Pharma Industry Calls for Responsible Regulation

Pakistan’s pharmaceutical industry has raised serious concerns over the Drug Regulatory Authority of Pakistan (DRAP) declaring medicines substandard before the completion of the full regulatory process. Industry representatives argue that such premature announcements undermine public trust, damage the credibility of local manufacturers, and hurt Pakistan’s drug exports.

According to the Pakistan Pharmaceutical Manufacturers Association (PPMA), public notices are often issued based on initial findings from provincial Drug Testing Laboratories (DTLs). However, many of these products are later cleared by appellate re-testing at the National Institute of Health (NIH). By the time final results are available, reputational harm has already been done, affecting both domestic confidence and international trade.

Officials stressed that while post-marketing surveillance and quality testing are essential for patient safety, interim findings should not be communicated as final decisions. Premature announcements create unnecessary alarm among patients, influence doctors’ prescribing behavior, and disrupt pharmacists’ dispensing practices.

The impact extends beyond Pakistan’s borders. Exports of pharmaceutical products, particularly to Afghanistan, have already suffered setbacks due to international buyers misinterpreting preliminary findings as final regulatory outcomes. This has led to delayed consignments, additional scrutiny, and complications in product registrations abroad.

Industry leaders emphasized that Pakistan’s regulatory framework already provides for a multi-step process to ensure fairness and scientific accuracy. They urged DRAP to adopt a balanced communication strategy that clearly distinguishes between preliminary observations and verified conclusions.

The PPMA reaffirmed its support for strong quality surveillance and strict enforcement against genuinely substandard medicines. However, it stressed that responsible communication is vital to protect patient trust, ensure healthcare stability, and safeguard Pakistan’s growing pharmaceutical export ambitions.