Lok Sabha Question No. 1952 (UNSTARRED), answered on 2024-12-06
Subject: Reduction in Price of Cancer Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri V K Sreekandan

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

LOK SABHA UNSTARRED QUESTION NO. 1952 TO BE ANSWERED ON 06 th  DECEMBER, 2024

## Reduction in Price of Cancer Drugs

## 1952. Shri V K Sreekandan:

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

- (a)  whether it is  a  fact  that  the  National  Pharmaceutical  Pricing  Authority  has  directed the manufacturers to reduce the maximum retail price of three anti-cancer drugs Trastuzumab, Osimertinib, and Durvalumab, if so, the details thereof;
- (b) whether it is also a fact that this initiative was undertaken in view of the fact that the customs duty on these three drugs has been reduced to nil;
- (c) if so, the response received from the manufacturers in this regard;
- (d) whether it is true that the anti-cancer drug manufacturers have been advised to put QR codes to check fakes; and
- (e) if so the details thereof?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SMT. ANUPRIYA PATEL)

(a) to (c): Department of Revenue, Ministry of Finance reduced the Customs Duty to Nil in respect of three anticancer drugs viz., Trastuzumab Deruxtecan, Osimertinib, and Durvalumab vide Notification  30/2024  dated  23.07.2024.  Further,  GST  rates  were  also reduced  on  these  anticancer  drugs  from  12%  to  5% vide  Notification no.  05/2024 dated 08.10.2024. As per the Drugs (Prices Control) Order, 2013 (DPCO, 2013), Maximum Retail Price (MRP)  of drugs/formulations is inclusive of taxes and duties, as applicable. Accordingly, the  National  Pharmaceutical  Pricing  Authority  (NPPA)  has  issued  an  Office Memorandum directing the companies to reduce MRP on these drugs on account of reduction in GST rates and exemption from Custom Duties so as to pass on the benefit of reduced taxes and duties to the consumer and to file Form II/V furnishing information about change in prices.

In compliance to the aforesaid notification, manufacturers reduced the MRP on these drugs and filed the information with NPPA. ( Annexure )

(d) & (e): As per information received from Ministry of Health & Family Welfare (MoHFW), on 17.11.2022, the Drugs Rules, 1945 were amended vide G.S.R. 823 (E) w.e.f. 01.08.2023 providing that the manufacturers of top 300 brands of drug formulation products, as specified in Schedule H2, shall print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store various data or information legible with software application to facilitate authentication.

Annexure referred to in reply to parts (a) to (c) of Lok Sabha Unstarred Question No. 1952 for answer on 06.12.2024

## Information filed by the Companies with NPPA regarding reduction in MRP on account of reduction in Custom Duty and GST

## Durvalumab

|   S. No | Formulation                                                      | Company                          | Unit     |   Pre Revised MRP(in Rs) (including taxes) |   Revised MRP(in Rs) (including taxes) |
|---------|------------------------------------------------------------------|----------------------------------|----------|--------------------------------------------|----------------------------------------|
|       1 | Imfinzi 120 Mg Injection 2.4ML(1.00 Vial) (Durvalumab INJECTION) | AstraZeneca Pharma India Limited | per vial |                                      45500 |                                  40791 |
|       2 | Imfinzy 500 Mg Injection 10 ML(1.00 Vial) (Durvalumab INJECTION) | AstraZeneca Pharma India Limited | per vial |                                     189585 |                                 171324 |

## Osimertinib

| S. No   | Formulation              | Company                          | Unit           |   Pre Revised MRP(in Rs) (including taxes) |   Revised MRP(in Rs) (including taxes) |
|---------|--------------------------|----------------------------------|----------------|--------------------------------------------|----------------------------------------|
| 1*      | Tagrisso 40 Mg Tablet 10 | AstraZeneca Pharma India Limited | per 10 tablets |                                     150154 |                                 140769 |
| 2       | Tagrisso 80 Mg Tablet 30 | AstraZeneca Pharma India Limited | per 30 tablets |                                     455010 |                                 416492 |
| 3       | Tagrisso 80 Mg Tablet 10 | AstraZeneca Pharma India Limited | per 10 tablets |                                     151670 |                                 138831 |

## Trastuzumab Deruxtecan

|   S. No | Formulation                                               | Company                          | Unit     |   Pre Revised MRP(in Rs) (including taxes) |   Revised MRP(in Rs) (including taxes) |
|---------|-----------------------------------------------------------|----------------------------------|----------|--------------------------------------------|----------------------------------------|
|       1 | Enhertu 100mg/5ml Inj. Vial(1.00 Vial) (Trastuzumab VIAL) | AstraZeneca Pharma India Limited | per vial |                                     187000 |                                 167069 |

*As informed by the company vide letter dated 19.11.2024, downward revision on account of BCD becoming Nil shall be implemented when the stocks benefitting from BCD relief are released for commercial sales in the market.

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