Lok Sabha Question No. 3326 (UNSTARRED), answered on 2025-08-08
Subject: High Cost of Life Saving Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Ms. S Jothimani

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

LOK SABHA UNSTARRED QUESTION NO. 3326 TO BE ANSWERED ON 8 TH  AUGUST, 2025

## High Cost of Life Saving Drugs

## 3326. Ms. S Jothimani:

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

- (a) whether the Government has taken note of the high cost of life-saving drugs for diseases such as cancer, diabetes and cardiovascular conditions and if so, the measures taken to regulate and reduce their prices;

(b) the details of drugs for the said diseases that are currently under price control by the National Pharmaceutical Pricing Authority (NPPA) indicating the extent of reduction achieved in their prices;

- (c) whether the Government plans to expand the National List of Essential Medicines (NLEM) to include newer life-saving drugs and make them affordable, if so, the details thereof;
- (d) the status of availability of these medicines through Jan Aushadhi Kendras;

(e) whether there are gaps in supply or awareness, in the State of Tamil Nadu particularly in Karur, Dindigul, Trichy and Pudukottai districts in this regards; and

(f)  whether  any  pharmaceutical  companies  have  been  found  overcharging  for  essential  or lifesaving drugs and if so the details thereof alongwith the action taken by NPPA in such cases during the last five years?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF  CHEMICALS  AND FERTILIZERS

## (SMT. ANUPRIYA PATEL)

(a)  to  (c):  Prices  of  drugs  in  India  are  regulated  as  per  the  provisions  of  the  Drugs  (Prices Control)  Order,  2013  ('DPCO,  2013').  The  National  Pharmaceutical  Pricing  Authority (NPPA) fixes ceiling prices of scheduled medicines specified in the First Schedule to DPCO, 2013. Further, as per the provisions of DPCO, 2013, the ceiling prices of scheduled medicines are  revised  annually  based  on  Wholesale  Price  Index  (All  commodities)  for  the  preceding calendar year, on or before the 1 st of  April of every year. All manufacturers, importers and marketers of scheduled medicines are required to sell their products within the ceiling price plus applicable local taxes. NPPA also fixes retail prices of 'new drugs', that is, formulations launched by existing manufacturers of a medicine listed in NLEM by combining it with another drug, or by changing the strength or dosage or both of such medicine. Further, DPCO, 2013 also provides for fixation of prices of drugs in public interest under extraordinary circumstances and  monitoring  of  price  increase  of  non-scheduled  drugs.  Accordingly,  prices  of  drugs, particularly drugs  for  diseases  such  as  cancer,  diabetes  and  cardiovascular  conditions  are regulated in the following manner:

- (i) NPPA has fixed the ceiling prices for 930 scheduled formulations, including 131 anti-cancer, 11 anti-diabetic and 66 cardiovascular formulations. All manufacturers,

importers and marketers of scheduled medicines are required to sell their products within the ceiling price plus applicable local taxes. The average price reduction due to fixation or refixation of prices under NLEM, 2022 was about 17%, resulting in estimated annual savings of approximately ₹3,788 crore to patients.

- (ii) Retail prices of 3,482 such new drugs also stand fixed as on 14.7.2025, of which 1,924 are  in  the  anti-diabetic,  anti-cancer  and  cardiovascular  categories.  The  applicant manufacturers and marketing companies are required to sell these drugs within the said retail price.
- (iii) Besides  the  above,  the  maximum  retail  price  (MRP)  of  22  diabetic  and  84 cardiovascular  non-scheduled  medicines  has  been  capped,  resulting  in  estimated annual savings of about ₹350 crore to patients.
- (iv) Trade margin of 42 non-scheduled anti-cancer medicines have been capped, resulting in reduction in prices of 526 brands of medicines by an average of about 50%, resulting in estimated annual savings of about ₹984 crore to patients.
- (v) For  non-scheduled  formulations,  including  for  non-scheduled  anti-diabetic,  anticancer and cardiovascular formulations, manufacturers are required to not increase MRP of drugs launched by them by more than 10% during the preceding 12 months.

Details of prices fixed by NPPA are available on its website (www.nppa.gov.in).

The Standing National Committee on Medicines (SNCM), consisting of all stakeholders and experts, carefully evaluates the relative safety, efficacy, availability and affordability of medicines  from  each  therapeutic  class,  consults  all  stakeholders  and  considers  WHO's Essential Medicines List, drugs used in national health programmes, Indian Pharmacopoeia, National  Formulary,  etc.,  to  recommend  drugs  for  inclusion  in  NLEM.  Based  on  the  said recommendations,  the  Ministry  of  Health  and  Family  Welfare  publishes  NLEM,  which  is notified as the First Schedule to DPCO, 2013. SNCM reviews and revises NLEM from time to time to address the issues of changing disease prevalence, treatment modalities, introduction of newer medicines and identification of unacceptable risk-benefit profile as well as therapeutic profile  of  medicine.  Drugs  under  NLEM  are  categorised  under  therapeutic  groups  and  no categorisation of drugs as life-saving drugs is made.

(d) and (e): Under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana scheme product basket, 2,110 medicines and 315 surgical, medical consumables and devices are available, covering all major  therapeutic  groups,  such  as  cardiovascular,  anti-cancers,  anti-diabetic,  anti-infective, anti-allergic and gastro-intestinal medicines and nutraceuticals. Almost all generic medicines included  in  NLEM,  except  lab  reagents  and  vaccines,  are  included  in  the  scheme  product basket.

To spread awareness about the scheme throughout the country, including in the State of Tamil Nadu, the Pharmaceuticals and Medical Devices Bureau of India, which is the scheme implementing  agency,  regularly  undertakes  number  of  activities,  including  issuance  of advertisements in various modes, such as the print media, radio, television, mobile application, cinema, hoardings, branding of bus queue shelters and buses, auto wrapping and  television screens at Common Service Centres, outreach through social media platforms and celebration of Jan Aushadhi Diwas on the 7 th of March every year.

As on 30.6.2025, 16,912 Jan Aushadhi Kendras (JAKs) have been opened across the country under the scheme, of which 1,432 JAKs have been opened in the State of Tamil Nadu, including 20 JAKs in Karur district, 40 in Dindigul district, 71 in Tiruchirappalli district and 32 in Pudukottai district.

(f): During last five years, that is, during the period from 1.4.2020 to 31.3.2025, 436 cases of overcharging have been initiated by NPPA and an amount of ₹133.19 crore has been recovered from the companies concerned during the same  period.  Detailed list  of overcharging  cases where demand notices have been issued is available on the website of NPPA (www.nppa.gov.in).

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