DTAB Recommends Legal Provisions for OTC Drug Licensing
New Delhi: Considering the proposal for submission of report of the Sub-Committee constituted to examine the matter of Over-The-Counter (OTC) Drugs, the Drug Technical Advisory Board (DTAB) has agreed to the recommendation of sub-committee and opined that legal provisions to 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.
In addition, the DTAB has recommended that the list as submitted by the sub-committee may be considered initially which will be dynamic and updated from time to time.
This aligned with the proposal to consider the submission of the Sub-Committee's report on the examination of Over-The-Counter (OTC) drugs. The matter was discussed during the 92nd DTAB meeting held on April 24, 2025.
The board was apprised about the draft G.S.R. 393(E) dated 25.05.2022, and subsequently DTAB sub-committee constituted for the purpose.
Over-the-counter or off-exchange trading or pink sheet trading is done directly between two parties, without the supervision of an exchange. It is contrasted with exchange trading, which occurs via exchanges.
After detailed deliberation, DTAB agreed with the recommendation of the subcommittee and recommended that -
i. Legal provisions to 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.
ii. The list as submitted by the sub-committee may be considered initially which will be dynamic and updated from time to time.
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