vaccine manufacturing.

The reality proved the opposite -- making recombinant Covid-19 vaccines is a brand-new practice for the South Asian country, key aspects of which, including facilities and quality control standards, had to start from scratch, said Xin, who also leads a taskforce with members from both countries.

The task was further challenged by the global supply shortage including key equipment for a lab, chemicals necessary for the production, and subsequent reliance on some manual work.

"It's like we were asked to start our experiments in an empty room," Xin recalled.

Despite all these challenges, the team created a facility that can conduct analyses such as western-blotting essential to the production process.

Working alongside Chinese counterparts has enabled Pakistani members to gain hands-on experience in key quality control techniques such as virus particle testing, said Rafique Ahmed Channa, a Pakistani with more than 30 years of experience in the field.

The team also overcame ingredient shortages by finding best suited substitutes via rounds of trial-and-error.

"It's like wading the river by groping for stones. We shared our own experiences so as to find the best solution," said Xin.


MAKING KNOWLEDGE MORE INCLUSIVE

In the eyes of Pakistani experts, each and every attempt will add up to upgrading the country's health infrastructure and final fulfilment of self-sufficiency.

The localisation came as another first-time experience for the South Asian country in Covid-19 vaccine technology, after a successful phase III clinical trial of the vaccine under the cooperation between the NIH and CanSino.

So far, the Drug Regulatory Authority of Pakistan has approved three types of Chinese vaccines developed by pharmaceutical companies Sinovac, CanSino and Sinopharm, for emergency use.
Technology transfer enabled by bilateral cooperation has helped Pakistan to stride forward in achieving vaccine production capacity, said Ghazala Parveen, chief of the Biological Production Division at the NIH.

"The technology transfer is extremely crucial for the people of Pakistan. It helps us save money rather than buying vaccines from other countries," said Saba Haq, research official at the NIH.

New data from the Bloomberg Vaccine Tracker shows that the least wealthy 37 places worldwide covering more than a tenth of the world population have only received one percent of all doses.
Yet countries like China have been striving to expand the global supply of the life-saving shots, closing the widening gap between rich and poor nations.

From his experience, Xin said the most urgent task is to ensure the supply chain of vaccine production. "Take syringes as an example. It may not be the focal point when you talk about vaccine patents. But it can be the thing that slows down the delivery of the vaccines," he said.

More work needs to be done in making vaccine production technology transferable to developing countries, he added.

Seeing the upgraded infrastructure and better-trained manpower, Parveen said it gave her greater confidence that her country can now better handle infectious diseases.

"If another pandemic in the future will arrive, we know how to control it," she said.

 

[Deltadart]

Pharmaceuticals can do wonders for our country. India supplies the cheap meds to greedy US pharmacy chains, who in turn charge exorbitant prices to the US insurance companies. The consumers also get stuck with very expensive meds that were gotten for pennies from india and sold at a great mark up.

 

[American Pakistani]

The easiest industry but the most crucial critical industry which has been ignored by pakistan.

 

[ghazi52]

Currently Pakistan has more than 800 large volume pharmaceutical formulation units, including those operated by 25 multinationals present in the country.
Almost all the raw materials used in making of medicine are sourced from abroad. About 50 percent of them are imported from India.

 

[ghazi52]

Pakistan’s pharmaceutical sector has not seen the growth and dynamism one would expect from industries with an upward growth trajectory. It has also not been competitive internationally, with limited exports. Further, the pharmaceutical industry in Pakistan has developed a top-heavy structure in terms of market share, where the top 100 firms, out of a total of around 750, cater to 97% of the market. It follows that approximately 650 firms survive on only 3% of the market.

Together, the poor competitiveness and the skewed industry structure suggest that there are factors preventing this sector from contributing to economic growth and public health. This paper investigates private corruption in the pharmaceutical sector – understood as the capture of rents – as a possible factor harming development.

The paper focuses on three issues in particular that have been highlighted through preliminary research on the pharmaceutical industry in Pakistan as restricting development. These are pricing, poor quality drugs and government procurement of medicines. For each of these issues the authors have examined the processes over time that have resulted in the creation of rents and that encourage rent-seeking. The study used key informant interviews and data from the government on testing and procurement for its analysis.

https://ace.soas.ac.uk/wp-content/uploads/2019/08/ACE-WorkingPaper012-PakistanPharmaSector-190801.pdf

 

[ghazi52]

Pharmaceutical sector of Pakistan


The country holds annual pharmaceutical sales of 3.1 billion US-$ with systematic anti-infectives followed by drugs used for gastrointestinal and metabolic disorders representing the major categories of sold finished pharmaceuticals . The larger share (about 60%) of sales goes to domestically produced medicines with 95% of the Active Pharmaceutical Ingredients (APIs) being imported from abroad.

According to the press release issued by the “Drug Regulatory Authority of Pakistan” (DRAP) on 26th January 2019, Pakistan has 647 actively operating drug manufacturing licenses, and 6440 medicines were registered in the year of 2018 .

The manufacturing licenses cover formulation, basic and semi-basic manufacturing (raw material manufacturing), as well as repacking. However, the list of importers of finished pharmaceutical products including mainly biologicals, vaccines, anticancers, newly approved medicines, contrast media, etc., exceed the number of pharmaceutical manufacturers. Out of all licensed manufacturing units in Pakistan, none has been approved by the United States Food and Drug Administration (FDA) which is in strong contrast to the neighbours India and Bangladesh. Only one pharmaceutical company actually holds a Good Manufacturing Practice (GMP) certification issued by the European Medicines Agency and accreditation issued by the Medicines and Healthcare Products Regulatory Agency of the UK (MHRA) for solid dosage form manufacturing.

In early 2018, moxifloxacin tablets produced by Getz Pharma Pvt., Ltd. achieved the status of a “first-ever WHO prequalified pharmaceutical product from Pakistan” . Nationally manufactured pharmaceuticals are exported to other countries, mainly to Jordan (80%), Africa, and the Middle East. A Central Research Fund (CRF) is operated under the “Drug (licensing, registration, and advertising) rules” from 1976 , according to which 1% of the gross profit of pharmaceutical companies before tax deduction is deposited to the government for supporting research of public and national interests.

According to the figures reported in 2007, CRF amounted to 467 million Pakistani rupees (3.3 million US-$), with the estimates of 75–85 million Pakistani rupees (0.5–0.6 million US-$) collected per annum. However, since the beginning of an actual approval of projects under this fund in 2001, only a meagre amount has been consumed which caters to a handful of projects showing underutilization of funds, lack of planning, and poor execution of policies .


Identification of medicine quality as a prevailing health sector crisis

Poor-quality pharmaceuticals and medicine supply shortages were identified as major challenges in distributing and accessing essential medicines during the humanitarian crisis following the 2005 earthquake , floods (2010), and internally displaced people (2011). In Pakistan, the issue has gained national as well as international attention after two major incidences of poor-quality medicines claimed lives of hundreds of people in 2011 and 2012 . The first incidence is the case of contaminated cardiovascular drugs in December 2011 which claimed more than 230 lives (“The Fake Drug Crisis”) . This incidence led to the establishment of the autonomous Drug Regulatory Authority of Pakistan (DRAP) and also became a driving force for improving the regulatory structures of the country both at provincial and federal levels. These changes are detailed in the latter sections of this article. In November 2012, another major case of medicine quality failure occurred, causing death of hundreds of people after ingesting contaminated cough syrup.

It is important to note that the public sector medicine quality control laboratories were unable to identify the presence of an erroneous substance (pyrimethamine) in the cardiovascular drug in the first case, and similarly high amounts of toxic levomethorphan were not identified timely in substandard dextromethorphan cough syrup samples. Through these incidences, the inadequacy of the system became evident and quality issues of pharmaceuticals were gradually identified as a major health system concern in Pakistan.


Regulatory infrastructure for pharmaceuticals

In Pakistan, medicine licensing, manufacturing, registration, pricing, imports, and exports are dealt by the federal government, whereas distribution and sales are regulated by the respective provincial governments . International experts consider this decentralized regulatory control as a structural weakness of the system; the situation worsened on devolution of drug regulatory powers from the federal government to the provinces under the 18th amendment of the constitution of Pakistan. The decision was later revoked by issuance of a “no objection” certificate by provinces through the Council of Common Interest . Along with drug regulation, the Higher Education Commission is another example of the organizational body that remained under the federal body .

DRAP was formed in November 2012 with enforcement of the DRAP act. DRAP functions as an autonomous body under the Ministry of National Health Services. The new organizational structure of DRAP consists of eight technical and five supportive divisions. The department of quality assurance has five field offices supported by federal drug inspectors, assistant drug controllers, and an appellate board. The other seven technical divisions include registration, medical devices, biological drugs, controlled drugs, pharmacy services, health & over-the-counter, costing, and pricing.

The pharmacy services division covers pharmacovigilance, clinical trials, regulation of contract research organizations, and research. The regulatory functions enforced through DRAP in the short period of 7 years (2012–2019), in comparison to the working of previous regulatory entity Drug Control Organization (DCO), are shown in Table 1 which also depicts the basic differences between the two organizations.

 

[ghazi52]

Federal govt announces to produce PakVac on large scale

Web Desk
5:20 PM | June 20, 2021


The Federal government, on Sunday, has decided to produce PakVac on a large scale to overcome the scarcity of corona vaccine across the country.

The decision has been taken to initiate preparations for mass scale production of the single-dose PakVac from next month, sources said.

As per the sources, the National Institute of Health (NIH) Islamabad will prepare three million doses of PakVac monthly and the government has been informed about the decision.

The decision to produce vaccines on a large scale has been taken in view of the increased demand of the vaccine, sources said.

“Monthly production of three million vaccine doses will ensure sufficient availability of the corona vaccine jabs, which would significantly reduce the country’s dependence on other countries. The raw material of the vaccine will be provided by China’s Cansino Biologics,” sources said.

Pakistan has made a procurement deal with Cansino Bio for 20 million prepared doses and the raw material, according to sources.

The government will buy more raw material from the Chinese vaccine company for preparation of PakVac, sources said.

Pakistan has earlier made bulk purchases over 27.5 million vaccine doses of China made vaccines including Sinopharm, Sinovac and CanSino vaccines.

According to the sources, “Under the procurement agreements raw material and prepared coronavirus vaccines will be purchased from the Chinese companies,”