Drug regulation follows heart patient deaths

Pakistan's drug controversy highlights need for a central regulatory body. Copyright: David Richfield

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[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 delay."

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 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.