CHENNAI/NEW DELHI: The Centre has prohibited the manufacture, sale and distribution of 16 fixed-dose combination (FDC) drugs, saying they lack "therapeutic justification" and their continued use was not considered beneficial in relation to the potential risks involved.
The move, the Union Health Ministry said, was to safeguard public health and promote rational use of medicines while ensuring only effective and scientifically validated medicines are available to the public.
An FDC combines two or more active pharmaceutical ingredients in a fixed proportion. Such products are approved only when each component contributes to treatment and the combination offers a clear therapeutic advantage over administering the medicines separately.
The 16 prohibited formulations included antibiotic combinations such as Amoxicillin with Serratiopeptidase, medicines used for pain and gastrointestinal disorders, and several dermatological products containing Aloe Vera, Vitamin E, Tea Tree Oil, Olive Oil and other ingredients, besides antispasmodic (muscle relaxants) medicines and antibiotic-based combinations.
The decision follows a review of FDCs undertaken in compliance with the Supreme Court directives. The Drugs Technical Advisory Board (DTAB) had constituted an expert committee to examine various drug combinations and identify those that were irrational, therapeutically unjustified or potentially harmful.
"The manufacture for sale, sale, distribution and supply of the identified 16 FDCs for human use shall stand prohibited with immediate effect across the country," the ministry said.
Experts who viewed the combinations said there was inadequate scientific evidence to show they improved treatment outcomes or patient safety.
According to a Chemists and Druggists Association official, irrational combinations could expose patients to unnecessary medication, increase the risk of adverse reactions and make treatment more complicated. In the case of antibiotic combinations, inappropriate use may also contribute to antimicrobial resistance, a major public health concern.
The DTAB further concluded that safer and more effective alternatives were already available for the conditions these products were intended to treat. Based on these findings, the government prohibited the manufacture, sale and distribution of the 16 formulations under Section 26A of the Drugs and Cosmetics Act, 1940.
All state drug controllers, regulatory authorities and enforcement agencies have been directed to ensure strict implementation of the notifications.
Manufacturers, importers, distributors and other stakeholders have also been advised to take necessary corrective measures to comply with the law.
The ministry recalled that several irrational FDCs had been prohibited in previous years following detailed scientific reviews.