The conundrum of counterfeiting


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

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

About 4,000 pharmaceutical companies are legally registered in the country, while more than 100,000 companies manufacture and sell drugs.

People avoid going to government hospitals only because they are not sure about the drugs they get in the hospital or even in the drug stores near the hospital. There is said to be a wholesale drug market at Marriot Road in Karachi and all kinds of drugs are available here even though they are banned.

According to reports, empty capsules are abundantly available in the market and are filled with counterfeit drugs.

These counterfeit and falsified drugs can contain toxic doses of dangerous ingredients and cause mass poisoning. Poor quality drugs compromise the treatment of chronic and infectious diseases, causing disease progression, drug resistance and death.

Despite the establishment of the Drugs 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 fake drugs have been found in medical stores and public hospitals in recent years. years, resulting in the loss of precious lives.

This has been revealed in a new research report by a government think tank, the Pakistan Institute of Development Economics (PIDE), which states that more than 4,800 types of drugs were found to be substandard in the market. Pakistani since 2015, while 454 drugs were found to be fake.

According to a survey conducted by the PIDE research team, about 222 bad brand drugs were sold openly in the market, while 1,710 expired drugs were discovered on the shelves of medical stores.

It may be mentioned here that, in line with DRAP’s mission statement, its main role is to ensure access to safe, quality and effective medicines at affordable prices and the rapid availability of new treatment possibilities for the people of Pakistan.

The failure of the DRAP

So far, the DRAP has failed to ensure the sale of drugs at an affordable price. The PIDE report suggests that, unfortunately, the DRAP remains unclear whether it was created to control drug prices or to ensure the supply of more and better drugs in the country. Moreover, the research revealed that the work pace of the DRAP is quite slow which leads to unfavorable growth of the pharmaceutical industries in the country.

According to another research conducted by the Journal of Pharmaceutical Policy and Practice, “Case reports, investigations, and general data listed for Pakistan suggest the need to strengthen regulatory systems for premises inspections and good manufacturing practices ( GMP), analytical laboratories, as well as overall capacity building in the area of ​​dismantling and control of substandard and falsified medicines.

“Therefore, there is an urgent need to conduct well-planned and properly-funded studies to collect critical statistics regarding the prevalence of substandard and falsified medicines in Pakistan.”

The results argue that the figure of 40-50% of poor quality medicines in Pakistan “cannot be defended”. Therefore, there is a need for systematic objective data to be developed through well-planned funded studies to collect critical statistics regarding substandard and falsified medicines in Pakistan.

“Although the country is moving rapidly towards an improved regulatory structure, a comprehensive and long-term vision with a multidisciplinary, open, progressive and evidence-based approach is necessary to successfully transition to a well-regulated system to combat the threat of fake drugs,” the newspaper read.

According to the limited number of studies on the extent of the problem, organized criminal groups engage in crime related to falsified medical products using the same routes and techniques used to traffic other illicit products. In doing so, they exploit gaps and discrepancies in national legislation and criminal justice systems.

The World Health Organization (WHO) recognizes that falsified medical products are more likely to be found where access to affordable, quality, safe and effective medical products is limited; governance standards are weak or tools and technical capacity to ensure good practices in manufacturing, quality control and distribution are limited.

At the same time, the harmful effects of falsified medical products are difficult to quantify. There is no doubt that these 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 trust in health professionals and health systems.

On the other hand, PIDE research has shown that the measures taken by DRAP in Pakistan to simplify the local drug manufacturing process are still insufficient, which has prevented multinational pharmaceutical companies from thriving compared to other countries in the world. South Asia. .

According to experts, the process of manufacturing drugs and setting up a pharmaceutical unit in Pakistan is very complicated. They say the sector is very complex and difficult for businessmen because the process of setting up and licensing a pharmaceutical unit takes years.

Only five laboratories

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

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

According to a report, shoppers are attracted to fake drugs due to falling prices. Detecting counterfeits is often difficult, as many of these goods pass through a long and complicated distribution network, creating opportunities for counterfeits to enter the legitimate supply chain.

Counterfeit drugs are dangerous to public health and safety in general. A case that illustrates this problem is that of a patient who was treated with injections for anemia after a liver transplant. After eight weeks of injections, the patient was still not responding to the treatment. The treating physicians discovered that the medication the patient was using 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 fake drugs.

In early December 2011, patients bleeding from the mouth and gastrointestinal tract were reportedly admitted to various hospitals in Lahore. By mid-January 2012, 25 people had died, a number that would rise to over 200, and another 1,000 would fall seriously ill. The cause was attributed to locally manufactured cardiovascular drugs which had been distributed free of charge by the Punjab Heart Institute in Lahore.

With the help of the WHO, it was revealed that large amounts of the antiparasitic drug pyrimethamine had been accidentally mixed with a batch of a drug called Isotab. The incident led to the DRAP Act 2012, which established the regulatory body under the Department of National Health Services, Regulation and Coordination (NHSRC).

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