E-DRUG: Lancet: Pakistan's deadly cocktail of substandard drugs
Lancet 2012; 379( 9819) Mar 10
Sania Nishtar, Heartfile, Chak Shahzad, Islamabad, Pakistan
On Feb 3, 2012, WHO issued a drug safety alert about
pyrimethamine-contaminated isosorbide 5 mononitrate in Pakistan (1). 125
people have died as a result of fatal bone-marrow suppression after taking
the contaminated drug, which was given free of cost to the poor from a
public cardiology pharmacy in Lahore, in the province of Punjab (Haroon
Jehangir Khan, Director Health Services [Management Information System Cell]
Directorate General of Health Services, Government of Punjab, personal
communication). These events are linked to the country's decision to abolish
its Ministry of Health last year, which has led to a massive
decentralisation in favour of provincial autonomy (2). Despite
good intentions, the reforms have decentralised functions that need to be
federally (nationally) mandated in a globalised environment (3). The ?drug
regulation turf? became complicated by an existing political rivalry between
the federal and provincial government. The resulting 7-month struggle?since the
Ministry of Health's abolition?delayed the process of establishing an
independent Federal Drug Regulation Authority.
Cabinet approval for the establishment of a Federal Drug Regulation
Authority was given in 2005, but the Ministry of Health moved slowly because it
was reluctant to relinquish its prerogative. After devolution, steps to create
a Federal Drug Regulation Authority were complicated when the provinces
objected to the proposed structure on the grounds that it was too federal.
Early provincial calls for devolving drug regulation seemed misinformed and
deviated from the international norm of national regulatory authorities. There
is now a clear imperative for Pakistan to retain drug regulatory arrangements
for licensing, registration, and pricing under a unified federal statutory
autonomous structure. But an innovative approach will have to be adopted for
the governance of a Federal Drug Regulation Authority. Past experience with
so-called independent regulatory agencies in Pakistan, for which unqualified
members are often handpicked, has seen control remaining with the government.
Therefore, the priority should be to address existing weaknesses in regulation,
including capacity and resource constraints, by taking advantage of experiences
from other established regulatory agencies.
The issue of substandard drugs has been long standing: Pakistan's
progressive Superior Court demanded independent action on the issue in 2006
(4). In 2004, WHO estimated that 40?50% of drugs consumed in Pakistan were
counterfeit or substandard (5). The reasons for this situation are complex.
Pakistan's Drug Act of 1976 has exploitable covenants and enforcement of the
law is additionally weak. Traditional medicines are prescribed by about 130 000
practitioners and remain outside the law's purview (6). A draft bill on
traditional medicines has been in the parliamentary review pipeline for the
past 10 years, without action. Drug regulation is also weak. There are 15
federal drug inspectors to oversee more than 500 licensed pharmaceutical
manufacturing units (Farnaz Malik, Chief/Joint Executive Director Drug Control
and Traditional Medicine Division, National Institute of Health, Islamabad,
personal communication). There is just one laboratory for testing drug quality
in each province but most are either closed or lack infrastructure. Sale and
resale of second-hand manufacturing machinery is unregulated and pharmaceutical
raw materials are traded in the open market.
Hospitality-based intensive marketing by many pharmaceutical entities or
companies is rife and corruption in procurement is common (7).
The government needs to document the magnitude of substandard and
counterfeit medicines in Pakistan, which has become a major public health
concern just as it has in many other countries (8,9). A systemic approach to
this problem is needed. The first two steps?the creation of a Federal Drug
Regulation Authority and a revamp of the Drug Act?are crucial, but transparency
and capacity-building initiatives are also needed. More broadly beyond drug
regulation, challenges arising as a result of the abolition of the Ministry of
Health require attention at a time when
the outlook for health care in Pakistan seems uncertain (2). Effective
regulation is an absolute responsibility of the state to the population.
While the deaths from contaminated isosorbide 5 mononitrate have focused
attention on a major regulatory failure, it is also important to establish
how many other patients have been unknown victims of a regulatory failure to
enforce quality standards of locally manufactured medicines in Pakistan. It is
conceivable that a similar disaster might occur in other provinces or other
I declare that I have no conflicts of interest.
1 World Health Organization. Drug safety alert, number 125.
(accessed Feb 10, 2012).
2 Nishtar S, Mehboob AB. Pakistan prepares to abolish Ministry of Health.
Lancet 2011; 378: 648-649.
3 Nishtar S. Health and the 18th Amendment: retaining national roles in
devolution. Islamabad: Heartfile, 2011.
http://www.heartfile.org/pdf/HEALTH_18AM_FINAL.pdf. (accessed Feb 10, 2012).
4 Pak Tribune. Supreme Court decision against spurious drugs hailed.
(accessed Feb 27, 2012).
5 McGinnis N. Media reports on medicine quality: focusing on USAID-assisted
countries by the promoting the quality of medicines program. Rockville, MD:
United States Pharmacopeia, 2011.
6 WHO. National policy on traditional medicine and regulation of herbal
medicines. Report of a WHO global survey.
http://apps.who.int/medicinedocs/en/d/Js7916e. (accessed Feb 27, 2012).
7 Nishtar S. Choked pipes: reforming Pakistan's health system. Oxford:
Oxford University Press, 2010.
8 Newton PN, Green MD, Fernandez FM, Day NJP, White NJ. Counterfeit
anti-infective medicines. Lancet Infect Dis 2006; 6: 602-613.
9 Sengaloundeth S, Green MD, Fernández FM, et al. A stratified random survey of
the proportion of poor quality oral artesunate sold at medicine outlets in the
Lao PDR?implications for therapeutic failure and drug resistance. Malar J 2009;