Not even a single drug or manufacturing site in Pakistan is internationally approved — be it by the Food and Drug Administration (FDA) authority (of the United States) or by the World Health Organisation (WHO).
This has a two-fold effect — it means that none of the medicines sold domestically are examined by any quality standards and that Pakistan cannot earn much moolah from the global pharmaceutical market.
The country adviser on essential medicine and pharmaceutical policies, World Health Organisation (WHO), Khalid Saeed Bukhari, confirmed to Dawn that there is no WHO pre-qualified drug or manufacturing site in Pakistan.
He added that no drug is pre-qualified by Food and Drug Administration (FDA), US or the Europe Medicine Evaluation Authority (EMEA) and the Medicines and Healthcare products Regulatory Agency (MHRA), UK.
In other words no medicine manufactured in Pakistan can be exported to any regulated country.
An official in the health sector, on basis of anonymity, told Dawn that no regulated countries such as USA, Europe, Canada, Australia, Japan England and Bangladesh import drugs from Pakistan.
The official added that even Sudan and Ethiopia after getting regulated stopped importing drugs from Pakistan, conceding that the fault was Pakistan’s for it had made no effort to implement quality standards. However, Pakistan does export drugs to 40 countries in Africa, Far East and South and Central Asian Republics; around 60 per cent of the medical exports are directed to African countries.
When contacted, General Secretary Pakistan Pharmacists Association, Nadeem Iqbal said there are some 640 registered pharmaceutical companies in Pakistan which export medicines to non-regulated countries earning a foreign exchange of $140 million annually for the national exchequer.
“If our manufacturing sites improve their quality or follow the quality benchmarks devised internationally, our foreign exchange earnings can surpass $20 billion,” he claimed.
However, experts think that more important than the foreign exchange that can be earned is the health implication for the Pakistani citizens.
Dr Sania Nishtar, head of Heartfile, a think tank working on health policy issues in Pakistan, said: “The main issue is not of export. It shows the weak capacity of the medicines manufacturing sector in Pakistan. It is important that a country’s manufacturing facilities should produce quality drugs for domestic consumers,” she said.
She added that the issue of spurious drugs was linked to this. “There are many backstreet clandestine production facilities producing counterfeit medicines and this is the core problem.”
However, she agreed that the responsibility lay with the weak drug regulatory capacity.
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 Authority operating under the Drug Law 1976 under the ambit of the federal government.
According to Drug Regulatory Act 2012, this body is responsible to monitor and regulate the marketing practices, so as to ensure rational use of drugs, and ethical criteria for promotion and use of therapeutic goods in line with international practices; monitor enforcement of licensing of therapeutic goods; registration of therapeutic goods; specifications and laboratory practices; determining standards for biological manufacturing and testing; regulation for pricing and mechanism for fixation of prices of various Healthcare services under its ambit; implementation of internationally recognised standards such as Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) etc.; regulation and allocation of quota of narcotics and psychotropic drugs and precursor substances and inspections, investigations and other like functions.
However, the weaknesses in our drug regulation sector clearly indicating the performance of DRA and how effectively they are monitoring and regulating the manufacturing and marketing practices.
The official in the health sector is of the same opinion. He pointed out that “two years ago, the registration board gave approval to 4,000 drugs in a single sitting. How was it possible to evaluate the effectiveness of 4,000 drugs in a single three-hour meeting?”
The havoc poor quality drugs can cause was brought home by the recent scandal in Lahore where heart patients lost their lives due to dubious medication
During late January 2012, a fake medicine crisis at the Punjab Institute of Cardiology (PIC) hospital in Lahore claimed the lives of over 100 heart patients.
Several cardiac patients registered with the PIC started showing up at different public and private hospitals in Lahore suffering from a sudden drop in platelets and white blood cells and bleeding from different parts of the body.
The doctors initially took the symptoms as that of dengue outbreak that had hit the city in the last fall.
However, it was soon realised that the symptoms were seen in a PIC cohort and were more consistent of a drug reaction. As a result, the Department of Health constituted a high-powered committee to probe the incident.
Tests performed by the British Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom indicated that one of the five suspected drugs — Isotab — was contaminated. The report also showed that Isotab containedPyrimethamine, which is in fact used for the treatment of malaria. The presence of pyrimethamine proved to be toxic.
Tests done at the Central Drugs Laboratory in Karachi also verified the presence of pyrimethamine used in certain combinations to treat malaria in a sample of the Isotab tablet (20mg). The laboratory also declared a batch of Alfagril as substandard.Subsequently, Afghanistan, Sri Lanka, Sudan, and Cambodia, which had been major buyers of Pakistani medicines, have cancelled orders to the tune of millions of dollars, said Nadeem Iqbal.
Health Official in Capital Administration and Development Division (CADD) whished not to be named also confirmed that Kabul is refusing containers carrying locally manufactured drugs; before this scandal Pakistan exported medicines worth $20 million dollars annually to the war-stricken country.
These events show that the poor quality of drugs sold in Pakistan; their impact on the health of citizens and the international trade are linked.
However, what is more unfortunate is that no one is doing anything to address this issue. Two of the main stakeholders — the government and the pharmaceutical industry — simply blame each other for the state of affairs.
Chairman of Pakistan Pharmaceutical Manufacturing Association Muhammad Asad claimed that the government had failed to “provide the environment conducive to investment”.
He said investors were scared of investing here because of the poor security situation and the energy crisis; hence, he said, they invested in Dubai or Bangladesh. “India has also opened its markets for Pakistani manufacturers, which is a golden opportunity for us.”
He recommended that a qualified pharmacist should be the head of Drug Regulatory Authority to ensure the quality.
A senior government official in Drug Regulation Authority, when contacted, told Dawn that FDA or WHO prequalification is not an indicator of quality control and that Pakistan is manufacturing drugs that meet international standards.
He said: “last month we took 3,800 samples from the markets and manufacturing sites and only 1.5 per cent were of poor standards while 0.53 per cent were spurious.”
However, he did concede that without FDA and WHO qualification Pakistan was facing a financial loss in terms of export but he blamed the pharmaceutical companies for this; in his opinion getting FDA approval was their responsibility.