Delhi HC quashes government ban on fixed dose combination drugs

•  Delhi high court has quashed the ban on Fixed dose combination (FDCs).
• The ban was imposed based on the recommendations of Kokate committee. It was imposed over fears that these drugs cause anti-microbial resistance and might even cause organ-failure because of high toxicity. It also aimed at curbing the misuse of medicines. However, the pharmaceutical companies contend that no prior enquiry was made from them or show cause notice issued prior to ban notification by the Central Government. They also held that these drugs in the same combination are being marketed in other countries.
• With this, the banned drugs – including D’Cold, Benadryl and Phensedyl that are widely used to treat headaches and colds – will continue be available freely in the market.
• The court observed that the decision was taken by the Centre without following procedure prescribed in the Drugs and Cosmetics Act. It noted that the government had not consulted the Drugs Technical Advisory Board or the Drugs Consultative Committee but had acted on the advice of a ‘technical committee’, which, they said, violated the provisions of the Drugs and Cosmetics Act.

Combination medicines (or fixed-dose combination [FDC] medicines) are:

• medicines containing two or more active components in fixed proportions in a single dosage form
• Several medications in fixed combination to be taken together, presented in composite packaging (co-pack).

Analysis:

• 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 of them slip through India’s labyrinthine regulation process with agencies at the central and state level, which often don’t coordinate.
• The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. Such combinations of drugs are being used in the treatment of a wide range of conditions and are particularly useful in the management of HIV/AIDS, malaria and tuberculosis, which are considered to be the foremost infectious disease threats in the world today.
• FDCs have advantages when there is an identifiable patient population for whom treatment with a particular combination of actives in a fixed ratio of doses has been shown to be safe and effective and when all of the actives contribute to the overall therapeutic effect. In addition there can be real clinical benefits in the form of increased efficacy and/or a reduced incidence of adverse effects, but such claims should be supported by evidence.
• Additional advantages of FDCs are potentially lower costs of manufacturing compared to the costs of producing separate products administered concurrently, simpler logistics of distribution, improved patient adherence and reduced development of resistance in the case of antimicrobials.

By: Vishal