New Delhi: The Narendra Modi government has proposed constituting a new Gene Therapy Advisory and Evaluation Committee (GTAEC) — comprising scientists and clinicians — to rigorously monitor all clinical trials of gene therapy in India.
The Indian Council of Medical Research (ICMR) has initiated the process of drafting 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 national guidelines outline what encompasses gene therapy and GTPs. 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.
GTAEC will be composed of a core group of scientists and clinicians who have prior knowledge of gene therapy as evidenced by publications and participation in clinical trials of gene therapeutic products (GTP), as well as representation from government agencies.
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What is gene therapy?
Gene therapy refers to the process of modifying an individual’s genetic material to treat diseases. Such therapies provide a highly personalised, long-term cure for illnesses such as haemophilia, thalassemia, sickle-cell anaemia and certain forms of muscular dystrophies.
At present, about 72 to 96 million people in India are expected to be affected by some form of rare disease.
Under the new national guidelines, germ-line gene therapy remains prohibited in India. The concept of germ-line gene therapy involves introduction of gene modified cells at the embryo stage.
Somatic cell gene therapy is the only acceptable approach under the policy as it affects targeted cells or organs in the patient and is not passed on to subsequent generations.
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Mushrooming of genomics labs
“At this point, any hole in the wall can call itself a genetics lab in this country,” said Vijay Chandru, director at Strand Life Sciences, a Bengaluru-based genomics lab.
“Patients are going to these labs and getting reports that are completely meaningless. We need to get on with the implementation of regulations to protect interests of patients,” Chandru said.
He added that there is a huge global market for gene therapies, and biologists in our country have the capacity to address it.
S.R. Rao, former senior advisor to DBT, Ministry of Science and Technology, said while the science of gene therapy has gone very far, the legislation governing it has not been keeping up.
“The cost of gene-editing tools have gone down, leading to mushrooming of clinics and startups. There are several unregulated clinics offering stem cell therapies in India,” Rao added.
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