The Union health ministry has issued a guidance document for regulatory approvals of stem cell and cell based products (SCCPs) which will suggest a road map for regulation of stem cells and other cell based therapies being practiced in the country. The rules and regulations in this document will apply to all organizations such as hospitals, private clinics, institutes, universities, tissue banks and companies who wish to obtain a license for the use of SCCPs for therapeutic purposes in India.
The ministry in June last year had formed an expert panel to suggest a road map for regulation of stem cells and other cell based therapies being practiced in India. This guidance document is based on the recommendations of that committee and it is subsidiary to the amendments made in 2013 to the Drugs and Cosmetics Act (D&C Act), 1940 and the new rules proscribed thereunder.
This document describes the mandatory requirements to be administered by the government of India for development, manufacturing, and doing quality control of SCCPs for the purpose of their non-clinical and clinical usages. It addresses both autologous and allogeneic SCCPs. The document gives a detailed description of requirements related to non-clinical studies that are necessary to demonstrate proof of concept and define the pharmacological, safety and non-toxicological effects of SCCPs.
Descriptions on designing pharmacodynamic/pharmacokinetic studies i.e. dose finding clinical efficacy and safety studies are also available in which the pharmacovigilance aspects and the risk management plans have been given special consideration. The document will assist the DCGI/CDSCO in setting a road map to regulate the usage of SCCPs for regenerative medicine in India. It will also assist the stakeholders for regulatory submission.
This document will be in addition to other existing guidelines on SCCPs usage in India. The document is applicable only for the commercial usage of SCCPs in the prevention and treatment of human diseases and for doing clinical trials with SCCPs in India.
All institutions and investigators carrying out clinical trials and commercial usage of SCCPs, i.e. conducting a study in human subjects to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and/or adverse effects with the objective of determining safety and/or efficacy of the said SCCP as per the amended provisions of the D&C Act, is required to obtain a license/approval from the CDSCO.
The aim and scope of this document is to define the role of CDSCO in regulating the manufacturing, licensing and usage of SCCPs; to describe the various categories of licensing/approvals for facilities, clinical trials and protocols for SCCP usage for specific indications; to provide guidance to the applicants for isolation, characterization, culturing, processing, manufacturing, quality control, labeling and distribution of SCCPs; and to provide guidance for compliance, with all the regulatory requirements, to carry out clinical trials with SCCPs.