THE recent death toll of heart patients in Lahore after taking spurious drugs is alarming. The steps taken in this connection by the Punjab chief minister is commendable as he has sent the drugs abroad for testing their efficacy and causes of death. However, it is highly surprising as to why the name of the companies involved in the making of spurious drugs that have caused deaths have not been revealed. I have some suggestions for stopping this menace. They require the attention of the health ministry, drug inspectors and drug companies.

All pharmaceutical companies should have a quality control/testing laboratory equipped with sophisticated testing facilities of both pharmaceutical raw materials of active and inactive finished products in accordance with the approved pharmacopoeia (BP, USP, etc). These pharmacopoeia are recommended to test the drugs by physical and chemical methods involving instruments such as high performance, thin layer and gas chromatographies, spectrophotometric analyses such as ultra-violet and infrared spectrometry.

Furthermore, these instruments should be calibrated periodically. As such these instruments involve high cost and experienced chemists and physical chemists to run and maintain them, which most of the pharmaceutical companies avoid, perhaps. If the testing practice is also done by hospitals at their end, the matter would become more transparent.

The production manager should be well versed with the chemistry of raw materials and equations of mixing. Sometimes wrong steps in mixing may develop mutation in the chemical structure of active raw materials, which may, beside other factors, cause an adverse reaction.

The owner of pharmaceutical companies should be a pharmacist or chemist so that he may not be duped by inexperienced employees.

The health ministry has allowed manufacturing of non-pharmaceutical drugs, i.e., drugs which are not given in any pharmacopoeia. It has become advantageous to manufacture drugs having no specific quality control. This practice either should be stopped or testing methods of quality be standardised. If the death-causing drug in Lahore was non-pharmaceutical, its spurious quality may not be ruled out.

DR M. QUDRAT-I-KHUDA Former Quality Assurance Manager, Swiss Pharma Karachi

Regulatory body

THE responsibility for ensuring the safety and standard of medicines in Pakistan by securing compliance with good manufacturing practices by the industry is assigned to the Drug Regulatory Organisation operating under the Drug Law 1976 under the ambit of the federal health ministry.

However, with the abolition of this ministry following the 18th Amendment, and faced with drug manufacturing associations’ demands for creating an autonomous federal regulatory authority and provincial health departments to allow the provinces to establish their own regulatory authorities, the federal government did nothing.

For over a year no decision has been taken on this vital element of the state’s regulatory functions by which the quality and safety of therapeutic drugs are ensured and prices controlled. Unbelievably, the regulatory organisation has been attached to the cabinet division with its secretary, Nargis Sethi, having the additional charge.

As a result, all interested observers can see that the authority in the current arrangement stands dysfunctional. The staff, especially the political appointees, pays no attention to its statutory responsibilities and devotes its energies to extorting illegal gratification from the pharmaceutical industry.

In the absence of efficient regulation, the spurious drug crisis of the Punjab Institute of Cardiology, Lahore, was a catastrophe that was waiting to happen. To allow drug regulation to wither on the vane, as has been done since July 2010, is negligence of monumental proportions.

Before questioning drug manufacturers or provincial officials, those in Islamabad who have contributed to this most serious lapse of governance need to be made to see the consequences of their actions or rather their failure to act.

If they see the error, or their ways, functional drug regulation may return which is essential for protecting the public from spurious drugs and the local pharmaceutical industry from losing its share in the export markets by being tainted with the label of ‘unsafe and substandard’.

MOHSIN ALI SHAIKH Larkana

Medicinal negligence

LAHORE is still reeling from the effects of last year’s dengue epidemic and now its public hospitals are facing yet another catastrophe with hundreds of patients, bleeding and with serious malfunctioning of their bone marrow, approaching them. Scores have died in the process.

In one government hospital alone more than 200 cases have been reported in the past fortnight. All these patients have a common factor, they received heart medicines from the Punjab Institute of Cardiology and their symptoms are consistent with the harmful effects of a faulty medicine.

The doctors seemed to have prescribed these medicines in good faith but most of these patients are too poor to buy medicines from the market.

Will there be a transparent inquiry into the loss of lives due to the criminal negligence? Or, will the truth be muffled by the injustice and corruption prevalent in society? There has been no coverage in the media about which medication is to blame and which company manufactured it.

KANWAL EJAZ, MD United States