WHA confirms delay in fake drug mechanism review

It has been confirmed that a World Health Assembly-led initiative to tackle the trade in falsified and substandard medicines will be held back by a year to 2017.

The delay in the review of the mechanism (MSM) on so-called substandard/spurious/falsely-labelled/falsified/counterfeit medical products (SSFFCs) was first revealed in March and confirmed during the WHA's 68th session, which came to a close on May 26.

The member state working group on the MSM requested the delay after its third meeting - held last October - at which the scope of the project was expanded to increase the emphasis on in-transit medicines and supply chain issues, including control of starting materials, along with the establishment of a dedicated workgroup on track-and-trace technologies

It is likely significant that the World Health Organization (WHO) is in the process of revising its Good Trade and Distribution Practice (GTDP) guide for starting materials which was published in 2003.

The revision of the 2003 version of the GTDP was prompted by various serious incidents of diethylene glycol (DEG) contamination in excipients used in liquid medicines, including an incident in Nigeria a few years ago which led to the deaths of 84 children.

The latest GTDP draft has now been passed onto the WHO subgroups for review is scheduled to be discussed in October when the WHO Expert Committee on Specifications for Pharmaceutical Preparations next convenes.