Outdated drug laws hindering growth potential of Pakistan’s pharmaceutical sector

KARACHI: The pharmaceutical sector, a vital component of Pakistan’s healthcare system, is grappling with challenges posed by outdated legislation.

The cornerstone of this regulatory framework, the Drug Act 1976, has not kept pace with global advancements, creating significant hurdles for innovation, growth, and operational efficiency, say experts.

Dr Qaiser Waheed, former chairman of the Pakistan Pharmaceutical Manufacturers Association (PPMA), voiced his concerns. “The DRAP Act 1976 needs to be revised. Medicines are recalled if they are out-of-specifications medicines. World over, out-of-specification medicines are termed as such, but in Pakistan’s old law—Drug Act 1976—it is termed as substandard, which gives an impression that someone has done it on purpose, which is not the case.”

He elaborated on the implications of this terminology, pointing out that it tarnishes the reputation of pharmaceutical companies.

“World over, out-of-specification medicines are recalled. Company incurs great financial losses on recalling of medicines as well as losing brand image. In Pakistan, courts initiate criminal proceedings against non-technical owners, directors, and top-tier management, who are mostly not directly related to manufacturing medicines,” Dr Waheed explained.

One alarming consequence of the outdated legislation is the exodus of multinational pharmaceutical companies from Pakistan. Dr Waheed cited a case where a multinational CEO was sentenced to prison despite being out of the country at the time of the alleged offence.

“Businessmen are staying away from the pharma business because of this anomaly,” he said, adding that companies dealing in substandard products like confectionery and ghee face far fewer repercussions.

The Drug Act 1976 was designed to regulate the production, distribution, and quality of medicines. However, its punitive provisions, particularly against out-of-specification medicines, are seen as excessive. Business owners and CEOs are held personally liable for systemic lapses, fostering a culture of fear rather than encouraging innovation.

Pharmaceutical leaders have called for urgent amendments to the Drug Act 1976. Modernising the law, they argue, is essential to aligning Pakistan’s pharmaceutical industry with international standards.

“We need a legal framework that supports growth, innovation, and compliance rather than one that stifles the industry,” an official from the PPMA remarked.

The Drug Regulatory Authority of Pakistan (DRAP), under the Ministry of National Health Services, has initiated discussions to address these challenges. DRAP’s policy board, which includes key stakeholders like the Secretary of Health, is working on drafting reforms aimed at improving the regulatory environment.

The Special Investment Facilitation Council (SIFC), a government initiative to attract foreign investment, has also turned its attention to the pharmaceutical sector. By integrating DRAP’s efforts with broader investment-friendly policies, the SIFC hopes to position Pakistan as a global contender in pharmaceuticals.

Health coordinators are being enlisted to bridge the gap between industry and regulators, ensuring that reforms are practical while maintaining high public health standards.

Pakistan’s pharmaceutical sector has immense potential for exports, job creation, and healthcare advancements. Realizing this potential, however, requires a comprehensive overhaul of the Drug Act 1976.

Dr Waheed emphasized, “There should be accountability on technical grounds and in technical courts.” He argued that fair accountability mechanisms and updated laws would encourage both local and international investments.

Copyright Business Recorder, 2024