In a groundbreaking move, the Drug Regulatory Authority of Pakistan (DRAP) has authorized local pharmaceutical companies to manufacture Sildenafil Citrate and Tadalafil tablets for the treatment of Erectile Dysfunction (ED). Additionally, approvals have been granted for the production of new medications targeting cancers, and non-communicable diseases (NCDs) such as diabetes, hypertension, and kidney diseases, officials confirmed.
During the 345th meeting of DRAP’s Drug Registration Board (DRB), which concluded on Friday, all complete applications submitted by January 30, 2025, received approval. This decision marks a significant shift in Pakistan’s pharmaceutical policies.
Previously, Pakistan and Afghanistan were among the few countries enforcing an informal ban on locally producing ED medications like Viagra and Cialis. This restriction contributed to a thriving black market, with millions of smuggled tablets—sourced from India, China, Thailand, the UAE, Turkey, Egypt, the USA, and Saudi Arabia—sold illegally each year. Many of these unregulated products posed serious health risks due to questionable quality and authenticity.
A DRAP official stated that approximately 100 applications for manufacturing Sildenafil Citrate in 25 mg, 50 mg, and 100 mg strengths were evaluated. Similarly, dozens of companies applied to produce Tadalafil in 5 mg, 10 mg, and 20 mg doses. After a thorough assessment, over 40 applications from 20 leading pharmaceutical firms were approved—some targeting export markets while others plan domestic sales.
“The approval for local production ensures the availability of high-quality, regulated ED medications, protecting consumers from counterfeit products,” the official said. Legal manufacturing is expected to curb smuggling, promote safer consumption, and strengthen Pakistan’s pharmaceutical industry through job creation, business opportunities, and increased exports.
Historically, smuggled ED drugs often contained incorrect active ingredient dosages or were entirely counterfeit, posing significant health risks. DRAP has emphasized strict regulatory oversight, requiring valid prescriptions for dispensing these medications. Federal and provincial drug inspectors will oversee compliance to prevent misuse.
This policy shift aligns Pakistan with global practices where medications like Sildenafil (Viagra) and Tadalafil (Cialis) are accessible under medical supervision.