The government has ordered the state drug controllers not to allow companies to sell the drug formulations in which the composition has been changed while retaining the old name. This order may affect several widely selling old household brands of medicine.
According to the official sources, the Drugs Controller General directed state regulatory authorities on Thursday to “discourage the practice of marketing of drug formulations with changed composition, without changing the brand name”. As a result, certain companies will not be allowed to retain the brand name in medicines that have undergone a change in raw material (active pharmaceutical ingredient). It could not be ascertained whether this would apply with retrospective effect.
The problem is mainly with those widely used dose combinations (FDCs)  and mainly over-the-counter medications, which may have a huge brand recall. For example, when codeine (as a composition) was banned, companies like Pfizer changed the cough preparation and relaunched it, but retained the brand name Corex, which has a huge recall.  The government feels retaining the brand name in a new formulation where an ingredient has been changed is misleading and harmful for patients.
The issue has been discussed even before and was debated in several Drugs Consultative Committee meetings held since 2008. According to the expert panel’s opinion, such medicines, where the ingredient was tweaked by companies but brand name retained is “not only misleading but may result in undesirable pharmacological effects” as the consumer would take the formulation, assuming it as the earlier composition.
Three years ago, the government banned over 340 FDCs, after which the ban was legally contested with the matter still pending in the courts. The banned FDCs included popular, widely-selling cough & cold syrups, painkillers, flu medicines and skin medication, after an expert panel, Drug Technical Advisory Board said they were “irrational and harmful”.

Source: Times of India, Economic Times Health

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