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Quality uncontrolled

January 20, 2013

Mukhtar Alam exposes the inadequacies and flaws of our drug regulatory procedures

Drug associated mishaps or deaths can take place anywhere in the world but in our case the situation remains worrisome because we refuse to learn from our mistakes. The deaths associated with ‘adulterated’ Isotabs reported in Punjab last year are still not forgotten, but, unfortunately no lessons were learnt as far as the pharma dealings are concerned.

Interviews with the stakeholders brought to light that neither the government nor the manufacturers completely test the quality of imported or locally made active raw materials and excipients, mainly due to financial constraints and inefficiency of both the regulators and the manufacturers.

Besides material and ingredients, machines are also concerned in the manufacturing of drugs. For economic reasons, the manufacturers are now mostly using imported reconditioned or substandard machines, which indirectly contribute to the deterioration of the active ingredients. The technical manpower employed by the federal government’s drug regulation authority is not up to the mark either, and as such there remains a lot to be done beyond compromises, expediencies and short-term measures.

However, according to the former chairman of Pakistan Pharmaceutical Manufacturers Association, Muhammad Haroon Qasim, no person or group investing millions of rupees in the shape of pharmaceutical industry ever wants to turn criminal. It can be said that due to procedural inadequacies or flaws some of the industries may produce products of varied or low efficacy but they never generate or market killer drugs or medicine.

“If the medicines are contaminated at a later stage or abused in stores or by habitual users, it should be the responsibility of the government’s regulators,” he added saying that every industry has a mechanism of quality control which is also examined by the government officials, particularly at the time of licensing or registration of products.”

A recent notification regarding appointments in the Drugs Regulatory Authority of Pakistan (DRAP) shows that there is either a dearth of suitable and experienced professionals or wisdom is yet to prevail in the quarters concerned. Major functions like licensing, quality assurance and quality control have been handed over to one director, while pharmaceutical evaluation and regulation and drug manufacturing control assignments to another director. The notification itself raises the question as to whether two people can do justice to six key functions.

Apart from the top hierarchies, drug inspectors are considered the backbone of quality manufacturing and marketing of drugs.

These field men, under the Drug Act-1976, are required to collect samples from factories and wholesale and retail sale points and send those to the designated government testing laboratories on a regular basis. However, these officers are failing to come up to the mark for various reasons that include back-up support like laboratories and legal sections to establish the faults and penalise the defaulters.

Across the country, there are about 50 federal drug inspectors and assistant drug controllers, who, if on average collect two samples per person/per day, can send 20,000 to 24,000 samples to their respective laboratory every year. However, a study of sample statistics pertaining to the Central Drug Testing Laboratory, Karachi, the only federal laboratory in the country, revealed that the field-officers in question on average submitted 3,000 samples per year collectively during 2008 to 2011. The laboratory received only 1,450 samples in 2011, while there are over 500 manufacturing units generating over 75,000 molecules in the country.

What happens in the case of bulk supplies to major government hospitals is another story. The hospitals mostly hand over the medicines to thousands of patients without conducting any laboratory or quality test or formulation verifications, because, as their officials say, quality confirmation consumes time, while the government laboratory is also not well equipped or adequately manned or funded for purchase of chemicals and reagents, neither is it prompt in giving results. “We rely on the reputation of the manufacturer and supplier,” said a senior officer at a large public sector hospital in Karachi.

According to Salim Isharat Husain, Chief Inspector of Drugs, government of Sindh, drugs are tested on a request basis: “Whenever hospitals and other drug purchasing authorities request the drug inspectors to take samples the inspector concerned draws the sample and after the standard report from the laboratory is received the same is communicated to the hospital concerned.”