Dr Bilawal Kamran
Pakistan’s pharmaceutical sector, a critical pillar of the country’s healthcare system, is facing significant challenges due to outdated and ineffective regulations. At the heart of this regulatory framework lies the Drug Act of 1976, a law that was initially designed to regulate the production, distribution, and quality of medicines but has struggled to keep up with global advancements in pharmaceutical practices. Experts argue that this outdated legislation not only hinders growth and innovation within the sector but also creates operational inefficiencies that are stifling the industry’s potential.
Dr. Qaiser Waheed, a former chairman of the Pakistan Pharmaceutical Manufacturers Association (PPMA), has been vocal about the need to overhaul the Drug Act 1976. He explains that one of the key issues with the law is its terminology surrounding medicines that fail to meet specifications. “Medicines are recalled if they are out of specification, which is a global standard. However, Pakistan’s Drug Act of 1976 labels these medicines as ‘substandard,'” Dr. Waheed points out. This terminology creates a damaging impression that the issue is due to intentional negligence or malfeasance by pharmaceutical companies, which is not necessarily the case. The term “substandard” carries a stigma that unfairly tarnishes the reputation of pharmaceutical companies, he adds.
The consequences of this outdated legislation are far-reaching. Dr. Waheed highlights that when medicines are recalled under these provisions, companies face significant financial losses, not just due to the recall itself but also from the damage to their brand image. In Pakistan, however, the legal ramifications are even more severe. Courts often initiate criminal proceedings against non-technical owners, directors, and top-tier management, many of whom have no direct involvement in the manufacturing process. This practice has been described as excessive and punitive, contributing to a climate of fear within the industry.
Perhaps the most alarming consequence of the outdated Drug Act is the flight of multinational pharmaceutical companies from Pakistan. These companies, which have the resources and expertise to comply with international standards, are increasingly choosing to exit the Pakistani market due to the legal risks and regulatory challenges. One such case involved the conviction of a multinational CEO, who was sentenced to prison despite being outside the country at the time of the alleged offense. This has created an atmosphere where foreign investors and business leaders are increasingly hesitant to engage with the pharmaceutical sector, given the potential legal repercussions they could face. Experts warn that this trend could have long-term negative effects on the sector, particularly as the global pharmaceutical industry becomes more competitive.
It is also worth noting that businesses in other sectors, such as confectionery and ghee, are subject to far fewer regulatory burdens. These industries, which deal with products that do not have the same level of scrutiny as medicines, are able to operate with fewer legal hurdles and less risk of criminal prosecution. In contrast, the pharmaceutical sector faces punitive measures that disproportionately impact business owners and CEOs, further discouraging innovation and investment.
The call for reform is growing louder. Pharmaceutical leaders argue that the Drug Act of 1976 needs to be modernized in order to foster a regulatory environment that encourages growth, innovation, and compliance. “We need a legal framework that supports growth and innovation, not one that stifles the industry,” a PPMA official remarked. The current system, they argue, creates an atmosphere of fear, where business owners are more concerned with avoiding legal consequences than with advancing their businesses or the industry as a whole.
Recognizing the urgency of the situation, the Drug Regulatory Authority of Pakistan (DRAP), under the Ministry of National Health Services, has begun to engage in discussions to address these challenges. DRAP’s policy board, which includes key stakeholders such as the Secretary of Health, is working to draft reforms aimed at improving the regulatory environment. However, many experts argue that these reforms must go beyond superficial changes and address the core issues that have led to the current state of affairs.
One of the major efforts to attract investment in the pharmaceutical sector comes from the Special Investment Facilitation Council (SIFC), a government initiative aimed at promoting foreign investment in various industries. The SIFC has turned its focus to the pharmaceutical sector, recognizing its immense potential for growth, both within Pakistan and on the global stage. By aligning DRAP’s efforts with investment-friendly policies, the SIFC hopes to position Pakistan as a key player in the global pharmaceutical market. However, this vision will only become a reality if the legal and regulatory framework is modernized to provide both local and international investors with the confidence they need to invest in the sector.
The reforms being discussed by DRAP are not limited to changes in the Drug Act 1976 alone. Health coordinators are being enlisted to bridge the gap between industry stakeholders and regulators, ensuring that any reforms are not only practical but also maintain high standards of public health. The aim is to create a regulatory system that promotes innovation while also safeguarding the health and safety of the public.
Pakistan’s pharmaceutical sector holds immense potential, particularly in terms of exports, job creation, and advancements in healthcare. However, realizing this potential requires a comprehensive overhaul of the Drug Act 1976, which has become a significant barrier to progress. Experts argue that the regulatory environment must be revamped to support the growth of the industry while maintaining the high standards required to protect public health.
One of the key proposals is to establish fair accountability mechanisms that focus on technical aspects rather than penalizing individuals who may not be directly responsible for operational issues. This would involve the creation of specialized technical courts where pharmaceutical industry cases could be adjudicated based on the technical merits of the situation, rather than criminalizing business owners who may lack direct technical expertise. Such a system, experts argue, would encourage both local and international investments by providing a more predictable and transparent legal framework.
In conclusion, Pakistan’s pharmaceutical sector is at a crossroads. The outdated Drug Act 1976, with its punitive provisions and excessive legal repercussions, is holding back the industry’s potential for growth and innovation. Reforming the law to align with international standards, create a supportive regulatory environment, and ensure fair accountability could help unlock the sector’s vast potential, benefiting not only the pharmaceutical industry but also Pakistan’s economy and public health. The need for urgent action is clear, and it is crucial that policymakers, regulators, and industry leaders work together to modernize the legal framework that governs Pakistan’s pharmaceutical sector. Only then can the country’s pharmaceutical industry compete on a global scale and contribute to the overall advancement of healthcare.
