Daily Pharma News - 30 September 2026

Today's pharma headlines span drug approvals, generic filings, enforcement action, and landmark first-in-class therapies - from India's DCGI to the US FDA, China's NMPA, and Russia's Health Ministry. Here is what matters for pharmacy students and professionals.

Akums Drugs receives DCGI approval for Colchicine 0.5 mg tablets - India's first for cardiovascular risk reduction

Akums Drugs and Pharmaceuticals has received approval from the Drugs Controller General of India (DCGI) for Colchicine 0.5 mg tablets, making it the first colchicine formulation in India approved for reducing cardiovascular risk. The approval covers reduction in the risk of heart attack, stroke, and other cardiovascular events - a significant label expansion for a molecule long known to pharmacy students primarily as a gout therapy.

Colchicine's anti-inflammatory action has been studied in coronary artery disease in major international trials, where low-dose colchicine showed benefit in patients with established atherosclerotic cardiovascular disease. For Indian pharmacy practice, this approval is a textbook example of drug repurposing and label extension: a well-understood, inexpensive molecule finding a new therapeutic role through regulatory science. With cardiovascular disease being India's leading cause of mortality, an affordable domestic option in this space carries substantial public-health relevance.

Morepen Laboratories files first US ANDA for Sitagliptin diabetes tablets

Morepen Laboratories has submitted its first Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (US FDA) for Sitagliptin tablets in 25 mg, 50 mg, and 100 mg strengths, used in the management of type 2 diabetes mellitus. The filing marks Morepen's strategic move from an active pharmaceutical ingredient (API) and contract development and manufacturing (CDMO) player into finished-dosage generic formulations for the regulated US market.

Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is one of the world's most prescribed oral antidiabetics, making it a high-value generic target as innovator exclusivities expire. For Indian pharma students, this story illustrates the ANDA pathway, patent-expiry-driven generic strategy, and how Indian companies climb the value chain from bulk drugs to finished formulations. Given India's enormous type 2 diabetes burden, the domestic generic ecosystem around gliptins is also a model worth studying.

Bengaluru spurious-drug racket: SIT arrests seventh accused in Chennai

The Special Investigation Team (SIT) probing the interstate spurious-medicine racket centred on Bengaluru has arrested a seventh accused in Chennai, while the prime suspect was reportedly apprehended at Kempegowda International Airport (KIA). The case involves the distribution of fake and substandard medicines across state lines, striking at the heart of drug supply-chain integrity.

Spurious and substandard drugs remain one of the gravest threats to public health and to trust in the pharmaceutical system. This enforcement action is a live case study for students on the Drugs and Cosmetics Act, the role of state drug controllers, and why pharmacovigilance, supply-chain traceability, and the pharmacist's duty to source only from licensed distributors matter in everyday practice. Karnataka's regulatory response - including licence cancellations in the state - underscores how seriously regulators treat quality-system violations.

China NMPA approves Jaypirca (pirtobrutinib) for all-line CLL/SLL treatment

China's National Medical Products Administration (NMPA) has approved Jaypirca (pirtobrutinib) as monotherapy across all treatment lines of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). Pirtobrutinib is a non-covalent Bruton's tyrosine kinase (BTK) inhibitor, a newer class designed to remain active against disease that has developed resistance to covalent BTK inhibitors.

For pharmacy students, the pharmacology is the headline: covalent BTK inhibitors bind irreversibly to the C481 residue of the BTK enzyme, and resistance commonly arises through C481 mutations - a non-covalent inhibitor bypasses that resistance mechanism. The all-line approval in China reflects growing global acceptance of this drug class and highlights how targeted oncology therapy continues to evolve toward overcoming resistance, a recurring theme in modern haematology.

Russia registers Mentetra - first domestic quadrivalent meningitis vaccine

Russia's Health Ministry has registered Mentetra, developed by Petrovax Pharm, as the country's first domestically produced quadrivalent meningococcal vaccine. Quadrivalent vaccines protect against four major meningococcal serogroups - A, C, W, and Y - which together account for most invasive meningococcal disease worldwide.

The registration is a milestone in Russia's pharmaceutical import-substitution strategy, reducing dependence on foreign vaccine suppliers for a critical public-health product. For Indian students, the story resonates: India too has pursued vaccine self-reliance, and quadrivalent meningococcal vaccines are relevant to travel medicine, military and Hajj vaccination requirements, and outbreak preparedness. It is also a clear example of how national regulatory agencies balance speed of access with quality assurance for biologics.

US FDA approves EMCITATE (tiratricol) - first drug for MCT8 deficiency

The US FDA has approved EMCITATE (tiratricol), developed by Egetis Therapeutics, as the first-ever treatment for MCT8 deficiency, a rare genetic disorder also known as Allan-Herndon-Dudley syndrome. MCT8 deficiency is caused by mutations in the SLC16A2 gene encoding the monocarboxylate transporter 8, which carries thyroid hormone into brain cells; affected patients suffer severe neurodevelopmental impairment alongside peripheral thyrotoxicosis.

Tiratricol is a thyroid hormone analogue and thyroid hormone receptor agonist that bypasses the defective transporter, addressing the peripheral hormonal imbalance. This approval is a landmark in orphan-drug development and a compelling study case for students on rare-disease pharmacology, the FDA's orphan drug incentives, and how mechanistic understanding of a transporter defect can be translated into a targeted therapy where none existed.

US FDA approves Teva's DEGEVMA (denosumab-adet), biosimilar to Xgeva

The US FDA has approved Teva's DEGEVMA (denosumab-adet) as a biosimilar to Xgeva (denosumab) across all of the reference product's indications, covering the prevention of skeletal-related events - such as bone fractures and spinal cord compression - in patients with bone metastases from solid tumours, as well as giant cell tumour of bone. Denosumab is a monoclonal antibody that inhibits RANK ligand (RANKL), blocking osteoclast formation and bone resorption.

Biosimilar approvals like this one expand affordable access to high-cost biologics and intensify competition in the oncology supportive-care market. For pharmacy students, DEGEVMA is an excellent case study in biosimilarity: the demonstration of no clinically meaningful differences from the reference product, extrapolation across indications, and the naming convention (the four-letter suffix "-adet") that the FDA uses to distinguish biosimilars. With India being a global biosimilars manufacturing hub, this approval also signals opportunities for Indian companies in regulated markets.

Conclusion

Today's news captures the full spectrum of modern pharmacy: regulatory innovation in India with first-in-country approvals and a first US generic filing, enforcement action protecting the drug supply chain, and global advances from oncology and vaccines to rare-disease and biosimilar therapies. For pharmacy students, the connecting thread is the regulator's central role - DCGI, US FDA, NMPA, and Russia's Health Ministry each shaped today's headlines - and the reminder that pharmacology, law, and public health move together. Staying current with these decisions is not just exam preparation; it is the foundation of competent, future-ready pharmacy practice.

References

1. New Indian Express - Akums Drugs and Pharmaceuticals receives DCGI approval for Colchicine 0.5 mg tablets https://www.newindianexpress.com/amp/story/india/2026/Sep/29/akums-drugs-pharmaceuticals-receives-dcgi-approval-for-colchicine-05-mg-tablets
2. Fortune India - Morepen Laboratories shares jump 5% after first US ANDA filing for diabetes drug https://www.fortuneindia.com/markets/morepen-laboratories-shares-jump-5-after-first-us-anda-filing-for-diabetes-drug-zoom-267-in-6-months/161519
3. The Indian Express - Spurious medicine racket: SIT arrests seventh accused in Chennai https://indianexpress.com/article/cities/bangalore/spurious-medicine-racket-sit-arrests-seventh-accused-chennai-10899571/
4. OncLive - China's NMPA approves pirtobrutinib across CLL https://www.onclive.com/view/china-s-nmpa-approves-pirtobrutinib-across-cll
5. GxP News - Russia gets domestic quadrivalent meningitis vaccine https://gxpnews.net/en/2026/09/russia-gets-domestic-quadrivalent-meningitis-vaccine/
6. Manila Times (GlobeNewswire) - Egetis Therapeutics announces US FDA approval of EMCITATE (tiratricol) for patients with MCT8 deficiency https://www.manilatimes.net/2026/09/29/tmt-newswire/globenewswire/egetis-therapeutics-announces-us-fda-approval-of-emcitate-tiratricol-for-patients-with-mct8-deficiency/2434566/amp
7. BioSpace - Teva continues biosimilar momentum with US FDA approval of DEGEVMA (denosumab-adet), a biosimilar to Xgeva https://www.biospace.com/press-releases/teva-continues-biosimilar-momentum-with-u-s-fda-approval-of-degevma-denosumab-adet-a-biosimilar-to-xgeva-denosumab

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