PHARMA LITERATI

The Drugs Technical Advisory Board (DTAB) of the Union health ministry has constituted a sub-committee to evaluate 324 irrational fixed dose combinations (FDCs) based on Prof C K Kokate Committee final report and has directed the sub-committee to come out with final report in three months time. The matter was deliberated at the 82nd meeting of the DTAB held on April 2, 2019.  The sub-committee has been formed under the chairpersonship of Dr Nilima Kshirsagar, Chair in Clinical Pharmacology, Indian Council of Medical Research (ICMR), Mumbai to evaluate Kokate Committee report on 324 FDCs considered as irrational.  After examining 418 applications of FDCs, the Kokate Committee found 324 FDCs as irrational, 28 FDCs as rational, 2 FDCs require further generation of data and 4 FDCs require further deliberation after evaluating all the data submitted.  It was also observed that out of the remaining 60 FDCs, 48 FDCs have been prohibited, 11 FDCs have been alread...

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