KARACHI: The menace of counterfeit drugs is a global phenomenon. But the situation in developing countries like Pakistan is particularly disturbing.

It is alleged that the Pakistani market is filled with almost 50 per cent spurious drugs. However, according to a survey conducted last year by Profit, a local publication, more than 40pc of medicines sold in the Pakistani market are either counterfeit or substandard.

About 4,000 pharmaceutical companies are legally registered in the country, while more than 100,000 firms are making and selling drugs.

People avoid going to government-run hospitals only because they are not sure about the medicine they get in the hospital or even the medicine shops in the vicinity of the hospital. Reportedly, there is a wholesale market for medicines at Marriot Road in Karachi and all kinds of medicines are available here, even if they are banned.

According to reports, empty capsules are available in abundance in the market which are filled with counterfeit medicines.

Such falsified and spurious drugs may contain toxic doses of dangerous ingredients and cause mass poisoning. Poor-quality medicines compromise the treatment of chronic and infectious diseases, causing disease progression, drug resistance, and death.

Despite the establishment of the Drug Regulatory Authority of Pakistan (DRAP) in 2012, there has been no significant improvement in the quality and production of drugs in the country and thousands of spurious drugs have been found in medical stores and government hospitals in the last few years, resulting in loss of precious lives.

This has been revealed in a new research report of a government think tank, Pakistan Institute of Development Economics (PIDE), which says that more than 4,800 types of medicines have been found substandard in the Pakistani market since 2015, while 454 medicines have turned out to be spurious.

According to a survey, conducted by the PIDE research team, about 222 medicines of wrong brands have been sold openly in the market, while 1,710 expired medicines have been discovered from the shelves of medical stores.

It may be mentioned here that as per the mission statement of DRAP, its main role is to ensure access to safe, quality and efficacious medicine at affordable prices and earliest availability of new treatment opportunities for the people of Pakistan.

DRAP’s failure

DRAP has so far failed to ensure the sale of medicine at affordable price. The PIDE report suggests that unfortunately DRAP is still not clear whether it was established to control the prices of medicines, or to ensure the supply of more and better medicines in the country. Moreover, the research has found DRAP’s pace of work pretty much slow resulting in adverse growth of pharmaceutical industries in the country.

According to another research carried out by the Journal of Pharmaceutical Policy and Practice, “The case reports, investigations, and general data listed for Pakistan suggests the need of strengthening regulatory systems for premises and Good Manufacturing Practice (GMP) inspections, analytical laboratories, as well as an overall capacity building in the field of unravelling and controlling substandard and falsified medicines.

“Therefore, there is a dire need for well-planned and properly funded studies to be carried out for collecting critical statistics regarding the prevalence of substandard and falsified medicines in Pakistan.”

The findings argue that the figure of 40pc to 50pc of poor-quality drugs in Pakistan “cannot be defended.” Therefore, it is necessary that systematic objective data be developed through well-planned funded studies for collecting critical statistics regarding substandard and falsified medicinal products in Pakistan.

“Although the country is progressing towards an improved regulatory structure at a fast pace, a comprehensive and long-term vision with multidisciplinary, open, progressive and evidence-based approach is needed for successful transition towards a well-regulated system to curb the menace of spurious drugs,” the journal read.

According to the limited number of studies on the magnitude of the problem, organised criminal groups engage in falsified medical product-related crime using the same routes and techniques employed in the trafficking in other illicit commodities. In so doing, they exploit gaps and discrepancies in national legislation and criminal justice systems.

The World Health Organisation (WHO) recognises that falsified medical products are most likely to be found where access to affordable, quality, safe and effective medical products is constrained; the standards of governance are low or the tools and technical capacity to ensure good practices in manufacturing, quality control and distribution are limited.

Meanwhile, the harmful impacts of falsified medical products are difficult to quantify. There is no doubt that such products have a multidimensional impact that includes health. They endanger health, prolong illness, kill, promote antimicrobial resistance and the spread of drug-resistant infections, and undermine confidence in health professionals and health systems.

On the other hand, the PIDE research has shown that steps taken by DRAP in Pakistan to simplify the process of local manufacturing of medicines are still inadequate, due to which the multinational pharmaceutical companies have not been able to flourish compared to other countries in South Asia.

According to experts, the process of making medicines and setting up of a pharmaceutical unit in Pakistan is very complicated. They say that the sector is very complex and difficult for businesspeople because the process of setting up and approving a pharmaceutical unit takes years.

Only five labs

Moreover, they say that so far only five laboratories have been set up in Pakistan to test the quality of medicines but they too are not up to the standards set by US agency FDA, due to which Pakistani medicines cannot be exported to a number of countries and these drugs are now being exported only to Afghanistan and a few other countries.

Also, the Punjab health department has issued a notification following which crackdown has been started to curb counterfeit medicines, especially against herbal or indigenous medicines available in the market. According to the notification, it will include any drug which has not been approved by DRAP.

According to a report, buyers are attracted to spurious medicine because of lower prices. Detecting counterfeits is often difficult, because many of these goods pass through a long and complicated distribution network, thereby creating opportunities for counterfeits to enter the legitimate supply chain.

Counterfeit medications are dangerous for public health and overall safety. One case that illustrates this problem is that of a patient who was treated with injections for anaemia, after a liver transplant. After eight weeks of injections, the patient was still not responding to treatment. The treating physicians discovered that the medicine the patient used was counterfeit. In such cases, the consequences of counterfeits can be serious.

A report also suggested that ‘Katchi Gali’ near Marriott Road is a well-known hotbed for spurious medicines.

In early December 2011, patients bleeding from the mouth and gastrointestinal tract were reportedly admitted to different hospitals in Lahore. By mid-January 2012, 25 people had died, a number that would rise to over 200 with another 1,000 becoming seriously ill. The cause was traced back to locally manufactured cardiovascular medications that had been distributed freely by the Punjab Institute of Cardiology in Lahore.

With assistance from WHO, it was revealed that large quantities of antiparasitic drug pyrimethamine that had been accidentally mixed in a batch of a medication called Isotab. The incident led to the DRAP Act of 2012, which established the regulator under the Ministry of National Health Services, Regulation and Coordination (NHSRC).