India Pharma Outlook Team | Monday, 19 October 2026
India’s pharmaceutical sector is seeing major developments in drug pricing, cancer treatment, manufacturing, and international market expansion. The Centre has notified a 30 percent trade-margin cap on 137 anti-cancer drugs, while Lupin has secured regulatory approval for a nivolumab biosimilar in India.
Meanwhile, Zydus Lifesciences is expanding its manufacturing footprint in Sri Lanka, and Venus Remedies has received five marketing authorizations across four countries. In a separate research development, Novartis has ended a mid-stage clinical trial of Fabhalta for lupus nephritis, citing strategic considerations.
Here’s a look at the latest pharma industry updates.
The National Pharmaceutical Pricing Authority (NPPA) has notified a 30 percent trade-margin cap on 137 non-scheduled anti-cancer drugs to curb excessive markups and improve medicine affordability. The measure will take effect on November 9, 2026.
The list includes medicines such as pembrolizumab, osimertinib, nivolumab, and pertuzumab. The government expects the intervention to reduce prices of selected medicines by up to 70 percent and generate annual savings of around Rs 2,500 crore.
However, the impact may vary across brands and medicines. The latest list also includes 32 drugs covered under the previous 2019 exercise, raising questions about the effectiveness of earlier price-control measures. Medicines supplied under patient access programs will be exempt from the new trade-margin cap.
Lupin Limited has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market a biosimilar version of nivolumab in India. The drug is a biosimilar alternative to Bristol Myers Squibb’s immunotherapy Opdivo.
The approval covers the finished formulation and the bulk drug, with manufacturing planned in partnership with Hyderabad-based Virchow Biotech. Lupin’s application was supported by a local Phase III study that assessed the biosimilar’s efficacy, immunogenicity, and pharmacokinetics against the reference product.
Nivolumab is used to treat several cancers, including melanoma, non-small cell lung cancer, kidney cancer, and head and neck cancer. Lupin has also been directed to conduct a Phase IV study to monitor the medicine’s safety and efficacy after its introduction into the market.
The approval comes as Indian drugmakers expand their presence in the immuno-oncology market, where biosimilars could offer additional treatment options.
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Zydus Lifesciences plans to establish a new manufacturing facility in Sri Lanka through a joint venture with Sunshine Healthcare. The project involves an investment of USD 20 million, or approximately Rs 200 crore.
The greenfield facility will be developed on four acres in the Board of Investment zone in Horana. During the first phase, it will manufacture oral solid dosage forms for the Sri Lankan market.
Commercial operations are projected to begin in 2028. The investment marks another step in Zydus’ international expansion and strengthens its manufacturing presence in a neighboring South Asian market.
The facility is expected to support local medicine production and expand the company’s ability to serve demand in Sri Lanka.
Swiss pharmaceutical company Novartis has terminated a mid-stage clinical trial evaluating Fabhalta for lupus nephritis, a serious kidney complication associated with the autoimmune disease lupus. The company cited strategic considerations for ending the study.
The trial was assessing whether the oral drug could safely and effectively treat lupus nephritis when added to standard medical care. According to the clinical trial registry, Novartis decided to conclude the study after completing its first part.
The registry did not provide further details about the decision or indicate whether safety or efficacy concerns contributed to the termination.
Fabhalta, also known as iptacopan, was first approved by the US Food and Drug Administration in 2023 for paroxysmal nocturnal hemoglobinuria, a rare blood disorder. It has since received approvals for other kidney-related conditions, including IgA nephropathy and C3 glomerulopathy.
The trial termination marks a change in the drugmaker’s development plans for lupus nephritis, although the available information does not establish the specific reasons behind the decision.
Venus Remedies has secured five marketing authorizations across Kazakhstan, Peru, Kuwait, and Argentina, strengthening its international presence and expanding its pharmaceutical portfolio in global markets.
The approvals cover vancomycin and fluorouracil in Kazakhstan, fulvestrant in Peru, methotrexate in Kuwait, and meropenem in Argentina. These authorizations extend the company’s reach across the Commonwealth of Independent States region, Latin America, and the Middle East.
The development supports Venus Remedies’ strategy of expanding exports and building its presence in markets with growth potential. The company, which focuses on critical-care injectables, already has an international footprint spanning more than 100 countries.
The latest approvals could help broaden access to its medicines and create further opportunities for international business growth.
The latest developments reflect the pharmaceutical industry’s focus on affordability, regulatory compliance, research priorities, and global expansion. The Centre’s trade-margin cap aims to ease the cost of selected cancer medicines, while biosimilar approvals could broaden treatment options in India.
At the same time, investments in overseas manufacturing and new marketing authorizations highlight Indian drugmakers’ efforts to strengthen their international presence. Novartis’ trial termination also underlines how strategic decisions can shape the development of treatments for complex diseases.
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