The Supreme Court has reversed plans by the Centre to ban three of the 328 combination medications it announced plans to ban last week over safety concerns.
Saridon, Piriton and Dart are the three products given a reprieve by the apex court. The ban will still apply to 325 of 343 fixed dose combination (FDC) medications whose ban was recommended by the Drug and Technical Advisory Board (DTAB) in July. FDCs are pharmaceutical products which contain two or more active pharmaceutical ingredients (APIs). Saridon, which combines caffeine, paracetamol and propyphenazone to treat headaches, is a popular example of an FDC.
The DTAB also proposed restrictions on the sale of six other FDCs. The Union Health Ministry is similarly planning to implement this recommendation.
“The ban will still apply to 325 of 343 fixed dose combination (FDC) medications whose ban was recommended by the Drug and Technical Advisory Board (DTAB) in July.”
The ban was anticipated to cost India’s pharmaceutical sector Rs 1,500 crore (207.4 million USD). Popular brands such as steroid cream Panderm Plus will be affected. However, cough syrups and cold medicines such as Phensedyl were given a reprieve. This is despite earlier plans by the Centre to ban them.
The decision not to ban these FDCs followed a directive issued by the Supreme Court earlier this month. The SC said that any change to the legal status of fifteen FDCs licensed in India before 1988 was beyond the Centre’s purview. The SC has said, however, that the Centre can look into the health effects of these products anew.
“The ban was anticipated to cost India’s pharmaceutical sector Rs 1,500 crore.”
The commercial availability of FDCs is widespread in India and their use is common. Concerns have been expressed in the past over the regulatory framework surrounding FDCs in India. Drug regulators at the state level have been known to license the manufacture and sale of medications banned from sale by the Central Drugs Standard Control Organisation (CDSCO). The objective of the Centre’s new notification is to prevent this and secure the withdrawal of such products from the market.
FDCs can be an effective and useful part of treatment regimens for conditions ranging from diabetes to tuberculosis. There is concern, however, that their use in many cases is irrational and has a deleterious effect on patient health. One notable example of this is the excessive use of the use of fixed-drug antimicrobial combinations, which is considered a driver of the antimicrobial resistance crisis in India.