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CDSCO has ordered all union states and territories that stop the production, sale and distribution of 35 fixed dose combination that is manufactured without security and efficacy review of medicines
The list of these medications includes analgesics, antidiabetic medications, hypertension medications, neuropathic analgesics, fertility medications and nutritional supplements. (PTI image for representation)
The Indian Health Regulatory Agency, the Organization for the Control of Standard of Central Medicines (CDSCO), has ordered “urgently” that all states and trade union territories stop the production, sale and distribution of 35 combined medications of fixed doses and other unmpeaed medications, News18 has larnt medications, News18 has LANTT.
The list of these medications includes analgesics, antidiabetic medications, hypertension medications, neuropathic analgesics, fertility medications and nutritional supplements. These medications contain multiple drug combinations in a pill without valid scientific justification. Moreover, all states and UTS have been asked to reassess their approval procedures for said FDC and guarantee strict adhesion while approved the combined medications.
Fixed dose combinations (FDC) are medications that combine more than one medication in a single pill and are also called “cocktails” medications.
The General Drug Controller of India (DCGI), which runs CDSCO, has written a letter to drug controllers of all states and UT on the manufacture and marketing of “FDC not trapped”, while attached a list of 35 FDC not caught that were previous security and efficiency reviews, but then they were canceled or voluntarily withdrawn after notice.
The lack of scientific validation raises risks to patient safety and can lead to harmful side effects.
DCGI has asked state drug regulators and UT to carry out the investigation and take the necessary measures. In a letter dated April 11 and which is accessed by News18, DCGI Rajeev Singh Raguvanshi warned: “This raises a serious risk to health and public safety” and emphasized: “This issue can be treated as urgent and serious.”
What does the letter say?
The movement was activated after CDSCO discovered that some FDC medications were approved without adequate safety and efficiency controls.
“… has received notice from this address that certain fixed dose combination medications (FDC) have a leg license for manufacturing, sale and distribution with the prior evaluation of the safety and efficiency axis according to the provision of NDT 1940.
“The approval of said FDC not approved compromises patient safety and can lead to advertising medication reactions, medication interactions and other health risks due to the absence of scientific validation.”
What led to unequal application or rules?
The confusion occurred because different states gave an approach to these drugs without following the same rules. In turn, the companies responded when they were convened, saying that they did not violate any law since they obtained the appropriate licenses of the state authorities.
After the issuance of display causes of the manufacturers, according to the letter, these pharmaceutical fellow have stated that “these licenses were granted by the authorities of licenses for respected medicines and have not violated any rule. This hash of the lack of the lack of the lack of the lack of the lack of the lack of ND Rossy and the formation of medications.
Concluding the letter, DCGI has asked all state and territory controllers of the Union “to review their approval process for said FDC and guarantee strict compliance with the provisions of the law and rules.”