Pharma Combination Drugs Lost Interest

In spite of favourable court verdicts, top pharmaceutical companies are losing enthusiasm for fixed dose combination medicines.

- Joe C. Mathew

Early this year, the Indian arm of Pfizer decided to discontinue the manufacture and sale of Corex cough syrup, the crown jewel in its domestic portfolio. Corex was its biggest revenue generator and among the country’s top five drug brands. What made the decision more surprising was that Pfizer had fought a legal battle against a March 2016 Central government ban on sale of this fixed dose combination, or FDC, medicine, along with 333 others, and won. The decision to discontinue the syrup came a month after the court ruling. The government had banned these FDC drugs in March 2016 after a committee of experts found that they were likely to pose a risk to patients and safer alternatives were available. An FDC drug includes two or more active pharmaceutical ingredients combined in a single dosage form.

Pfizer says the decision was based on a review of “respiratory offerings” that happened independent of the legal issues. “We decided to discontinue the manufacture of the erstwhile Corex cough syrup. At the same time, we decided to launch a series of line extensions of the Corex brand that will address specific sub-therapeutic areas under the broad respiratory segment,” says a Pfizer spokesperson.

Perhaps, that was not the only reason. By winning the case, Pfizer proved its argument that there was no legal basis for banning Corex (a combination of chlorpheniramine maleate, codeine phosphate and some colorants). At the same time, the decision to discontinue the sale of the specific FDC drug made a bigger point — that Pfizer was not opposing the spirit behind the government decision, which was to stop the sale of ‘irrational’ and ‘unapproved’ FDC drugs. An FDC is called ‘irrational’ when there is no scientific rationale for combining two or more individual drugs in a particular combination.