ISLAMABAD – Cancer cases in Pakistan are on the increase, but patients and health advocates are caught in a struggle for access to life-saving treatment amid concerns about the quality of generic drugs and the rising cost of medicine.

Tahmeena Kausar Parveen, a 45-year-old resident of Islamabad, was shocked by the news that she needs to see an oncologist about a lump in her breast after a screening at the Breast Cancer Hospital at Pakistan Institute of Medical Sciences.

Although she knows that early diagnosis makes this disease treatable, she has many anxieties. She is wrestling with the challenges of finding a reliable oncologist, covering the cost of treatment, and accessing quality medicines.

“I have the courage to fight this disease, but I fear that the difficult journey to get treatment may wear me down,” said Parveen.

The shadow of substandard drugs

Pakistan faces an estimated burden of 185,748 new cancer cases annually, according to the latest data from the World Health Organization (WHO).

But the fight against this disease extends far beyond the hospital ward – it is a battle fought on the supply chain, in regulatory offices, and in the courts, where the integrity and affordability of essential drugs hang in the balance.

The country’s cancer crisis is multifaceted, with access to cancer medication being one of the most complex problems.

There are fears about the quality of generic drugs, particularly following a report on failures in generic chemotherapy drugs published in The Lancet in late July.

The report, which involved testing various generic versions of seven key cancer drugs distributed in four African countries, found that around 20% failed various tests, most commonly over their active pharmaceutical ingredients (API). 

Many of these generic drugs are distributed worldwide, including in Pakistan.

Dr Maqbool Ahmed, an oncologist at Deaconess Hospital in Evansville in Indiana in the United States, says that the stakes could not be higher.

“Patients may not get the correct dose in a timely fashion, allowing their cancer to progress,” he warned. Medicines with lower APIs may be ineffective, while those with too high doses could have “toxic side effects”, said Ahmed.

Ahmed said that Pakistan “does not apparently have the know-how to test the drugs and no political desire to open this can of worms.”

Regulation of medicine

However, Dr Akhtar Abbas, a representative from the  Drug Regulatory Authority of Pakistan (DRAP) disputes this.

While DRAP has not had any specific complaints about failed generic cancer treatments, Abbas confirmed that, in the wake of the report on failed generics elsewhere, the authority has initiated “proactive sampling and laboratory testing of suspect products already in the market.”

Initial tests on samples of Doxorubicin and Methotrexate performed successfully, said Abbas, adding that DRAP’s mandate is to ensure quality through strict regulatory mechanisms, including a detailed evaluation of safety, efficacy, and quality before a drug can be registered.

The authority also regulates the storage and distribution of anti-cancer medicines at the manufacturer and importers level and this includes mandatory adherence to Good Distribution Practices (GDP).

He said cold chain compliance, storage conditions, batch tracking, and recall procedures are routinely checked through inspections and audits.

DRAP is also scaling up its post-marketing surveillance activities including risk-based sampling, increased coordination with provincial drug control units, digital pharmacovigilance platforms, and a National Quality Control Surveillance Plan, added Abbas.

“DRAP also works with WHO and other global partners to track international alerts and trace counterfeit or substandard drugs entering the supply chain and is also going to introduce a bar code reader app in near future for detection of Spurious and counterfeit medicines,” said Abbas.

Underlying anxiety

However, the assurances from the regulator have done little to end the underlying anxiety.

For institutions like the Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH&RC), which treat a significant portion of Pakistan’s cancer patients, the reliance on a national regulatory body is not enough.

“We, at SKMCH, have strong institutional mechanisms to ensure the quality of the products we get,” said CEO Dr Faisal Sultan.

He detailed the hospital’s own rigorous process of comprehensive pre-qualification assessments, review of quality documentation, and, when necessary, chemical equivalency tests and facility inspections.

According to Sultan, breast cancer is the most common cancer in Pakistani women, accounting for 31.3% of all new cases. Ovarian cancer ranks third with 4,987 new cases and 3,492 deaths annually.

Manufacturing success, pricing failure

Alongside concerns over drug quality and regulation, a significant success story has been unfolding in Pakistan’s pharmaceutical landscape: the rise of local anti-cancer drug manufacturing.

Noor Mahar, a pharmacist and president Pakistan Pharmacist Lawyers Forum (PPLF), points out that companies like Pharmasol, Oncogen Pharma, and BF Biosciences are now producing a range of essential oncology medications locally.

These include drugs to treat breast and ovarian cancer, as well as leukemia, said Mahar, marking a “major milestone for public health” by reducing the nation’s reliance on foreign imports, mitigating supply chain risks, and potentially lowering costs.

It is also a testament to the country’s growing industrial capabilities and represents a critical step towards achieving self-sufficiency in a highly specialized field.

However, Mahar warned that this progress is being undermined by an unwelcome policy called “price decontrol”.

In 2024, the country’s caretaker government enacted a policy to remove the maximum retail price (MRP) cap on non-essential medicines, allowing pharmaceutical companies to set their own prices. This has resulted in huge price hikes for certain medicines.

This decision is currently being challenged in the Lahore High Court.

Mahar argued that decontrol is a “clear violation of the Drug Act 1976,” which mandates strict regulation of life-saving medicines. 

He described the government’s stance as one of deep insensitivity towards patients and warns that the unchecked increase in drug prices will render essential cancer treatments “unaffordable for the common man”.

However, DRAP’s Abbas said that “the prices of the anti-cancer drugs included in Essential Medicine List are fixed and regulated”.

System under strain

The struggle with drug quality and pricing is compounded by a larger, systemic problem, namely the lack of a cohesive national framework for cancer care.

While the number of women presenting with breast cancer in early stages has increased at Shaukat Khanum Hospital, CEO Sultan notes that many women still present late and there is not enough understanding about why this is.

A functional national cancer registry would provide the data necessary for informed policy and resource allocation.

The supply chain is also under significant stress with several essential cancer medications not locally registered, making timely procurement a challenge, added Sultan.

Several multinational pharmaceutical companies have scaled down activities in Pakistan, which has contributed to the scarcity of essential cancer medications, creating additional challenges in ensuring consistent and timely patient care.

“This precarious environment puts immense pressure on healthcare providers,” said Sultan.

His hospital procures drugs from approved sources that comply with international standards.

“However, institutions like SKMCH&RC can only do so much. The core problems – the lack of political will, the absence of comprehensive data, and the recent dismantling of price controls – require a national-level solution,” he said.

Image Credits: Roche, WHO.