Lok Sabha Question No. 1475 (UNSTARRED), answered on 2016-05-03
Subject: Ban on Manufacturing of Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: VEENA DEVI

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

## LOK SABHA

## UNSTARRED QUESTION No. 1475

## TO BE ANSWERED ON THE 3 rd  May, 2016

## Ban on Manufacturing of Drugs

## 1475. SHRIMATI VEENA DEVI:

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

- (a) whether the Government has banned the manufacturing, sale and use  of  approximately  350  drugs  in  the  country  on  the  basis  of  a study conducted by an expert committee;
- (b) if so, the details thereof and the reasons therefor;
- (c) whether  the  ban  imposed  by  the  Government  has  been  enforced country-wide; and
- (d) if not, the reasons therefor?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI HANSRAJ GANGARAM AHIR)

- (a): Yes, Madam.
- (b): The Central Government appointed an Expert Committee to examine the matter of safety and efficacy of those Fixed Dose Combinations (FDCs) which have been granted license for manufacture without the permission of Drugs Controller General (India) (DCG(I)). The Committee was also assisted by  eminent  experts  in  different  therapeutic  areas  from  premier  Medical Institutions and hospitals. The Expert Committee, after detailed examination and deliberations categorized these FDCs into four categories. One of these category    is  of  those  FDCs  which  have  been  declared  as  irrational  by  the Committee on account of their lack of therapeutic justification; pharmacokinetically or pharmacodynamically incompatiblity; abuse potential:  or  possibility  of  leading  to  antibiotic  resistance  in  the  population

etc. The Expert Committee carried out a comprehensive review of the FDCs keeping in view the contemporary Scientific knowledge and expertise and on the basis of the recommendations of the Expert Committee, the Government examined  the  matter  further  and  requested  the  Committee  to  provide specific  reasons  in  respect  of  each  FDC  that  was  found  irrational.  The Committee,  accordingly reviewed the matter further  and finalized its recommendations. After careful consideration of the matter, the Government issued show cause notices to the manufacturers whose products were found to be irrational and submitted applications to CDSCO. At the request of the manufacturers,  additional  time  of  three  months  was  given  to  them  to respond to the show cause notice. Thereafter, after due consideration of the report  and  replies,  the  Government  vide  Gazette  Notifications  S.O.  Nos. 705(E)  to  1048(E)  dated  10.03.2016  prohibited  the  manufacture  for  sale, sale  and  distribution  for  human  use  of  344  FDCs  with  immediate  effect  in public interest as these FDCs were likely to involve risk to human beings and safer alternatives were available to these drugs. (c) & (d): Subsequent  to  the  prohibition  of  344  FDCs  by  the  Central Government,  many  pharmaceuticals  companies  have  filed  various  writ petitions in various courts. The matter is sub-judice.

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