Chemist Body Opposes DTAB Proposals on Drug Ads, Nicotine Gum OTC, Pushes for Regulated Trade

New Delhi: The All India Organisation of Chemists and Druggists (AIOCD) has submitted a consolidated representation to the Chairman and Secretary of the Drug Technical Advisory Board (DTAB) regarding key agenda items (2, 5, 7, 9, and 12) discussed during the 93rd DTAB meeting held on February 16, 2026.

In its submission, AIOCD leadership, including President J. S. Shinde and General Secretary Rajiv Singhal, reaffirmed their commitment to public health, rational use of medicines, and the protection of the regulated drug distribution system. The organisation also raised serious concerns over the growing menace of illegal and unregulated e-pharmacies, stating that such platforms pose significant risks to patient safety and undermine licensed brick-and-mortar chemists.

Addressing Agenda 2 (Good Distribution Practices – GDP), the proposal under discussion aimed to introduce structured guidelines and regulatory standards for the proper storage, handling, and distribution of pharmaceutical products across the supply chain, ensuring drug quality, safety, and traceability from manufacturer to end user.

The Organization welcomed this move in principle, recognizing its importance in strengthening the drug distribution system, saying, "This is a progressive step towards ensuring quality, safety, and integrity in the pharmaceutical supply chain in line with international regulation."

However, the organization recommended, " Implementation of said guideline should be phase wise and practical, allowing adequate transition time and small and medium traders should not face disproportionate compliance burden."

On Agenda 5 (Advertisement of Schedule H, H1 & X Drugs), the DTAB recommended that suitable provisions be incorporated in the Drugs Rules, 1945, to allow advertisement of drugs specified under Schedule H, H1 and X only with the prior sanction of the Central Government for licensed entities engaged in sale, stocking, or distribution.

These categories—Schedule H, H1, and X—include strictly prescription-only medicines, which are meant to be used under medical supervision due to their potential risks, including misuse and adverse effects.

The All India Organisation of Chemists and Druggists strongly opposed this proposal, arguing that allowing advertisements of such drugs would violate the core principle of prescription-only usage. The organization raised concerns that it could encourage self-medication, irrational drug use, and misuse, while also leading to the commercialization of medicines at the cost of ethics and public health. It further pointed out that monitoring digital and indirect advertisements would be impractical.

The AIOCD mentioned the following key concerns:

• Violates the core principle of prescription-only medicines.

• Encourages self-medication, misuse, and irrational drug use.

• Monitoring digital and indirect advertisements is impractical.

• Leads to the commercialization of medicines at the cost of ethics and public health.

Regarding Agenda 7 (Amendment in Rule 64 – Competent Person Qualification), the matter relates to a proposed amendment in the Drugs Rules, 1945 to revise the qualification requirements for the “competent person” responsible for supervising wholesale drug operations.

The proposal seeks to modify/strengthen the eligibility criteria (qualification and/or experience) for individuals designated as “competent persons” in wholesale drug establishments, who are responsible for ensuring proper handling, storage, and distribution of medicines.

AIOCD has strongly opposed the proposed amendment, raising the following concerns:

• Wholesale trade is primarily B2B (business-to-business) and has no direct interface with patients
• The proposed qualifications are excessive and impractical
• It would impose a heavy compliance burden on MSME wholesalers
• It may lead to supply chain disruptions, especially in rural areas.

AIOCD has suggested that the existing regulation should be continued, stating that it is already effective and practical, and does not require such stringent changes.

On Agenda 9 (Schedule K Exemption for Nicotine Gum 2 mg), the proposal under consideration was to grant exemption under Schedule K of the Drugs Rules, 1945 to Nicotine Gum (2 mg), which would allow its sale without the requirement of a retail drug license, thereby enabling wider over-the-counter availability.

The All India Organisation of Chemists and Druggists strongly and categorically opposed this proposal, stating that nicotine is an addictive substance with a high risk of misuse.

AIOCD strongly and categorically opposes this proposal.

The All India Organisation of Chemists and Druggists presented the following key concerns:

• Nicotine is an addictive substance with risk of misuse.

• Safeguards like age restriction and monitoring are not practically enforceable.

• May bypass licensed chemists, weakening the regulated system.

• Contradicts broader public health and tobacco control objectives.

As a recommendation, AIOCD urged that Nicotine Gum (2 mg) should continue to be sold only through licensed chemists, and that granting a Schedule K exemption is not warranted.

On Agenda 12 (Stocking of Homoeopathic Medicines by Allopathic Wholesalers), the proposal under consideration was to allow allopathic (conventional) drug wholesalers to stock and distribute homoeopathic medicines, thereby enabling a broader and more integrated distribution network for such products.

The All India Organisation of Chemists and Druggists welcomed this progressive proposal.

Further, it suggested,

• It will be helpful to maintain proper records and traceability.

• Avoid additional compliance burden.

• Ensure uniform implementation across states.

In continuation, the organisation also reiterated its serious concern regarding illegal e-pharmacies operating without valid licenses and called for strict enforcement measures.

It added, "Several illegal E-Pharmacies who are operating without licenses required under Drugs and cosmetics act and against order of High courts, will further misuse this exemption. There will be uncontrolled sale of such drugs. There are many Homoeopathic drug which are poisonous if consumed indiscriminately. It is undermining the licensed brick-and-mortar chemist network and compromising patient safety."

In addition, it says:

"Immediate and strict stern enforcement action against illegal e-pharmacies is anticipated since long. As submitted on and often before this we again strongly urge that draft e-pharmacy GSR 817 and covid period door delivery GSR 220 be withdrawn immediately in the interest of public health, and regulatory clarity. AIOCD respectfully submits that, public health must remain the paramount consideration. Drug distribution must continue through regulated and licensed channels only. Any policy leading to misuse, regulatory dilution or trade imbalance must be reconsidered."

In its concluding remarks, AIOCD requested the DTAB to reject proposals under Agenda 5, 7, and 9, implement Agenda 2 and Agenda 12.

To view the official letter, click the link below: