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DTAB recommends enabling legal provision on OTCs
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Gireesh Babu, New Delhi
May 06 , 2025
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The Drugs Technical Advisory Board (DTAB) has recommended enabling legal provisions under the Drugs Rules, 1945 along with other measures related to licensing and sale of over-the-counter (OTC) drugs in the country.
It has also formed a sub-committee to examine a proposal for withdrawal of a notification issued in March, 2020, during the Covid-19 pandemic period, allowing door step delivery of certain medicines.
In response to these proposals, the largest trade organisation All India Organisation of Chemists and Druggists (AIOCD) has requested the ministry of health and family welfare to ensure stakeholder consultation before finalising the proposed list of OTC medicines and any associated regulations. It has also sought the Ministry to withdraw the notification allowing doorstep delivery, alleging misuse of the notification by online platforms.
A recent DTAB meeting has considered recommendations of a sub-committee, formed by the Board last year to examine matters regarding amendment of the Drugs Rules to incorporate necessary provisions for drugs to be declared as over-the-counter (OTC), and deliberated its recommendations.
The sub-committee proposed that legal provisions should be enabled under Drugs Rules, 1945 along with manner of submitting application, prescribe the licensing requirements for the sale of OTC drugs which does not require the supervision of registered pharmacist, requirements for considering a drug as an OTC, Labelling requirements, etc. and incorporation of separate Schedule.
Agreeing with the recommendation of the Sub-Committee, the Board said, "The list as submitted by the sub-committee may be considered initially which will be dynamic and updated from time to time."
The Sub-Committee was formed following a recommendation from the DTAB. This was in response draft notification by the Department of Health and Family Welfare on May 25, 2022 for amendment of the Schedule K of the Drugs Rules, 1945, to incorporate necessary provisions for drugs to be sold OTC for providing exemptions from requirements of prescription from Registered Medical Practitioners (RMPs) for sales. The sub-committee was constituted to look into the proposal for amendment.
Meanwhile, the AIOCD president J S Shinde and general secretary Rajiv Singhal have requested the ministry of health & family welfare to ensure detailed stakeholder consultations before finalizing the proposed list of OTC medicines and any associated regulations.
The Organisation has highlighted that such a move, if not properly scrutinized, could pose serious risks including violation of existing laws, increased risk of irrational drug use, rise in spurious and substandard medicines, and public health hazards including drug resistance and adverse drug reactions (ADR).
Similarly, it demanded the urgent revocation of the notification issued on 26th March 2020 for door delivery of medicines during the Covid emergency. The Organisation has alleged that online platforms are grossly misusing this provision, bypassing mandatory pharmacist supervision and prescription norms, leading to unchecked distribution of critical medications.
"AIOCD welcomes the Government’s move to refer both issues to the Drugs Technical Advisory Board (DTAB), but insists that as a key stakeholder, it must be included in all deliberations before any final decision is taken," said J S Shinde in a press note on May 3, 2025.
“We urge the government to protect public health and uphold the integrity of drug distribution laws by involving all stakeholders in the discussion, especially the licensed retail chemists who are the backbone of India’s pharmaceutical delivery system,” added Rajiv Singhal.
"As this is a law making process and we as a major and most impacted stakeholder, we again request you to give us opportunity to deliberate on these issues before finalisation of the regulation in these matters," both added in a letter to Union health minister J P Nadda.
The Organisation has earlier opposed a proposal to allow OTC drugs to be sold at general and grocery stores without pharmacists and without license. It said that such a move would be in violation of the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rule, 1945, Pharmacy Act, 1948, and Pharmacy Practices Regulation, 2015. It would be in violation of Supreme Court directives in an order on November 29, 2022, and result in lack of pharmacists' consultation service, along with promoting self medication and the risk of drug abuse, among others.
Requesting the withdrawal of notification regarding doorstep delivery of certain medicines, in another letter to the Ministry last year, said the provision is not a blanket permission for long time or permanent bypass of the main statutory Rule, it is only emergency or exigency.
"These powers are restrictive, it is essential to satisfy that there is an emergency arising due to epidemic or natural calamities. Covid-19 situation is over almost three years back. In view of this legislative intent this notification shall be withdrawn now immediately to avoid continuous violation of rules with government permission," it added in a letter in November, 2024. It has been raising this issue through letters in the year 2022 and 2023.
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