The Ministry of Health banned 328 fixed-dose combinations (FDC) drugs and barred the manufacture of it for sale or distribution with immediate effect on Wednesday.
The Ministry had restricted the manufacture, sale or distribution of six FDCs subject to certain conditions. The banned medicines brands include Alkem Laboratories’ Taxim AZ, Macleods Pharma’s Panderm Plus cream and Piramal’s Saridon.
FDS is the combination of two or more drugs in a fixed ratio into a single dosage form.
Government sources said that the ban may close around 6,000 medicine brands belonging to different companies and with a combined market size of Rs 2,000-2,500 from the drug market in the country.
The Health Ministry had earlier notified to prohibit the manufacture for sale and distribution for human use of 349 FDCs under Section 26 A of the Drugs and Cosmetics Act, 1940 on March 10, 2016.
The affected manufacturers approached in various high courts and the Supreme Court. The Supreme court ordered to form a committee to cross-check the matter. An expert panel formed by the Drugs Technical Advisory Board (DTAB) presented its report to the Centre stating that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings.
Drugs Technical Advisory Board said that the combination of two or three drugs may lead to overuse and there was no need to introduce the patients to many ingredients when one would work for the health issue.
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.”
The ministry stated that the initiative to prohibit the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 was made for the benefit of people.