The story of a drug that India has failed to ban

The Centre banned the sale of Deanxit, a contested psychiatric drug approved without clinical data. But 10 years on, it continues to be sold by other companies.

Jan 4, 2024 - 07:30

The story of a drug that India has failed to ban

In 2009, an article in Monthly Index of Medical Specialities drew attention to a psychiatric drug from Denmark being sold in the Indian market.

In the article, the editor of the journal, Dr Chandra Gulhati, pointed out that India’s drug regulatory authorities should never have approved the sale of the drug, Deanxit, for a simple reason – the medicine was prohibited for sale in Denmark itself.

This was a violation of India’s Drugs and Cosmetics Act, 1940, which says that a drug can only be imported in India if it has been approved for sale in the home country.

In 2013, the Union health ministry banned the sale of Deanxit, which was a fixed dose combination of flupenthixol and melitracen.

Though the Danish manufacturer, Lundbeck, moved court against the order, it eventually wound up its operations and left India in 2021.

But 10 years after the ban, the combination of flupenthixol and melitracen continues to be sold by at least 10 other companies in India under various brand names. This is the story of how gaps in India’s drug regulatory system and legal hurdles made it difficult for drug regulators to remove a contested drug from the Indian market.