Lok Sabha Question No. 2667 (UNSTARRED), answered on 2016-05-10
Subject: Ban on FDCs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: PRABHAS KUMAR SINGH

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS

## DEPARTMENT OF PHARMACEUTICALS

## LOK SABHA

## UNSTARRED QUESTION No. 2667

## TO BE ANSWERED ON THE 10 th  May, 2016

## Ban on FDCs

## 2667. DR. PRABHAS KUMAR SINGH:

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

- (a) whether  the  Central  Drugs  Standard  Control  Organisations  has issued a notification prohibiting the manufacture, sale and distribution of Fixed Dose Combinations of drugs (FDCs), if so, the details thereof;
- (b) whether  the  Government  has  taken  cognizance  of  FDCs  entering the Indian market illegally, if so, the details thereof and the action taken, if any thereon, if not, the reasons therefor; and
- (c) whether  the  Government  has  undertaken  measures  to  strengthen the legal and regulatory framework on pharmaceutical regulation, if so, the details thereof, if not, the reasons therefor?

## ANSWER

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

(a): 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

Cont…

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.

(b) & (c): 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. The Drugs & Cosmetics Act  which  regulates  the  sale  of  medicines  in  the  Country  contains  enough safeguards.

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