India May Ease Drug Rules To Allow Allopathic Sellers To Stock Homoeopathic Medicines

Last Updated:February 06, 2026, 17:35 IST

The proposal is still under deliberation and has been placed before the country’s top drug advisory body, Drugs Technical Advisory Board (DTAB)

India may ease drug rules to allow allopathic sellers to stock homoeopathic medicines more easily, News18 has learnt.

The country’s top regulatory body, Central Drugs Standard Control Organisation (CDSCO), is reviewing existing provisions to prevent supply disruptions and improve access to homoeopathy drugs through retail pharmacies.

The proposal is still under deliberation and has been placed before the country’s top drug advisory body, Drugs Technical Advisory Board (DTAB). According to the agenda document submitted to DTAB for consideration, seen by News18, it explained that the move is being examined to ensure smoother availability of homoeopathic medicines, especially in regions where specialised homoeopathy pharmacies are limited, while maintaining regulatory oversight.

What is being proposed and why concerns were raised

According to the document, the issue relates to Schedule K of the Drugs Rules, 1945, which grants certain exemptions for homoeopathic medicines. Under the current framework, allopathic retail drug licence holders are allowed to keep and sell homoeopathic medicines, but only in sealed packs and under specific conditions.

The document explains that “the objective of this exemption under Schedule K was to enhance the availability of homoeopathic medicines to the masses as allopathic drugs retail sale outlets are presently available at far-reaching places as compared to homoeopathic medicines retail sale outlets".

However, manufacturers have raised concerns that the intent of the rule is not being fully achieved because of gaps in the supply chain. The agenda records representations from the Indian Homoeopathic Drug Manufacturers Forum, which has flagged that “the supply chain of allopathy drugs and homoeopathic medicines are different," and that without allowing broader stocking and distribution, the objective of Schedule K “is not being realised."

These concerns were first examined by the Ayurvedic, Siddha, Unani Drug Technical Advisory Board (ASUDTAB), which recommended that the matter be referred to DTAB for wider deliberation.

How the plan could work if approved

As per the proposal outlined in the document, regulators may amend entry of Schedule K to simplify how exemptions apply. The agenda states that “to give effect to the above suggestion, it was proposed that in Schedule K of the principal Rules, for entry number 31… the words ‘in Form 20C’ and ‘retail’ wherever appearing shall be omitted".

The issue was forwarded to the Ministry of Ayush, which constituted an expert committee to review storage and licensing requirements. The committee proposed issuing a clarification that licence holders under Rule 61 “can obtain the homoeopathic medicines for retail sale in sealed packaging only either from licensed allopathic medicines or licensed homoeopathic medicines wholesale dealers."

Importantly, the document adds that “no separate storage conditions need to be framed other than already mentioned under Schedule K point 31 for homoeopathic medicines," suggesting that existing safeguards could largely remain in place.

The proposal will now be taken up for further discussion, with any change to the rules expected only after the expert panel, DTAB, completes its deliberations and issues its recommendations.

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