Lindane Ban Comes After Years Of Regulatory Hesitation

After years of regulatory hesitation, India has moved closer to ending the use of lindane, a persistent organic pollutant once widely used as an insecticide and later retained in medicine cabinets as a second-line treatment for scabies and lice.

The Drugs Technical Advisory Board (DTAB) has now recommended prohibition of the manufacture, sale and import of topical lindane, reversing its own 2025 position that had allowed the drug to remain in the market with guidance on safe disposal. The latest recommendation followed a review of its international regulatory status and the availability of alternative treatments in India.

The move has implications beyond one medicine. Lindane is listed under Annex A of the Stockholm Convention on Persistent Organic Pollutants, reflecting the global objective of eliminating its production and use. The Convention had retained a specific exemption for its use as a second-line human-health treatment for head lice and scabies because alternatives were historically considered limited in some settings. However, the Convention's register now shows that there are no registered specific exemptions for lindane for this pharmaceutical use.

Lindane is the gamma isomer of hexachlorocyclohexane. It is persistent, can bioaccumulate and can travel long distances in the environment. The Stockholm Convention has cited evidence of toxic effects, including immunotoxic, reproductive and developmental effects in laboratory animals and aquatic organisms.

In March 2011, the agriculture ministry issued the Banning of Lindane Order, 2011, prohibiting its manufacture, import and formulation as an insecticide and providing for an end to its use after two years.

But that did not settle the question of topical pharmaceutical preparations. Lindane continued to be viewed differently when used as a medicine for scabies and lice. The Stockholm Convention itself had allowed this limited second-line use, reflecting the concern that some patients might not respond to or tolerate first-line therapies.

That distinction became important in India's regulatory deliberations.

When the DTAB examined the issue in April 2025, it noted that topical lindane was being used as a second-line treatment and that the Stockholm Convention permitted such use. The Board concluded that it was an affordable and effective treatment and recommended continued marketing, while suggesting guidance on safe disposal.

However, at its August 27 meeting, the DTAB noted that lindane lotions and other formulations had been discontinued by the US Food and Drug Administration and were not available in Australia's Therapeutic Goods Administration database. More importantly, the Board noted that alternative therapeutic options were available in India. It therefore recommended prohibition of manufacture, sale and import.

The World Health Organization has listed treatments such as 5% permethrin cream, malathion, benzyl benzoate and sulphur preparations among topical options for scabies, with oral ivermectin also used in appropriate patients.

WHO has also documented the wide restrictions imposed internationally because of concerns associated with persistent organic pollutants.

The environmental implications are particularly important because lindane does not simply disappear after it has served its immediate purpose. The Stockholm Convention notes its persistence, bioaccumulation and long-range environmental transport. Its continued production and disposal can therefore have consequences beyond the individual patient who uses a lotion or shampoo.