Lok Sabha Question No. 81 (STARRED), answered on 2018-07-24
Subject: Generic Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: KIRIT PREMJIBHAI SOLANKI

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

LOK SABHA STARRED QUESTION No. 81 TO BE ANSWERED ON THE 24 th  July, 2018

## Generic Drugs

- *81. DR. KIRIT P. SOLANKI:

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

- (a) whether the Government had made or is planning to make it mandatory for doctors to prescribe low-cost generic drugs to the patients;
- (b)  if  so,  the  steps  taken/being  taken/  considered  by  the  Government  to  monitor  the drugs prescribed by doctors and in pharmacies;
- (c)  whether  the  Government has taken any steps to promote the use of domestically manufactured drugs and medicines; and
- (d) if so, the details thereof?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI ANANTHKUMAR)

- (a) to (d): A statement is laid on the Table of the House.

## STATEMENT  REFFERED  TO  IN  REPLY  TO  PARTS  (a)  TO  (d)  OF  STARRED QUESTION NO. 81 FOR REPLY ON 24.07.2018

(a)  :  Ministry  of  Health  &  Family  Welfare  vide  their  Circular  dated  08.04.2015  has directed all the specialists/ Doctors working in 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.

(b):  Medical  Council  of  India  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  17.07.2018,  3,851  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  on  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.