Drugs Controller General (India) approves clinical trials of Antibiotics on children under one year of age

In a recent press release issued by the Press Information Bureau dated 8th August, 2017, the Central Licensing Authority, i.e. Drugs Controller General (India) (“DCGI”) has given approval for conduct of various clinical trials of Antibiotics on children under one year of age.

In the last three years, the clinical trials related to Multi Drug Resistant Tuberculosis (MDRTB) and Tuberculosis Meningitis in children were approved. All the details of the clinical trials are registered in Clinical Trial Registry of India (CTRI), which is publicly available (www.ctri.nic.in).

The DCGI has informed the following in context of antibiotics:

  1. Functional infectioncontrol programmesthat are being launched by the DCGI not only help in cutting down the rates of nosocomial infections, but also help reduce the volume of antibiotic consumption and are a critical part of any comprehensive strategy to contain antimicrobial resistance (AMR). It is informed thatIndian Council of Medical Research (ICMR) has launched a programme on Antimicrobial Stewardship, Prevention of Infection and Control (ASPIC) in 2012.
  1. It is pertinent to note that Antibiotics are included in Schedule H and H1 to the Drugs & Cosmetics Rules, 1945, and, therefore, cannot be sold in retail except on and in accordance with the prescription of a Registered Medical Practitioner. Therefore, the Government has also launched a red line campaign to regulate over the counter sale of Schedule H antibiotics.
  1. The red line campaign is aimed at discouraging unnecessaryprescription andover-the-counter sale of antibiotics causing drug resistance for several critical diseases including TB, malaria, urinary tract infection and even HIV.

Source: Press Information Bureau

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