Pakistan ends decades-long wait as ED drugs legally available in country
ISLAMABAD: Pakistani men suffering from erectile dysfunction (ED) can now legally access treatment, as medicines such as Sildenafil and Tadalafil have been formally approved for local manufacturing — a long-overdue move that ends decades of reliance on smuggled, unregulated alternatives.
The Drug Regulatory Authority of Pakistan (DRAP) granted registration to a group of pharmaceutical companies earlier this year, allowing them to produce various strengths of the two most commonly used ED drugs: Sildenafil, better known globally as Viagra, and Tadalafil, known by the brand name Cialis. The approval came during DRAP’s 345th meeting of the Drug Registration Board held in February 2025.
Until recently, Pakistan was among the few countries where local manufacturing of these medications remained informally restricted. This regulatory gap gave rise to a thriving black market, with pharmacies often forced to sell unregistered pills imported illegally from India, Thailand, and the Gulf.
These products, many of questionable quality, frequently lacked dosage accuracy, posing serious health risks to users. “Legal production brings dignity and safety to patients who have quietly suffered for years,” said an official close to the approval process. He added that companies underwent rigorous audits and facility inspections before being granted licences to manufacture the drugs in strengths ranging from 25mg to 100mg for Sildenafil, and 5mg to 20mg for Tadalafil.
Industry insiders say the move is expected to transform access and affordability in a market where patients previously had to pay inflated prices for unverified drugs. One of the companies that has begun manufacturing these medicines, Genix Pharma, was among the first to bring multiple dosage options to pharmacies after fulfilling DRAP’s compliance criteria. Its early market presence has helped set the tone for a more structured and quality-controlled supply of ED treatments.
Pharmacy owners also breathed a sigh of relief. Abdul Samad Budhani, chairman of the Pakistan Chemists and Druggists Association (PCDA), said the informal ban had placed undue burden on pharmacists who were frequently penalized during drug inspections despite responding to patient needs.
“Now that registered medicines are available, this grey area has finally been addressed,” he said, acknowledging that Genix Pharma’s rollout played a key role in resolving the issue at the retail level.
Health experts, however, cautioned that legal availability must not lead to indiscriminate use. “These drugs affect vascular function and can pose serious risks for those with heart conditions,” warned Sardar Shabbir Ahmed, secretary of the Quality Control Board in Islamabad. “They must be dispensed strictly with a doctor’s advice.”
The legalization also opens up opportunities for Pakistan’s pharmaceutical sector, not just in terms of domestic demand but also potential exports. Companies that meet international standards may soon be eligible to supply these drugs to regional markets, adding value to the country’s medicine manufacturing ecosystem.
While several firms have received licences, early entrants such as Genix are already shaping the market through rapid deployment and competitive pricing. Their role in bridging a long-standing regulatory and medical gap has drawn cautious praise from both industry watchers and patient advocates.
Pakistan’s decision to regulate and domestically produce ED drugs is being seen as part of a broader shift towards modernizing its healthcare offerings, with DRAP also approving medications for cancer, diabetes, and cardiovascular diseases in recent months. For thousands of men seeking discreet, safe, and medically supervised treatment, the move finally offers a legal, dignified alternative to backroom remedies.
