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DTAB asks govt to amend Rules to introduce separate form for bulk drug license for wholesale
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Gireesh Babu, New Delhi
March 19 , 2026
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The Drugs Technical Advisory Board (DTAB) has recommended introduction of a separate form for bulk drug license for wholesale to gather information regarding those who are dealing with the Narcotic Drugs and Psychotropic Substances (NDPS) and fixing the qualification of the competent wholesaler.
The recommendation is in line with the advice of the Drugs Consultative Committee, which has in November, 2025, agreed with the proposal to the Centre to introduce separate requirements and forms for wholesale license for bulk drugs and excipients.
The DTAB, in a latest meeting held in February, agreed with the DCC's recommendations, including, "to create a separate ‘FORM’ for bulk drug license for wholesale in such a way that the information regarding wholesalers dealing with NDPS category is captured in the license."
It also agreed to the recommendation that the qualification of a competent person may be a degree in Science with two years experience in dealing of such raw materials or a registered pharmacist.
The Board also recommended providing adequate time to the existing wholesaler licenses to obtain the proposed bulk drug license.
"Accordingly, rules may be amended suitably for the consequential changes," it added.
The DCC, in its meeting held on November 17, 2025 agreed with the proposal for separate requirements and form(s) for bulk drugs and excipients and also sought the Central Drugs Standard Control Organisation (CDSCO) to examine matters related to regulation of formulation intermediates and their quality standards.
During the meeting, the DCC was apprised that sale and distribution of bulk drugs including active pharmaceutical ingredients (APIs) are covered under a wholesale license which is common for formulation as well as bulk meaning there are no separate forms for licensing of API or excipient and formulation for wholesale.
These two activities are not common as bulk drug sellers deal with the manufactures while formulations sellers deal with retail sellers. Further, there is no data in the country about how many wholesalers are dealing with the bulk drugs, it observed.
The Committee also suggested incorporating provision in such a way that the information regarding wholesalers dealing with NDPS category is captured in the license.
It also recommended that "qualification of competent person may be degree in Science with one year experience in dealing with such raw materials or a registered pharmacist."
Besides, the Committee also considered a proposal for regulation of formulation intermediates. It was apprised on regulation of formulation intermediates such as Direct Compressible granules or Pellets containing API and other excipients for direct compression /capsule filling which have to be considered as formulated bulk to meet the applicable quality standards such as dissolution profile, etc.
Deliberating the issue in detail, the DCC opined that the matter may be examined internally at CDSCO and shall be placed before the DCC for appropriate action.
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