SHCC orders offering stem cell therapy for free with Drap’s nod

Declaring that stem cell therapy is still an experimental treatment except for specific oncology disorders and blood immune system conditions, the Sindh Health Care Commission (SHCC) has directed stem cell therapy practitioners to seek the Drug Regulatory Authority of Pakistan’s (Drap) approval for site and trial protocols, and to offer the treatment for free.

“Stem cell therapy is a highly specialised treatment modality that is mostly experimental and still in trial phase to obtain the clinical efficacy of these treatments for regulatory approvals,” the SHCC said in a latest advisory on stem cell therapy services.

“It has come to our attention that various healthcare providers are offering stem cell therapy services for conditions beyond the approved scope of such services, which raises serious safety, ethical, scientific and legal concerns.”

Sindh caretaker health minister Dr Saad Khalid Niaz has already warned healthcare professionals and institutions in the province against offering stem cell therapy as definite treatment and cure for many diseases where it is still in the experimental phase and not approved by any regulatory authority around the world.

In its latest advisory the SHCC also warned all healthcare providers engaged in the provision of stem cell speciality services that the use of stem cell treatment for purposes other than those approved for specific oncology disorders and blood immune system conditions is not approved by the Food & Drug Administration of the United States or any other regulatory body, awaiting research evidence.

Accordingly, any stem cell therapy conducted outside the bounds of the approved protocols should be considered experimental and must only be carried out within the framework of a clinical trial, the advisory said. The SHCC states that prior approval must be obtained from Drap for site and trial protocol, and that engaging in unauthorised stem cell therapy practices without this approval is in direct violation of national regulations, and may lead to legal repercussions.

Similarly, the advisory states further, all clinical trials must be approved and supervised by an ethical committee to ensure that the research conducted adheres to the highest ethical standards and respects the safety and rights of the participants.

The commission also advises that these trials be offered free of charge to the participants, saying that this is to ensure that patient care and ethical considerations are prioritised above financial incentives.

The advisory states that the SHCC, as the governing body for healthcare services in Sindh, is entrusted with the responsibility to monitor and regulate healthcare practices within the province. “Our mandate includes ensuring that all medical and therapeutic interventions meet the established legal and ethical standards.” SHCC CEO Dr Ahson Qavi Siddiqi warned healthcare professionals and institutions that any deviation from these guidelines may result in punitive actions by the commission in accordance with the SHCC Act and Regulations.