Question : Over Use of Antibiotics

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a) whether India is the world’s largest consumer of antibiotics and if so, the details thereof;

(b) whether use of antibiotics has doubled between 2000 and 2015 as against global antibiotic increased of 65 per cent;

(c) if so, the details and the reasons for the same;

(d) whether US Food and Drug Administration (FDA) has warned against the fluoroquinolone class of antibiotics which cause serious health problems and if so, the details thereof;

(e) whether the said antibiotic is widely used in the country in various generic versions of the drugs; and

(f) if so, the details and the reasons for the same along with the corrective measures taken/being taken by the Government in this regard?

ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(SMT. ANUPRIYA PATEL)
(a) to (c): As per information with the Drug Controller General of India, the leading High Income Country (HIC) consumers of antibiotics in 2015 were the U.S.A, France and Italy, while the leading Low and Middle Income Country (LMIC) consumers were India, China and Pakistan. Between 2000 and 2015, antibiotic consumption increased from 3.2 to 6.5 billion Defined Daily Doses (DDDs) (103%) in India, from 2.3 to 4.2 billion DDDs (79%) in China and from 0.8 to 1.3 billion DDDs (65%) in Pakistan. The increased availability and affordability of antibiotics and healthcare services in the country is considered as the reason for its increased use.



(d): Yes. As per the U.S Food and Drug Administration news release dated 10-07-2018, the Administration requires safety labeling changes for fluoroquinolone class of antibiotics to strengthen the warning about the risks of mental health side effects and serious blood sugar disturbances, including hypoglycemic coma and make these warnings more consistent across the labeling for all fluoroquinolones taken by mouth or given by injection.

(e) & (f): Various Fluoroquinolones such as Ciprofloxacin, Norfloxacin, Ofloxacin, Levofloxacin, Moxifloxacin, etc. are available in the country. In view of the action of USFDA on labeling changes of Fluoroquinolones, the Drug Controller General of India is examining the issue in consultation with subject expert committee of the Central Drugs Standard Control Organization (CDSCO).