Lok Sabha Question No. 5979 (UNSTARRED), answered on 2018-04-03
Subject: New Drug Policy
Ministry: CHEMICALS AND FERTILIZERS
Asked by: GOPAL CHINAYYA SHETTY, KOTHA PRABHAKAR REDDY, KANWAR SINGH TANWAR

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

LOK SABHA UNSTARRED QUESTION No. 5979

TO BE ANSWERED ON THE 3 rd  April, 2018

## New Drug Policy

†5979. SHRI GOPAL SHETTY: SHRI PRABHAKAR REDDY KOTHA: SHRI KANWAR SINGH TANWAR:

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

- (a)  whether  the  Government  proposes  to  formulate  a  new  drug  policy  to  provide  life saving drugs at affordable prices;
- (b) if so, the details thereof along with the time by which the said policy is likely to be made effective;
- (c) whether the Government has received the report of the task force constituted under the  Chairmanship  of  Dr.  Pronab  Sen  on  Drug  Pricing  Control  and  if  so,  the  details thereof; and
- (d) the details of recommendation made by the task force on Drug Pricing Control and the action taken by the Government thereon?

## 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) & (b): At  present  there  is  no  concrete  proposal  of  a  new  drug  policy  at Governmental level. A discussion draft eliciting the basic contents that should go into  a  draft  pharmaceutical  policy  was  discussed  amongst  some  stakeholders which included:
-  Making essential drugs accessible at affordable prices to the common masses;
-  Providing a longer term stable policy environment for the Pharmaceutical sector;
-  Making India sufficiently self-reliant in end to end indigenous drug manufacturing;
-  Ensuring world class quality of drugs for domestic consumption & exports;
-  Creating an environment for R&D to produce innovator drugs;
-  Ensuring growth and development of the Indian Pharma Industry.

It was a preliminary discussion and no timeline has been fixed in this regard.

(c): In November, 2004 the Government set up a Task Force under the Chairmanship of Dr.  Pronab  Sen,  Principal  Advisor,  erstwhile  Planning  Commission,  to  look  into  the issue  of  price  control,  option  other  than  price  control  and  other  issues  and  to  make recommendations for making available life saving drugs.  The Pronab Sen Committee submitted its recommendation in September, 2005.

- (d): The Task Force had recommended that the price regulation should  be  on  the basis of essentiality of the drugs and it should be applied only for formulations and not to  upstream  products  such  as  bulk  drugs.    The  Department  of  Pharmaceuticals prepared a draft National Pharmaceutical Pricing Policy, 2011 (NPPP-2011) based on the criteria of essentiality on which comments were received from various stakeholders and  the  same  was  placed  before  the  Group  of  Ministers  (GoM).    Based  on  the recommendations  of  the  GoM,  National  Pharmaceuticals  Pricing  Policy-2012(NPPP2012) was formulated for controlling and regulating the prices of medicines of specified dosages and strengths as under National List of Essential Medicines-2011.  NPPP-2012 was  placed  before  the  Cabinet  and  after  its  approval  by  the  Cabinet  on  22.11.2012, NPPP-2012  was  notified  on  07.12.2012.  Subsequently,  the  Drugs  (Prices  Control) Order, 2013 (DPCO, 2013) was also notified.

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