Lok Sabha Question No. 1789 (UNSTARRED), answered on 2018-03-06
Subject: Sale of Unapproved Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: MAUSAM NOOR

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

## LOK SABHA

## UNSTARRED QUESTION No. 1789

## TO BE ANSWERED ON THE 6 th  March, 2018

## Sale of Unapproved Drugs

1789. SHRIMATI MAUSAM NOOR:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether the Government is aware of a study published in British Journal of Clinical Pharmacology stating that out of 118 different formulations of fixed dose combinations being  sold  in  India  between  2007  and  2012,  over  64%  were  not  approved  by  the Central Drugs Standard Control Organisation;
- (b)  if  so,  whether  the  Government  has  conducted  a  preliminary  enquiry  into  the matter;
- (c)  if  so,  the  details  thereof  along  with  the  steps  taken  to  address  such  anomalies through policy intervention and if not, the reasons therefor;
- (d)  whether  the  Government  is  also  seized  of  the  report  that  the  rampant  sale  of unapproved antibiotics is triggering antimicrobial resistance in the country and puts its healthcare priorities at risk; and
- (e) if so, the details of the action taken thereon?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS;  MINISTRY  OF  SHIPPING  AND  MINISTRY  OF  CHEMICALS  AND FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

- (a): Yes, Madam. A study was published in British Journal of Clinical Pharmacology dated 04.02.2018 regarding Centrally approved and unapproved antibiotic formulations sold in India.
- (b) to (e): As per Rule 122E of Drugs & Cosmetics Rules 1945, the combination of two or more drugs i.e. Fixed Dose Combination (FDC) combined for the first time fall  under  the  definition  of  New  Drug  and  therefore  permission  from  the  office  of Drugs Controller General of India (DCGI) is required before these are licensed by State Licensing Authorities (SLAs) for manufacture for sale in the country. However it  was  observed  that  SLAs  were  granting  licenses  of  such  unapproved  FDCs including antibiotic combinations without due approval from DCG(I).

Further,  as  per  the  Action  Taken  report  (ATR)  on  the  Parliamentary  Standing Committee report, DCGI vide letter dated 15.01.2013 had requested all state/UT Drugs Controllers to ask the concerned manufacturers in their State to prove the safety and efficacy of such FDCs as mentioned above before the office of DCG (I) within  a  period  of  18  months,  failing  which  such  FDCs  would  be  considered  for being  prohibited  for  manufacture  and  marketing  in  the  country.  To  examine  the applications received in response to the direction of the DCG (I), Ministry of Health & Family Welfare vide order No. X11035/53/2014-DQC dated: 16.09.2014 constituted an Expert Committee under the Chairmanship of Prof. C. K. Kokate for examining the safety and efficacy of these FDCs.

Based on the recommendations of the Prof. C. K. Kokate Expert  Committee, the Central  Government  prohibited  344  FDCs  vide  notification  dated  10.03.2016. Further the Central Government has also prohibited 5 FDCs vide notification dated 08.06.2017.  Out  of  these  349  (344+5)  FDCs  prohibited,  there  were  46  FDCs  of antibiotics (44 FDCs  prohibited on 10.03.2016  and  02  FDCs  prohibited on 08.06.2017). Prior to this, the Central Government had also prohibited 5 antibiotic FDCs.

However,  with  respect  to  above  said  344  FDCs  which  includes  44  FDCs  of antibiotics, various stakeholders filed writ petitions in different High Courts across the country and the said  notification was quashed by Hon'ble High Court of Delhi vide its order dated 01.12.2016. Subsequently, the Union of India had challenged the  order  of  Delhi  High  Court  before  the  Supreme  Court  by  way  of  SLP.  Further about  20  cases  including  5  FDCs  prohibited  on  08.06.2017  which  were  pending before  various  High  Courts  across  the  country  were  also  transferred  to  Hon'ble Supreme Court.

Hon'ble  Supreme  Court  vide  its  order  15.12.2017  has  directed  that  to  have  an analysis  made  in  greater  depth,  these  cases  [(344+5)  FDCs]  should  go  to  the Drugs  Technical  Advisory  Board  (DTAB)  and/or  a  Sub-Committee  formed  by  the DTAB for the purpose of having a relook into these cases.

With regard to the issue relating to antimicrobial resistances, it may be mentioned that  Ministry  of  Health  and  Family  Welfare  and  Central  Drugs  Standard  Control Organisation (CDSCO) has taken various regulatory measures to curb the misuse of antibiotics. Details are as under:

Antibiotics are included in Schedule H and 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  to  restrict  the  over  the  counter  availability  of  certain antibiotics,  the  Drug  &  Cosmetics  Rules,  1945  have  since  been  amended  vide

Gazette  Notification  No  GSR  588  (E)  dated  30-08-2013  incorporating  a  new Schedule H1 under the Drugs & Cosmetics Rules containing 46 drugs which include 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  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 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 also be labeled with the following words in a box with a red border:

## 'SCHEDULE H1 DRUG-WARNING:

- -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.'

The Drugs and Cosmetics Rules were amended by the Ministry of Health and Family Welfare  vide  Gazette  notification  G.S.R.  28(E)  dated  17.01.2012,  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.

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