Islamabad, Apr 9, 2025: Transparency International (TI) Pakistan has sent a formal request to Prime Minister Shehbaz Sharif, drawing attention to concerns regarding regulatory deficiencies, breaches of the Drug Act 2012, and the failure to appoint Federal Inspectors of Drugs (FIDs) in the pharmaceutical industry.
Despite the introduction of the Medical Devices Rules in 2017, manufacturers and importers have allegedly failed to apply for the required approvals within the prescribed time frame, submit incomplete documentation, and cause frequent delays.
Pharmaceutical companies, particularly those involved in medical devices, are allegedly taking advantage of these delays to request last-minute extensions every year, thereby manipulating the market by artificially creating shortages and inflating prices.
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Critics accuse the Federal Government of not curbing the pharmaceutical sector’s influence, allowing it to operate with little oversight and accountability.
The government has not appointed new Federal Inspectors of Drugs in the past two and a half years, leaving only two FIDs currently functioning nationwide and resulting in limited monitoring of the industry.
This lack of regulatory supervision has allegedly enabled over 700 Drug Manufacturing License holders, 500 alternative medicine producers, and many medical device importers and manufacturers to operate without proper oversight.
The absence of inspections is contributing to an environment where substandard or dangerous medical products could enter the market without adequate quality checks.
Since the enactment of the DRAP Act in 2012, the Federal Government has continuously failed to appoint a permanent Director for the Drug Regulatory Authority of Pakistan (DRAP).
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TI Pakistan’s initial assessment of these allegations suggests they are valid.
The organization has urged the Prime Minister to probe these concerns and, if substantiated, instruct the Federal Minister for National Health Services, Regulations & Coordination, as well as DRAP, to immediately appoint the required federal drug inspectors and enforce pharmaceutical regulations with utmost rigor.
However, TI Pakistan stressed that decisive actions and their enforcement are vital to preserving the integrity of Pakistan’s healthcare system.
