Islamabad (Umar Faridoon): Transparency International (TI) Pakistan has sent letter to Prime Minister Shehbaz Sharif, highlighting alleged regulatory lapses, violations of the Drug Act 2012, and the non-appointment of Federal Inspectors of Drugs (FIDs) within the pharmaceutical sector.

Despite the 2017 notification of Medical Devices Rules, manufacturers and importers are allegedly failing to apply for necessary approvals within the stipulated time, submitting incomplete applications leading to repeated delays. Pharmaceutical companies, particularly medical device manufacturers, are reportedly exploiting these delays to seek last-minute extensions annually, allegedly manipulating the market by creating artificial shortages and selling products at exorbitant prices.

The Federal Government is accused of failing to curb the influence of the pharmaceutical industry, allowing it to operate with minimal oversight and accountability.No new Federal Inspectors of Drugs have been officially notified in the last two and a half years. Only two FIDs are currently operational nationwide, leaving the sector largely unmonitored.

The absence of effective regulatory oversight has allegedly allowed over 700 Drug Manufacturing License holders, 500 alternative medicine manufacturers, and numerous medical device importers and manufacturers to operate without adequate supervision. The lack of inspections and scrutiny is creating a dangerous environment where unregulated and potentially harmful medical products can enter the market without proper quality control.

Since the promulgation of the DRAP Act in 2012, the Federal Government has persistently failed to appoint a regular Director for the Drug Regulatory Authority of Pakistan (DRAP).

TI Pakistan stated that a preliminary review of the allegations suggests they are correct. The organization has urged the Prime Minister to investigate these allegations and, if found true, direct the Federal Minister for National Health Services, Regulations & Coordination, and DRAP to appoint the necessary federal drug inspectors and ensure strict enforcement of pharmaceutical regulations. TI Pakistan emphasized that decisive measures and their strict enforcement are crucial to maintaining the integrity of Pakistan’s healthcare system.