Lok Sabha Question No. 4552 (UNSTARRED), answered on 2020-03-20
Subject: Banned/Unapproved Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Kani K. Navas, Balubhau (Alias Suresh Narayan) Dhanorkar

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

LOK SABHA UNSTARRED QUESTION NO. 4552 TO BE ANSWERED ON 20 TH MARCH, 2020

## BANNED/UNAPPROVED DR UGS

## 4552. SHRI K. NAVASKANI: SHRI BALUBHAU ALIAS SURESH NARAYAN DHANORKAR:

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

- (a)  whether  th e  Government  proposes  to  put  in place  a  comprehensive mechanism  to  stop manufacturing and marketing of ban ned/unapproved drugs across the country;
- (b) if so, the details thereof;
- (c)  whether  cer tain  cases  of  manufacturing  and marketing  of  ba nned/unapproved  drugs  have beenreported in the country;
- (d) if so, the details t hereof indicating the number of such cases reported duri ng each of the last three years and the current year, State/UT - wise; and
- (e) the action taken a gainst the offenders during the said period, State/UT -wise?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

(SHRI ASHWINI KUMAR CHOUBEY)

(a)to (e): The manufacture, sale and distribution of drugs in the country are regulated the  provisions  of  Drugs  &  Cosmetics  Act,  1940  and  Rules  thereunder  through  a  system licensing and inspection. Licenses for manufacture, sale and distribution of drugs are granted by the State Licensing Authorities (SLAs) appointed by respective State Governments.

Under the said Rules, for manufacture of any New Drug, permission is required fr Central Drugs Standard Control Organsiation (CDSCO) before obtaining m anufacturing license for the New Drug from the concerned State Licensing Authority.

Under  the  afore - said  Act,  manufacture/sale/distribution  of  any  banned  drug  is punishable offence. State Licensing Authorities are empowered to take action in this regard.

Some  cases  of  grant  of  manufacturing  license  of  new  drugs  including  Fixed  Dos Combinations (FDCs) falling under the purview of Rule 122E of the Drugs & Cosmetics Rule 1945  by  some  of  the  State  Licensing  Authorities  (SLAs)  without  du e  approval  of  the  Drugs Controller General (India) [DCG (I)] came to the notice of the Government.

Apart  from  issuing  repeated  statutory  directions  under  Section  33P  of  the  Drug Cosmetics  Act,  1940  to  the  State  Governments  in  this  regard,  the  Ce ntral  Government constituted an Expert Committee under the chairmanship of Prof C.K. Kokate to examine safety and efficacy of such 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  Cent Government had also prohibited 5 FDCs vide notification dated 08.06.2017.

However, with respect to the said 344 FDCs, several w rit petitions were filed in different High Courts across the country challenging the ban of the FDCs. After that, the High Co Delhi  vide  its  order  dated  01.12.2016  quashed  the  said  notification.  The  Union  of challenged the said order of Delhi H igh Court before the Supreme Court by way of filing Special Leave Petition (SLP). Further, about 20 cases against 5 FDCs prohibited on 08.06.2017 w were pending before various High Courts across the country, were also transferred to Su Court. Hon' ble Supreme Court vide its order dated 15.12.2017 directed that an analysis be in greater depth and these cases of (344+5) FDCs should go to the Drugs Technical Advi Board (DTAB) and/or a Sub - Committee formed by the DTAB for the purpose of having a relook into these cases.

Accordingly, a Sub -Committee of DTAB was constituted which after providing hearing to all the petitioners/appellants, submitted its report to DTAB which was accepted by DTAB.

Based on the recommendations of DTAB ,the Central Government vide notifications dated 07.09.2018 prohibited 328 FDCs for manufacture, sale or distribution as there was no therap justification for these FDCs and they could involve risk to human beings. The Government restricted 06 F DCs for manufacture, sale or distribution with certain conditions vide notifications issued on the same date. However, various firms/stakeholders have filed writ petitions in vari High  Courts  across  the  country  including  the  Hon'ble Supreme  Court  against  the  said notifications dated 07.09.2018.

Further,  based  on  the  recommendations  of  DTAB, the  Central  Government  vide notifications dated 11.01.2019 prohibited 80 FDCs for manufacture, sale or distribution as th was no thera peutic justification for these FDCs and they could involve risk to human bei These 80 FDCs were part of the list of 294 FDCs identified in year 2007, which were earli -judice in Hon'ble High Court of Madras.