Lok Sabha Question No. 386 (STARRED), answered on 2019-07-19
Subject: Consumption of Antibiotics
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Kirit Premjibhai Solanki

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA STARRED QUESTION NO. 386 TO BE ANSWERED ON THE 19 TH JULY , 2019 CONSUMPTION OF ANTIB IOTICS

## *386. DR. (PROF.) KIRIT PREMJIBHAI SOLANKI:

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

- (a) whether India is one of the largest consumers of antibiotics in the wor the details thereof and the reasons therefor;
- (b) whether there has been an increase in the resista nce to antibiotics during the past three years and if so, the details thereof;
- (c)  whether  the  Government  has  identified  the  key  factors  responsible  for rising antibiotic and antimicrobial resistance, if so, the details thereof the reasons therefor;

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- (d) whether the Government has taken measures to regulate the n consumption of antibiotics or issued any guidelines to restrict the over - the -counter availability of certain antibiotics and if so, the details thereof; and
- (e) whether the Government has made the dispensing of certain antibiotics ov counter pun ishable and if so, the details thereof?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE (DR. HARSH VARDHAN)

- (a) to ( e):  A statement is laid on the Table of the House

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 386* FOR 19 TH JULY , 2019

(a): As per a report available in public domain, the Drug Controller General of India has reported that in the year 2015, U.S.A, France and Italy were leadi Income Country (HIC) consumers of antibiotics while India, China and Pakis were the leading Low and Middle Income Country (LMIC) consumers .

(b) : Increase in the resistance to antibiotics like third generation cepha fluoroquinolones and carbapenems is observed in the AMR surveillance networ of ICMR.

(c): High  burden  of  bacterial  infections  leading  to  higher  use  of  antibi overuse and misuse of antibiotics in humans and animals; syndromic managemen of  infectious  diseases  due  to  poor  utilization  /  access  to  microbiology culture  and  antimicrobial  sensitivity  testing;  over  the  counter  availab antimicrobials; p rescribing antimicrobials for viral infections, such as, cold influenza;  use  of  antimicrobials  for  animals  and  fish  as  growth  promo inadequate  management  of  pharmaceutical  waste;  inadequate  infection  contr sanitary conditions and inappropriate food- handling are the key factors for rising antimicrobial resistance.

(d): Antibiotics are included in Schedule H of the Drugs and Cosmetics Rul 1945  and  are  required  to  be  sold  in  retail  only  under  the  prescriptio Registered Medical Practition er. To further regulate the human consumption and restrict over the counter availability of certain antibiotics, the Drugs & Rules,  1945  were  amended  in  August  2013,  incorporating  a  new  Schedule  H1 wherein 24 third/fourth generation antimicrobial s are covered. The supply of these drugs  need  to  be  recorded  in  a  separate  register  giving  name  and  addre prescriber, patient and name of drugs and quantity supplied. The records sh maintained for 3 years and be open for inspection. Schedule H1 drugs also have specific labelling requirements.

(e): Sale  and  distribution  of  drugs  are  regulated  under  the  provisions  o Drugs and Cosmetics Act, 1940 & Rules,1945 made thereunder. License for sa and distribution of drugs are granted by State Li censing Authorities appointed by respective State Government. State Licensing Authorities are empowered to action against any violations of the conditions of license including over th sale against guidelines.