[dropcap]O[/dropcap]n Wednesday the Ministry of Health banned the sale or distribution of 328 fixed-dose combination (FDC) drugs with immediate effect. It has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions, an official statement said.
The banned medicines include brands like Piramal’s Saridon, Alkem Laboratories’ Taxim AZ and Macleods Pharma’s Panderm Plus cream.
This means that around 6,000 medicine brands belonging to different companies and with a combined market size of Rs 2,000-2,500 crore may soon vanish from the drug market in the country. FDCs are two or more drugs combined in a fixed ratio into a single dosage form.
Through a notification published on March 10, 2016, the Health Ministry had prohibited the manufacture for sale and distribution for human use of 349 FDCs under Section 26 A of the Drugs and Cosmetics Act, 1940. But the affected manufacturers contested the prohibition in various high courts and the Supreme Court.
Complying with the Supreme Court verdict in December 2017, an expert panel formed by the Drugs Technical Advisory Board (DTAB), in its report to the Centre, stated that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings, stated the statement.
DTAB also said that these combinations may lead to overuse. According to the technical body, there is no need to expose a patient to that many ingredients when one can do the work. The notification stated, “Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC…any kind of regulation or restriction to allow for any use in patients is not justifiable.”
Therefore, the Board recommended a necessary prohibition on the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 in the larger public interest.
(With inputs from PTI)