Govt Panel Proposes Separate Licensing System for Bulk Drugs and Excipients Wholesalers
New Delhi: In a move aimed at improving regulatory oversight of bulk drugs and excipients, the Drugs Consultative Committee (DCC) has agreed to introduce separate licensing requirements and dedicated forms for wholesale dealers of these raw materials.
DCC also suggested incorporating a provision in such a way that the information regarding wholesalers dealing with the NDPS category is captured in the license and also recommended that the qualification of a competent person be a degree in Science with one year of experience in dealing with such raw materials or a registered pharmacist.
During the meeting, the DCC was apprised that the sale and distribution of bulk drugs, including APIs, are covered under a wholesale license, which is common for both formulation and bulk, meaning there are no separate forms for licensing of API/Excipient and formulation for wholesale.
"These two activities are not common, as bulk drug sellers deal with the manufacturers, while formulation sellers deal with retail sellers. Further, there is no data in the country on how many wholesalers are dealing with the bulk drugs," the committee noted.
After detailed deliberations, the DCC supported the proposal for creating separate forms and criteria for bulk drugs and excipients. The Committee further suggested incorporating provisions to capture details of wholesalers handling substances classified under the NDPS (Narcotic Drugs and Psychotropic Substances) category.
Additionally, the DCC recommended,
"Qualification of a competent person may be a degree in Science with one year of experience in dealing with such raw materials or a registered pharmacist."
