Lok Sabha Question No. 1562 (UNSTARRED), answered on 2015-12-08
Subject: Drug Pricing Policy &amp; Drug Price Control Order (DPCO)
Ministry: CHEMICALS AND FERTILIZERS
Asked by: MURALI MOHAN MAGANTI, KIRIT SOMAIYA, KRISHNAN NARAYANASAMY RAMACHANDRAN, KANWAR SINGH TANWAR

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

## LOK SABHA

## UNSTARRED QUESTION No. 1562

## TO BE ANSWERED ON THE 8 th  December, 2015

## Drug Pricing Policy & Drug Price Control Order (DPCO)

1562. SHRI M. MURALI MOHAN:

DR. KIRIT SOMAIYA: SHRI K.N. RAMACHANDRAN: SHRI KANWAR SINGH TANWAR:

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

- (a) the details of medicines which have been brought under the DPCO and National List of Essential Medicines till date and the proposal to include all essential medicines  there  under  to  keep  the  price of these medicines whithin the reach of poor people;
- (b) the details of the actions that can be taken against a company which fails to comply with the retail price cap as prescribed by the National Pharmaceutical Pricing Authority (NPPA) under DPCO;
- (c) whether  the  Government  proposes  to  review  the  National  List  of Essential  Medicines  to  include  more  medicines  in  this  list,  if  so,  the details thereof, if not, the reasons therefor;
- (d) whether the Government has received any complaint regarding Drug Pricing  Policy,  if  so,  the  details  regarding  re-examination  or  reassessment of it; and
- (e) whether  the  NPPA  has  any  proposal  to  cap  the  prices  of  life  saving drugs like HIV, cancer etc. if so, the details thereof?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI HANSRAJ GANGARAM AHIR)

(a): Pursuant  to  the  announcement  of  National  Pharmaceutical  Pricing Policy,  2012,  Government  notified  Drugs  (Prices  Control)  Order,  2013 (DPCO, 2013) on 15th May, 2013. All the medicines specified in the National List of Essential Medicines 2011 (NLEM) have been included in the First

Schedule  of  DPCO,  2013  and  brought  under  price  control.    Under  DPCO, 2013,  prices  of  drugs  are  fixed  on  'Market  based  pricing'  methodology. Consequent to the price fixation of drugs under this order, affordability of the  medicines  has  improved.  Out  of  total  680  NLEM  medicines  (628  net medicines) under scheduled category of DPCO, 2013, National Pharmaceutical  Pricing  Authority  (NPPA)  has  fixed  the  ceiling  prices  in respect of 530 medicines including 47 medicines for cancer and 22 for HIV medicines based on market price data under provisions of the said order.

In addition, maximum retail price (MRP) has been capped  under para 19 of DPCO, 2013, in respect of 106 non scheduled medicines, out of which 84 are used for treatment of cardiovascular diseases and 22 for diabetes. NPPA has also fixed the retail price of 247 'new drugs' under para 5 of DPCO, 2013.

(b): National  Pharmaceutical  Pricing  Authority  (NPPA)  issue  notices  for overcharging as and when price violation cases come to notice based on the reports  received  from  State  Drug  Controllers  or  samples  purchased  from market or complaints received from NGOs / individuals.

Action  for  recovery  of  the  overcharged  amount  is  taken  as  per  the provisions of DPCO, 1995 and DPCO, 2013. The cases are also referred to District Collector for recovery of the overcharged amount as arrears of land revenue under Section-3 of the Essential Commodities Act, 1955.

(c): Ministry of Health and Family Welfare has constituted an expert core committee  to  review  and  recommend  the  revision  of  National  List  of Essential Medicines (NLEM)-2011 in the context of contemporary knowledge of use of therapeutic products.

(d): A representation in the matter of  Writ Petition  (Civil)  423/2003  has been  received  from  All-India  Drug  Action  Network  and  Other  Petitioners pursuant to the order of the Supreme Court dated 15 th  July, 2015. The four main  issues  highlighted in the order pertain to  pricing  methodology, exclusion of some essential life-saving drugs form price control, manufacture of  irrational  combination  of  drugs  and  pricing  of  patented  medicines.  The matter is under examination at the Department of Pharmaceuticals.

(e):  National  Pharmaceutical  Pricing  Authority  (NPPA)  fixes/controls  the prices of medicines including those used for HIV, cancer etc. It is an ongoing process.

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