Islamabad, April 9, 2025: Transparency International (TI) Pakistan has raised serious concerns over alleged regulatory failures and violations of the Drug Act 2012 within the country’s pharmaceutical and medical device sectors. In a letter addressed to Prime Minister Shehbaz Sharif, the watchdog highlighted critical lapses, including the prolonged non-appointment of Federal Inspectors of Drugs (FIDs), inadequate oversight, and market manipulation by pharmaceutical companies.
Despite the introduction of the Medical Devices Rules in 2017, TI Pakistan claims that many manufacturers and importers have consistently failed to apply for required approvals within the stipulated timeframes. Instead, they are said to submit incomplete applications, resulting in repeated processing delays.
The letter alleges that medical device manufacturers are exploiting these delays to secure last-minute extensions each year, manipulating the supply chain by creating artificial shortages and selling products at inflated prices. This, according to TI Pakistan, is contributing to a distorted and unregulated market environment.
The organization also criticized the Federal Government for what it called a failure to regulate the powerful pharmaceutical lobby, allowing the industry to operate with minimal accountability.
One of the most alarming revelations is the fact that no new Federal Inspectors of Drugs have been appointed in over two and a half years. At present, only two FIDs are operational across the entire country, leaving the pharmaceutical and medical device sectors largely unsupervised.
TI Pakistan warns that this lack of oversight has created a critical vacuum in enforcement. As a result, over 700 licensed drug manufacturers, 500 alternative medicine producers, and a large number of medical device importers are reportedly functioning without proper regulatory scrutiny, posing serious risks to public health.
The letter further highlights that since the enactment of the DRAP Act in 2012, the Federal Government has consistently failed to appoint a regular Director for the Drug Regulatory Authority of Pakistan (DRAP). The absence of stable leadership at DRAP, coupled with the dearth of inspectors, has allegedly crippled regulatory enforcement mechanisms.
TI Pakistan stated that a preliminary review of these allegations suggests they are credible, and it has called on the Prime Minister to take immediate action. The organization urged the government to launch a thorough investigation, and if the allegations are substantiated, to direct the Federal Minister for National Health Services, Regulations & Coordination and DRAP to expedite the appointment of drug inspectors and enforce pharmaceutical laws rigorously.
“Decisive action and strict enforcement of regulations are essential to preserve the integrity of Pakistan’s healthcare system,” TI Pakistan emphasized.
The allegations, if confirmed, expose a serious regulatory gap in the country’s health sector, with far-reaching implications for public safety and access to affordable, quality medicines.
