Lok Sabha Question No. 2451 (UNSTARRED), answered on 2018-03-09
Subject: Anti-Microbial Resistance
Ministry: HEALTH AND FAMILY WELFARE
Asked by: KAMAL NATH

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

## LOK SABHA UNSTARRED QUESTION NO. 2451 TO BE ANSWERED ON 9 TH MARCH, 2018

## ANTI - MICROBIAL RESISTANCE

## 2451. SHRI KAMAL NATH:

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

- (a) whether multinational companies continue to produce and sell unregulated antibiotics in the country;
- (b) if so, the details thereof and whether a UK based research has revealed that antibiotics pills in the Indian market are not yet regulated;
- (c) if so, the reaction of the Government thereto;
- (d) whether the problem of antimicrobial resistance in the country is worsening day by day; and
- (e) if so, the steps taken or proposed to be taken by the Government to address the matter in an effective way?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

(a) to (c): A  study  was  published  in  British  Journal  of  Clinical  Pharmacology  date 04.02.2018  regarding Centrally  approved  and  unapproved  antibiotic  formulations  sold  in India.

As per Rule 122 E 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 defi of New Drug and therefore permission from the Drugs Controller General (India) [DCG(I)] required before these are licensed by State Licensing Authorities (SLAs) for manufactu sale in the country. However it was observed that some SLAs were grantin g licenses of such unapproved FDCs including antibiotic combinations without due approval from DCG (I).

DCG (I) vide letter dated 15.01.2013 had requested all States/UTs Drugs Controller ask the concerned manufacturers in their State to prove the safety and efficacy of such FDCs within  a  period  of  18  months,  failing  which  such  FDCs  would  be  considered  for  bei prohibited for manufacture and marketing in the country. An Expert Committee under chairmanship  of  Prof.  C.K.  Kokate  was  constitut ed  vide  this  Ministry's  Order  dated 16.09.2014 to examine such applications and also for examining the safety and effica these FDCs.

Based on the recommendations of the Prof. C. K. Kokate Expert Committee, the Centr Government  prohibited  344 FDCs  vide  notification  dated  10.03.2016.  Further  the  Central Government had also prohibited 5 FDCs vide notification dated 08.06.2017. Out of these (344+5) FDCs prohibited, 46 FDCs were antibiotics (44 FDCs prohibited on 10.03.2016 an 02 FDCs prohibit ed on 08.06.2017).

It is pertinent to mention that the Central Government had also prohibited 5 ant FDCs during the period from 1983 to 2001, which are still in force.

However, with respect to the said 344 FDCs including 44 FDCs of antibiotics, several writ petitions were filed in different High Courts across the country challenging th the FDCs. After that, the High Court of Delhi vide its order dated 01.12.2016 quashe said notification. The Union of India challenged th e said order of Delhi High Court before the Supreme  Court  by  way  of  filing  Special  Leave  Petitions  (SLPs).  Further,  about  20  c against 5 FDCs prohibited on 08.06.2017 which were pending before various High Court across the country, were also transferr ed to Supreme Court. Hon'ble Supreme Court vide its order  15.12.2017  has  directed  that  an  analysis  be  made  in  greater  depth  and  these (344+5)  FDCs  should  go  to  the  Drugs  Technical  Advisory  Board  (DTAB)  and/or  a  Sub -Committee formed by the DTAB for th e purpose of having a relook into these cases.

Thus, Government has taken measures to prohibit manufacture and marketing of vario FDCs as above, which have been found irrational.

(d) & (e): Manufacture, sale and distribution of drugs including antibiotics in the country are  regulated  under  the  provisions  of  Drugs  &  Cosmetics  Act,  1940  and  Rules,  19 thereunder through a system of licensing and inspection . Licenses for manufacture, sale and distribution  of  drugs  are  granted  by  the  State  Licensin g  Authorities  (SLAs)  appointed  by respective State Governments.

Following measures have been taken by the Ministry to curb the misuse of antibiotic s:

- Antibiotics are included in Schedule H and H1 of the Drugs and Cosmetics Rules, 19 and  are  required  t o  be  sold  by  retail  only  under  the  prescription  of  a  Registered  Medi Practitioner.
- A  new  Schedule  H1  under  the  Drugs  &  Cosmetics  Rules,  1945  containing  46  drugs which  include  antibiotic  drugs,  Anti  TB  drugs  and  certain  habit  forming  drugs  has noti fied.  The  drugs  falling  under  Schedule  H1  are  required  to  be  sold  in  the  country certain strict conditions.