Aurobindo Pharma arm Eugia Pharma's Telangana unit gets warning letter from USFDA

Aurobindo Pharma announced its subsidiary Eugia Pharma received a USFDA warning letter. This follows an inspection of their Telangana formulation manufacturing facility. The inspection concluded with four observations and an official action indicated status. The company stated existing US market supplies remain unaffected by this development. Aurobindo Pharma continues its commitment to ongoing compliance with the US FDA.

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Gland Pharma appoints Dr Reddy’s senior executive Deepak Sapra as CEO

Gland Pharma has appointed Deepak Sapra as its new chief executive officer, with his tenure set to begin on November 16, 2026, subject to his acceptance of the offer. Sapra brings 27 years of executive experience, including over 23 years in pharmaceuticals, and currently leads API and Services at Dr Reddy’s Laboratories.

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Delhi HC backs Zydus in trademark row

The Delhi High Court upheld a single-judge order against Alder Biochem. This ruling prevents them from using the 'Biochem' trademark. Alder Biochem's claim of the term being public property was rejected. Zydus Healthcare has held the registered trademark since 1959. The court's decision protects Zydus Healthcare's established brand.

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Narayana Health, NDB sign pact to share smart hospital expertise

Narayana Health and the New Development Bank have signed a knowledge-sharing agreement. This partnership aims to strengthen smart hospital capabilities and patient-centric healthcare services. The collaboration will focus on digital health and technology transfer for emerging economies. NDB president Dilma Rousseff and Narayana Health chairman Dr Devi Shetty signed the memorandum. This initiative supports NDB's mission to finance development projects in emerging markets.

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Govt tightens drug quality net, initiates 950 actions since 2022: Over 1,100 cough syrup makers are also facing intensive audits amid quality concerns

The government has initiated 950 enforcement actions against pharmaceutical companies since December 2022. These actions aim to improve the quality of locally made medicines and prevent spurious drug sales. More than 1,100 cough syrup manufacturers are facing intense audits due to quality concerns. Drug manufacturing premises are inspected periodically to verify compliance with good manufacturing practices. Risk-based inspections are now prioritized based on a company's risk profile.

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Maharashtra FDA cracks down on Ayurvedic drug makers, cancels 10 licences

Maharashtra FDA has launched a statewide crackdown on Ayurvedic drug manufacturers. Inspections revealed serious violations of manufacturing and quality control standards at many establishments. Following these findings, 135 manufacturers received show-cause notices for non-compliance issues. Ten manufacturers had their licenses permanently cancelled due to major violations affecting public health. The FDA is ensuring Ayurvedic medicines meet required standards and addressing public health lapses.

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Regulator mandates full review of globally unapproved drugs

India’s drug regulator has clarified that new drugs not approved anywhere globally must undergo the full domestic regulatory process, even if Indian patients participated in global clinical trials. CDSCO said such applications require comprehensive safety and efficacy evaluation under existing rules.

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