International Journal of Experiential Learning & Case Studies
5 : 2 (December 2020) pp. 193-203. dx.doi.org/10.22555/ijelcs.v5i2.51
Challenges of Pakistani Pharmaceutical Industry:
Pakistan Case
Afaq Kazi Ahmed*, Seema Chandani**
Abstract
The population of Pakistan is fast growing and the need for supply of medicine
will continue to increase. The local pharmaceutical market is growing at a faster
pace as compared with the international market. Until 1990, the reliance on
the supply of medicine to cater to the national demand was on multinational
companies holding major market share. Thereafter, the national pharmaceutical
companies started investing to improve the quality of their product lines, employing qualif ied professionals, and ensuring compliance with the global standard of quality and good manufacturing practices. Consequently, national companies' market share drastically increased and the national demand for medicine
is locally produced. The study results based on interviews of key stakeholders
and available literature revealed that the local pharmaceutical sector is facing
critical challenges of counterfeit medicine, pricing controversies, affordability of
the medicine, lack of Research and Development (R&D) initiatives, and unethical marketing (bribing/cash incentives to the doctors). The Drug Regulatory
Authority of Pakistan (DRAP) seems ineffective to overcome these challenges,
eliminate counterfeit medicines, and take measures to curb the unethical marketing practices that are risking patient life, health, and treatment cost. The study
further explored that unethical marketing practices, and prescribing expensive
brands by doctors, creates a serious conflict of interests and fast a decline in patient trust and affordability of medicine cost. Thus strong regulatory controls,
transparency, moral and ethical values are needed to enforce drug acts and make
the stakeholder's groups accountable. There is a need to punish both the companies
bribing the doctors on the pretext of product promotion and doctors accepting such
benef its to protect the patient's interest and limit treatment cost. Strict regulations and incentive plans for the pharmaceutical sector are needed to promote
Research and Development (R&D).
Keywords: Pharmaceutical, counterfeit, prices control, unethical marketing
JEL Classification: M30, M31
Correspondence:
* Research Associate, and Consultant, Institute of Business Management, Karachi, Pakistan.
** Research Scholar, Institute of Business Management, Karachi, Pakistan.
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International Journal of Experiential Learning & Case Studies, 5(2), 2020
INTRODUCTION
Pakistan with a population of 199m has the sixth biggest population in the world and is
expected to grow to 254.7m by 2030. Pakistan's population is increasing at a rate of 1.65%
(World Bank Report 2015). World Bank data (1961-2014) shows average GDP growth of
6.18% (7). The per capita income of Pakistan is $1.629 (The Economic Survey 2016-17)
and with the increase of per capita income, the health care facilities are expected to increase
(World Bank Report 2015). In view of the above, it is evident that the population of Pakistan
is increasing, and the need for medicine will continue to increase. However, due to lower per
capita income, the affordability of medicine is the biggest challenge in Pakistan. The role of
the pharmaceutical sector is very important in providing low-cost quality medicine within the
reach of a common-men.
Pharmaceutical Industry
Historically, Pakistan in 1947 did not have any pharmaceutical manufacturing facility and
dependence majorly was on imports. The pharmaceutical sector made steady growth and in
1980, it started exporting finished medicines that reached to 1.2billion US$ by 2007 ( Jamshed
et al., 2013; World Health Organization, 2004). The growth rate of the local pharmaceutical
sector in 2013 was 17% as compared with the global growth rate of 8% (Ahmed & Batool,
2017) and by 2015 Pakistan's pharmaceutical market size reached 2.6billion US (Hafeez &
Akbar, 2015).
Currently, the global pharmaceutical market size is around $1 trillion and Pakistan shares
only 0.3%. The total size of the pharmaceutical industry in Pakistan is PKR 423 billion, national
and multinational companies hold a market share of 69% and 31% respectively. The top 25
companies enjoy a 60% share and the top 50 companies claim an 80% share with an industry
growth rate of 13.23% (Pakistan Credit Rating Agency (PACRA) Report, 2020). Around
650 companies are operating in Pakistan however multinationals are only 31 that is less than
3%. Top players in the industry are ranked as 1. GlaxoSmithKline Pakistan Limited, 2. Getz
Pharma (Private) Limited, 3. Sami Pharmaceutical (Private) Limited, 4. Abbott Laboratories
(Pakistan) Limited, 5. High Q Pharmaceuticals 6. Searle Company Limited, 7. Sanofi-Aventis
Pakistan Limited and Hilton Pharma (Private) Limited (Intercontinental Medical Statistics
(IMS) Pharma Report 2019).
Industry Mix
100%
90%
80%
38%
37%
34%
34%
32%
70%
60%
50%
40%
30%
20%
62%
63%
66%
66%
68%
10%
0%
2014
2015
Local Procedures
2016
2017
Multinationals
Table 1: Source Pakistan Credit Rating Agency (PACRA) report in May 2018
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2018
Ahmed & Chandani
The above table shows the industry mix between multinational companies (MNCs) and
local producers and depicts a consistent increase in the market share of local producers from
62% in 2014 to 68% in 2018. Accordingly, the market share of MNCs declined from 38% in
2014 to 32% in 2018.
Revenue Growth Trend
400
Amounts (PKR bln)
350
20%
18%
18%
16%
16%
300
14%
250
11%
200
12%
10%
8%
10%
9%
150
6%
100
4%
50
2%
0
0%
2014
2015
2016
Sales (PKR bln)G
2017
2018
rowth (%)
Table 2: Source Pakistan Credit Rating Agency (PACRA) report in May 2018
Table-2 shows the growth of the pharmaceutical sector that was 16%, 9%, 18%, 10%, and
11% in 2014, 2015, 2016, 2017, and 2018 respectively with an average growth rate of 12.3%
during the last five years.
National Pharmaceutical Companies:
The local pharmaceutical market once dominated by MNCs till 1990, is now led by
national companies and 90% of the demand is locally met. According to Aamir and Zaman
(2011) Sami Pharmaceutical and Getz, pharmaceuticals have been fast-growing, capturing a
market share of 2.79% and 3.76 % respectively. The effectiveness of national Pharmaceutical
companies increased and they have been able to meet the international standards of quality
and good manufacturing practices. Pakistan Pharmaceutical Industry is fast-growing and
new research-based products are entering the market in collaboration with global research
laboratories and corporations to improve the healthcare system (Intercontinental Medical
Statistics (IMS) Pharma Sale Report 2019). The focused group interviews with pharmaceutical
industry professionals and local entrepreneurs revealed that one of the underlying causes of the
growth of national companies in the mergers and acquisitions of MNCs and closure of their
manufacturing facilities. Consequently, a lot of professionals and experts trained by MNCs
became surplus and available in the market. National companies availed this opportunity and
hired MNCs trained professionals to improve the quality and capacity of their plants. National
companies made investments in the erection of new plants to cater to the need of the local and
international markets and eventually their export capacity significantly increased.
Multinational Companies
MNCs are considered the main hub for research and development as they invest significant
amounts for the development of new molecules or New Chemical Entities (NCEs). This is the
main cause of widespread information and knowledge within the industry and hence everyone
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International Journal of Experiential Learning & Case Studies, 5(2), 2020
is benefitting from this pool of information. The first multinational company started operations
in Pakistan in 1951 and within four years there were 9 MNCs and this number increased to 40 in
1990. However, with the development of national companies and capturing major market share,
currently, only 6 or 7 companies are actively engaged in the production of medicine. The decline
in the market share of MNCs was mainly due to the improvement of manufacturing facilities,
hiring competent professionals, offering them market-based packages, investing heavily in sales
promotion, and incentivizing the doctors by national companies. The other reason was price
freeze for more than a decade (2011-2013), ineffective enforcement of Intellectual Property
rights, and tough competition from national companies because of a drastic improvement in
the quality of their production lines which in turn make an environment of tough competition
for MNCs.
CHALLENGES
Price Control
Under Drug Act 1976, the Drug Regulatory Authority of Pakistan (DRAP) is responsible
to fix the prices of the medicine in the country. However, no transparent formula is mentioned
in the drug act for price fixation. Cost of production and retail mark up is considered for
calculation of the prices of medicine whereas, in the case of imported products, shipment and
other costs are also included. The issue of the greatest retail value- Maximum Retail Price
(MRP) of medication has always been dubious (Hussain et al., 2019). The drug prices in
Pakistan have always been a burning issue of the pharmaceutical industry. The manufacturers
consistently make hue and cry for the price increase and use their influence for price increase
as if they have hardships and are not making profits. Numerous organizations that at present
produce successful medications might be compelled to change from costly to less expensive
particles for securing their gross edges (Hussain et al., 2019). There were 36 MNCs working
in Pakistan in the mid-2000s that number is currently reduced to around 22. That is an
enlightening number of ways out. As of late the circumstance has gotten more regrettable as
the greater part of the crude material is imported and any expansion in dollar rates unfavorably
influences the productivity of the nearby makers. However, the fast pace of growth of national
pharmaceutical companies, and the multiplication of their assets and facilities witness high
profitability. The prevalent public perception is that pharmaceutical companies have perfect
documentation practices to prove that they cannot survive without a price increase. However,
the credibility of the data presented for price determination due to unethical practices remains
questionable. Multinational companies in case of patent products and otherwise, purchase the
raw material from their prequalified sources and earn in transfer pricing while showing losses
in local businesses.
Pakistan follows the SAARC countries or international market trends while fixing the
prices. As per the survey conducted by WHO and Health International, the prices of medicine
were found reasonable with a few exceptions if compared with international prices until 2004.
However, as per the WHO survey in 2015, it has changed. The prices of patent and generic
products were 2.36 and 2.26 times higher as compared to international market prices (World
Bank Report 2015). The price increase in 2013 and thereafter, significantly elevated the cost of
treatment. DRAP has allowed price increase formula effective July 16. 2016 key highlights are
1. Schedule drugs up to 50% of Consumer Price Index (CPI) (with a cap of 4%), Non-schedule
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Ahmed & Chandani
drugs up to 70% of CPI (with a cap of 6%). Lower priced drugs shall be allowed a maximum
increase equal to CPI once in any financial year. The last price increase was allowed in January
2018 with CPI 4.16 (Pakistan Credit Rating Agency (PACRA), 2015).
Counterfeit Medicine
There are three major issues in this pharmaceutical industry. They are counterfeit drugs,
drug diversion, and drug shortage which have been considered as very serious issues in the
pharmaceutical industry. Low quality (e.g., Substandard, Spurious, Falsely labeled, Falsified,
and Counterfeit - SSFFC) pharmaceutical products are a global health problem that affects the
health of patients and lead to an increase in morbidity and mortality. Trading counterfeit goods
have a significant negative, damaging impact on society and the economy. For instance, trading
fake medicines not only has a dangerous outcome on people's health and, thus, on their life but
also costs the economy millions of dollars (Choi et al., 2015).
According to European pharmaceutical manufacturing and US trade offices, large amounts
of drugs sold in Pakistan are counterfeit. The Pakistan Health minister in 2010 made a statement
that a large part of the drugs sold in Pakistan is counterfeit. After two incidents that include
one in which cough syrup found contaminated excipient import of medicine from Pakistan
was banned in Sri Lanka. Foreign Counterfeit Drugs, expanding stream of fake medications
into the market is another key issue that would influence pharmaceutical organizations in a
major manner (Shah et al., 2019). Strong mafias are operating in the country, who have nexus
in power corridors consequently the counterfeit medicine could not be eliminated. The bribing
of drug inspectors is also a common issue that has also been reported at various times in the
media (Chaudhry, 2017). According to the daily time's article, they stated that the developing
hazard of counterfeit medicines has become a difficult issue for pharmaceutical organizations.
The expansion of phony and adjusted products isn't just harming the business but also the
customers. The hazard is unfavorably influencing the administration incomes and along these
lines the open area financial projects. Fake prescriptions are assessed to cost the administration
over PKR 12 billion every (Dawani & Sayeed, 2019). The Drug Regulatory Authority seems
to be ineffective in controlling this business may be due to limited staff (3,134). Corruption
in government procurement of low-quality medicines at higher rates is widely common across
various regions. The procurement of these medicines by the government is worth roughly US$1
billion (Atif et al., 2017). Although the government is working to improve the situation and
curb the practices, yet a lot of efforts are needed to control such malpractices and overcome
this challenge. There are strict punishments on the manufacture, sale, and distribution of
spurious and substandard drugs. DRAP dropped/suspended the enlistment of 89 medications
of the pharmaceutical organizations producing inadequate prescriptions. Also, licenses of 18
medication producers have been dropped/suspended during the most recent four years," service
educated the house. The National Assembly banned 89 medicines and suspended 18 drug
manufacturers' licenses in 2017 for producing substandard medicines during the last four years
(Dawn News, 2017).
Affordability of Medicine
Pakistan is a developing country and around 45% of the population lives below the poverty
line and availing healthcare by a common man has become unaffordable. Consumer Price
Index (CPI) shows a yearly increase in inflation at the rate of 1.3%. The Pakistan government
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International Journal of Experiential Learning & Case Studies, 5(2), 2020
has subsidized this sector and allowed exemption on import of equipment, raw material, and
exemption from General Sales Tax besides full tax exemption on the medicines funded by donor
agencies. The prices of the medicine are unaffordable due to the expansion of the originator
brand and inconsistency in price regulation. The availability of essential generic medicine in
public and private healthcare sector facilities is only 15% and 31% respectively. Despite the use
of low-cost generic medicine the cost of treatment of chronic illnesses hypertension, diabetes,
Peptic Ulcer, epilepsy, arthritis, depression, and other diseases is unaffordable (50,59,60).
Another challenge is the low amount of investment in the healthcare industry and the lack of
health insurance schemes (Atif et al., 2017).
The public health care facilities in Pakistan are insufficient and lack quality of care. The
government hospitals are available in urban and suburban areas but the availability of medicine
is insufficient and the cost of medicine has to be borne by the patients. The investigations into
the affordability of the minimum wage worker revealed that the Price of treatment of long
term diseases fluctuated between 1 and 7.7 days' wages generic medicines of the lowest cost
or 1.4 to 36.4 days' wages if research brand is purchased. If labor class or low paid people to
need medication for hypertension, arthritis, and a peptic ulcer, 7.6 to 53.1 days' wages monthly
would be required to buy drugs. The issue remains open and needs further work to explore how
to make quality medicine affordable for the general public while resolving the pharmaceutical
industry's critical issues?
Unethical Marketing Practices
The patients consult the doctors and pay their professional fees; in return, they deserve
the independent and unbiased best choice of medication without any influence. The doctor's
prescription must be in the best interest of the patient both in terms of cost and efficacy.
When doctors receive expensive gifts, monetary rewards, and incentives on the number
of prescriptions generated for a particular brand, a serious conflict of interest situation
arises. General practitioner physicians often get affected by the pharmaceutical company's
promotional gifts and prescribe new expensive medications, even if treatment can effectively
be done using cheap substitute drugs (Chren et al., 1989; Norris et al., 2004) their respective
studies showed that there is a great impact of gifts on doctors prescribing behavior. The study
revealed that both gifts and relationships play a role in influencing doctors to prescribe certain
drugs. McKinney et al., (1990) stated that there is a correlation between doctors' tendency to
recommend drugs and the gifts, sponsorship they receive. The interaction between doctors and
medical representatives through gift-giving is the most common reason for conflicts of interest
for doctors as it negatively influences their prescribing behaviors all over the world (Mikhael
& Alhilali, 2014). Doctor's connections with the industry build complex relations, influence
physician's decisions and prescribing patterns, and damage patient's trust in the profession
(Buck et al., 2007). Green et al., (2012) mentioned that the receipt of a gift could create doubts
in respect of physician credibility and it is perceived as problematic by the patients. Blake and
Early (1995) pointed out that gifts of trivial value are viewed by the patients as acceptable
however disapprove of it when the gifts are of high value and it has little or no benefit to the
patient. In one US study, investigators found that the public is generally ignorant about peculiar
gifts from pharmaceutical companies, Mainous et al., (1995) but patients also believe that such
gifts are both more influential and less appropriate than do physicians (Gibbons et al., 1998).
Ethical questions are continually asked if it is ethical to offer to give away and free samples to
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patients (Noordin, 2012).
Unethical marketing practices of the pharmaceutical industry in Pakistan have become so
strong that it is now difficult to inverse (Parmar & Jalees, 2004). The drugs are promoted by
giving monetary rewards; visits in the name of scientific activities are the tools of promotion
(Ahmed, 2012). According to Dr. Sania Nishtaran corruption in the pharmaceutical industry
must receive careful and objective analysis as it has a direct impact on the performance of
the health system. The spending on sales and marketing is more than the R&D cost. The
pharmaceutical industry spent over 25% of their annual turnover on sales promotions and
only 7% on R&D. (Sinah et al., 2012). Conclusively, pharmaceutical companies are involved
in corrupt practices by offering high-value incentives both in cash and kind on prescription,
to the doctors. The practice of offering gifts, lavish dinners, and international travel were the
traditional tools to incentivize. However, now the pharmaceutical companies are offering direct
cash incentives to the doctors on prescriptions. The doctors prescribe excessive medication and
at times compromise even on product quality to meet the minimum prescription target for
getting the incentive. Lack of availability of any regulatory framework on ethical marketing,
the autonomy of the doctors, and declining moral values have impacted on quality and cost
of treatment. The patient trust and confidence in doctors is declining. The pharmaceutical
companies are needed to bring under the legal framework to curb such unethical practices.
Pakistan Young Pharmacists Association (PYPA) and the Pakistan Drug Lawyers Forum
(PDLF) accused the Drug Regulatory Authority of Pakistan and Minister and Secretary of
Health of legalizing corruption by authorizing "expenditure incurred on sales promotion of
pharmaceutical companies has been enhanced to 10 percent," meaning that pharmaceutical
companies can now give commissions of up to 10 percent to doctors for sales promotion".
(Drug Lawyers, Pharmacists Condemn DRAP, Ministry of Health for ‘Legalizing Corruption).
Research & Development
Research and Development (R&D) spending is forecasted to grow at a compound annual
growth rate (CAGR) of 3 percent over the 2019–24 period. In 2019, there were 16,181 drugs
in the pharmaceutical pipeline, compared with 15,267 in 2018, an increase of almost 6 percent.
The pipeline includes all drugs being developed by Pharmaceutical companies (Deloitte
Insight Report 2020). In Pakistan, 1% of the Gross Profit Before-tax (GPBT) is contributed
towards research and development of medicine. Pakistani pharmaceutical organizations are
fundamentally repackaging organizations. R&D on medications is nearly non-existent in
Pakistan (Dawn Report 2017). The fast pace of growth of national pharmaceutical companies is
based on the production of generic medication. The national companies invest in projects that
can increase their profitability in the short term and lack the motivation to start R&D activities.
The lack of R&D facilities is a limiting factor for the future growth of the national companies
and their dependence on MNCs will continue limited to generics or toll manufacturing for
MNCs. The increased rate of profit contribution for research, lucrative incentive plan, and
government subsidies for the companies involved in Research and Development (R&D) in the
country is essential to encourage companies willing to invest.
CONCLUSION
The population of Pakistan is fast growing and the need for supply of medicine will
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International Journal of Experiential Learning & Case Studies, 5(2), 2020
continue to increase. The local pharmaceutical market is growing at a faster pace as compared
with the international market. Until 1990, the reliance on the supply of medicine to cater to
the national demand was on multinational companies holding major market share. Thereafter,
the national pharmaceutical companies started investing to improve the quality of their product
lines, employing qualified professionals, and ensuring compliance with the global standard of
quality and good manufacturing practices. Consequently, national companies' market share
drastically increased to 69% and 90% of the national demand for medicine is locally produced.
The people of Pakistan are facing serious challenges of consistent increase in prices of medicine
and unethical marketing practices (doctors prescribing expensive brands in presence of lowcost generic medicine under the influence of heavy incentives both cash and kind) that have
significantly declined affordability of medicine and patient trust. Hence, the country needs to
strengthen the system, use of technology, and put in place high standards of accountability to
have a realistic and transparent system of price determination and control unethical marketing
practices. The other challenges are the counterfeit supply of medicine, lack of research, and
development in the country. The Drug Regulatory Authority of Pakistan is responsible for
enforcement of the Drug Act 1976 to regulate the pharmaceutical industry seems helpless and
ineffective to play its role.
Limitations
This study has focused on a limited number of issues in the pharmaceutical sector in Pakistan,
Several essential issues of this sector include lack of raw material production domestically,
mandatory adoption of domestic and global standards for drug manufacturing, quality control
and assurance, good manufacturing practices (GMP), ISO 9000, and other series, common
technical document (CTD), etc. The other important issues are abrupt shortages of medicines
and price hikes by cartels, abuse of raw materials of anti-narcotic type of drugs, smuggling of
drugs. The real problems faced by drug manufacturers like the ever-increasing cost of doing
business. This is the reason; many global pharmaceutical firms found it un-feasible or unprofitable to operate in the country. Many of them either merged with some other company
domestically or left the country. The said issues could not be included in this study due to its
limited scope however recommended for future studies.
Recommendations
1
2
3
4
5
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The price increase allowed by DRAP has negatively impacted the affordability
of the medicine by a common man who needs review restoration of strict price
control.
The promotion of medicine must strictly comply with ethical global standards and
regulations. Offering incentives to the doctors by a company to prescribe a particular brand creates a serious conf lict of interest and is against the patient's interest.
There is a need for a regulatory framework to punish both the companies bribing
the doctors on the pretext of product promotion and doctors accepting such benefits to protect the patient's interest and limit treatment cost.
Strict regulations and incentive plans for the pharmaceutical sector are needed to
promote Research and development (R&D).
The strong mafias operate counterfeit & substandard medicine businesses in the
country, which have nexus in power corridors and drug regulators need to be elim-
Ahmed & Chandani
inated through the stronger legislative framework, speedy trial of cases, and exemplary punishments.
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