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DRAP phases out 1cc syringes, restricts 10cc sales to hospitals amid HIV concerns

Islamabad: Pakistan’s drug regulator has ordered the phase-out of conventional 1cc (1mL) non-insulin disposable syringes and restricted the sale of conventional 10cc (10mL) syringes exclusively to secondary and tertiary healthcare hospitals from January 1, 2027, as part of sweeping measures to prevent the reuse of syringes and curb the transmission of HIV and other blood-borne infections.

The decisions were taken by the Medical Devices Board (MDB) of the Drug Regulatory Authority of Pakistan (DRAP) after reviewing recommendations of a federal task force constituted by the Ministry of National Health Services, Regulations and Coordination to investigate the recent increase in HIV infections linked to unsafe medical practices, particularly the reuse of contaminated syringes and weaknesses in infection prevention and control.

According to an official notification, the Board expressed grave concern over epidemiological evidence linking healthcare-associated transmission of HIV to unsafe injection practices and the reuse of disposable syringes in healthcare facilities.

The recommendations were first endorsed by DRAP’s Policy Board before being approved by the Medical Devices Board at its 135th meeting held on June 30, 2026.

Under the new policy, manufacturers, importers and suppliers have been allowed a transition period until December 31, 2026. Thereafter, the manufacture, import and sale of conventional 1cc (1mL) non-insulin disposable syringes will no longer be permitted, and only safety-engineered reuse-prevention syringes incorporating validated auto-disable, retractable or auto-lock technologies will be allowed for routine use.

The Board has also prohibited the retail and open market sale of conventional 10cc (10mL) syringes from January 1, 2027. They will be supplied only to public and private secondary and tertiary healthcare hospitals and institutions for specialised clinical procedures under a regulated distribution system.

To strengthen accountability, manufacturers and importers have been directed to print the name of the procuring institution on the primary packaging of every 10cc syringe supplied to hospitals.

Healthcare institutions will also establish inventory control mechanisms, while manufacturers, importers and procuring institutions will maintain end-to-end digital records of the manufacture, import, procurement, supply and utilisation of these syringes through an electronic portal to be developed by DRAP.

The notification has been circulated to provincial health departments and other relevant authorities for implementation of the Board’s decisions and to facilitate the transition to safer injection technologies.

The regulatory action comes amid growing concern over HIV outbreaks linked to unsafe injection practices. Investigations into paediatric HIV outbreaks in Larkana, Khairpur and, more recently, Karachi’s Pathan Colony (Valika) have repeatedly identified the alleged reuse of disposable syringes and poor infection prevention and control practices among the factors suspected to have contributed to the spread of infection.

Conventional 1cc syringes are also widely used by people who inject drugs, including heroin and methamphetamine users. Public health experts say the reuse and sharing of contaminated syringes remain a major driver of HIV, hepatitis B and hepatitis C transmission among injecting drug users, while unsafe injection practices in healthcare settings continue to pose a serious risk to patients, particularly children.

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