Lok Sabha Question No. 3371 (UNSTARRED), answered on 2022-08-05
Subject: Regulation on Use of Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Vishnu Dutt Sharma

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

## LOK SABHA UNSTARRED QUESTION NO. 3371 TO BE ANSWERED ON 05 th  AUGUST, 2022

## REGULATION ON USE OF DRUGS

## 3371: SHRI VISHNU DATT SHARMA:

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

- (a) the achievements in fulfilment of aims and targets set in 'National action plan of the year 2017' of the Government to regulate the use of drugs;
- (b) whether the Government  has any data on the compliance of schedule H1  by pharmacies/drug retailers in the country;
- (c) if so, the details thereof; and
- (d) if not, the reasons therefor?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

- (a)  to  (d):  Central  Drugs  Standard  Control  Organisation  (CDSCO)  has  informed  that  they have taken various regulatory steps in this regard as under:
1. Antibiotics are included in Schedule H1 of the Drugs and Cosmetics Rules, 1945 and are required  to  be  sold  by  retail  only  under  the  prescription  of  a  Registered  Medical Practitioner. Further in order to regulate the human consumption of antibiotics and further restrict  their  retail  sale  without  prescription,  the  Drug  &  Cosmetics  Rules,  1945  have since  been  amended  vide  Notification  dated  30.08.2013  incorporating  a  new,  namely, Schedule H1 under the Drugs & Cosmetics Rules containing antibiotics, anti TB drugs and certain habit forming drugs. The drugs falling under Schedule H1 are required to be sold in the country with the following conditions:
- a) The  supply  of  a  drug  specified  in  Schedule  H1  shall  be  recorded  in  a  separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection.
- b) The drug specified in Schedule H1, be labeled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label, and shall also be labeled with the following words in legible black coloured font size in completely red rectangular box:

## SCHEDULE H1 PRESCRIPTION DRUG-CAUTION

-It  is  dangerous  to  take  this  preparation  except  in  accordance  with  the  medical advice.

-Not  to  be  sold  by  retail  without  the  prescription  of  a  Registered  Medical Practitioner.

2. The  Drugs  and  Cosmetics  Rules  were  amended  by  the  Ministry  of  Health  and  Family Welfare,  to  make  a  provision  that  the  container  of  a  medicine  for  treatment  of  food producing animals shall be labelled with the withdrawal period of the drug for the species on which it is intended to be used.
3. The Department of Animal Husbandry, Dairying and Fisheries has issued a circular to Directors/Commissioners (Animal Husbandry) of all State and UTs on 03.06.2014 and directed  judicious  use  of  antibiotics  and  hormones  for  the  treatment  of  ailing  food producing animals and that the use of antibiotics and hormones in animal feed should also be stopped. Subsequently DCG (I) has also issued an advisory to States/UTs that use of Antibiotics and Hormones in animal feed should also be stopped.
4. Colistin and its formulations have been prohibited for manufacture, sale and distribution for food producing animals, poultry, aqua farming and animal feed supplements.
5. The  State  Drugs  Controllers/other  stake  holders  have  been  sensitized  about  concerns regarding sale of prescription drugs by retail without prescription of Registered Medical Practitioners. Various Notices/Advisories/Letters have been issued to State  Drugs Controllers and other stake holders for strict compliance of the requirements of Drugs and Cosmetics Act and Rules.
6. In  58 th DCC meeting  deliberations  were  made  regarding  strong  implementation  of  the provisions of the Drug & Cosmetics Act, 1940 and Rules to ensure quality, safety and efficacy of drugs including antibiotics sold in the country and also to ensure that no drugs in Schedule H & H1 are sold by retail without prescription of RMP.
7. Sales and distribution of drugs are regulated under Drugs and Cosmetics Act 1940 & Rules by the State Licensing Authorities (SLAs) appointed by the State Governments. The SLAs are empowered to take action in case of any non-compliance.
8. National  action  plan  on  containment  of  Antimicrobial  Resistance  (NAP-AMR)  was launched  on  19 th April  2017  and  is  implemented  by  various  stakeholder  ministries  and departments. National AMR surveillance network of state medical college labs (NARS-Net) has  been  established  to  generate  quality  data  on  AMR  for  priority  bacterial  pathogens  of public health importance.

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