Lok Sabha Question No. 161 (UNSTARRED), answered on 2017-12-15
Subject: Anti-Microbial Resistance
Ministry: HEALTH AND FAMILY WELFARE
Asked by: SANTOSH AHLAWAT, SUMEDHANAND SARASWATI, RANGASWAMY DHRUVANARAYANA, NALIN KUMAR KATEEL, DODDAALAHALLI KEMPEGOWDA SURESH

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

## LOK SABHA UNSTARRED QUESTION NO. 161 TO BE ANSWERED ON   15 TH DECEMBER, 2017

## ANTI - MICROBIAL RESISTANCE

## 161. SHRIMATI SANTOSH AHLAWAT:

SHRI SUMEDHANAND SARSWATI:

SHRI R. DHRUVA NARAYANA:

SHRI NALIN KUMAR KATEEL:

SHRI D.K. SURESH:

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

- (a) whether the Government proposes to roll out prescription audits as part of a multi - pronged strategy against antimicrobial resistance or antibiotic resistance;
- (b) if so, the details thereof;
- (c)  whether  the  Government  also proposes  to  ban  OTC  sale  of  antibiotics,  if so,  the  details thereof;
- (d) whether the Government plans to direct all the hospitals and pharmacists to upload all the prescriptions issued and received by them for evaluation by central agency; and
- (e)  if  so,  the  details  of  existing mandatory  protocols  and  guidelines  for hospitals  and pharmacists?

## ANSWER THE MINISTER OF STATE IN THE MI NISTRY OF HEALTH AND FAMILY WELFARE (SMT. ANUPRIYA PATEL)

- (a) & (b): Ministry of Health and Family Welfare has developed strategic National Action Plan  on  antimicrobial  resistance  containment  in  consultation  with  all  relevant  stake Optimizing  the  use  of  antimicrobials  is  one  of  the  key  strategies  in  this  plan  i prescription auditing.
- (c): Import/manufacture, sale, distribution of drugs including antibiotics are regulated the provisions of Drugs & Cosmetics Act and Rules. Antibiotics are included in Schedule H & H1 ofthe Drugs & Cosmetics Rules, 1945 and are required to be sold by retail onl y under the prescription of a Registered Medical Practitioner.

The  Drug  &  Cosmetics  Rules,  1945  have  since  been  amended in  the  year  2013 incorporating a new, namely, Schedule H1 under the Drugs & Cosmetics Rules, 1945 containi 46 drugs which incl ude antibiotic drugs, Anti - TB  drugs  and  certain habit forming drugs. The drugs  falling  under  Schedule  H1  are  required  to  be  sold  in  the  country  with  the  fol conditions:

1. The supply of a drug specified in Schedule H1 shall be recorded in a separate re gister at the time of the supply giving the name and address of the prescriber, the name o patient,  the  name  of  the  drug  and  the  quantity  supplied  and  such  records  shal maintained for three years and be open for inspection.
2. The drug specified in Schedule H1 shall be labeled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label, and shall labeled  with  the  following  words  in  a  box  with  a  red  border -'Schedule  H1  Drug -Warning:
3. -It is dangerou s to take this preparation except in accordance with the medical advice.
4. -Not to be sold by retail without the prescription of a Registered Medical Practitioner.'
5. (d) : No.
6. (e) : Does not arise.