Lok Sabha Question No. 319 (UNSTARRED), answered on 2016-07-19
Subject: Mechanism for Regulating Essential Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: RABINDRA KUMAR JENA, HEENA VIJAYKUMAR GAVIT, VIJAYSINH MOHITE PATIL, PRATHAP SIMHA, T. RADHAKRISHNAN

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

## LOK SABHA

## UNSTARRED QUESTION No. 319

## TO BE ANSWERED ON THE 19 TH  July, 2016

## Mechanism for Regulating Essential Drugs

319. SHRI RABINDRA KUMAR JENA:

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

- (a) whether  the  Government  has  any mechanism to check the manufacturing, sale and  use  of  approximately  350  essential 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 on illegal sale of essential drugs has been enforced country-wise; and
- (d) if not, the reasons therefor?

## ANSWER

MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY OF SHIPPING AND MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

- (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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