AstraZeneca Pharma India Limited said on 2 November 2026 that the Delhi High Court has directed the National Pharmaceutical Pricing Authority (NPPA) to take no coercive steps against the company over alleged overcharging on its Symbicort Turbuhaler 160/4.5 asthma inhaler. The interim order, dated 29 October 2026, shields a demand of about ₹151.20 crore until the next hearing on 11 January 2027.

The case adds to a busy season for drug pricing enforcement, which has also seen the regulator issue revised MRPs for 543 anti-cancer brands under a new trade margin cap.

What the Delhi High Court ordered

In its disclosure to BSE and NSE under Regulation 30 of the SEBI listing rules, the company said the court directed that NPPA cannot take coercive steps in the matter until the next date of hearing. The company received the order on 30 October 2026.

• Product: Symbicort Turbuhaler 160/4.5, a budesonide and formoterol dry powder inhaler for asthma.
• Alleged overcharging period: May 2016 to November 2025, under the Drugs (Prices Control) Order, 2013 (DPCO 2013).
• Amount covered: ₹1,51,19,66,035, made up of the alleged overcharged amount and interest up to 30 October 2026.
• Next hearing: 11 January 2027.

According to news reports on the order, Justice Amit Mahajan observed that the company had made out a prima facie case that the inhaler may not fall within the category of drugs whose prices are controlled under DPCO 2013, and sought the pricing authority’s response to the petition.

How the NPPA dispute started

NPPA first issued a show cause notice to the company on 11 September 2025. It followed with a demand notice on 29 July 2026 and a later reminder, alleging that the inhaler was sold above the price permitted for such formulations. AstraZeneca Pharma India denied selling the product above the notified price and challenged the demand in the Delhi High Court.

The pricing regulator itself is under closer scrutiny, after the Supreme Court questioned the Centre over the MRP gap in medicines in October.

Why it matters for India’s pharma industry

Overcharging demands under DPCO 2013 often stretch back many years and carry interest, so a ruling on whether a product is price-controlled can decide large sums for drugmakers. For inhaler makers, the case is also a reminder that fixed-dose combination devices sit in a grey zone of pricing rules, even as companies such as Cipla build their respiratory and inhaler pipelines.

AstraZeneca has continued to invest in India, including its ₹166 crore expansion in Bengaluru. The final outcome of the pricing challenge now depends on the January hearing.

Key takeaways

• The Delhi High Court barred NPPA from coercive action against AstraZeneca Pharma India until 11 January 2027.
• The dispute concerns about ₹151.20 crore in alleged overcharging on Symbicort Turbuhaler 160/4.5 from May 2016 to November 2025.
• The company argues the inhaler is not a price-controlled formulation under DPCO 2013.

FAQ

What is AstraZeneca accused of by NPPA?

NPPA alleges the company overcharged for Symbicort Turbuhaler 160/4.5 between May 2016 and November 2025, in breach of DPCO 2013.

Does the order end the case?

No. It is interim relief that stops recovery action until the next hearing on 11 January 2027, when the court will hear the matter further.

Featured image: Dry powder inhalers, including a Turbuhaler (left). Photo: BrettMontgomery, Wikimedia Commons (CC BY-SA 4.0)

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