Daily Pharma News - 21 October 2026

DCGI Questions NFI 2026: National Formulary of India Lists Drugs Without CDSCO Approval

The Drugs Controller General of India (DCGI) has sought an explanation from the Indian Pharmacopoeia Commission (IPC) after at least five drugs in the seventh edition of the National Formulary of India (NFI 2026), released on 21 September, were found to lack approval from the Central Drugs Standard Control Organisation (CDSCO). The NFI is a key prescribing reference used by doctors and pharmacists across India, so any inaccuracy in its drug listings raises serious questions about patient safety and rational prescribing.

For pharmacy students, this story is a powerful lesson in regulatory pharmacology. The NFI is meant to contain only drugs with established efficacy, safety and CDSCO marketing approval. The DCGI's intervention shows that even official reference documents can contain errors — and that pharmacists must always cross-check regulatory status through CDSCO before dispensing or recommending a medicine.

CDSCO Export NOC Waiver for r-DNA Drugs: New Rule Simplifies Biotech Exports

CDSCO has clarified, in a notice dated 12 October 2026, that approved recombinant DNA (r-DNA) drug products holding a valid marketing authorisation in Form CT-23 do not require a separate Export NOC when exported under a different brand name. The waiver applies as long as the composition, strength, manufacturing site and other critical particulars remain unchanged.

This is significant for India's growing biotech and biosimilar industry. r-DNA technology drugs — including insulin analogues, monoclonal antibodies and vaccines — are a major export segment for Indian pharmaceutical companies. By removing a redundant regulatory step, CDSCO is making it easier for Indian manufacturers to rebrand and market approved biotech products in international markets, a welcome simplification for regulatory affairs professionals.

Mankind Pharma Backs CAR-T Start-Up Armed Cell: Indian Pharma Enters Cell Therapy

Mankind Pharma has taken a majority stake in Armed Cell Therapeutics, a new CAR-T start-up founded by former Galapagos CEO Paul Stoffels, investing €48 million as part of a raise of over €50 million. The funding will be used to revive preclinical CAR-T (chimeric antigen receptor T-cell) therapy programmes at a time when venture capital appetite for cell therapy has been weak.

CAR-T cell therapy is one of the most advanced frontiers in oncology, using genetically engineered T cells to attack blood cancers. An established Indian generics company betting on next-generation cell therapy signals how far Indian pharma is moving beyond generics into advanced therapeutics. For pharmacy and pharmacology students, CAR-T is a must-watch topic bridging immunology, gene therapy and personalised medicine.

Tamil Nadu Monsoon Alert: Hospitals Ordered to Keep 7-Day Medicine Stocks

Tamil Nadu Health Minister K G Arunraj has directed all government and private hospitals in the state to maintain seven-day stocks of essential medicines ahead of the northeast monsoon. The directive covers IV fluids, oral rehydration salts (ORS), snakebite antivenom and oxygen, alongside keeping ambulances and generators ready and strengthening dengue surveillance.

Monsoon-related health emergencies — from waterborne infections to dengue outbreaks — test drug supply chains every year. This story matters for pharmacy students because hospital pharmacy and inventory management are core professional skills: anticipating seasonal demand, maintaining buffer stocks of life-saving medicines like antivenom and IV fluids, and coordinating cold-chain logistics during power disruptions are exactly the responsibilities pharmacists carry in public health emergencies.

Lisaftoclax Wins NMPA Breakthrough Tag: China's First Bcl-2 Inhibitor for Untreated CLL

China's National Medical Products Administration (NMPA), through its Center for Drug Evaluation (CDE), has granted Breakthrough Therapy Designation to Ascentage Pharma's lisaftoclax, an oral Bcl-2 inhibitor, in combination with acalabrutinib for treatment-naïve chronic lymphocytic leukaemia / small lymphocytic lymphoma (CLL/SLL). Lisaftoclax is the first Bcl-2 inhibitor developed in China, and the combination offers a fixed-duration treatment alternative to continuous BTK inhibitor therapy.

Bcl-2 inhibitors work by blocking a protein that helps cancer cells survive, triggering programmed cell death in malignant lymphocytes. The breakthrough designation speeds up regulatory review for drugs showing substantial improvement over existing treatments. For Indian pharmacy students, this is a strong example of how Asian biopharma innovation — alongside Indian companies — is reshaping global oncology drug development beyond traditional Western pipelines.

Russia Clears Hengrui's SHR-A1811 Trial: HER2 Antibody-Drug Conjugate Advances

Russia's Health Ministry has authorised a clinical trial of Jiangsu Hengrui's trastuzumab rezetecan (SHR-A1811), an antibody-drug conjugate (ADC) targeting HER2. The study will assess how the antifungal drug itraconazole affects the pharmacokinetics and safety of rezetecan, the active metabolite of the ADC.

ADCs are among the most sophisticated cancer drugs in development: a monoclonal antibody delivers a potent cytotoxic payload directly to tumour cells expressing the HER2 receptor. Drug–drug interaction studies like this one — itraconazole is a known CYP3A4 inhibitor — are a standard but critical part of clinical pharmacology, determining whether co-administered medicines alter exposure and toxicity. Watch this space: HER2-targeted ADCs are transforming breast and gastric cancer treatment worldwide.

FDA Approves GSK's Hibsago (Bepirovirsen): First Antisense Drug for Chronic Hepatitis B

The US Food and Drug Administration (FDA) approved GSK's Hibsago (bepirovirsen) on 20 October — the first antisense oligonucleotide approved for chronic hepatitis B. The drug lets patients keep the virus controlled after stopping treatment: clinical trials showed roughly one in five patients reached undetectable virus levels for at least six months after coming off therapy.

Antisense oligonucleotides are short synthetic strands of nucleic acid that bind to viral mRNA and block protein production — a completely new drug class for hepatitis B, which still causes hundreds of thousands of deaths globally each year. The concept of finite-duration therapy with durable viral suppression after stopping treatment, sometimes called functional cure, is a paradigm shift from lifelong antiviral therapy. India carries a large hepatitis B burden, so this approval is directly relevant to Indian pharmacology and clinical practice.

Conclusion

Today's news spans the full spectrum of what pharmacy students need to master. On the regulatory front, the DCGI's questioning of the National Formulary of India and CDSCO's export NOC waiver show regulation cutting both ways — tightening accuracy where patient safety is at stake, and easing paperwork where industry needs speed. Mankind Pharma's bet on CAR-T cell therapy marks Indian pharma's push into advanced therapeutics, while Tamil Nadu's monsoon preparedness order is a real-world case study in hospital pharmacy and supply-chain management. Globally, the day belonged to innovation: China's first homegrown Bcl-2 inhibitor earning breakthrough status, a HER2 antibody-drug conjugate advancing through Russian trials, and the FDA's landmark approval of the first antisense drug for chronic hepatitis B. Together, these stories reinforce one message for pharmacy students — the profession today spans regulation, public health, cutting-edge drug delivery and entirely new therapeutic classes, and staying current is part of the job.

References

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