New Delhi, 21 March 2016
“MSF welcomes the Indian Ministry of Health’s 10th March notification on the prohibition of manufacture, sale and distribution of certain Fixed Dose Combination (FDCs) drugs that put public health and lives of people at risk. The list of banned drugs includes several FDCs containing multiple antibiotics that have long been used injudiciously, contributing to the development of resistant strains of infection-causing bacteria.
Irrational FDCs containing important anti TB drugs such as quinolones (ofloxacin and levofloxacin) and linezolid are rampantly available in the Indian private market, which has resulted in worsening prevalence of drug-resistant tuberculosis (DR-TB) in India.
This year, India has a double challenge: to phase out irrational antibiotic FDCs in the private sector that are contributing to resistance generation, and to phase in the WHO-recommended daily FDC regimen for drug-sensitive TB (DS-TB) to the national TB program, which has been shown to increase adherence and reduce pill burden.
Ahead of World TB Day, we appeal to the Indian government to continue its efforts to address the growing DR-TB epidemic in the country”.
Dr Grania Brigden, TB and AMR Advisor, Access Campaign, Medecins Sans Frontieres
FDCs, when quality-assured and with dosages recommended in accordance with World Health Organisation’s treatment guidelines, are important tools to provide effective treatment. In case of HIV, TB and malaria, FDCs have been proven to boost treatment adherence by reducing pill burden and simplifying treatment in resource-poor areas. Such FDCs are recommended for use by the HIV, TB and malaria control programs in the country.
Several research studies, a parliamentary report and expert committees that examined FDCs in the Indian market point to the proliferation of antibiotic/antimicrobial FDCs which have not been recommended in any standard treatment guidelines, but continue to be heavily marketed and prescribed in the country.
Gazette notification issued on 10th March 2016 under Section 26A of the Drugs and Cosmetics Act, 1940