Gene Therapy Current Affairs - 2020

Ministry of Health: Complaints to ICMR on misuse of Stem Cell therapy

On March 20, 2020, the Ministry of Heath informed Lok Sabha that ICMR (Indian Council of Medical Research) has received several complaints on misuse of stem cell therapy.

Highlights

The National Apex Committee operating under the ministry is evaluating the complaints. The committee is to recommend actions against these complaints. The National Apex Committee for Stem Cell Research and Therapy examines technical, scientific, legal and social issues related to Stem Cell Research and therapy in Inia

What is the issue?

According to the National Guidelines for Stem Cell Research, there are no approved stem cell therapy other than Haematopoietic Stem Cell Transplantation (HSCT). However, evidences have been submitted to ICMR that there are other advanced Stem Cell therapies being conducted in India though GoI is yet to bring upon approval for such technologies and therapies.

ICMR

The ICMR is the apex body for the formulation, promotion and coordination of biomedical research in the country. Currently, ICMR is the nodal agency that is looking after the control of Corona Virus and the guidelines to test the virus

Facts Box: ICMR Guidelines on Gene Therapy

The Indian Council on Medical Research has issued guidelines on Gene Therapy. The aim of the guideline is to enable the stakeholders comply with the R&D of Gene Therapeutic Products being produced and tested inside the country.

Overview of the guidelines

The guide includes scientific and ethical considerations that are allowed in gene therapy. It explains the responsibilities of investigators, sponsors, institutions. It also lists the considerations like quality assurance, manufacturing and control, etc. The guidelines give clear overview about rules to be followed during clinical trials.

The guide also explains on the principles to hold while signing international collaboration and procurement of Genetic Therapeutic Products (GTP). The GTP are entities that deliver nucleic acid by various means for therapeutic benefit to patients.

Significance

In the past three years the cell therapy products in the country have increased. Their approvals have so far been provided by EU and US regulators hired by GoI. This paved way for the industry to develop. These therapies are mainly used to treat rare diseases. India is home to 70 million patients suffering from these rare diseases.

Also, the market for treating these rare diseases is expected to grow in the country. It is predicted that the revenue from these industries is to reach 250 billion USD by 2024 and is expected to grow by 11.3%.