KARACHI: The Pakistan Pharmaceutical Manufacturers Association (PPMA) on Tuesday strongly condemned and categorically dismissed recent media reports in which it was alleged that the drugs produced in Pakistan often “do not meet international standards”.
The above remarks were made during a session of the Senate Standing Committee on National Health Services, Regulations, and Coordination which was reviewing the performance of the Drug Regulatory Authority of Pakistan (DRAP) over the past five years.
“PPMA vehemently refutes this narrative, which is based on conjecture and without any proper analysis or evidence and are, therefore, grossly misleading,” the PPMA said in a statement.
“The national pharmaceutical industry holds over 70% market shares, with 90% of medicines in the country being produced by either national or multinational companies. This significant market share reflects the trust that the medical community places in domestic manufacturers.
“Furthermore, such irresponsible statements are not conducive to enhancing export of pharmaceuticals from Pakistan. The past year has been very fruitful with exports recording over 25% growth in the pharmaceutical sector and the future looks bright. How is that possible without quality products?”
It added that DRAP has significantly tightened its monitoring processes.
“For a company to obtain a license or for a medicine to be registered, it must meet stringent quality control and production standards that align with international requirements. Products are now registered under the Common Technical Dossier (CTD) format, which is comprehensive and internationally recognised. This includes rigorous evaluations such as a six-month stability test for generic drugs. Any deviations identified by DRAP’s evaluation cell result in the application being sent back for corrective action.
“There are also World Health Organization (WHO) qualified laboratories, which can conduct random testing. Any drugs found to be out of specification are recalled, and strict actions are taken - a practice common in pharmaceutical industries worldwide.”
Pakistani pharmaceutical companies have established a strong export presence in countries such as Sri Lanka, the Commonwealth of Independent States, Cambodia, Vietnam, Philippines and Central Asian States.
“It is important to note that these companies cannot export without passing stringent inspections by the regulatory authorities of the importing countries, who only approve plants that meet international standards.
“It is, therefore, once again emphasised that the committee’s statement could create unnecessary confusion in public. The industry has proven its capability by meeting domestic medicine demands during crises, such as the COVID-19 pandemic and recent floods.
“If Pakistani medicines did not meet international standards, the country’s pharmaceutical companies would not be able to export them,” the PPMA asserted.
The PPMA urged the government, Parliament and respected committees to focus on supporting the industry in increasing exports to US$3 billion rather than “issuing statements without technical analysis or proper evidence.”
It also emphasised that such reports will also greatly affect the pharmaceutical industry’s efforts to bring in foreign exchange for Pakistan.
“Remarks without basis and made by officials in important positions also unnecessarily damage the reputation of the country and our medicines. All it achieves is to provide an opportunity to our neighbouring country India (who is our competitor as well), to create a negative image of our medicines, which could affect our exports at this critical time for our national economy and growth.”
Copyright Business Recorder, 2024
Comments
Comments are closed.