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Sub-committee to look into one-time NOC and manufacturing license for unapproved, new drugs solely for exports
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Gireesh Babu, New Delhi
April 15 , 2024
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The Drugs Consultative Committee (DCC) has recommended constitution of a sub-committee to examine the pros and cons involved in grant of one-time export No Objection Certificate (NOC) and manufacturing license for unapproved, new drugs solely for the purpose of exports.
The decision is followed by the industry request to grant a one-time export NOC and manufacturing license followed by Certificate of Pharmaceutical Product (CoPP) for pharmaceutical and biological products under unapproved or banned or new drugs category, only for exports.
"Committee deliberated the matter and discussed that grant of such one-time export NOC may be considered for certain categories of drugs like approved/ unapproved new drugs, and not for the banned drugs," said the DCC after its 63rd meeting held in January, this year.
However, the committee opined that due to misuse potential, the current practice for issuance of NOCs for export of drugs may continue. The DCC also recommended constituting a sub-committee to examine the pros and cons involved for taking further decisions in the matter.
The DCC also recommended the sub-committee to examine the industry's request for relaxation of NOC conditions on destruction of excess quantities of unapproved drugs and approved new drugs for exports, since it leads to economic loss to the industry and the country.
At present, as per the Drugs Controller General of India's (DCGI) notification on August 2, 2018, export NOC and manufacturing license are granted by State Licensing Authority (SLA) for manufacture of unapproved/banned/new drugs solely for export purpose.
A circular from the DCGI mandated that the companies shall ensure that the drugs manufactured on the basis of the permission granted is exported and no part of it is diverted for domestic sale in India and the applicant company shall ensure physical destruction of all un-exported quantity of drugs.
The industry argued that this process is a time-consuming approach which renders delay in the export consignment since for each Purchase Orders (for repetitive export purchase orders), applicants need to obtain export NOC (specific to quantity, country & buyer) and manufacturing license from SLA which takes a considerable amount of time and eventually CoPP from SLA based on joint inspection takes further additional time, leading to delays in getting the CoPP required for export purposes.
For biological products, at present the export NOC from CDSCO headquarters, New Delhi is a prerequisite to obtain manufacturing license including counter sign from CLA to manufacture unapproved, or banned drugs, or new drugs derived r-DNA technology (biological products) solely for export purpose and followed by CoPP from SLA.
Industry informed that it takes about 8 to 10 months to get these approvals and the entire process is very cumbersome and time consuming to approach every time to apply for repetitive export orders as is conveyed by the Industry.
As per the earlier procedure for manufacture of unapproved, or banned, or new drugs, the manufacturer was required to take NOC from CDSCO prior to obtaining manufacturing license from states for export purpose. In light of that, a one-time export NOC and manufacturing license was insisted on by the manufacturers.
The matter was earlier discussed in the 48th DCC meeting held on July 24, 2015 and it was recommended that NOCs for export of drugs which are prohibited for marketing in the country are only required to be issued country specific and quantity specific. In other cases of repetitive export orders, the office of DCGI may review the guidelines in consultation with MoHFW, said the DCC during the time.
However, in order to streamline export, the process to grant NOC and manufacturing licenses for such products were delegated to the states in 2018.
Regarding the relaxation of the NOC condition, the industry raised concerns that the excess quantity manufactured under test license and un-exported, needs to be destroyed by the manufacturer as per the NOC conditions and this leads to great economical loss to the industry and in turn to the nation.
The DCC, after discussing the matter, recommended that the same sub-committee shall also examine the issue and submit the report.
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