Delhi HC scraps government ban on 344 fixed dose combination drugs

Mangalore Today News Network

New Delhi, Dec 01, 2016: Popular drugs such as Benadryl may soon be back on shop shelves after the Delhi high court scrapped on Thursday the government’s decision to ban 344 fixed dose combination drugs.

The health ministry had banned these fixed-dose combination medicines – including popular brands such as Vicks Action 500, Benadryl and Phensedyl -- in March over fears that they cause anti-microbial resistance and might even cause organ-failure because of high toxicity.

Read | FDC drugs banned keeping safety in mind: Govt tells Delhi HC

India is one of the world’s largest markets for fixed dose combination drugs that make up almost half the market share but medical experts say most of them are irrational, that is they haven’t been approved by the national regulator. Many aren’t approved for sale in countries with more stringent regulation.

Fixed-dose combination drugs, or FDCs, combine two or more drugs in a single pill and are widely used to improve patient compliance as it is easier to get someone to take one drug than several.

Many of them slip through India’s labyrinthine regulation process with agencies at the central and state level, which often don’t coordinate.