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Zara Kayani

Zara Kayani

<em>The writer is working as a Research Associate at the Institute of Social and Policy Sciences (I-SAPS) in Islamabad</em>

Ensuring quality of medicines

Published on: September 26, 2019 3:03 AM

Health of people of a nation depends upon the quality of its healthcare system, something also emphasised in the Sustainable Development Goals (SDGs). One such component of this vast system is the pharmaceutical industry, which is bestowed with the responsibility of manufacturing quality and affordable medication. The contributions of this sector ultimately impacts how far we get to achieve the targets enshrined in SDG-3, which include reducing mortality (infant, child and maternal) and the spread of non-communicable diseases. However, the question arises as to what measures are being taken at the state level to support the functioning of this sector by also keeping into consideration the wellbeing of the public.

Comprising of around 700 manufacturing units, the perception of the pharmaindustry has mostly been negative and has frequently taken the notion of one bad apple spoiling the whole bunch. Various incidents such as the drug manufacturing error that occurred in Lahore in 2012, due to which over a 100 lives were lost, led to blaming the industry as a whole rather than focusing on the intricacies this sector is engulfed in, especially from a regulatory perspective.

For instance, the regulatory authority of the pharma sector in Pakistan does not pay attention to the corrective measures that need to be taken in order to revive the sector’s credibility. Instead, political mileage is scored where pharmacies are sealed, arrests are carried out and extortion money is demanded. In other cases, the culprits are either set free or inadequate action is taken against them due to personal interests being at stake. After all this, no one bats an eye on whether regulatory authorities and the pharmaceutical companies have done anything to ensure that the public does not suffer again.

On the other hand, in order to ensure that quality medicines are being manufactured, the pharmaceutical industry has to adjust prices according to the increasing cost of production. However, even realistic pricing is dramatised in the media as being unfair to the public. As a result, the state enacts freezing of prices in the name of welfare of the general public. How is a product that is cheaper but of lower quality be considered as providing relief to the public?

Moreover, as a reaction to the price freeze, several multinational companies (MNCs) have left Pakistan for greener pastures, a blow to our industry as MNCs are known of adequately training their staff, which in turn has a positive effect upon human capacity and quality within the industry.

Comprising of around 700 manufacturing units, the perception of the pharma industry has mostly been negative and has frequently taken the notion of one bad apple spoiling the whole bunch

It might seem that only Pakistan’s pharmaceutical sector has had it worse. Where we can learn from the success of others, we can also get some insights from their failures as well and put our own house in order. Taking an example of our next-door neighbour India, Ranbaxy is a story of a pharmaceutical giant that fell from grace. The United States Food and Drug Administrative Authority (FDA) issued several warning letters to the company after it was found that the company had violated on several fronts, such as by not complying with the United States Current Good Manufacturing Practices. Ultimately, FDA had also banned review of drug applications from several plants being operated by Ranbaxy due to evidence of falsified data. Such incidents, where a credible international organisation like FDA takes action against a company operating from elsewhere, are also reflective of a nation’s weak regulatory regime. If the Indian drug regulatory regime had actively pursued this case, the pharmaceutical industry of India would have been saved from embarrassment. Despite this, India is still considered as the ‘pharmacy of the world’, especially due to its contribution in tackling HIV/AIDS in Africa, owing to the India’s Patent’s Act of 1970. Such examples of a single country therefore highlight what happens when 1) the state supports the sector and 2) when it lets it loose.

An industry that employs around 90,000 people directly and around 150,000 indirectly, there is a need to provide a level playing field for pharma companies in Pakistan alongside taking stringent actions against wrongdoers and taking corrective measures. At the same time, just like the state voices the concerns of general public, the industry also deserves a similar platform where they can highlight their plight with regards to what barriers are in place that are disallowing them to manufacture quality and affordable medicines.

The writer is an Islamabad-based freelance contributor 

Filed Under: Perspectives Tagged With: editorspick

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