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The pharmaceutical industry faces several significant challenges in today’s dynamic and complex landscape. These challenges have implications for research and development, regulatory compliance, market access, pricing, patient safety, and public perception. Here are some key challenges currently faced by the pharmaceutical industry, not just in Pakistan, but all over the world. Our market is different in the sense that we manufacture only generic products, and our R&D is limited to developing generic formulations only; we do not do any innovative work in Pakistan. Our challenges also vary, for example, the MNCs worldwide are concerned about the expiration of their patents because they will face an onslaught of generic companies eroding their share; we worry about patents not getting expired soon because we want to market generic versions of latest molecules. We shall look at both sides to see the whole picture.
- Developing new drugs is a now a rather lengthy and very expensive process. The high costs associated with research, clinical trials, and regulatory approvals pose a challenge for pharmaceutical companies to bring innovative therapies to market while maintaining profitability. The fallout is that the Big Pharma is focusing on fewer diseases such as cancer which can bring big money.
- Many blockbuster drugs have reached or are approaching patent expiration, which will lead to increased competition from generic alternatives. This loss of exclusivity impacts pharmaceutical companies’ revenue streams and necessitates a focus on developing new therapies or strategies to extend product life cycles. Finding new blockbusters with wide usage, such as cholesterol lowering statins, is not possible anymore.
- Pharmaceutical companies must navigate a complex regulatory landscape now, including stringent safety and efficacy regulations, ethical considerations, and compliance with good manufacturing practices – GMP guidelines. Staying up to date with evolving regulations and ensuring compliance is challenging, time-consuming, and costly.
- Balancing the need for affordable medicines with the high costs of research, development, and manufacturing is a significant challenge. Ensuring access to life-saving therapies while maintaining profitability requires collaboration among industry stakeholders, governments, and healthcare systems. Big Pharma do not care much about affordability, but the generic companies in our country are forced by the government and market factors to do so.
- The pharmaceutical supply chain is complex and global, making it susceptible to disruptions. Drug shortages, quality control issues, and supply chain vulnerabilities impact patient access to critical medications and pose logistical challenges for pharmaceutical companies. Sometimes even the basic drugs go out of market causing serious difficulty for patients.
- Protecting intellectual property rights is crucial for the pharmaceutical industry to incentivize innovation. However, counterfeiting, and intellectual property infringement pose risks to patient safety, erode revenue streams, and hinder market growth. Counterfeiting in Pakistan and similar countries attacks the best-selling drugs and eat up their business. Law enforcement agencies are preoccupied with political witch-hunt assigned by the government and do not have time and resources to check crimes of public importance.
- The pharmaceutical industry currently faces scrutiny from the public and media regarding drug pricing, marketing practices, and transparency. Building and maintaining public trust requires increased transparency, ethical marketing practices, and effective communication about the value of innovative therapies. Even common people now blame doctors for taking bribes from Pharma companies for prescribing their brands.
- As the global population ages and the burden of chronic diseases increases, there is a growing demand for effective treatments and management options. Meeting these healthcare needs requires ongoing research and development efforts to address unmet medical needs. Pakistan has a large portion of young population, but we are also carrying a sizeable old population due to increased life expectancy.
Navigating these challenges requires collaboration among industry stakeholders, policymakers, healthcare providers, and drug regulators. However, it is not happening here.
Let us now focus on the Pakistan situation exclusively. Read along with the global situation, it will be easier to compare where do we stand and how are we performing.
The Ministry of National Health Services, Regulations & Coordination – MoNHSRC – is the parent ministry that controls all health services. The twist in the situation occurred with the passing of 18th amendment in 2010 which devolved the health portfolio from the center to the provinces, which had not been primed and prepared for the change. After some initial confusion, there was a settlement in which drug registration and pricing were returned to the Ministry of Health at the center, as it was at that time. In 2012, Drug Regulatory Authority was formed, who became the regulators for pharmaceutical industry. DRAP had had its own share of difficulties. Ministry of Health was converted into MoNHSRC under successive ministers who had/have no qualification to understand the health landscape in Pakistan. Brief tenure of Dr. Faisal Sultan was as an advisor, and not as a federal minister. Secondly, the ministries are run by federal secretaries who think much of themselves but know nothing when it comes to technical matters like health. The motto of bureaucrats is to maintain the status quo because it is the safe zone for them. The contribution of ministers and secretaries, therefore, has not been anything to write home about.
DRAP itself is understaffed, underdeveloped, underpowered, and unduly dominated by few officers who run it the way they wish. Drug regulators are required to regulate and upgrade the industry they regulate. DRAP has been largely ineffective on the second count because its staff has been historically doing policing and making money, rather than looking for upgrading the industry.
DRAP has not made (and this appears to be deliberate) systems which would make most routine things running automatically. The pace of work is therefore very slow, and quality of work is questionable.
In the market, the challenges are different. The market is dominated by few giants who control over 90% of market share. Their marketing strength and resources are unmatchable, and the fight is practically now among elephants. The large number of smaller companies have resorted to other business models which are not approved by DRAP, but it does not stop them either. In this chaos, the ultimate sufferer is the patient who is being exploited by the healthcare professionals as well as pharmaceutical companies.
The summary is that a lot of correction is needed at many levels to make things right. Pharmaceutical industry is facing multiple challenges, but these can be tackled with vision, leadership, and consistent hard work.
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