Lok Sabha Question No. 5795 (UNSTARRED), answered on 2018-04-03
Subject: Unregulated Antibiotics
Ministry: CHEMICALS AND FERTILIZERS
Asked by: BALASUBRAMANIAM SENGUTTUVAN

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

LOK SABHA UNSTARRED QUESTION No. 5795 TO BE ANSWERED ON THE 3 rd  April, 2018

## Unregulated Antibiotics

5795. SHRI B. SENGUTTUVAN:

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

- (a) whether the Government is aware of the fact that MNCs continue to produce and sell unregulated antibiotics which result in the problem of antimicrobial resistance and if so, the details thereof;
- (b)  whether out of  the  118  Fixed  Dose  Combination Antibiotics sold  in  India between 2007 and 2012, 64 per cent were not approved by the Central Drugs Standard Control Organisation (CDSCO) and if so, the details thereof;
- (c)  whether  the  country  has  one  of  the  highest  rate  of  antibiotic  consumption  and antimicrobial resistance and if so, the details thereof; and
- (d) the proactive steps likely to be taken by the Government to curb the production and sale of antibiotics not approved by the CDSCO?

## 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), (b) & (d): 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  Drug Controller  General  of  India  (DCG(I))  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  unapproved  FDCs  including  antibiotic combinations without due approval from DCG(I).

DCG(I) 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 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 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).

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.

Accordingly,  in  the  78 th meeting  of  DTAB  held  on  12.02.2018,  a  sub-committee  is constituted to examine the banned FDCs.

The  Central  Government  had  also  prohibited  5  antibiotic  FDCs  during  from  1983  to 2001, which are still under prohibition.

Further,  Ministry  of  Health  and  Family  welfare  and  CDSCO  have  taken  various regulatory measures to curb the misuse of antibiotics. Details are as under:-

- (i) 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.
- (ii) 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.
- (c): No such data regarding rate of antibiotic consumption and antimicrobial resistance is maintained by the Department.

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