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.


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%.




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