All states and Union territories' drug controllers have been instructed by CDSCO to cease producing, marketing, and distributing 35 unapproved fixed-dose combination medications, which include anti-diabetics, nutrition supplements, and painkillers.
Additionally, they have been requested to examine their approval procedure for these fixed dose combination medications (FDC) and make sure that the laws and conditions of the medications and Cosmetics Act of 1940 are strictly followed.
FDC medications include two or more active pharmaceutical ingredients (APIs) in a predetermined ratio.
After discovering that several FDC medications had been approved for production, distribution, and sale without first undergoing safety and efficacy testing, the FDA issued the directives, creating a major risk to public health and safety.
In a letter dated april 11, Dr. rajeev Raghuvanshi, the drugs Controller General of india (DCGI), cited a january 2013 letter from his office expressing concerns about the issuance of manufacturing licenses for the sale of FDC drugs that are classified as "New Drugs" in the nation without the DCGI's proper approval.
The same issue has occasionally come up, and numerous letters have been sent to the state licensing bodies that authorized the production and sale of unlicensed FDCs. This year's february saw the issuance of the most recent such letter.
This directorate has discovered that, following the NDCT Rules 2019 under the drugs and Cosmetics Act 1940, some FDC medications have been authorized for production, distribution, and sale without first undergoing a safety and effectiveness assessment. Public health and safety are seriously at risk because of this," the letter said. The approval of such unapproved FDCs compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards due to the absence of scientific validation, the letter underlined.
The manufacturers have responded to show-cause orders by claiming that these licenses were issued by the appropriate drug licensing agencies and that they have not broken any laws, the statement read.
The letter noted that this has led to inconsistent execution of the NDCT Rules 2019 clause under the drugs and Cosmetics Act 1940 throughout the nation.
"Because of the above, all state and union territory drug controllers are requested to review their approval process for such FDCs and ensure strict compliance with the provisions of the act and rules," the letter read.
For reference, the letter also listed 35 FDCs that were previously licensed by state/UT drug controllers for production, distribution, and sale without a Central drugs Standard Organization (CDSCO) safety and efficacy evaluation. These licenses were later revoked by Drug Licensing Authorities (SLAs) or voluntarily turned in by manufacturers after show-cause notices were sent.
Additionally, they have been requested to examine their approval procedure for these fixed dose combination medications (FDC) and make sure that the laws and conditions of the medications and Cosmetics Act of 1940 are strictly followed.
FDC medications include two or more active pharmaceutical ingredients (APIs) in a predetermined ratio.
After discovering that several FDC medications had been approved for production, distribution, and sale without first undergoing safety and efficacy testing, the FDA issued the directives, creating a major risk to public health and safety.
In a letter dated april 11, Dr. rajeev Raghuvanshi, the drugs Controller General of india (DCGI), cited a january 2013 letter from his office expressing concerns about the issuance of manufacturing licenses for the sale of FDC drugs that are classified as "New Drugs" in the nation without the DCGI's proper approval.
The same issue has occasionally come up, and numerous letters have been sent to the state licensing bodies that authorized the production and sale of unlicensed FDCs. This year's february saw the issuance of the most recent such letter.
This directorate has discovered that, following the NDCT Rules 2019 under the drugs and Cosmetics Act 1940, some FDC medications have been authorized for production, distribution, and sale without first undergoing a safety and effectiveness assessment. Public health and safety are seriously at risk because of this," the letter said. The approval of such unapproved FDCs compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards due to the absence of scientific validation, the letter underlined.
The manufacturers have responded to show-cause orders by claiming that these licenses were issued by the appropriate drug licensing agencies and that they have not broken any laws, the statement read.
The letter noted that this has led to inconsistent execution of the NDCT Rules 2019 clause under the drugs and Cosmetics Act 1940 throughout the nation.
"Because of the above, all state and union territory drug controllers are requested to review their approval process for such FDCs and ensure strict compliance with the provisions of the act and rules," the letter read.
For reference, the letter also listed 35 FDCs that were previously licensed by state/UT drug controllers for production, distribution, and sale without a Central drugs Standard Organization (CDSCO) safety and efficacy evaluation. These licenses were later revoked by Drug Licensing Authorities (SLAs) or voluntarily turned in by manufacturers after show-cause notices were sent.
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