Fixed-dose B-complex preparations banned

This followed the Drug Technical Advisory Board8217;s observation that B-complex vitamins in a 8220;fixed-dose combination8221; were not beneficial in the way they were promoted, and the drug controller announcing that such B1 B6 B12 preparations should be phased out by January 2001.

The result: Now people don8217;t know which B-complex formulation to go for.

As a result of the ban, while drugs such as Neurobion would be phased out, B-complex preparations in other combinations 8212; sold under brand names such as Becosules, Polybion and Cobadex, among others 8212; will continue to be available as before. Theseusually have additional vitamins of the B-complex family, apart from the other water-soluble vitamin, Vitamin C.

Fixed-dose B1 B6 B12 preparations are usually prescribed to treat neurological disturbances, B6 deficiency-induced anaemia, subacute combined degeneration, beri beri vitamin B1 deficiency, hepatitis, debilities and psychological disturbances in women on oral contraceptives.

8220;There was a need for the ban because scientific evaluation by medical experts showed that there were no proven benefits of fixed-dose preparations, even for the nerve-related disorders that they are projected to cure,8221; said a Health Ministry official.

Adds Dr S K Gupta, Head of the Department, Pharmacology, All India Institute of Medical Sciences AIIMS: 8220;Vitamins B1, B6 and B12 are needed for the treatment of nerve disorders, but the fixed-dose tablets available over the counter are often misused as dietary supplements.8221; After the ban, the three vitamins can be prescribed independently according to thepatient8217;s needs.

On the other hand, other B-complex preparations are used to treat nutritional disorders that may have been caused by bad eating habits, anorexia, pregnancy or lactation, apart from being prescribed to help convalescents to get back on their feet quickly. They have no side-effects.