Daily Pharma News - 3 October 2026

CDSCO Approves NovaLead's Repurposed Esmolol Gel for Diabetic Foot Ulcer in India

NovaLead Pharma, a Pune-based company, has received approval from India's Central Drugs Standard Control Organization (CDSCO) for a novel topical gel formulation of esmolol hydrochloride for the treatment of diabetic foot ulcer (DFU). The approval makes this the first repurposed drug developed end-to-end in India - from concept and formulation through clinical development to regulatory clearance.

The approval rests on a positive Phase 3 trial in which the esmolol gel outperformed standard care. Drug repurposing - finding new therapeutic uses for established molecules - is a strategy every pharmacy student should understand: it shortens development timelines, lowers costs and de-risks safety, since the molecule's pharmacology is already well characterised. Esmolol itself is a familiar ultra-short-acting beta-1 blocker used intravenously in cardiology; its repositioning as a topical wound-healing agent is a striking example of how old drugs can find new lives.

The India context matters here. India carries one of the world's heaviest diabetes burdens, and diabetic foot ulcer is a leading cause of non-traumatic lower-limb amputation in the country. A topical, locally developed and affordable option could meaningfully change wound-care practice in Indian hospitals and clinics - and it positions Indian pharma as an innovator, not just a generics manufacturer.

Maharashtra FDA Cancels Drug Licences of Cipla's Pune Warehouse Over Violations

The Maharashtra Food and Drug Administration has cancelled the drug licences of Cipla Pharma & Life Sciences' warehouse at Wadki, Pune, with effect from 1 October. The action cites misleading packaging claims for Reactin Plus, along with lapses in storage conditions, documentation practices and the handling of expired medicines. The cancellation follows fresh proceedings ordered by the Bombay High Court.

For pharmacy students, this is a live case study in good distribution practice and pharmaceutical jurisprudence. Warehousing is not a passive activity: storage temperatures, batch traceability, labelling compliance, segregation of expired stock and complete documentation are legal obligations under the Drugs and Cosmetics Rules, and this case shows regulators will enforce them even against the industry's biggest names.

The episode also illustrates how enforcement now moves through both administrative and judicial channels - the High Court's direction for fresh proceedings gave the action added legal weight. Expect this case to be cited in regulatory-affairs classrooms for a long time.

CDSCO Seeks DGHS View on Schedule K Exemption for Mercury-Based Mercurochrome

CDSCO has sought the opinion of the Directorate General of Health Services (DGHS) on whether merbromin - the mercury-based antiseptic generations of Indians know as Mercurochrome - should continue to enjoy the relaxed manufacturing and distribution provisions granted under Schedule K of the Drugs Rules.

Mercury-based antiseptics have fallen out of favour worldwide over toxicity concerns, and India is a party to the Minamata Convention on Mercury, which commits countries to phasing mercury out of products and processes. If the Schedule K relaxation is withdrawn, manufacturers would face full licensing rigour - and the product could eventually be pushed off the market altogether, as has already happened in several countries.

Pharmacy students will recognise Mercurochrome from pharmacology and jurisprudence classes as the classic example of an organomercurial antiseptic. This story connects that classroom learning - heavy-metal antiseptics, their toxicity, and international treaties - directly to live Indian regulation.

China's NMPA Grants Priority Review to Everest's Locally Made VELSIPITY (Etrasimod)

Everest Medicines has announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted - with priority review - its application to manufacture VELSIPITY (etrasimod) tablets locally in China for ulcerative colitis. Production at Everest's Jiashan facility is expected to begin in 2027.

Etrasimod is a sphingosine-1-phosphate (S1P) receptor modulator, part of a newer oral drug class for inflammatory bowel disease that works by trapping lymphocytes in lymph nodes and keeping them out of inflamed gut tissue. Local manufacturing reflects Beijing's broader push for domestic production of innovative therapies - a strategy that parallels India's own production-linked incentive schemes for APIs and formulations.

For Indian students, the ulcerative colitis pipeline deserves attention: inflammatory bowel disease incidence is rising across Asia, including India, and S1P modulators are exactly the kind of mechanism examiners love to ask about. Understanding etrasimod now puts you ahead of the curve.

Russia Begins Domestic Production of 10 Previously Unreleased Vital Medicines

Russia's Health Ministry has said that ten vital and essential drugs never before produced domestically - covering cancer, epilepsy, multiple sclerosis and rheumatoid arthritis - entered production in the first half of 2026. In parallel, CAR-T cell therapies and personalised cancer vaccines have been brought under the state guarantee programme for free medical care.

The move is part of Russia's import-substitution drive in pharmaceuticals: building domestic capacity for critical therapies rather than depending on imports. It mirrors strategies seen in India and China, where governments are using policy levers - essential-medicines lists, state procurement, manufacturing incentives - to secure supply of life-saving drugs.

For pharmacy students, this is a window into pharmaceutical policy as a living subject. How a country decides which drugs are "vital", how it pays for them, and how it builds the factories to make them are core questions in drug regulatory science and health economics worldwide.

FDA Extends Review of Novo Nordisk's Denecimig BLA for Haemophilia A Over Plant Remediation

The US Food and Drug Administration has extended its review of Novo Nordisk's biologics licence application (BLA) for denecimig, an investigational therapy for haemophilia A, because remediation at the manufacturing site is still under way following a pre-licence inspection. The company emphasised that no clinical data deficiencies were flagged, and it now targets a US launch in the first half of 2027.

This is a textbook illustration of chemistry, manufacturing and controls (CMC) deciding a drug's fate. Students should note the distinction carefully: this is not a clinical hold and not a rejection of the data - it is a manufacturing-compliance-driven extension. Even with sound clinical evidence, a plant that has not closed out its inspection observations can delay approval by months.

Denecimig would enter a competitive haemophilia A landscape that already includes factor VIII replacement products, emicizumab and gene therapies. Watch how clinicians and payers position a new entrant when it reaches the market in 2027.

EMA Validates Biosplice's Lorecivivint Application for Knee Osteoarthritis

The European Medicines Agency has validated Biosplice's marketing authorisation application for lorecivivint (LOR) in knee osteoarthritis, formally starting its scientific review. Lorecivivint is a first-in-class inhibitor of CLK and DYRK kinases, administered as an injection directly into the knee once or twice a year.

If approved, lorecivivint could become the first disease-modifying osteoarthritis drug (DMOAD) - every existing treatment only manages symptoms. That would be a landmark for one of the most common musculoskeletal conditions in the world, and it is highly relevant in India, where knee osteoarthritis is widespread and joint-replacement surgery remains out of reach for many patients.

For students, lorecivivint is a neat pharmacology story worth adding to your notes: by inhibiting CLK and DYRK kinases, it modulates Wnt signalling to protect cartilage - a mechanism that connects cell signalling, a familiar exam topic, to a genuinely novel therapy.

Conclusion

Today's news spans the full arc of a drug's life. Indian innovation won CDSCO approval through clever repurposing; regulators enforced storage and labelling discipline at a major company's warehouse; an old mercury antiseptic faces modern safety rules; China and Russia pushed domestic manufacturing of critical therapies; and the US and Europe weighed new treatments for haemophilia and osteoarthritis. For pharmacy students, the thread running through all seven stories is the same: regulation, manufacturing quality and clinical evidence move together, and staying current with them is what turns a pharmacy degree into a career.

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