Ban on fixed dose combination drugs in India

By – Dr. Anu Sukhdev,

Assistant Professor (School of Engineering), Presidency University


On March 10 2016, the Central Drugs Standard Control Organisation (CDSCO) has banned the sale of 344 fixed dose combination (FDC) drugs in India, including several antibiotics, analgesics like Combiflam, Nimesulide and  most popular codeine-containing cough syrups like Benadryl, Corex as they ‘involve risk to humans’ and safer alternatives are available.

What are fixed dose combination drugs?

These are medicines which contain multiple drugs used to treat different symptoms. For instance, someone suffering from cold may have a cough but no head ache or fever. However, these medicines havea combination of drugs used to treat all the symptoms. Hence there is no medical justification for the intake of such medicine.

The history behind FDC sale in India:

As per pharmaceutical companies, popular FDCs like Corex, Benadryl, Phensydyl, Nimesulide, Vicks action 500 etc have been sold in India for several years now. The sale of FDC’s in India requires the approval of the Central government. Unfortunately, several drug combinations have entered the Indian market over the years based solely on approval from individual state governments.This is due to inconsistent enforcement of laws between state and central regulators and points to a failure in our drug regulatory system.Because of this, the Indian drug market is flooded with hundreds of FDC formulations.

The reasons behind the recent ban:

In 2007, the CDSCOhad ordered states to recall about 300 such combination drugs, but drug makers challenged it in court and the order was stayed.In 2014, India set up a committee to review more than 6000 combinations that had entered the market based only on state regulators’ approval and asked companies to submit data to prove safety and efficacy of their drugs. In Oct 2015, Indian drug regulators had asked pharmaceutical companies to self-regulate Codeine based cough syrups that were reportedly used for recreational purposes.However, based on the responses from companies, the panel banned more than 300 drugs stating that these drugs lacked therapeutic justification, likely to involve risk to human beings, no data available on drug-drug interaction and side effects of these FDC drugs.

The impact:

Many doctors have welcomed the initiative to stop the irrational use of medicines which can lead to drug resistance and other side effects. Most developed countries do not encourage the sale of fixed dose combination drugs in their markets. The safer alternate to FDCs could be single dose medications.

The pharmaceutical companiesclaim that the ban would cause an impact of Rs.3800 Crores per year on Indian pharmaceutical industry and hence have decided to challenge the ban in Indian courts.