AstraZeneca Pharma India Limited, a prominent pharmaceutical company, has received a show cause notice from the National Pharmaceutical Pricing Authority (NPPA) on September 11, 2025. The notice alleges that the company overcharged for its popular respiratory medication, 'Symbicort Turbuhaler' Inhalation Powder.

Allegations of Overcharging

According to the NPPA, AstraZeneca Pharma India is accused of marketing or manufacturing batches of 'Symbicort Turbuhaler' Inhalation Powder, 60 Doses each, at prices exceeding the notified ceiling price. The alleged overcharging spans from April 2016 to July 2025.

Financial Implications

The quantum of the claim made by the NPPA amounts to Rs 60,49,79,385 (approximately Rs 60.50 crore) plus interest. This figure represents the alleged overcharged amount during the specified period. However, AstraZeneca Pharma India has stated that it disputes this claim.

Company's Response

In its disclosure to the stock exchanges, AstraZeneca Pharma India emphasized that the expected overall financial implication cannot be determined at this stage. The company has been given a 30-day window to respond to the allegations made in the show cause notice.

Regulatory Compliance

The show cause notice was issued by the NPPA, which falls under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India. This action underscores the regulatory body's role in monitoring and enforcing pharmaceutical pricing regulations in the country.

Market Impact

While the immediate financial impact remains uncertain, this development could potentially affect investor sentiment towards AstraZeneca Pharma India. The company's ability to address these allegations and its future pricing strategies for key products like Symbicort Turbuhaler will be closely watched by stakeholders.

Looking Ahead

As the situation unfolds, the pharmaceutical industry and investors will be observing how AstraZeneca Pharma India navigates this regulatory challenge. The company's response to the show cause notice and any subsequent actions by the NPPA will be crucial in determining the outcome of this pricing dispute.

AstraZeneca Pharma India Limited's management is expected to provide further updates as they respond to the NPPA's allegations within the stipulated 30-day period.

AstraZeneca Pharma India has taken a significant step in its site exit strategy by surrendering its manufacturing license, marking the end of its manufacturing operations in India. The pharmaceutical company has voluntarily relinquished the license, which was originally valid until December 2027, ahead of its expiration date.

Manufacturing License Surrender

According to a regulatory filing dated September 2, 2025, AstraZeneca Pharma India Limited has officially surrendered its manufacturing license to the Drugs Controller and Licensing Authority for cancellation. This move is in line with the company's previously announced exit strategy for its manufacturing site in India.

The company stated in its filing, "Pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 and in furtherance to our intimation to stock exchanges on June 21, 2024, regarding the exit from our manufacturing site, we wish to inform you that AstraZeneca Pharma India Limited ('the Company') has surrendered its manufacturing license, which was valid up to December 2027, to the Drugs Controller and Licensing Authority for cancellation."

Background and Timeline

The decision to exit manufacturing operations in India appears to have been in the works for some time. The company had previously informed stock exchanges about its plans to exit the manufacturing site on June 21, 2024. This latest development represents the culmination of that strategy, with the company now formally surrendering its manufacturing license.

ESG Rating Disclosure

In a separate but noteworthy development, AstraZeneca Pharma India also disclosed its Environmental, Social, and Governance (ESG) rating in a filing dated September 1, 2025. Crisil ESG Ratings & Analytics Limited has assigned an ESG rating of 58.00 to the company based on publicly available information for the fiscal period 2025.

The company clarified that it had not engaged Crisil ESG Ratings for this assessment, stating, "Please note that the Company has not engaged Crisil ESG Ratings. They have independently prepared the report based on publicly available information."

This ESG rating disclosure aligns with the company's compliance with SEBI regulations and demonstrates its commitment to transparency in environmental, social, and governance matters.

As AstraZeneca Pharma India moves forward with these strategic decisions, stakeholders will be watching closely to see how these changes impact the company's operations and market position in India's pharmaceutical landscape.