328 combination drugs banned over safety worries
In a bid to stop the irrational use of fixed-dose combination (FDC) medicines, the Union health ministry on Wednesday banned the manufacture, sale or distribution of 328 varieties of FDC drugs for human consumption.
Combination products, also known as fixed-dose combinations (FDCs) drugs, are combinations of two or more active drugs in a single dosage form.
The decision has been taken by the health ministry after the Drugs Technical Advisory Board recommended that there's no therapeutic justification for the ingredients contained in 328 FDC drugs, and that these may involve risk to human beings. The action has been taken under Section 26A of the Drugs and Cosmetics Act, 1940 in the larger public interest.
Talking to Mail Today, Delhi's drug controller Dr Atul Nasa, said, "It is a good move by the government to ban combination drugs. It has been seen that there was no rational use of FDC medicines. Previously, in March 2010, the government had brought the notification to restrict about 344 categories of FDCs. However, it was challenged by various manufacturers in the court."
"In compliance with the directions given by the Supreme Court of India in its judgment dated December 15, 2017, the matter was examined by the Drugs Technical Advisory Board constituted under Section 5 of the Drugs and Cosmetics Act, 1940 and which furnished its report on these drugs to the central government," he said. The central government considered the recommendations of the expert committee and Drugs Technical Advisory Board and concluded that it was necessary and expedient in public interest to prohibit these 328 FDCs.
He said that physicians should be aware of the usage of a drug combination. If it does not have rational benefits, then they should not prescribe. Unnecessary use of combination drugs makes the human body resistant to treatment.
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