Delhi HC asks NPPA to reconsider show cause issued to AstraZeneca over cancer drug Tagrisso

The Medical Dialogues team had reported earlier that the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, had granted AstraZeneca Pharma India Limited import and marketing approval for Osimertinib Film-coated Tablets 40mg/80mg (Osimertinib Mesylate) for lung cancer.

Osimertinib Film-coated Tablet is marketed under brand name Tagrisso 80mg. Osimertinib is used to treat locally advanced or metastatic non-small-cell lung cancer (NSCLC) when cancer has the specific T790M mutation in the gene coding for epidermal growth factor receptor.

The court order came following a petition submitted by AstraZeneca seeking to

(a) Pass an appropriate writ, order or declaration quashing the Gazette Notification dated February 27, 2019 issued by NPPA

(b) Pass an appropriate writ, order or declaration quashing the Show-Cause Notice dated October 14, 2020 issued by NPPA;

(c) Pass an appropriate writ, order or declaration quashing the Order dated January 13, 2021 passed by NPPA; and

(d) Pass any other or further order (s) which the Court deems fit in the interest of justice.

The learned Senior Counsel appearing for AstraZeneca submitted that NPPA, through an order dated 13th January 2021, directed the pharma firm to furnish CA certified data for selling Tagrisso 80mg tablet.

In addition to this, it was ensured that on 4th February 2021, AstraZeneca supplied the necessary details to NPPA in response to the order dated 13.01.2021.

The NPPA order dated 13.01.2021 read,

"6. Based on the abovementioned facts, the company has overcharged in the sale of Tagrisso 80mg tablet. The company has not submitted details of quantity sold since 08th March 2019 duly certified by Chartered Accountant as sought vide Show Cause Notice dated 14th October 2020. Therefore, the company is once again directed to furnish CA certified data for the sale of the formulation in reference in the Annexure attached herewith within 15 days of receipt of this order, failing which demand notice will be issued based on market data available with NPPA"

Challenging the show cause notice issued by NPPA, the Counsel for AstraZeneca further submitted that Osimertinib (Tagrisso 80mg tablet) is a patented product qualifying for exemption for five years from the date of commencement of its commercial marketing in India.

Therefore, Para 32 (i) of DPCO, 2013 stipulates that the provisions of the above-said order shall not apply to a manufacturer producing a new drug patented under the Indian Patent Act, 1970 for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country.

"The AstraZeneca pharma India Pvt. limited has a product patent covering the molecule OSIMERTINIB (TAGRISSO) and the same is valid for twenty years i.e. up to 24.07.2032. The Show Cause Notice dated 14.10.2020 and the impugned order dated 13.01.2021 is thus illegal and deserve to be quashed." added the Counsel for AstraZeneca.

In addition, apart from the various grounds urged to challenge the show cause notice and the impugned order, the Counsel also highlighted that the NPPA has no power, jurisdiction and authority to issue the aforesaid Show Cause Notice and raise a demand on the drugmaker.

After hearing the submissions made by AstraZeneca, the Delhi High Court noted,

" We have heard learned senior counsel for AstraZeneca and learned counsels for NPPA. We have perused the order dated 13.01.2021 and it is clear that NPPA has directed the pharma firm to furnish CA certified data before issuing a Demand Notice."

In view of the above observation, the Delhi High Court pronounced its order as quoted;

"Since the matter still rests at a stage where requisite information and data has been sought by NPPA and the decision is yet to be taken, we hereby direct NPPA to pass a fresh order taking into account the information given in the communication dated 4th February, 2021 by the petitioner and also the various contentions raised in the present writ petition including the reply(s) filed by the petitioner. The Authority will also consider the issue of jurisdiction raised herein and needless to state that the decision so taken on all counts shall be in accordance with law and after giving adequate opportunity of being heard to the petitioner."

It noted;

"Till the decision is taken by NPPA, it shall not raise any demand against the petitioner with regard to the issues in question. In case AstraZeneca is still aggrieved by the decision rendered by NPPA, it shall have the liberty to challenge the same in accordance with the law in the appropriate Forum."

In light of the above, the writ petition is disposed of along with the pending application.

https://indiankanoon.org/doc/43105145/