Why Was Neurobion Banned? Debunking the Myth and Unpacking the Facts

October 7, 2025 •

4 min read

Despite widespread rumors and public confusion, the popular vitamin supplement Neurobion has never been subjected to a global, universal ban. The misconception is primarily rooted in specific, regional regulatory actions concerning fixed-dose combinations (FDCs), the circulation of counterfeit products, and safety concerns related to high dosages.

Quick Summary

This article explains that Neurobion's 'ban' is a misunderstanding, clarifying that regulatory actions targeted specific formulations or counterfeit versions in certain countries like India and the Philippines. It details the safety concerns over high-dose B6 and differentiates standard Neurobion from other products.

Key Points

No Universal Ban: The widespread rumor that Neurobion was globally banned is a myth; it remains available in many countries.
Indian FDC Restriction: In India, the government banned a specific fixed-dose combination (FDC) of vitamins B1, B6, and B12 in 2001, not the Neurobion brand itself.
Counterfeit Issues: Some regulatory actions, like in the Philippines and Belize, targeted counterfeit or unregistered versions of Neurobion, not the legitimate product.
Dolo Neurobion is Different: Products like Dolo Neurobion contain additional active ingredients like diclofenac, and regulatory issues with them do not apply to standard Neurobion supplements.
High-Dose B6 Concerns: Prolonged, high dosages of vitamin B6, an ingredient in Neurobion, can potentially cause peripheral neuropathy (nerve damage).
Regulatory Variation: The regulatory status of vitamin supplements varies significantly by country, leading to confusion when restrictions are applied in specific regions.

The Widespread Availability and Purpose of Neurobion

Neurobion is a brand name for a combination of B vitamins, most commonly B1 (thiamine), B6 (pyridoxine), and B12 (cyanocobalamin). These neurotropic vitamins are vital for the health of the nervous system and are often used to treat conditions like neuritis, neuralgia, and diabetic neuropathy. The product remains widely available globally, often sold over-the-counter or with a prescription, depending on the country and specific formulation. The persistent public belief that the product was universally banned is largely unfounded and a result of conflating different, highly specific regulatory issues.

The Reality of Global Regulation

Unlike a singular event, the regulatory status of Neurobion has varied across different countries due to differing standards and specific local issues. The manufacturer, Merck, produces various versions, including standard Neurobion tablets and Neurobion Forte, which contain different concentrations of B vitamins. This variation adds to the confusion, as some formulations may face scrutiny while others do not. The regulations are typically not about banning the vitamins themselves, but about controlling how they are combined and marketed, especially when combined with other drugs.

Investigating the Indian Ban on Fixed-Dose Combinations (FDCs)

One of the most cited instances fueling the ban myth comes from India. In 2001, the Indian government, through a gazette notification, banned a specific Fixed-Dose Combination (FDC) of vitamins B1, B6, and B12. The ban targeted this particular combination, not the Neurobion brand itself. The issue was related to the lack of therapeutic justification for this specific FDC, not the inherent danger of the individual vitamins at normal doses. Critically, some manufacturers have found ways to legally circumvent these regulations by adding other minor ingredients, allowing them to continue selling their products under different names or formulations, further confusing the market.

What Happened in the Philippines? Counterfeit and Unregistered Concerns

Another major source of confusion stems from regulatory alerts regarding counterfeit or unregistered products. In the Philippines, the Food and Drug Administration (FDA) issued an advisory in 2016 warning the public against the use of unauthorized Neurobion coated tablets. These specific tablets were found to be distributed without FDA approval, potentially comprising their quality and safety. Similar issues with unregistered or unauthorized Neurobion products have occurred elsewhere, such as in Belize in 2017. These instances were bans on specific, illegal batches or versions of the product, not a rejection of Neurobion as a whole. Legitimate, registered Neurobion products continue to be available in the Philippines.

Dolo Neurobion vs. Neurobion: A Crucial Distinction

It is important to distinguish between standard Neurobion and other products that share a similar name, particularly Dolo Neurobion. Dolo Neurobion is a different drug entirely, as it contains not only B vitamins but also the non-steroidal anti-inflammatory drug (NSAID) diclofenac. This combination is used for pain management, and its safety profile is completely different from a simple B vitamin supplement. Any regulatory action or safety concern associated with Dolo Neurobion is separate and does not apply to standard Neurobion.

The Risks Associated with High-Dose Vitamin B6

Beyond regulatory bans, the safety of high-dose vitamin B supplementation is a legitimate concern that contributes to public wariness. High doses of vitamin B6, specifically doses exceeding 100 mg per day for extended periods, can lead to peripheral neuropathy, a condition involving nerve damage in the hands and feet. While Neurobion products typically contain high levels of B vitamins, the risk of neuropathy is primarily linked to overuse or very high, prolonged dosages, not the recommended therapeutic dose. This is a potential side effect for any high-dose B6 supplement, not just Neurobion. This side effect, combined with existing nerve pain conditions, can be a serious concern and is part of the reason for increased regulatory oversight.

A Comparative Look at Neurobion's Status


Feature	Status in India	Status in Philippines	Status in the US
Availability	Available, but specific FDC formulations were banned in 2001.	Available, but specific batches of counterfeit products were banned in 2016.	Available, various strengths and formulations are sold as dietary supplements.
Regulatory Action	Ban on a specific fixed-dose combination of B1, B6, B12.	Ban on unregistered, unauthorized product batches.	FDA has not approved certain injectable products from other companies, but Neurobion supplements are sold.
Primary Issue	Lack of therapeutic justification for the specific FDC.	Illegal distribution of counterfeit products.	Regulatory issues related to unapproved injectable manufacturers, not oral Neurobion.
Safety Concerns	Primarily related to the FDC, not the safety of the vitamins individually.	Quality and safety of counterfeit batches were compromised.	General concerns with high-dose B6 and potential for peripheral neuropathy.

Conclusion: The Nuanced Story Behind the 'Ban'

The question, 'Why was Neurobion banned?' is based on a fundamental misunderstanding. No global or universal ban was ever implemented against the product. Instead, the perception is the result of isolated regulatory actions, often targeting specific, unauthorized formulations or counterfeit versions in certain countries. The Indian government’s ban on a particular Fixed-Dose Combination of B vitamins was a decision based on therapeutic rationale, not a condemnation of Neurobion itself. The existence of products like Dolo Neurobion, which contain additional active ingredients, also complicates the picture. Ultimately, the key takeaway is that consumers should always purchase medications and supplements from reputable sources and consult a healthcare professional, especially when considering high-dose vitamin B regimens due to risks like peripheral neuropathy.

For additional information on the Indian ban on FDCs and the reasoning behind it, see the article 'Prescribing vitamin B complex: Need for reassessment' from the National Institutes of Health.

Frequently Asked Questions

No, Neurobion is not banned in the United States. Various forms of the product are sold as dietary supplements. However, the FDA has previously issued warnings regarding specific injectable vitamin products from unauthorized distributors, which are separate from Neurobion's oral supplements.

In 2001, India banned a specific fixed-dose combination (FDC) of vitamins B1, B6, and B12 because regulators deemed the combination lacked therapeutic justification, meaning the combination did not offer a proven advantage over using the individual vitamins.

Side effects are rare with standard use, but very high, long-term dosages of vitamin B6 can lead to peripheral neuropathy, or nerve damage. Overconsumption of B vitamins can also cause harmless yellow discoloration of urine.

Yes, some counterfeit versions have been identified. In 2016, the FDA in the Philippines warned against unregistered and unauthorized Neurobion tablets, and similar issues have been reported elsewhere.

Yes, Neurobion Forte is generally considered safe for daily consumption when taken as directed by a healthcare professional. However, individuals with existing medical conditions or those taking other medications should consult a doctor before starting any new supplement.

Standard Neurobion contains B vitamins (B1, B6, B12) for nerve health. Dolo Neurobion is a distinct product that combines these B vitamins with the NSAID painkiller diclofenac, making it a different drug with separate indications and safety warnings.

Public confusion often arises from misinterpreting news of specific, local regulatory actions. Reports of bans on particular counterfeit batches, unapproved formulations, or fixed-dose combinations can be misunderstood as a blanket ban on the entire product.