DRAP allows production of new drugs for cancer, other ailments

ISLAMABAD: In a landmark decision, the Drug Regulatory Authority of Pakistan (DRAP) has authorised local pharmaceutical companies to manufacture Sildenafil Citrate and Tadalafil tablets for the treatment of Erectile Dysfunction (ED) and new drugs for the treatment of cancers, non-communicable diseases (NCDs), including diabetes, hypertension, kidney diseases among many others, officials said.

Officials added that all the complete applications for registration till January 30, 2025 were approved.

The approvals were granted during the 345th meeting of DRAP’s Drug Registration Board (DRB), which concluded on Friday, marking a major policy shift in the country’s pharmaceutical regulations.

Pakistan and Afghanistan were among the only countries in the world that had imposed an unannounced ban on the local manufacturing of Viagra and other ED drugs including Cialis.

This restriction led to a booming black market, with millions of smuggled tablets being sold illegally in Pakistan every year. These unregulated drugs, sourced from countries including India, China, Thailand, the UAE, Turkey, Egypt, the USA, and Saudi Arabia, posed serious risks as their quality and authenticity remained unverified.

A DRAP official confirmed that around 100 applications from different pharmaceutical companies were reviewed during the meeting for granting registration to manufacture Sildenafil Citrate in 25 mg, 50 mg, and 100 mg strengths.

Similarly, dozens of companies applied for approval to manufacture Tadalafil (Cialis) in 5 mg, 10 mg, and 20 mg dosages. Following a detailed review, over 40 applications by 20 leading pharmaceutical companies were approved, with some pharmaceutical firms seeking registration for export purposes while others intend to manufacture and market the drugs domestically.

“The decision to allow local production is expected to bring multiple benefits. First, it ensures the availability of high-quality, regulated ED medications, protecting consumers from counterfeit and substandard products”, the DRAP official claimed.

Previously, many smuggled Viagra tablets and their generics contained either incorrect dosages of the active pharmaceutical ingredient (API) or were completely fraudulent, raising serious health concerns.

“Legal manufacturing will curb the rampant smuggling and illegal sales of these drugs, bringing them into a controlled pharmaceutical framework. This move will also strengthen Pakistan’s pharmaceutical industry by creating business opportunities, generating employment, and increasing exports”, the official added.

DRAP official stressed the need for strict monitoring to ensure that these drugs are dispensed only with a valid prescription from a registered medical practitioner. “Federal and provincial drug inspectors will be responsible for preventing misuse and ensuring compliance with prescription-based sales”, he assured.

This decision aligns Pakistan with global practices, where Sildenafil Citrate (Viagra) and Tadalafil (Cialis) are widely available under medical supervision.