India: Food, Drugs, Healthcare, Life Sciences

The recent spate of inspections and raids conducted by the Food and Drug Administration (FDA) and the Food Safety and Standards Authority of India (FSSAI) across Maharashtra has triggered a wider debate on the balance between regulatory enforcement and procedural fairness. Several prominent restaurants, hotels and food establishments found themselves facing suspension orders, stop-business notices and threats of closure allegedly on account of hygiene discrepancies and alleged violations of food safety norms.

On 7 August 2026, the Delhi High Court stayed an order of the Food Safety and Standards Authority of India (“FSSAI”) prohibiting Dabur India Limited from selling certain food products carrying claims such as “100% Pure”, “100% Natural” and “100% Organic”. Hon’ble Justice Amit Mahajan (Delhi High Court) held that the prohibition ought not to have been passed without an opportunity of hearing. That order captures the season. In recent weeks, the regulator has intensified its enforcement measures to ensure compliance with the Food Safety and Standards Act, 2006, and the courts have begun to ask how far it may go.

The Food Safety and Standards Authority of India (“FSSAI”) has, over the course of late May 2025, taken two connected regulatory steps aimed at curbing misleading claims on packaged food labels. First, FSSAI issued a formal advisory to all Food Business Operators (“FBOs”) directing them to discontinue the use of the term “100%” on food labels, packaging, and promotional material. Second, and consistent with the concerns underlying that advisory, FSSAI issued a detailed notice to a confectionery company in India, flagging specific instances of non-compliant labelling and misleading claims across several of its product lines.

India's life sciences regulatory landscape in July 2026 saw major developments across pharmaceuticals, medical devices, and healthcare regulation. Key changes included the draft National Pharmacy Commission Bill proposing to replace the 80-year-old Pharmacy Act, CDSCO's final guidance on Medical Device Software establishing clear market access pathways, and stricter controls on high-alcohol oral formulations under Schedule H1.

The Union Ministry of Health and Family Welfare (the “Ministry”) has recently published a Draft Notification[1] in the Official Gazette proposing amendments to the Medical Devices Rules, 2017[2] (the “Rules”), promulgated under the Drugs and Cosmetics Act, 1940. The proposed amendments specifically target the statutory timelines prescribed for processing manufacturing licence applications across the four risk-based classifications of medical devices.

Patent pendency remains one of the most significant challenges in U.S. patent prosecution. Average first-action wait times range from approximately 20 to 29 months across Technology Centers, creating real costs for startups seeking investor credibility, life sciences companies racing toward product launches, and technology firms defending competitive market position.

An analysis of cross-border healthcare-data transfers under India’s Digital Personal Data Protection framework and the GDPR, examining consent, sensitive health information, processor obligations, transfer safeguards, localisation and regulatory risk.

India's life sciences regulatory landscape in July 2026 saw major developments across pharmaceuticals, medical devices, and healthcare regulation. Key changes included the draft National Pharmacy Commission Bill proposing to replace the 80-year-old Pharmacy Act, CDSCO's final guidance on Medical Device Software establishing clear market access pathways, and stricter controls on high-alcohol oral formulations under Schedule H1.

The Hon'ble Supreme Court, in 35 And Our Health Society v. Union of India vide order dated 10 February 2026, directed the Food Safety and Standards Authority of India to seriously consider the introduction of mandatory front-of-pack warning labels on packaged food products and to place its response on record within four weeks.