Lok Sabha Question No. 404 (UNSTARRED), answered on 2019-02-05
Subject: Generic Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: UDAY PRATAP SINGH

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

LOK SABHA UNSTARRED QUESTION No. 404 TO BE ANSWERED ON THE 05 th  February, 2019

## Generic Medicines

## †404. SHRI UDAY PRATAP SINGH:

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

- (a)  whether  the  Government  has  taken  any  steps  for  using/promoting  indigenously manufactured  drugs  and  medicines  during  the  last  three  years  and  if  so,  the  details thereof;
- (b)  whether  the  Government  has  any  plan/proposes  to  work  out  any  plan  for  making generic medicines accessible in the country;
- (c) if so, the details thereof;
- (d)  whether the Government has identified such places where huge shortage of generic medicines persists; and
- (e) if so, the details thereof?

## 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):  Following  steps  have  been  taken  by  the  Government  to  promote  the  use  of domestically manufactured drugs and medicines:
- (i) National  Pharmaceuticals  Pricing  Policy,  2012  (NPPP-2012)  was  notified  with  the objective to put in place a regulatory framework for pricing of drugs so as to ensure availability of required medicines - 'essential medicines' at reasonable prices even while  providing  sufficient  opportunity  for  innovation  and  competition  to  support  the growth  of  pharma  industry  thereby  meeting  the  goals  of  employment  and  shared economic well-being for all.
- (ii) In  order  to  promote and  to  make available quality  generic  medicines  at  affordable prices  to  all  through  specific  outlets,  a  scheme  in  the  name  of  'Pradhan  Mantri Bhartiya Janaushadhi Pariyojana' (PMBJP) is functioning across the country.
- (iii) In order to promote domestically manufactured drugs, the Government is providing financial  support  for  research  and  development  through  Drugs  &  Pharmaceuticals Research Programme (DPRP) run by the Department of Science & Technology. The companies undertaking Research & Development activities are provided income tax benefits.
- (iv) The Drugs (Prices Control) Order, 2013, Para-32(iii) provides exemptions from price control  to  a  manufacturer  producing  a  new  drug  involving  a  new  delivery  system developed through indigenous Research and Development for a period of five years from the date of its market approval in India.
- (v) The  government  vide  its  notification  dated  28 th January,  2016  has  withdrawn exemption of customs duty on certain categories on Bulk Drugs/APIs to provide level playing field to the domestic manufacturers.
- (b)  &  (c):  In  order  to  make  generic  medicines  more  accessible,  the  Department  of Pharmaceuticals has requested all the States/Union Territories to explore and enforce the proposal of keeping a separate shelf/rack for generic medicines in every pharmacy in the country. Further, Government is successfully operating a scheme in the name of 'Pradhan Mantri Bhartiya Janaushadhi Pariyojana' (PMBJP) for providing quality, unbranded generic medicines at affordable prices in the country. Under this Scheme dedicated outlets known as Pradhan Mantri Bhartiya Janaushadhi Kendra (PMBJK) are opened to provide generic medicines. As on 29.01.2019, 4,964 Pradhan Mantri Bhartiya Janaushadhi Kendras have been opened, across the country.
- (d): No, Madam.
- (e): In view of reply to (d) above, the question does not arise.

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