AstraZeneca Pharma India challenges NPPA's demand notice in Delhi High Court

AstraZeneca Pharma said that accordingly, the company was ordered to deposit the amount within 30 days from the date of notification.

AstraZeneca Pharma India challenges NPPA's demand notice in Delhi High Court

AstraZeneca Pharma India on Tuesday said it has filed a petition in the Delhi High Court challenging the National Pharmaceutical Pricing Authority's (NPPA) litigation notice alleging that the company is charging more than Tagrisso 80mg tablets. AstraZeneca Pharma, in a regulatory filing, said the company received a claim notice from NPPA on June 25, 2021 under the provisions of the 2013 Drug (Prices Control) Order in respect of Tagrisso tablets containing the osimertinib 80 mg formulation.

"The said notice of demand has been issued pursuant to the NPPA notification...dated 27th February 2019 whereby, the government put a cap on trade margin of 42 anti-cancer medicines at first point of sale of the product", he indicated. saying.

The notice of suit alleges that the company collected over Rs 157.38 million in respect of Tagrisso 80mg Tablets (Osimertinib) during the period March 8, 2019 to January 31, 2021.

AstraZeneca Pharma said that accordingly, the company was ordered to deposit the amount within 30 days from the date of notification.

The notice further establishes that the company is also bound to pay the interest calculated up to the date of actual payment in accordance with the applicable provisions of DPCO, 2013 read with the Essential Products Act of 1955.

"The company strongly believes that NPPA has not adequately considered several submissions made in support of the company's contentions, including the fact that Osimertinib is a patented drug and as such the DPCO, 2013 and the said notification dated 27th February 2019 are not applicable to Osimertinib as comprehended under Para 32 of the DPCO, 2013,"

The Company has made a thorough assessment of the matter and is of the firm view that the claim of NPPA is completely false and not legally valid.

AstraZeneca Pharma said the NPPA order could have an industry-wide impact on patient assistance programs and could result in increased drug affordability for patients.

Further, the notice penalizes the company for supplying government institutions through tenders at a rate below the Maximum Retail Price (MRP) and yet the MRP has been wrongly included for accounting purposes and not the actual amount recovered

AstraZeneca Pharma said, "... the company has filed a writ petition before the Hon'ble High Court of Delhi challenging the demand notice."

Shares of AstraZeneca Pharma India closed at Rs 3,621.10 per share on the BSE, down 0.80 per cent from the previous close.