Lok Sabha Question No. 744 (UNSTARRED), answered on 2025-02-07
Subject: High Prices of Cancer Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Saptagiri Sankar Ulaka

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

LOK SABHA UNSTARRED QUESTION NO. 744 TO BE ANSWERED ON 7 th  FEBRUARY, 2025

## High Prices of Cancer Drugs

## 744. Shri Saptagiri Sankar Ulaka:

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

- (a) whether the Government is aware of the high prices of cancer drugs in the country, if so, the steps being taken to make them affordable and accessible to the masses;
- (b) whether price caps or regulations have been imposed on cancer drugs by the National Pharmaceutical Pricing Authority (NPPA), if so, the number of drugs included in the essential medicines list and the criteria adopted for determining price reductions;
- (c) the details of initiatives to promote domestic manufacturing of cancer drugs and reduce dependency on imports; and
- (d) the efforts being made by the Government to provide subsidized or free cancer drugs to economically weaker sections of the society?

## ANSWER

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

(SMT. ANUPRIYA PATEL)

(a) and (b): The National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals fixes ceiling prices under the provisions of Drugs (Prices Control) Order, 2013  (DPCO,  2013)  in  respect  of  the  drugs  specified  in  Schedule-I  to  DPCO,  2013. Manufacturers of scheduled medicines (both branded and generic) are required to sell their products within the ceiling price (plus applicable Goods and Service Tax) fixed by NPPA. In addition, NPPA fixes the retail price of new drugs as defined in DPCO, 2013. The retail price of a new drug is applicable to the applicant manufacturer and marketer, who are required to sell the new drug within the price notified by NPPA. In case of non-scheduled formulations, a manufacturer is at liberty to fix the maximum retail price (MRP) of drugs launched by it. However, as per DPCO, 2013, a manufacturer is required to not increase MRP of a nonscheduled drug by more than 10% of MRP during the preceding 12 months. In addition to the above, the ceiling price of a drug may also be fixed under certain circumstances, in public interest.

The  aforesaid  Schedule  to  DPCO,  2013  consists  of  the  National  List  of  Essential Medicines (NLEM), 2022 notified by the Department of Health and Family Welfare. NLEM, 2022 includes 63 anti-cancer drugs, including immunosuppressives and medicines used in palliative care.

Various measures have been taken to make cancer drugs affordable and accessible to the masses, including, among others, the following:

- (i) NPPA has fixed ceiling prices of 131 scheduled anti-cancer formulations under NLEM. These include 111 formulations whose prices were fixed under the NLEM, 2015.  Refixation  of  the  same  under  NLEM,  2022  has  resulted  in  reduction  of around 21% from the ceiling prices fixed under NLEM, 2015, leading to annual savings of around ₹294.34 crore to patients.
- (ii) NPPA  has  fixed  retail prices of  28 anti-cancer formulations of applicant manufacturing  and  marketing  companies,  under  the  DPCO,  2013  provisions relating to fixing of retail prices of new drugs.
- (iii) In addition, NPPA has put a cap of 30% trade margin on 42 non-scheduled anticancer medicines, in public interest, which has resulted in reduction of MRP of 526 brands of these medicines by an average of around 50% and annual savings of around ₹984 crore to patients.
- (iv) Government reduced customs duty to nil and GST rates from 12% to 5% for three anti-cancer  drugs  in  the  financial  year  (FY)  2024-25  and  NPPA  has  issued directions to companies to reduce MRP to pass on the tax benefit to consumers.
- (v) Exemption/concessions in customs duty on identified anti-cancer medicines has also been announced in the budget for FY 2025-26.

(c):  With the objective of promoting domestic manufacturing of drugs, the Department of Pharmaceuticals  is  implementing  the  Production  Linked  Incentive  (PLI)  Scheme  for Pharmaceuticals  with  total  financial  outlay  of  ₹15,000  crore  with  scheme  tenure  till  the financial year 2027-28. 54 anti-cancer drugs are being manufactured under this scheme.

(d):  Under  Ayushman  Bharat  Pradhan  Mantri  Jan  Arogya  Yojana  (AB-PMJAY),  health assurance/insurance  cover  of  ₹5  lakh  per  family  per  year  for  secondary  or  tertiary  care hospitalisation  to  about  60  crore  beneficiaries  is  being  provided.  The  treatment  packages under AB-PMJAY are comprehensive and cover various treatment related aspects, including drugs and  diagnostic services. Further,  under  Pradhan  Mantri Bhartiya  Janaushadhi Pariyojana,  quality  medicine  are  offered  through  Jan  Aushadhi  Kendras  at  rates  that  are typically 50% to 80% lower than the prices of branded medicines available in the market. In addition,  under  the  Affordable  Medicines  and  Reliable  Implants  for  Treatment  (AMRIT) initiative of the Department of Health and Family Welfare, medicines for treatment of cancer, cardiovascular and other diseases, implants, surgical disposables and other consumables etc. are provided at significant discounts of up to 50% of market rates through AMRIT Pharmacy stores set up in some hospitals/institutions. Moreover, financial assistance is provided to poor patients  belonging  to  families  living  below  poverty  line,  who  suffer  from  major  lifethreatening diseases including cancer, under the umbrella scheme of Rashtriya Arogya Nidhi and the Health Minister's Discretionary Grant (HMDG). Financial assistance of up to ₹15 lakh is provided under the Health Minister's Cancer Patient Fund under the umbrella scheme of RAN, and assistance of up to ₹1.25 lakh is provided under HMDG to defray part of the treatment cost.

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