Lok Sabha Question No. 2951 (UNSTARRED), answered on 2018-08-03
Subject: Restructuring of National List of Essential Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Tejpratap Singh,Yadav, K. ASHOK KUMAR, ANJU BALA

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

## LOK SABHA UNSTARRED QUESTION NO. 2951 TO BE ANSWERED ON 3 rd AUGUST, 2018

## RESTRUCTURING OF NAT IONAL LIST OF ESSENTIAL MEDICINES

## 2951. SHRI TEJ PRATAP SINGH YADAV: SHRI K. ASHOK KUMAR: SHRIMATI ANJU BALA:

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

(a)  whether  the  Government  has decided  to  restructure  National  List  of Essential  Medicines (NLEM) which may include medical devices, disposables and consumables and if so, the details thereof;

(b) the perceived benefit therefrom;

(c) whether many unapproved drugs continue to be available in the market and if so, the details thereof and Government's reaction thereto including the meas urestaken to monitor compliance and enforce law regarding the same; and

(d) whether the Ministry has proposed changes to the Drugs and Cosmetics Rule 1945, requiring pharma companies to disclose information about their operation, products etc. and if so, the details thereof ?

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

## (SHRI ASHWINI KUMAR CHOUBEY)

(a) & (b): Ministry of Health & Family Welfare vide order dated 03.07.2018 has constitut Standing National Committee on Medicines (SNCM) to review and revise the National List of Essential Medicines (NLEM). Amongst other things, the committee will also suggest inclus of Medical Devices, Medical Disposables, Medical Consumables and other products used f Health  &  Hygiene of  general  public  in  NLEM. A  robust  and  dynamic  NLEM  will  aid  the Government's efforts in addressing the healthcare needs of the people.

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

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

However, with respect to the said 344 FDCs, several writ petitions were filed in di 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  India challenged the said order of Delhi High Court before the Supreme Court by way of filing S Leave Petitions (SLPs). Further, about 20 cases against 5 FDCs prohibited on 08.06.2017 w were pending bef ore various High Courts across the country, were also transferred to Supr Court. Hon'ble Supreme Court vide its order dated  15.12.2017 directed that an analysis be made in greater depth and these cases of  (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, DTAB has examined these FDCs.

(d): The  Government  has  published  draft  Rules  vide  Gazette  notification  No.  629(E dated11.07 .2018 inviting  public/stakeholders'  comments  to  amend  the  Drugs  &  Cosmetics Rules,  1945  providing  that  the  licensed  manufacturers  of  drugs  shall  register  with  SU portal of Central Drugs Standard Control Oganisation (CDSCO) and upload information as p the format provided in the portal pertaining to the licenses granted for manufacture fo distribution of drugs which shall be updated from time to time.