India’s m-RNA vaccine

India’s very own m-RNA (messenger-RNA) vaccine could be ready by March 2021.

Pune-based Gennova Biopharmaceutical’s novel m-RNA vaccine candidate was approved for funding in July, 2020 by the Department of Biotechnology (DBT).
Being a biological product that requires genetic manipulation, it needs to be cleared by the Review Committee on Genetic Manipulation (RCGM), a DBT body, before it can approach the Drug Controller General of India (DCGI) for human trials.

An m-RNA or simply “RNA vaccine” uses the genetic sequence of a portion of the virus that can be injected into the body.
Once taken in by the body’s cells, the hope is that it makes an antigen to which the immunity machinery can manufacture antibodies. In this way, the adverse reactions that can result from the traditional approach of introducing an actual virus, or a piece of it, can be avoided.
Another advantage of m-RNA vaccines is that they can be made in large quantities quicker than traditional vaccines as they don’t need to be cultured in chicken or mammalian cells.

A challenge, for M-RNA vaccines require extremely cold temperatures (less than minus 50 degrees C) that make them challenging to distribute in most of the world.
India has issues with continuous power supply in many parts of the country

Additional Details

The Department of Biotechnology (DBT) is an Indian government department, under the Ministry of Science and Technology responsible for administrating development and commercialisation in the field of modern biology and biotechnology in India. It was set up in 1986

Drugs Controller General of India (DCGI) is a department of the Central Drugs Standard Control Organization of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.
Drugs Controller General of India, comes under the Ministry of Health & Family Welfare.
DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.
DCGI lays down the standard and quality of manufacturing, selling, import and distribution of drugs in India.
- Acting as appellate authority in case of any dispute regarding the quality of drugs.
- Preparation and maintenance of national reference standard.
- To bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
- Training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions
- Analysis of Cosmetics received as survey samples from CDSCO (central drug standard control organisation)

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