Life‑Saving Drugs Registered in Pakistan Yet Remain Unavailable to Patients

When the Drug Regulatory Authority of Pakistan (DRAP) finally gave the green light to a batch of life‑saving medicines earlier this year, many hoped the country’s sickest patients would breathe a little easier. The truth, however, turned out to be far murkier.

Even after the drugs completed every safety test, passed quality checks and were formally registered, they have yet to appear on pharmacy shelves. The reason? A bureaucratic snag that is as frustrating as it is preventable – the federal government has not yet approved the Maximum Retail Prices (MRPs) for these products.

“A medicine cannot be marketed legally without a price notification,” explains a senior official at DRAP, who asked to remain anonymous. “The registration is only half the battle. The price‑setting process is equally crucial.”

In late 2024 the Drug Pricing Committee finished its recommendations, and by June 2025 the DRAP Policy Board had endorsed them. The next step was supposed to be a swift hand‑over to the federal authorities for final sign‑off. That hand‑off, however, never materialised.

As a result, roughly forty essential drugs – a mix of cancer therapies, insulin formulations, vaccines and critical ICU medicines – sit in a legal limbo. They exist on paper, they are ready for production, but they cannot be sold to the very people who need them.

Some of the names on the waiting list read like a who’s‑who of modern medicine: Keytruda and Nivolumab for advanced cancers, Humalog insulin for diabetes, Adalimumab for autoimmune disorders, recombinant Factor VIII for hemophilia A, and even the anti‑Parkinson drug Carbidopa‑Levodopa. Blood‑clot preventers such as Dabigatran and Heparin, as well as broad‑spectrum antibiotics like Meropenem and Fosfomycin, are also caught in the same bureaucratic bind.

For patients, the impact is stark and immediate. A mother in Karachi whose child needs recombinant Factor VIII now faces the prospect of buying the drug on the black market at double or triple the cost, or worse, going without it altogether. Cancer patients in Lahore are forced to travel abroad, or to rely on unregistered, potentially unsafe alternatives. Those battling diabetes in Peshawar watch the price of insulin climb each month, even though a domestic version has already cleared regulatory hurdles.

Health‑policy experts warn that this is not just a logistical hiccup; it’s a public‑health crisis in the making. “When you block access to proven, life‑saving medicines, you’re essentially penalising the poorest and most vulnerable,” says Dr. Ayesha Khan, a public‑health researcher at the University of Karachi. “The cost of inaction will be paid in lives, and in the long‑run, in higher overall health expenditures.”

What makes the situation even more perplexing is the transparency – or lack thereof – around the pending price approvals. No clear timeline has been communicated, and the list of the forty medicines remains partially undisclosed, leaving families to guess which treatments might finally become affordable.

Meanwhile, the pharmaceutical industry watches anxiously. Manufacturers who have invested millions in research, local production facilities and supply‑chain logistics are stuck with inventory they cannot move. “We are ready to ship, we have the licences, we have the capacity,” says the CEO of a major local pharma firm. “What we need now is a simple government notification, and then patients can finally get the medicines they deserve.”

In the corridors of power, officials point to the need for a balanced approach that protects consumers from price gouging while ensuring manufacturers can recover costs. Yet critics argue that the balance has tipped too far toward caution, leaving the country’s sickest citizens in limbo.

As the summer months approach, the pressure mounts. Advocacy groups are organising petitions, patients are filing complaints, and media outlets continue to spotlight the growing gap between registration and accessibility. The hope, if any, rests on a decisive move from the federal government – a clear, dated price notification that finally bridges the regulatory divide.

Until then, the forty registered medicines remain a stark reminder that paperwork and policy can sometimes be the biggest barriers to health.