The Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi noted that despite a nationwide ban since 2009, some producers are still suspected of selling these formulations in violation of global protocols and advisories of the World Health Organization (WHO). The issue is pertinent because using artemisinin alone accelerates resistance and risks undermining the “gold-standard” therapies that India relies on to treat the deadly plasmodium falciparum strain of the mosquito-borne disease.
The latest directive serves as a stringent reminder of a decision originally taken nearly two decades ago to protect the efficacy of life-saving medicines. The WHO has long warned against using this drug by itself in pill form, in a treatment known as ‘monotherapy’.
Following the 2009 domestic ban, the DCGI had issued an order in 2011, cancelling manufacturing licenses for exports to curb global resistance. The latest directive reinforces the earlier orders to close any remaining regulatory gaps.
In his letter to state and Union territory drug controllers, the DCGI said that in order to ensure the malaria parasite does not become resistant to the drug, the WHO had recommended the withdrawal of oral single-drug formulations of artemisinin and its derivatives.
An official explained that the oral single-ingredient artemisinin is dangerous because it behaves like a half-measure against the disease. In simple terms, while it kills some malaria parasites quickly, it often does not stay in the body long enough to clear the infection fully. “The parasites that survive are the most resilient ones, and they pass this survival ability to the next generation. This process creates “super-parasites” that can withstand standard medicines,” the official said.
To prevent this, the medical community shifted to artemisinin-based combination therapies (ACTs), where artemisinin is mixed with another drug. “This combination acts like a double-punch that the parasite cannot easily adapt to, ensuring a complete cure,” the official added.
While ACTs remain effective, local studies and the World Malaria Reports have periodically flagged “suspected” or “partial” artemisinin resistance in isolated pockets, particularly near India’s international borders. The ban aims to prevent this from evolving into widespread “confirmed” resistance.
State drug controllers have started market surveillance to detect sale of the single-drug formulation against the ban, as per DCGI’s directions. Manufacturing a banned drug violates Section 26A of the Drugs and Cosmetics Act, 1940. It is punishable by imprisonment of three years or more, fines, and the immediate cancellation of manufacturing licenses.
While specific drug seizure data has not been disclosed, the directive calls out “some producers” for continuing clandestine manufacturing. With the anti-malarial market valued at over $30 million, even a small percentage of non-compliant production could represent a significant volume of banned pills.
The crackdown comes at a critical time for India’s public health landscape. According to the WHO World Malaria Report 2025, India remains the epicentre of malaria in the WHO South-East Asia Region, bearing roughly 73.3% of the region’s estimated case burden and 88.7% of its malaria deaths in 2024. The country accounted for approximately 2 million estimated cases.
While India has achieved a massive reduction in malaria cases since 2015—a milestone that led to it officially exit WHO’s ‘High Burden to High Impact’ group in 2024—the progress has faced recent setbacks. The report notes an estimated 11.1% increase in cases from 2023 to 2024, keeping health officials on high alert.
“The DCGI has instructed state regulators to ensure strict compliance and immediately withdraw any existing manufacturing permissions for these single-drug oral pills to remove them from the market,” the second official said.
Officials did not disclose the names of companies producing the single-ingredient artemisinin pills or their share in the anti-malarial market.
India’s anti-malarial drugs market was valued at around $30.15 million in 2024 and is projected to grow to about $38.82 million by 2030, according to TechSci Research.
The sector is driven by major players including Cipla, IPCA Laboratories, Sun Pharma, Zydus Lifesciences, and Akums, alongside global firms like Lupin supplying generic artemisinin-based combination therapies.
Industry leaders have voiced support for the move. Ritesh Shah, joint managing director at Anuh Pharma, said the directive aims to strengthen regulatory enforcement in malaria treatment, which is in the interest of patients and the industry. He clarified that while his company does manufacture active pharmaceutical ingredients, it does not market oral single-ingredient artemisinin formulations.
Shah emphasized that Anuh’s anti-malarial offerings are already aligned with WHO-recommended combination therapies, supporting the scientific consensus that ACTs remain the most effective frontline treatment.
Despite the recent uptick in cases, India remains committed to eliminate malaria by 2030. Government data indicates the country has seen a reduction of over 78% in malaria cases and also malaria-related deaths between 2015 and 2024. Union Health Ministry data released in July 2025 indicates a 78.1% reduction in malaria cases and a 77.6% reduction in deaths between 2015 and 2024.
Queries related to the regulator’s move emailed to the health ministry spokesperson, the DCGI office and companies mentioned above on Wednesday remained unanswered till press time.
Payden, the acting WHO representative to India, said the DCGI’s renewed directive to halt the manufacture and sale of oral single-ingredient artemisinin formulations is a vital public-health measure.
“Artemisinin should never be used alone; doing so increases the risk that malaria parasites survive incomplete treatment and develop resistance. Such resistance would undermine the effectiveness of Artemisinin-based Combination Therapies (ACTs), which are the globally recommended first-line treatment for Plasmodium falciparum malaria,” she added.
The action will “strengthen global malaria-control efforts, protect vulnerable communities, and help preserve the long-term efficacy of ACTs, which remain essential tools in reducing severe disease and saving lives”, the WHO representative said.