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APEX Drugs Regulatory Regulatory Drugs Central Standard Control Organization (CDSCO) has directed medication controllers of all union states and territories to stop the manufacture, sale and distribution of 35 combined strains of fixed doses not approved that include analgesics, nutritions and antiabando.
They have also assessed to review their focus process for such fixed dose combination drugs (FDC) and guarantee strict compliance with the provisions of the Drug and Cosmetics Law of 1940 and rules.
FDC medications are those that contain a combination of two or more active pharmaceutical ingredients (API) in a fixed relationship.
The regulator issued the instructions after he discovered that certain FDC medications have licensed for manufacturing, sale and distribution without prior safety and efficiency evaluation, which represents a serious risk to health and public safety.
In a communication sent on April 11, the General Drug Controller of India (DCGI) Dr. Ir. Rajeev Raghuvanshi referred to the letter issued by his office in January 2013, where the concerns were raised regarding the concession of manufacturing licenses for the sale of FDC medications that fall under the definition of a “new medicine” in the country.
The same concern has been raised from time to time and multiple letters have been issued to the state -state licenses authorities that granted permission for the manufacture and commercialization of FDC not approved. The most recent letter was issued in February this year.
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The approval of such non -appealed FDC compromises patient safety and can lead to advertising reactions of medicines, medication interactions and other health risks due to the absence of scientific validation, the letter stressed.
After the issuance of the show, they cause notices to the manufacturers, they have declared that the thesis licenses were granted by the respective medication license authorities and have not violated any rule, he said.
This has resulted in a uniform lack of application of the 2019 NDCT rules under the 1940 drug and cosmetics law throughout the country, the letter said.
“In view of the above, all drug controllers of the state territory and the union are requested to review their approval process for said FDC and guarantee strict compliance with the provisions of the law and rules,” said the letter.
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Published – April 16, 2025 05:13 pm ist