Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi noted that despite a nationwide ban since 2009, some manufacturers are still suspected of selling these preparations in violation of global protocols and recommendations World Health Organization (WHO). The issue is relevant because the use of artemisinin alone accelerates resistance and risks undermining the “gold standard” therapies India relies on to treat the deadly mosquito-borne disease Plasmodium falciparum.
The latest guidelines serve as a stark reminder of the decision originally made nearly two decades ago to protect the effectiveness of life-saving drugs. The WHO has long warned against taking the drug alone in pill form in a treatment known as “monotherapy”.
After the 2009 domestic ban, The DCGI issued an order in 2011 revoking production licenses for exports to curb global backlash. The latest directive reinforces earlier orders to close remaining regulatory loopholes.
In a letter to state and territory drug controllers, the DCGI said that to ensure that the malaria parasite does not become resistant to the drug, WHO has recommended the withdrawal of oral single-drug preparations of artemisinin and its derivatives.
The official explained that oral single-component artemisinin is dangerous because it acts as a half-measure against the disease. Simply put, while it kills some malaria parasites quickly, it often doesn’t stay in the body long enough to completely clear the infection. “The parasites that survive are the most resistant and pass on this ability to survive to the next generation. This process creates ‘superparasites’ that can withstand standard drugs,” the official said.
To prevent this, the medical community has switched to artemisinin-based combination therapies (ACT), where artemisinin is mixed with another drug. “This combination acts as a double whammy to which the parasite cannot easily adapt and ensures a complete cure,” the official added.
While ACTs remain effective, local studies and World Malaria Reports regularly highlight “suspected” or “partial” resistance to artemisinin in isolated pockets, particularly near India’s international borders. The aim of the ban is to prevent this from developing into a widespread “confirmed” backlash.
State drug inspectors have launched market surveillance to detect the sale of the anti-ban dosage form as stated DCGI Guidelines. The manufacture of a prohibited drug contravenes section 26A of the Drugs and Cosmetics Act 1940. It is punishable by imprisonment for three years or more, fines and the immediate cancellation of manufacturing licences.
Although specific figures on drug seizures have not been released, the directive calls on “some manufacturers” to continue clandestine production. With an antimalarial market worth over $30 million, even a small percentage of non-compliant production could represent a significant volume of prohibited pills.
The intervention comes at a critical time for public health in India. According to the WHO World Malaria Report 2025, India remains the epicenter malaria in the WHO South-East Asia region, which will account for roughly 73.3% of the region’s estimated number of cases and 88.7% of 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 saw it officially leave the WHO’s “High Burden to High Impact” group in 2024 – progress has faced recent setbacks. The report cites an estimated 11.1% increase in cases from 2023 to 2024, keeping health professionals on alert.
“The DCGI has directed state regulatory authorities to ensure strict compliance and immediately withdraw all existing manufacturing permits for these single-drug oral pills to remove them from the market,” said a second official.
Officials did not release the names of the companies that make the single-ingredient artemisinin pills or their share of the anti-malaria market.
The Indian antimalarial drugs market was valued at approximately USD 30.15 million in 2024 and is projected to grow to approximately USD 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, along with global firms such as Lupin. providing generic artemisinin-based combination therapies.
Industry leaders expressed support for the move. Ritesh Shah, Joint Managing Director of Anuh Pharma, said the directive aims to strengthen enforcement in malaria treatment, which is in the interest of both patients and the industry. He clarified that while his company manufactures active pharmaceutical ingredients, it does not sell oral single-component artemisinin formulations.
Shah emphasized that Anuh’s antimalarial offerings are already in line with WHO-recommended combination therapies, supporting the scientific consensus that ACTs remain the most effective first-line treatment.
Despite the recent increase in cases, India is committed to eliminating malaria by 2030. Government data indicates that the country saw a more than 78% reduction in malaria cases and 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 20.6% reduction in 2015
Queries related to the regulator’s move emailed on Wednesday to the Health Department spokesperson, the DCGI office and the aforementioned companies remained unanswered as of press time.
