The International Conference of Drug Regulatory Authorities (ICDRA) has recommended to the World Health Organisation (WHO) to regulate blood and cell therapies across its members states.

In addition, it has also called upon the WHO to implement new tools for effective collaboration in combating SSFFC (Spurious, Sub-Standard, Falsified, Fake, Counterfeit) medicines. The member states mechanism would enable information exchange to help in the prevention and identification of national and regional actions in cases of suspect incidents of SSFFC medical products.

In this regard, 350 drug regulators from across the globe including those from India, represented by DCGI Dr GN Singh and Dr BR Jagashetty, drugs controller, government of Karnataka, at a workshop in Estonia in Europe put forth proposals related to quality assurance, safety and availability of blood for transfusion.

A consensus about blood and stem cell therapies came about because these are seen increasingly to become the treatment protocols of the future, said Dr Jagashetty in his special address at the STEM 2013, a day-long event which highlighted the current trends in stem cell based therapies to treat chronic liver disease, diabetes, myocardial infarction, critical limb ischemia (CLI) and osteoarthritis.

“WHO member states are encouraged to establish essential medicines lists and to include whole blood and blood components for transfusion under the same. Further steps to strengthen national blood regulatory systems through education and technical support of national medicines regulatory authorities should be given ample focus. Priority should be for publication and training support on the WHO Assessment Criteria for National Blood Regulatory Systems, and Training on GMP for Blood Establishments consistent with WHO Guidelines. There is need to develop national regulatory programmes for hematopoietic progenitor cell and other advanced blood cell therapies, taking into account similarities and critical differences with respect to regulation of blood components for transfusion,” he said.

The panel of regulators also called for WHO to encourage regulation of advanced blood cell therapies through consideration of relevant best practices, including the establishment and strengthening of national blood regulatory systems, said Dr Jagashetty.

Coming to the new tools for effective collaboration in combating SSFFC medicines, Dr Jagashetty said that it was suggested that all the member states of WHO should focus on the public health implications of SSFFC medical products by enabling the mechanism of information exchange.

The mechanism within the framework of WHO needs to enable international collaboration to combat SSFFC medical products, through ICDRA, regional anti-counterfeit initiatives and expert advice from other stakeholders.

Member States and regions should, with WHO and other partner assistance, look to strengthen capacity and develop tools to detect, prevent and control the circulation of SSFFC medical products through capacity building and international collaboration.

ICDRA has also pressed upon WHO to create a global monitoring system enabling exchange for information on SSFFC medical products, said Dr Jagashetty.