PPMA dismisses accusations regarding country’s drugs quality

KARACHI: The Pakistan Pharmaceutical Manufacturers Association (PPMA) has rejected the media reports alleging that most of the medicines made in the country fail to meet international standards. 

The allegations were leveled in the Senate Standing Committee on the National Health Services, Regulations, and Coordination, while it was assessing the Drug Regulatory Authority of Pakistan’s (DRAP’s) five-year performance.

A  PPMA statement termed these accusations baseless and misleading, saying these were only speculations lacking concrete evidence. 

“The national pharmaceutical industry commands over 70pc of the market share, with 90pc of medicines in Pakistan being produced by either national or multinational companies. This significant market presence reflects the trust that the medical community places in domestic manufacturers,” the PPMA stated.

The association says such claims undermine the efforts to enhance pharmaceutical exports. “The past year has seen remarkable success, with pharmaceutical exports increasing by over 25pc. This growth is a clear indicator of the quality of Pakistani products,” the association asserts.

It highlighted improvements in DRAP’s monitoring processes, saying the authority has implemented stringent quality control measures. “To obtain a license or register a medicine, companies must adhere to rigorous international quality standards. 

It adds that products are now registered under the internationally recognized Common Technical Dossier (CTD) format, which includes comprehensive evaluations such as a six-month stability test for generic drugs. Any deviations are corrected prior to approval, the PPMA explains.

Moreover, the association points out that drugs are subject to random testing by World Health Organization (WHO)-qualified laboratories. “Any drugs that fail to meet specifications are recalled, and strict actions are taken—a practice consistent with global pharmaceutical standards,” it says.

PPMA says that local pharmaceutical companies have established a robust export presence in countries such as Sri Lanka, the Commonwealth of Independent States, Cambodia, Vietnam, the Philippines, and Central Asia. 

It stressed that these exports are possible only because the companies pass stringent inspections by the regulatory authorities of the importing countries, confirming compliance with international standards.

The PPMA urged the government, Parliament, and relevant committees to focus on supporting the industry’s goal of increasing exports to $3 billion, rather than making statements without technical analysis or proper evidence. 

“Such unfounded remarks damage the industry’s reputation and could negatively impact our export efforts, particularly at a time when the national economy is striving for growth,” the statement concluded.

The PPMA also warned that such disparaging comments could benefit competitors like India by creating a negative perception of Pakistani medicines, potentially harming the country’s pharmaceutical export potential and economic progress.