Lok Sabha Question No. 447 (UNSTARRED), answered on 2023-02-03
Subject: Drugs (Prices Control) for Critical Diseases
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Sumedhanand Saraswati, Ranjeeta Koli, Balak Nath, Manoj Rajoria

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

LOK SABHA UNSTARRED QUESTION NO. †447 TO BE ANSWERED ON 03 rd  February, 2023

Drugs (Prices Control) for Critical Diseases

## †447.   SHRI SUMEDHANAND SARASWATI: SHRIMATI RANJEETA KOLI: SHRI BALAK NATH: DR. MANOJ RAJORIA:

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

- (a) whether medicines for cancer, diabetes, lung and heart diseases have been included under the  Drugs  (Prices  Control)  order  by  the  Government  as  a  part  of  the  new  list  of  essential medicines in the country and if so, the details thereof;
- (b)  whether  any  steps  have  been  taken  by  the  Government  to  ensure  affordability  and availability of medicines for cancer, diabetes, lung and heart diseases in the country and if so, the details thereof; and

(c) the total quantity of cancer medicines produced and supplied along with the total quantity of medicines imported by the Government in the country during the last five years?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI BHAGWANTH KHUBA)

- (a):       There are 47 anti-cancer medicines consisting of 85 formulations, 8 medicines used in diabetes  consisting  of  11  formulations  and  30  cardiovascular  medicines  consisting  of  69 formulations that are included in the National List of Essential Medicine (NLEM) notified by Ministry of Health and Family Welfare on 13.09.2022 and incorporated in Revised ScheduleI of  Drugs  (Prices  Control)  Order,  2013  (DPCO,  2013)  notified  by  Department  of Pharmaceuticals on 11.11.2022. There is no separate therapeutic category for medicines used for lung disease.
- (b):     To ensure affordability of medicines including those for cancer, diabetes, lung and heart diseases, National Pharmaceutical Pricing Authority (NPPA) under department of Pharmaceuticals  has  fixed  ceiling  prices  of  890  scheduled  formulations  across  various therapeutic categories under NLEM 2015 which includes 86 anti-cancer formulations, 12 antidiabetes formulations and 74 cardiovascular formulations. Further, under NLEM 2022, NPPA has fixed ceiling prices of 344 scheduled formulations till 26.01.2023 which includes 43 anticancer formulations, 5 anti-diabetes formulations and 36 cardio vascular formulations.  Also, in 2014, NPPA capped the MRP of 106 non-scheduled drug formulations under Para 19 of DPCO, 2013  which  includes  22  diabetic  and  84  cardiovascular  drugs.   In  addition,  Trade

Margin of non-scheduled formulations of 42 select Anti-cancer medicines were capped under 'Trade Margin Rationalization' approach, wherein price of above 500 brands of medicines were reduced by up to 90%.  The details of prices fixed by NPPA is available on the website of NPPA i.e., nppaindia.nic.in.

To ensure availability, the extant provisions of DPCO, 2013 provides for issuance of directions to manufacturers of scheduled formulations and active pharmaceutical ingredients (APIs) contained in scheduled formulations to increase their production in case of emergency or in circumstances of urgency, in public interest.  Also, NPPA regularly monitors availability of  specific  drugs.   In  addition,  measures  have  also  been  taken  to  encourage  domestic manufacturing of pharmaceutical drugs and their APIs, including for cancer, diabetes, lung and heart  diseases.  The  major  programmatic  interventions  to  support  pharma industries  include Production  Linked  Incentive  (PLI)  Scheme  and  Bulk  Drugs  Park  Scheme.   The  approved eligible  product  categories under  PLI  Scheme  for  Pharmaceuticals  include "Auto  immune drugs,  anti-cancer  drugs,  anti-diabetic  drugs,  anti-infective  drugs,  cardiovascular  drugs, psychotropic drugs and anti-retro viral drugs".

(c):       Data relating to production, supply and import of cancer medicines is not maintained by the Department of Pharmaceuticals.

*****