Regulatory Delays Stall Launch of Advanced Medicines in Pakistan

Regulatory Delays Stall Launch of Advanced Medicines in Pakistan

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The Government of Pakistan has delayed approving price notifications for advanced life-saving medicines for more than six months, effectively blocking their entry into the country’s healthcare system.

Despite multiple federal cabinet meetings where drug pricing was on the agenda, no final decision has been made, leaving dozens of essential treatments unavailable to patients.

According to Tauqeer Ul Haq, former chairman of the Pakistan Pharmaceutical Manufacturers Association, between 60 and 70 medicines are currently awaiting approval. These include treatments for serious conditions such as cancer, heart disease, and hypertension.

Pharmaceutical companies have continued submitting applications to the Drug Regulatory Authority of Pakistan, increasing the backlog. While DRAP and the pricing committee led by Finance Minister Muhammad Aurangzeb have reportedly determined prices for several drugs, final approval from the federal cabinet under Prime Minister Shehbaz Sharif remains pending.

Industry representatives clarified that the issue relates only to price determination for new medicines and not to any increase in prices of existing drugs. However, confusion between the two matters may be contributing to the delay.

Experts warn that the prolonged hold-up is limiting access to modern treatments and putting patients at risk. There are also concerns that continued delays could encourage the spread of unregulated or smuggled medicines, posing serious health and safety challenges.

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Syed Sadat Hussain Shah

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