Permanent Mission of India
140th Session of the Executive Board of the WHO
8.6 Member State mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products
Intervention by India
India welcomes the progress made by the MSM in its 5th meeting held in November 2016 and would support endorsement thereof, including the definitions as set out in Appendix 3 of its report. The agreement on definitions will promote common understanding among member states and various stakeholders in addressing the complex challenge of substandard and falsified medicines from a purely public health perspective and prevent conflation with IP and trade related issues. WHO should widely disseminate these definitions among member states, UN agencies and other relevant organizations. The MSM itself should be rechristened as MSM on substandard and falsified medicines and the tongue twisting and confusing acronym of SSFFC should be done away with.
India has been advocating a study on linkages between lack of access and emergence of ‘Substandard and Falsified’ medical products. We believe that such a study will be extremely helpful. We, therefore, welcome the update in the MSM report provided by the Secretariat on the WHO’s work aimed at deepening the understanding of the link between access to quality, safe, efficacious and affordable medical products and the emergence of SF medical products.
We are further of the view that under the name of ‘Regulatory System Strengthening’ WHO should not focus its entire attention only on assessment and WHO should not deny any support without assessment through Global Benchmarking Tools.
India has been strongly advocating with the MSM to request WHO to keep alternative channels other than going through assessment of Regulatory system strengthening open and to provide guidance manual on the use of Global Benchmarking Tools (GBT) for country’s advantage and also guidance on how to carry out self-assessment.
We would urge that MSM addresses other pending issues urgently, including the issue of transit of medicines. We would request WHO Secretariat to submit necessary background documents on this issue to the next steering committee.
We note that MSM has proven its utility. While we look forward to its review, we support the extension of its mandate.
With these comments, we strongly support the adoption of the draft decision proposed.