|
The Drugs Consultative Committee (DCC), the advisory committee that advises the Central and state governments on matters related to uniform implementation of drugs regulations, has agreed with a proposal to introduce separate requirements and forms for wholesale license for bulk drugs and excipients.
The Committee, in its meeting held on November 17, 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 drugs 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.
"DCC deliberated the matter in detail and agreed with the proposal for separate requirements and form(s) for bulk drugs and excipients," said the minutes of the meeting.
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 of 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.
It may be noted that the industry has earlier sought the drug regulator to simplify the licensing of drug pellets, which is a highly specialised segment within the pharmaceutical industry, requiring specific infrastructure, technology and expertise.
While the drug pellet segment in the country is well-established, it currently lacks exclusive regulatory guidelines, said the industry earlier.
Pellets have been considered as semi-finished formulations and manufacturing licenses have been issued for each drug, strength wise. However, different players from the formulation industry may seek different strengths of pellets even for same dose capsule pellets to suit their particular requirement.
The bulk drug manufacturers may have to seek separate licenses even if the variation is very minor, for instance a 0.5%, which is causing delay in meeting the customer requirement, said bulk drug manufacturers. They proposed a system where the manufacturing license for drug pellets may be issued based on strength ranges, based on market experience for individual drugs.
|