Daily Pharma News - 7 October 2026

Indian Pharmacopoeia 2026: 10th edition brings 121 new monographs and stronger drug quality standards

Union Health Minister JP Nadda has released the Indian Pharmacopoeia 2026, the 10th edition of the country's official drug standards compendium. The new edition adds 121 new monographs, taking the total to 3,340, and strengthens quality standards for anti-tuberculosis, anti-diabetic and anti-cancer medicines - three therapeutic areas where India treats enormous patient populations and also exports heavily.

For pharmacy students, the IP is the backbone of quality control and analysis syllabi. The 2026 edition's expanded standards reflect how fast new formulations, biosimilars and fixed-dose combinations are entering the Indian market. The IP is now recognised in 19 countries, which matters for students eyeing regulatory affairs and QC careers, since Indian manufacturers exporting to those markets must comply with these very monographs.

Source: PharmaBiz https://www.pharmabiz.com/NewsDetails.aspx?aid=183345&sid=2

Lupin Formoflo-G: world's first triple-combination COPD inhaler launched in India

Lupin has launched Formoflo-G MDI in India, described as the world's first triple-combination inhaler for chronic obstructive pulmonary disease. The metered-dose inhaler combines glycopyrronium, formoterol and fluticasone in a twice-daily formulation and has received approval from the Drugs Controller General of India (DCGI). It targets moderate-to-severe COPD, a condition affecting more than 55 million people in India.

Triple therapy for COPD combines a long-acting muscarinic antagonist (glycopyrronium), a long-acting beta-2 agonist (formoterol) and an inhaled corticosteroid (fluticasone) in a single device. Pharmacy students should note the pharmacological logic: the LAMA and LABA together maximise bronchodilation, while the ICS controls airway inflammation. A first-of-its-kind fixed combination also raises interesting questions about device design, dose uniformity and patient counselling on inhaler technique.

Source: The Free Press Journal https://www.freepressjournal.in/business/lupin-launches-formoflo-g-mdi-worlds-first-triple-combination-drug-for-copd-in-india

Central licensing of all sterile drugs: Centre may seek legal opinion on CLAA jurisdiction

The Centre is considering seeking a legal opinion on bringing all sterile drugs - injectables, parenterals and ophthalmics - under central licensing through the Central Licensing Approval Authority (CLAA). The Drugs Consultative Committee (DCC) has formed a sub-committee on the matter after the Supreme Court limited the enforcement powers of the Central Drugs Standard Control Organisation (CDSCO).

This is a significant regulatory development for pharmacy students studying pharmaceutical jurisprudence. Currently, manufacturing licences are largely issued by state authorities while the CDSCO handles central functions; shifting sterile products - the highest-risk dosage forms because contamination goes directly into blood or tissues - to central licensing would reshape inspection, enforcement and accountability across India's pharma manufacturing landscape. The Supreme Court ruling behind this move is worth reading in full for anyone preparing for regulatory or drug-inspector examinations.

Source: The Economic Times https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/centre-may-seek-legal-view-on-licensing-of-sterile-drugs/articleshow/134715676.cms

Karnataka High Court stays FSDA licence bans in Bidadi spurious-drugs crackdown

The Karnataka High Court has stayed orders of the Food Safety and Drug Administration (FSDA) cancelling and suspending drug licences in connection with the Bidadi spurious-drugs racket, allowing the affected firms to continue trading until 9 October. The Special Investigation Team (SIT) probe into the alleged Rs 5-crore fake-medicine network continues.

Spurious and substandard drugs remain one of Indian pharmacy's most serious enforcement challenges. The case illustrates the tension between swift regulatory action against suspected counterfeiters and the legal protections available to licensed firms - the court granted interim relief while the investigation proceeds. For pharmacy students, this is a live case study in drug law enforcement under the Drugs and Cosmetics Act, and a reminder that pharmacists on the ground are often the first line of defence in spotting suspicious products.

Source: The Indian Express https://indianexpress.com/article/legal-news/karnataka-high-court-drug-licence-suspension-cancellation-fake-medicines-10908417/

NMPA China: Sihuan Pharma's Dongyan skin booster gets five new specification approvals

China's National Medical Products Administration (NMPA) has approved five new specifications of Sihuan Pharmaceutical's Dongyan hyaluronic-acid skin booster, described as the first L-carnosine facial formula approved in China. The approvals complete a full dosage gradient covering hydration, antioxidant and collagen-regeneration effects.

Cosmeceuticals sit at the intersection of pharmacy, dermatology and regulation, and China's approach is instructive. Injectables for aesthetic use are regulated as medical devices or drugs depending on claims, and the NMPA's stepwise specification approvals show how regulators handle dose-ranging for hyaluronic-acid fillers. Indian pharmacy students interested in the fast-growing aesthetics and dermatology segment should watch how CDSCO frames similar combination products, since India is seeing rising demand for skin boosters and dermal fillers.

Source: MiniChart https://www.minichart.com.sg/2026/10/05/sihuan-pharmaceutical-wins-nmpa-approval-for-five-new-dongyan-skin-booster-specifications/

Expired medicines and kidney damage: Russian expert warns on drug stability risks

Hemotest expert Olga Ulankina told Izvestia on 6 October that expired medicines can lose potency and become hazardous, warning that degraded tetracyclines can cause irreversible kidney damage known as Fanconi syndrome. The warning is a timely refresher on drug stability for pharmacy students and practitioners alike.

Expiry dates are based on stability studies conducted under defined storage conditions, and degradation products can differ pharmacologically from the parent drug - the classic tetracycline example, where degraded anhydro-4-epitetracycline damages proximal renal tubules, is taught in pharmaceutics and pharmacology courses for exactly this reason. The story is also a useful counselling point: patients should never use medicines past their expiry date, and pharmacies must follow first-expiry-first-out stock rotation and proper disposal of expired stock.

Source: Izvestia https://en.iz.ru/en/2178654/2026-10-06/doctor-told-about-danger-expired-medicines

FDA priority review for BridgeBio's oral infigratinib in achondroplasia: global drug approval watch

The US Food and Drug Administration (FDA) has accepted BridgeBio's New Drug Application and granted priority review to oral infigratinib for children with achondroplasia, the most common form of disproportionate short stature. Infigratinib is the only candidate in this indication with Breakthrough Therapy designation, and trial data showed benefits beyond height - including improved sleep apnoea and fewer ear infections. A European Medicines Agency (EMA) filing is expected in Q4 2026.

Infigratinib is an FGFR3 inhibitor, targeting the overactive fibroblast growth factor receptor 3 signalling that causes achondroplasia - a clean example of precision medicine moving from molecular target to oral therapy. For pharmacy students, this story connects pharmacology (receptor tyrosine kinase inhibition), clinical pharmacy (paediatric dosing of an oral targeted therapy) and regulatory science (priority review and Breakthrough Therapy pathways). If approved, India-relevant access questions will follow, since rare-disease therapies face steep affordability and import hurdles here.

Source: The Manila Times (GlobeNewswire) https://www.manilatimes.net/2026/10/06/tmt-newswire/globenewswire/bridgebio-announces-fda-acceptance-and-priority-review-of-nda-for-oral-infigratinib-for-children-with-achondroplasia/2439864

Conclusion

Today's news spans the full arc of a pharmacist's world: quality standards (Indian Pharmacopoeia 2026), new dosage forms (Lupin's triple COPD inhaler), regulatory jurisdiction (central licensing of sterile drugs), enforcement (the Karnataka spurious-drugs case), regional regulation (China's NMPA), drug stability (expired medicines and renal risk) and global innovation (infigratinib's FDA priority review). For pharmacy students, the thread connecting them is clear - whether you end up in QC, manufacturing, clinical practice, regulatory affairs or research, these are the forces that shape what drugs reach patients and how safely they get there. Keep reading the regulations behind the headlines; the exam questions of tomorrow are written in today's press releases.

References

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