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Making the
pharmaceutical industry self-reliant
Dr. Khalid Jawed Chaudhry
(August 10 2002) : Soon after the inception of Pakistan, the
nation found himself striving hard to meet the basic health
care requirements because of non-existing pharmaceutical
manufacturing sector.
The needs of the country almost depended on imports. It would
not be out of place to mention that the 80% of the need of
basic health care - be it medicine or medical equipment - were
fulfilled through imports from multinational companies abroad.
The local pharmaceutical companies were only sharing 20
percent of the country's needs. Pakistan had to import nearly
all the drugs, chemicals, medical supplies and medical
equipment from abroad and in return was losing hard-earned
foreign exchange. Soon the need was felt by the private sector
to rise to the occasion and accept the challenge of meeting
national requirements. Pharmaceutical companies start taking
their roots and today the situation has reversed wherein
value-wise 58 percent of the national health-care
responsibilities are being shared by the local companies and
42 percent by the multinational companies.
The drastic change in this scenario could also be gauged from
fact that unit-wise market share of the national
pharmaceutical companies has, presently, reached 70% whereas
MNCs' share has slipped to 30%. Out of total 343
pharmaceutical units, 320 are national while multinational
companies are left only 23. This certainly speaks convincingly
of the entrepreneurial strength and the skill of national
pharmaceutical industry, who apart from fulfilling the
nation's requirement of healthcare, are also earning millions
of dollars of foreign exchange through exports and taking the
country towards self-reliance.
The strength of the pharmaceutical sector might have grown
manifold, had they been provided the level playing-field and
cleared of the bureaucratic hurdles and injustices to it. The
bureaucracy has failed to provide the much-needed
business-friendly facilities and incentives for the
pharmaceutical and healthcare system rather it has created
difficulties and barriers to make the private sector's effort
inefficient. The barriers, erected by the bureaucracy, have
hampered the progress of the pharmaceutical sector.
These barriers and problems were highlighted in a presentation
made to honourable members of the Cabinet, high ranking
officials of the Chief Executive Secretariat and the members
of the Economic Co-ordination Council on the instructions of
the President, General Pervez Musharraf. Those barriers have,
once again, been dilated upon here to seek the attention of
all those who are at the helm of affairs and top
decision-makers and have the responsibility of determining the
future industrial policy by rectifying the irritants.
Given below are the major causes that are impeding the growth
of the pharmaceutical industry in Pakistan: (1) injustices in
the fixation of prices, (2) problems faced in the registration
of drugs, (3) harshness of Drugs Act; impediment to growth and
investment in pharmaceutical industry, (4) irritants affecting
the export of the pharmaceutical industry, (5) unfriendly
Patent Ordinance 2000 which needs amendments to safeguard the
interest of the national pharmaceutical industry, (6)
non-supportive tariff policies of the government, (7) lack of
public-private partnership at government ministries.
The pricing policy followed at the Ministry of Health does not
provide a level playing-field and impedes the growth of this
sector as it discourages the new entrants through
discrimination in price fixation and unnecessary delays in
disposal of applications. In 1993, the same cases and problems
were amicably resolved when the EEC had taken a decision on
price fixation of medicines by strictly following the leader
price formula concept, which was proposed by the PPMA and
adopted by the Health Ministry. That formula was practised
with success by the industry and the government and
consequently helped the national industry in achieving
substantial growth. The PPMA, therefore, strongly advocates
that the same should be revived for a better management of the
growth of the industry.
The issues related to "MeeToo" products which is also known as
generics need the attention of the registration authorities.
The current procedures should be simplified in such a way that
in the cases where the molecule has already been registered,
the new product applicants should be accorded fast track
registration. Such steps would attract local investment in
this sector to the tune, where we can hope for having an
exportable surplus. In this regard, the PPMA is willing to
join hands with the Ministry of Health to come up with a
revised statutory draft of the registration law for MeeToo
products.
With respect to the registration of new research molecules and
products, there is a lot of homework that has to be done to
make it relevant to the needs of the industry. The Ministry of
Health should review the current registration procedures and
grant new molecules fast interim registration if these are
already approved by any two of the major regulatory
authorities of the USA, UK, Japan, Switzerland and EU
countries. The companies, however, would be required to
provide the post-marketing surveillance data for three years
to substantiate their development plans. The introduction of
new molecules and drugs will be beneficial both for the public
and the pharmaceutical industry.
The PPMA does not want to bypass controls and hoodwink the
authorities rather it believes in checks and balances. But the
way Drug Act has been scripted, it leaves a lot to be desired
at. There is a strong need to make it more business friendly.
Amendments are required to change its essence from that of a
criminal procedure to that of a civil law.
Furthermore the drug act should not just concentrate on
allopathic products, but should include in its purview Unani,
Ayurvedic and homeopathic products so that the actual
incidence of spread of spurious drugs is blocked through
effective quality control measures.
The Drug Act also empowers the drug inspectors to misuse their
discretionary powers at will. That state of affairs is
humiliating and discourages investment. These powers must be
curtailed especially the power to arrest on the spot the owner
of the unit and also the powers to close down the units.
Similarly the drug testing laboratory reports should be
treated as interim and not final documents.
The export potential of the pharmaceutical industry can get
the required boost, if the right kinds of steps are taken. To
begin with the quality of documents and certificates issued by
the MOH should improve in quality and presentation. They
should not give the semblance of an inferior product coming
from a backward country since these documents are the first
contract with regulatory authorities in a foreign country,
therefore, they must create an impression of the quality.
Upcoming challenges of WTO demand that the products to be
exported need to be certified by independently-designated and
WHO-approved accredited laboratories. Unfortunately we are too
late to catch up with the demands of the time. The Central
Research Fund of the MOH, the Export Development Fund of the
EPB available with the relevant ministries should be utilised
for the setting up of the Accredited laboratories especially
in the private sector under the umbrella of the WHO.
The duty drawback procedure also demands reforms on the
premise that they allow and facilitate export potential of the
medicines from Pakistan as practised in the neighbouring
countries. The Patent Ordinance 2000 also needs to be reviewed
in consultation with the stakeholders and necessary Amendments
must be brought about in order to safeguard the vital
interests of the local pharmaceutical Industry. With an aim to
develop export potential and to meet the international
standards of the GMP, the PPMA strongly proposes that the
import of plant and machinery besides equipment needed for
R&D, Quality Control and environment control equipment should
be allowed duty free for the pharmaceutical units to help them
towards the development of the CGMP.
The implementation of these measures would help develop the
pharmaceutical sector, making the country self-sufficient and
self-reliant. Besides it will promote the export potential of
the non-traditional items from Pakistan to many foreign
destinations.
All our manpower of bio-engineers, pharmacists, electrical and
electromedical engineers, metallurgists, bio-physicists,
biologists and bio-chemists are hardly put to use like Europe
and America. Dr Abdul Qadeer who created miracles for Pakistan
is a fine example to this effect. We have closed our eyes and
minds. We do not provide our scientists opportunities rather
letting them go waste.
The irony of ironies is that the priorities of those who are
at the helm of affairs are not based on national interests
rather they watch the interests of foreign suppliers or
multinational companies while drafting policies or in making
decisions. Health is a multifaceted industry and involves
several medical allied groups like pharmaceutical
manufacturers, suppliers and private hospital owners.
They all have different roles but a common objective of
healing a patient, and changing his "DISEASE to EASE". All the
allied medical groups have to make joint efforts to safeguard
the progress of the healthcare system in the country. They
will have to make consolidated efforts on unified platform
jointly with one voice. They should grow horizontally and
vertically so that they could reach the apex where national
policies are made.
(The writer is president of the Lahore Chamber of Commerce and
Industry and Pakistan Pharmaceutical Manufacturing
Association):
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