Lok Sabha Question No. 377 (UNSTARRED), answered on 2019-11-19
Subject: Generic Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Ajay Nishad

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

LOK SABHA UNSTARRED QUESTION No. 377

TO BE ANSWERED ON THE 19 th  NOVEMBER, 2019

## Generic Medicines

## †377. SHRI AJAY NISHAD:

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

- (a)  whether  the  Government  proposes  or  has  made  it  mandatory  for  the  doctors  to prescribe only the low priced generic medicines for the patients;
- (b)  if  so,  the  steps  taken/proposed  to  be  taken  by  the  Government for monitoring the medicines prescribed by the doctors or sold by the pharmacies;
- (c)  whether the Government has taken any steps to encourage the use of indigenous manufactured medicines; and
- (d) if so, the details thereof?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI D. V. SADANANDA GOWDA)

- (a) & (b): Ministry of Health & Family Welfare vide their Circular dated 08.04.2015 has directed  all  the  specialists/  Doctors  working  in  Central  Government  Health  Scheme (CGHS) to ensure that generic drugs are prescribed to the maximum extent possible with a view to make medical treatment cost effective and affordable. Further, Clause 1.5 of  Indian  Medical  Council  (Professional  Conduct,  Etiquette  and  Ethics)  Regulations, 2002 prescribes that every physician should prescribe drugs with generic names legibly and  preferably  in  capital  letters  and  he/she  shall  ensure  that  there  is  a  rational prescription  and  use  of  drugs.  Director,  CGHS  has  vide  Office  Memorandum  dated 08.09.2017, issued instructions to all CGHS  Wellness  Centres  to ensure that prescription  is  only  by  generic  name  wherever  generic  drugs  are  available.  Medical Council  of  India  (MCI)  has  issued  Circulars  dated  21.04.2017,  22.11.2012  and 18.01.2013 vide which all the Registered Medical Practitioners have been directed to comply  with  the  aforesaid  provisions.  The  MCI  or  the  appropriate  State  Medical Councils have been empowered to take disciplinary action against a doctor for violation of  the  provisions  of  the  aforesaid  Regulations.  As  and  when  complaints  are  received against  the  violation  of  these,  such  complaints  are  referred  by  MCI  to  the  concerned State  Medical  Councils  where  the  doctors/medical  practitioners  are  registered  for appropriate action.
- (c) & (d): 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. As on 15.11.2019, 5,760 PMBJP Kendras are functional in 33 States/Union Territories of 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 of Bulk Drugs/APIs to provide level playing field to the domestic manufacturers.
- (vi) The government is facilitating all kinds of clearances required by the manufacturers to give a boost to domestic manufacturing of bulk drugs.
- (vii)  In  order  to  encourage  'Make  in  India'  and  to  promote  manufacturing  and production of goods and services in India, the Department of Pharmaceuticals vide  its  Order  No.  31026/4/2018-Policy  dated  01.01.2019  has  notified  Public Procurement  (Preference  to  Make  in  India),  Order,  2017,  for  Pharmaceutical Formulations.

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