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Daily Pharma News - 11 October 2026

Today's pharma headlines are dominated by drug pricing and regulation in India, with the Centre capping cancer-drug trade margins, Kerala overhauling hospital procurement, and the DCGI questioning unapproved entries in the new National Formulary. Globally, oncology approvals advanced on three fronts - Enhertu in China, fuzuloparib in Russia, and Tecentriq in the United States - while a counterfeit-antibiotics racket busted in Karnataka is a stark reminder of supply-chain vigilance.

Government caps trade margins at 30% on non-scheduled cancer drugs - prices may fall up to 70%

In one of the most significant drug-pricing moves of the year, the Government of India has approved a 30% cap on trade margins for non-scheduled anti-cancer medicines, according to a Press Information Bureau release dated 8 October 2026. Trade margins on these medicines will be restricted to 30% of the maximum retail price (MRP). The government expects medicine prices to fall by up to 70%, delivering projected annual savings of around Rs. 2,500 crore to cancer patients.

The decision targets a genuine affordability crisis. NPPA's analysis of market data found that non-scheduled anti-cancer medicines carry an average price mark-up of roughly 170%, with some cases exceeding 700%. Concerns had poured in from state governments - Maharashtra, Rajasthan and Karnataka - as well as patients and civil society groups, about the gap between procurement costs and the MRP charged to consumers. Karnataka's health department had flagged instances of medicines costing Rs. 86 being sold for Rs. 4,528, and has now urged the Centre to extend similar caps to high-cost cardiac and kidney medicines.

Implementation will run through a familiar route: the Directorate General of Health Services will constitute an expert committee to finalise the list of covered medicines, after which the NPPA will issue the notification. The measure builds on the 2019 intervention, when NPPA restricted trade margins on 42 selected non-scheduled anti-cancer drugs under the Drugs (Prices Control) Order, 2013 - an exercise that cut MRPs by up to 91% and saved roughly Rs. 984 crore annually across 526 brands. Manufacturers will also be required to maintain current production levels so that price control does not trigger shortages. For pharmacy students, this is a live case study in how Paragraph 19 of the DPCO is used as a policy instrument beyond the scheduled list.

NFI 2026 lists drugs CDSCO never approved - DCGI seeks explanation from IPC

The seventh edition of the National Formulary of India (NFI 2026), released on 21 September 2026 by the Union Minister of State for Health during the 6th National Pharmacovigilance Week, has run into a regulatory controversy. The 653-monograph reference - published by the Indian Pharmacopoeia Commission to promote rational prescribing, dispensing and administration - includes multiple drugs or variants that were never approved by the Central Drugs Standard Control Organisation.

The Economic Times identified at least five such entries: methylene blue 10 mg/ml injection, flumazenil 0.1 mg/ml injection, folinic acid 3 mg/ml injection and 15 mg tablets, pyridostigmine 30/60/180 mg tablets, and alteplase 20 mg and 50 mg injection vials - with sources indicating more unapproved drugs are listed. The DCGI, who heads the CDSCO, flagged the discrepancy in a formal communication to the IPC in August and sought the rationale for inclusion, reportedly warning that the mismatch could have international implications. Notably, the CDSCO had representation on the NFI core committee and had raised concerns during preparation, yet the entries stayed.

For pharmacists and students, the episode underlines an important hierarchy: the formulary is a guidance document, but legal marketing approval flows from the CDSCO under the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019. Prescribing or dispensing a formulary-listed drug that lacks CDSCO approval is a compliance grey zone every practising pharmacist should understand.

15,000 fake antibiotic vials sold across India - Karnataka SIT busts counterfeit racket

The Karnataka Police Special Investigation Team has unearthed an interstate counterfeit-drug racket that sold around 15,000 vials of fake antibiotic injections across India over the past eighteen months. The racket allegedly imported fake labels - including those of Pfizer's Zavicefta and Emblavco - from Turkey and pasted them onto vials containing substandard or unusable medicines, selling them for roughly Rs. 10 crore in Bengaluru, Chennai and Delhi alone.

The alleged kingpin, Prashanth Rajan Babu, had been staying in Azerbaijan to evade arrest and was taken into custody after landing at Bengaluru airport. The case surfaced after Food Safety and Drug Administration raids on farmhouses in Karnataka in August seized counterfeit medicines worth Rs. 4.91 crore. Investigators found that cheap, expired and unusable medicines sourced from Haryana, Himachal Pradesh and Telangana were being relabelled and pushed through DM Pharma and Kripa Pharma networks.

For pharmacy practice, this is a textbook pharmacovigilance and supply-chain lesson: counterfeit injectables bypass every quality assumption a dispensing pharmacist makes. Verification of supplier credentials, batch traceability, and prompt reporting of suspect products to regulators are not paperwork - they are patient safety.

Kerala overhauls drug procurement - insulin and SMA drug prices to crash

The Kerala government is set to sharply cut medicine prices in public hospitals by eliminating intermediaries and purchasing directly from pharmaceutical manufacturers. Under the Kerala Medical Services Corporation's revised procurement, a 10 ml vial of insulin will fall from Rs. 99.60 to Rs. 73 - saving an estimated Rs. 18.50 crore on four months' supply - while erythropoietin injections drop from Rs. 110 to Rs. 80 per dose.

The most dramatic cut concerns risdiplam, the spinal muscular atrophy drug previously procured from Roche at Rs. 5.52 lakh per bottle: following a Supreme Court ruling that cleared a Natco Pharma generic, the price has been negotiated down to about Rs. 8,000 per bottle. Annual tenders will now be restricted to manufacturers and direct import agencies, with intermediaries excluded; suppliers offering gratuities will be barred and substandard suppliers face permanent blacklisting. Fresh supplies under the new system are expected in hospitals by February.

Read together with the Centre's cancer-drug margin cap, a clear national theme is emerging: Indian policymakers are attacking drug prices from both the retail-margin side and the public-procurement side simultaneously. Pharmacy students should watch how direct procurement, generic substitution and margin regulation interact - this is health economics in real time.

China's NMPA approves adjuvant Enhertu for HER2-positive early breast cancer

China's National Medical Products Administration has approved fam-trastuzumab deruxtecan-nxki (T-DXd, marketed as Enhertu) for the adjuvant treatment of adults with HER2-positive early breast cancer - defined as IHC 3+ or ISH-positive - who still have residual invasive disease after neoadjuvant therapy with a taxane and trastuzumab.

The approval rests on the phase 3 DESTINY-Breast05 trial, in which T-DXd (5.4 mg/kg every three weeks) was compared head-to-head with trastuzumab emtansine (T-DM1, Kadcyla) in 1,635 patients. At the interim analysis presented at ESMO 2025, T-DXd cut the risk of invasive disease recurrence or death by 53% (hazard ratio 0.47), with three-year invasive disease-free survival of 92.4% versus 83.7% for T-DM1. The main safety signal to know: drug-related interstitial lung disease occurred in 9.6% of T-DXd patients, mostly low grade, but with rare fatal cases - monitoring for respiratory symptoms is part of the drug's risk management everywhere it is used.

Notably, the same adjuvant indication was approved by the US FDA in May 2026 and is already cleared in Brazil, Canada and India, with the EU, Japan and Switzerland still reviewing. For pharmacology students, Enhertu is the flagship example of the antibody-drug conjugate class: a HER2-directed antibody delivering a topoisomerase I inhibitor payload straight into tumour cells - and DESTINY-Breast05 shows the class still has room to displace older ADCs.

Russia registers fuzuloparib (Elefusa) - new PARP inhibitor for ovarian and breast cancer

Russia's Health Ministry has granted registration to the original drug Elefusa (fuzuloparib), with Petrovax Pharm handling supply and further localisation. Fuzuloparib is a PARP inhibitor - it blocks a key DNA-repair pathway that becomes critical for tumour-cell survival when BRCA genes or other DNA-repair genes are defective.

The drug is approved as maintenance therapy for advanced epithelial ovarian, fallopian tube and primary peritoneal cancers in patients who responded to first-line platinum chemotherapy; as maintenance for platinum-sensitive relapse; and as monotherapy for metastatic HER2-negative breast cancer in patients with germline BRCA1/2 mutations previously treated with chemotherapy. It joins a PARP-inhibitor family that includes olaparib, niraparib and rucaparib - a class every oncology pharmacist must know for its synthetic-lethality mechanism and its signature toxicities (anaemia, nausea, fatigue).

The breast-cancer angle creates a neat cross-border correlation with China's Enhertu approval above: within the same week, two major regulators expanded targeted options for breast cancer - one an antibody-drug conjugate for HER2-positive disease, the other a PARP inhibitor for BRCA-mutated HER2-negative disease. Precision oncology is now genuinely global.

FDA approves Tecentriq plus chemotherapy for stage III dMMR colon cancer

The US FDA has approved atezolizumab (Tecentriq), together with a fluoropyrimidine and oxaliplatin, for the adjuvant treatment of stage III deficient mismatch repair (dMMR) colon cancer - the drug's twelfth US indication, and the first immunotherapy-based regimen approved in this setting. Both the intravenous Tecentriq and the subcutaneous Tecentriq Hybreza formulations are covered.

The approval is based on the landmark phase 3 ATOMIC trial (712 patients, results published in the New England Journal of Medicine), in which adding Tecentriq to mFOLFOX6 chemotherapy cut the risk of disease recurrence or death by 50% versus chemotherapy alone. Three-year disease-free survival was 86% with the combination against 76% with chemotherapy alone. About 15% of colon cancers are dMMR or microsatellite-instability-high, and their high mutation burden makes them responsive to PD-L1 blockade - until now, adjuvant treatment did not differ by mismatch-repair status.

For students, the pharmacology takeaway is mechanism-matched therapy: dMMR tumours accumulate mutations, produce more neoantigens, and therefore respond to checkpoint inhibition - the same biological logic that brought immunotherapy into metastatic dMMR colorectal cancer years ago, now moved earlier into the curative-intent adjuvant setting.

Conclusion

11 October's news ties together the two great currents in modern pharmacy: access and innovation. On access, India moved on two fronts at once - capping private-market cancer-drug margins while Kerala rebuilt public procurement around direct manufacturer deals - and regulators on both sides (DCGI on the formulary, Karnataka police on counterfeits) tightened quality oversight. On innovation, three regulators on three continents expanded precision oncology within days of each other. For pharmacy students, the message is simple: know your mechanisms, watch your supply chain, and follow the pricing - because all three decide what actually reaches the patient.

References

  1. PharmaTutor - Government Approves 30% Trade Margin Cap on Non-Scheduled Cancer Drugs; Rs. 2,500 Crore Annual Savings Expected https://www.pharmatutor.org/content/october-2026/government-approves-30-percent-trade-margin-cap-on-non-scheduled-cancer-drugs-2500-crore-annual-savings-expected
  2. MedicarePharmaBusiness - National Formulary of India 2026 Lists Unapproved Drugs; DCGI Seeks Urgent Explanation from IPC https://medicarepharmabusiness.com/national-formulary-of-india-2026-lists-unapproved-drugs-dcgi-seeks-urgent-explanation-from-ipc-over-regulatory-discrepancy/
  3. Onmanorama - Fake antibiotics with international labels: 15,000 counterfeit vials sold in India over 1.5 years https://www.onmanorama.com/news/india/2026/10/08/fake-antibiotics-with-international-labels-counterfeit-vials-sold-in-india-over-1-5-years.html
  4. Mathrubhumi English - Kerala govt plans major price cuts for insulin, SMA drugs https://english.mathrubhumi.com/amp/news/kerala/kerala-govt-plans-major-price-cuts-for-insulin-sma-drugs-move-part-of-procurement-overhaul-amid-shortage-row-anz3r9kq
  5. OncLive - China's NMPA Approves Adjuvant T-DXd for HER2+ Early Breast Cancer With Residual Invasive Disease https://www.onclive.com/view/china-s-nmpa-approves-adjuvant-t-dxd-for-her2-early-breast-cancer-with-residual-invasive-disease
  6. GxP News - Russia's Health Ministry registers drug for targeted therapy of ovarian cancer and HER2-negative breast cancer https://gxpnews.net/en/2026/10/russias-health-ministry-registers-drug-for-targeted-therapy-of-ovarian-cancer-and-her2-negative-breast-cancer/
  7. Business Wire - FDA Approves Genentech's Tecentriq in Combination With a Fluoropyrimidine and Oxaliplatin for the Adjuvant Treatment of a Certain Type of Stage III Colon Cancer https://www.businesswire.com/news/home/20261009492482/en/FDA-Approves-Genentechs-Tecentriq-in-Combination-With-a-Fluoropyrimidine-and-Oxaliplatin-for-the-Adjuvant-Treatment-of-a-Certain-Type-of-Stage-III-Colon-Cancer

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