PPMA strongly refutes allegations against quality of Pakistani medicines

Pharmaceutical body defends industry standards, warns against harmful impact on exports and national reputation

The Pakistan Pharmaceutical Manufacturers Association (PPMA) has condemned and outright dismissed recent allegations suggesting that drugs produced in Pakistan “do not meet international standards.”

These claims were raised during a session of the Senate Standing Committee on National Health Services, Regulations, and Coordination, which reviewed the performance of the Drug Regulatory Authority of Pakistan (DRAP) over the past five years.

In a statement issued here, the PPMA criticized the media reports, describing them as “based on conjecture without any proper analysis or evidence,” and labeled them as “grossly misleading.”

The association highlighted the national pharmaceutical industry’s significant market share, which exceeds 70%, with 90% of the country’s medicines produced by domestic or multinational companies.

“This substantial market share is a testament to the trust that the medical community places in domestic manufacturers,” the PPMA asserted.

The association further emphasized the potential harm such baseless statements could cause to Pakistan’s pharmaceutical exports, which have seen a remarkable 25% growth over the past year.

“Such irresponsible comments do not contribute to enhancing the export of pharmaceuticals from Pakistan. How could this growth be possible without quality products?” the PPMA questioned.

The statement also underscored DRAP’s stringent monitoring processes. “For any company to obtain a license or register a medicine, it must meet rigorous quality control and production standards that align with international requirements,” the PPMA explained. This includes the use of the Common Technical Dossier (CTD) format, recognized globally, and extensive evaluations such as a six-month stability test for generic drugs.

Moreover, the PPMA pointed out that WHO-qualified laboratories conduct random testing, and any drugs found to be out of specification are promptly recalled, with strict actions taken—a standard practice in pharmaceutical industries worldwide.

The association also highlighted the strong export presence of Pakistani pharmaceutical companies in markets such as Sri Lanka, the Commonwealth of Independent States, Cambodia, Vietnam, the Philippines, and Central Asian States. “These companies cannot export without passing stringent inspections by regulatory authorities in importing countries, which only approve plants that meet international standards,” the PPMA noted.

The PPMA warned that the committee’s unfounded statements could create unnecessary public confusion and harm the industry’s reputation. The association stressed that Pakistani pharmaceutical companies have proven their capability by meeting domestic medicine demands during crises like the COVID-19 pandemic and recent floods.

“If Pakistani medicines did not meet international standards, our pharmaceutical companies would not be able to export them,” the PPMA emphasized.

The association urged the government, Parliament, and relevant committees to focus on supporting the industry in increasing exports to $3 billion, rather than making statements “without technical analysis or proper evidence.”

The PPMA also cautioned that such unsubstantiated remarks could severely impact the pharmaceutical industry’s efforts to generate foreign exchange for Pakistan. “Comments without basis from officials in significant positions damage the reputation of our country and medicines, giving our competitor, India, an opportunity to create a negative image of our products, which could adversely affect our exports at this critical time for our national economy and growth,” the PPMA concluded.

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