LAHORE: “Unregistered” life-saving medicines are being administered to cardiac patients at the Punjab Institute of Cardiology (PIC) Lahore ignoring the fact that such practice had claimed lives of over 100 patients registered with the institute in 2012.

The PIC management has been procuring the medicines for the last many years in sheer violation of the Drug Regulatory Authority Act 2012 which categorically states: “such drugs shall not be sold or distributed in the market”.

The “illegal” practice had been going unchecked under the nose of Chief Minister Task Force on Spurious Drugs which launched a crackdown on the sale of such medicines in the market, an official close to the information told Dawn.

He said the unregistered medicines being procured in bulk included Isoptin 5mg, Colomycin 1 miu and Papaverin. Of these, Isoptin was being used in the Accident & Emergency wing of the PIC where it was administered to control abnormal rhythm of heartbeat, he said. The two other drugs were antibiotics and being recommended to serious patients admitted at the Intensive Care Unit of the institute, he added.

Moreover, he said, despite knowing the drugs were unregistered, the PIC management had never re-examined the patients taking them to evaluate any adverse reaction of the medicines.

He deplored there was no mechanism in the public as well as private sector to examine the quality or standard of these drugs. Consequently, the hospital management as well as the doctors were unaware of the drugs’ warranty, the official said.

He said the issue surfaced recently when some patients from Sheikhupura and Gujranwala complained about some “reaction” of the drugs at the PIC. They were, however, “satisfied” by the duty doctors instead of being referred to the administration for proper inquiry, the official said, adding that the matter must be investigated to avoid repetition of any tragedy like that happened in 2012.

He said in 2012 initially in the same the patients had started visiting the hospital with complaints of reaction of the medicines being supplied to them.

The issue of “unregistered medicines” was first reported to the provincial health department in June 2013 when an official verbally conveyed to the PIC management the feedback of some patients complaining drugs reaction.

The department later took up the issue with the DRAP, requesting it to confirm status of the drugs. The DRAP had declared these drugs unregistered clearly stating that their sale and distribution would be violation of the law, according to some documents.

The health deaprtment later conveyed to the PIC through a letter (dated Sept 12, 2013) that the matter was referred to the director of the Drug Registration Board of the DRAP. “It has been informed that the medicines are not registered in Pakistan. The sale and stock of these unregistered medicines is a cognizable offence under DRAP Act 2012/Drugs Act 1976 and rules framed thereunder”, the department told the PIC.

The department further informed the institute’s management that the DRAP had issued a notification regarding the import of unregistered drugs, including anti-cancer, cardiac and other life-saving medicines so considered by the licensing authority are exempted from registration and could be imported for use in the hospitals and institutions subject to the condition that the import shall be made with prior approval of the Licensing Authority under Rule 9 of the Drugs (Import and Export) Rules 1976 and the drugs shall not be sold or distributed in the market.

“Keeping in view of the above notification, if the PIC requires any unregistered cardiac drug for their patients, the institute can directly import it, subject to the conditions stated in the notification and can seek an NOC from the Durg Regulatory Authority of Pakistan for the purpose”, the health department said.

PIC Chief Execute Prof Dr Bilal Zakrya and Medical Superintendent Dr Obaida Nighat were not available for their versions.

Health Secretary Jawad Rafique Malik said these drugs were being administered to the patients to save their lives as there was no alternate medicines available in the market.

He said since these medicines were being used in a very limited number -- over 5,000 Isoptin 5mg annually and 3,000 doses each of the other two drugs. So, the companies were reluctant to get them registered by the DRAP to make them available in the market or the government hospitals, he said.

“Consequently, the PIC has no option but to administer these unregistered medicines to the patients,” the health secretary said, adding the medicines were being provided through local purchase to the patients at the institute.

Published in Dawn, May 15th, 2015

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