Gene therapy is a technique that uses genes to treat or prevent disease. This technique allows doctors to treat a disorder by inserting a gene into a patient’s cells instead of using drugs or surgery.
Is Gene Therapy available in India?
In India though interest in gene therapy took some time but with financial assistance provided by different government agencies, the country has shown rapid improvement in gene therapy-related research.
India is at third place among the major Asian countries having gene therapy laboratories. The main aim is to develop new institutions for gene therapy research, strengthening existing institutions which have good expertise in this area in order to initiate work in molecular genetics for decreasing the burden of genetic disorders in the country.
The pioneer of gene therapy-related research in India is Advanced Centre for Treatment, Research and Education for Cancer (ACTREC) where active work on gene therapy for head and neck cancer using synthetic vectors is being carried out.
Guidelines for Gene Therapy in India
The Indian Council of Medical Research (ICMR), in December 2019, issued the National Guidelines for Gene Therapy Product Development and Clinical Trials, in consultation with experts and government agencies — including the Department of Biotechnology (DBT) and the Central Drugs Standard Control Organisation (CDSCO).
The aim of the document is to ensure that gene therapies can be introduced in India and clinical trials for gene therapies can be performed in an ethical, scientific and safe manner.
Main features of the guidelines
- The national guidelines outline what encompasses gene therapy and GTPs. Gene Therapy Products (GTP) are defined as any entity which includes a nucleic acid component being delivered by various means for therapeutic benefit to patients.
- It brings new gene therapies under the umbrella of existing laws regulating drugs and medicinal practices in India — such as the Drug and Cosmetics Act, 1940 and the Drugs and Magical Remedies (The Objectionable Advertisements) Act, 1954.
- Under these guidelines, germ-line gene therapy remains prohibited in India.
- The national guidelines provide the general principles for developing GTPs for any human ailment and provide the framework for human clinical trials which must follow the established general principles of biomedical research for any human applications.
Gene Therapy Advisory and Evaluation Committee (GTAEC)
The Gene Therapy Advisory and Evaluation Committee (GTAEC) is an independent body of experts representing diverse areas of biomedical research, concerned government agencies and other stakeholders.
It was constituted and notified by the Department of Health Research, Ministry of Health and Family Welfare to oversee the activities in the field of gene therapy research in India.
Functions of the GTAEC
- To serve as an apex advisory body to Government of India for research and development in the field of gene therapy in India.
- To perform a comprehensive review of the pre-IND (Investigational New Drug) and IND applications of Gene Therapy Products.
- To formulate policies to inculcate scientific and ethical practices amongst stakeholders.
- To provide a forum for discussion of issues involved in basic and clinical research and progress in the field of gene therapy.
- To assess periodically the adequacy of the document in light of advancements occurring globally.
- To consider the unforeseen issues of public interests.
Also Read:
What is Gene Therapy and Mitochondrial Disease?
Human Genome Project (HGP) and its Significance