Government Lens on Hepatitis, Waives off Clinical Trial for 3 Drugs

Of the drugs, the manufacture of Sofosbuvir that is used in the treatment of chronic Hepatitis C in adults has already been kickstarted

Published: 30th December 2015 03:30 AM  |   Last Updated: 30th December 2015 05:39 AM   |  A+A-

NEW DELHI: Faced with a rising number of viral Hepatitis cases, the Centre has formed a national programme for the surveillance of the disease and has given approval for the manufacture of three antiviral drugs without clinical trials.

The National Centre for Disease Control (NCDC), Delhi, has been identified for coordinating the various activities under the programme on surveillance of viral Hepatitis, a senior Ministry of Health official told Express.

The NCDC, which falls under the purview of the Ministry of Health and Family Welfare, provides technical guidance to state governments on the prevention and control of water-borne diseases, including Hepatitis, and helps them in carrying out investigation of outbreaks of such diseases under the Integrated Disease Surveillance Programme.

The Ministry has also approved three antiviral Hepatitis drugs this year, waiving of local clinical trial for import, manufacturing and marketing in the country.

Out of the three, the manufacture of Sofosbuvir, which is used in the treatment of chronic Hepatitis C in adults has already been launched.  “The antiviral drugs have been approved for import,  manufacturing and marketing in the country subject to certain conditions.  One of the conditions is that the applicant shall conduct a time-bound Post Marketing Trial as per the protocol,” the official said.

Explaining further, the official said vaccination for Hepatitis B is already included under the Universal Immunisation Programme of the government and auto-disabled syringes are being used for all vaccinations.

AD syringes are single use, self-locking syringes that cannot be used more than once.

This prevents misuse and contamination  or cross-infection through repeated use of unsterile injection or equipment.

Blood banks also mandatorily screen for Hepatitis B and C as per Drug and Cosmetics Act 1940 as testing of blood reduces the risk of transmission of Hepatitis B and C by blood transfusion.


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