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[e-drug] Pakistan: Drug regulation follows heart patient deaths

E-DRUG: Pakistan: Drug regulation follows heart patient deaths

[Copied from Scidev.net as fair use]

Shahzada Irfan Ahmed
12 March 2012


[LAHORE] The deaths of at least 125 heart patients in Pakistan, after being
given a common cardiac drug contaminated with an anti-malarial, have
underlined the need for a strong central drug control authority to oversee
testing and quality in the country. 

Tests conducted on the drug 'Isotab' in a laboratory in the UK revealed that
it was contaminated with pyrimethamine, an anti-malarial, which apparently
affected the bone marrow of the heart patients being treated at the Punjab
Institute of Cardiology, a government hospital in Lahore. 

Investigation into the deaths, most of them in January, showed up
jurisdictional confusion following the passage of 18th amendment in
Pakistan's constitution in April 2010 that decentralised public health and
other socio-economic sectors, making them provincial subjects.

Pakistan's central drug regulatory authority, along with its parent ministry
of health, ceased to exist following the decentralisation. Its four
provinces were to develop individual regulatory mechanisms, but were
hampered by weak infrastructure and lack of qualified personnel. 

On 6 February, taking note of the Isotab tragedy, Pakistan's Supreme Court
directed the federal government to establish a central Drug Regulatory
Authority (DRA) and an ordinance was passed accordingly on 17 February. 

Riaz Ahmed, chairman, Pakistan Pharmaceutical Manufacturers Association,
told SciDev.Net that five countries had banned drug imports from Pakistani
following the tragedy. 

On 7 February WHO headquarters in Geneva, citing a report by the Medicines
and Healthcare products Regulatory Agency, London, issued an alert against
the use of Isotab. The factory that manufactured the drug was ordered sealed
by local authorities on 2 February. 

Ahmed said Pakistan's pharmaceutical industry was worth US$2 billion and
exported drugs worth US$190 million annually to some 60 countries. 

Fareed Khan, member, Pharmacy Council of Pakistan, said the DRA ordinance
will be in force for 120 days from passage, and becomes a law if approved by
parliament. "Therefore, I request the parliamentarians to take up this
matter on priority and pass the draft after necessary changes without

Khan hoped that satisfactory 'bioequivalence' tests, which study whether two
similar drugs are available in the same amount and have the same effect in a
body, would now be introduced under the new laws. The ordinance already
proposes to set out guidelines for the licensing and registration of
therapeutic goods as well as sound drug testing laboratory practices.

Sadia Moazzam, executive director of Pharma Bureau, the representative body
of multinational pharmaceutical manufacturers operating in Pakistan, said
she hoped the DRA will use the opportunity to devise new and rational rules
for  <http://www.scidev.net/en/health/access-to-medicine/> drug procurement
by government hospitals. 

"Under present rules the cheapest drug is given preference," she said.

An investigating committee had found the manufacturer of Isotab ignoring
standard manufacturing procedures in order to supply the drug cheaply to the
Lahore hospital.

The committee had also noted that there were several other medicines which
were neither registered nor subjected to examination by drug testing
laboratories being distributed to patients.

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