Indian Immunologicals Ltd. has launched the country's first indigenously developed Hepatitis A vaccine named 'Havisure'. This information was given by Indian Immunologicals (II) itself on January 19, 2024.

Indian Immunologicals Ltd. is a wholly-owned subsidiary of the National Dairy Development Board (NDDB).
Vaccine HeaviSure represents an important step in the country's fight against hepatitis A.
The Havisure vaccine is at par with the world's leading vaccines sold by multinational companies.

Dosage of Havisure:

Havisure is a two-dose vaccine. The first dose is given at the age above 12 months. Whereas the second dose is given at least 6 months after the first dose.

About Hepatitis A:

Hepatitis A is a viral infection. HAV is spread mainly through the fecal-oral route, which means it is spread through the consumption of contaminated food or water.
Hepatitis A is a liver inflammation that can cause mild to severe symptoms.

What Havisure works for:

The Hyderabad-based company's vaccine approved by the Drug Controller General of India (DCGI) is effective in preventing the disease. It is recommended for children in routine vaccination.
The vaccine is also recommended for individuals who are at risk or traveling to areas with high Hepatitis A prevalence.
In addition, people with occupational exposure to infection and those with chronic liver diseases also need hepatitis A vaccination.
Currently vaccines for Hepatitis A are imported into our country.
IIL Managing Director K. Anand Kumar said the vaccine has undergone extensive clinical trials in eight centers. It has been proven to be safe and effective and is equivalent to the world's leading vaccine by GSKPro.

Process and institutions of drug approval in the country:

The Central Drug Standards Control Organization (CDSCO) is the national regulatory authority of India.
CDSCO oversees the import, manufacturing, approval, and clinical trials of new drugs in accordance with the Drugs and Cosmetics Act, 1940.
DCGI is a regulatory agency under CDSCO which grants licenses for specific categories of drugs in India. Besides, standards are set for manufacturing, selling etc. of medicines.
Additionally, it administers the sale and distribution of drugs in collaboration with state drug regulatory authorities.