Fifteen fixed-dose combination drugs (FDCs) including cough syrups Phensedyl and Tixylix will not be banned. The Supreme Court
on Friday restrained central government from acting on panel recommendations to restrict the sale of those FDCs
which were approved prior to 1988.
The apex court order came in response to pleas by Abbott and Laboratories Griffon which argued that the recommendation to include fifteen pre 1988 approved FDCs
in the ban list was against the court order.
The drug technical advisory board (DTAB) in July accepted the recommendations of an expert panel which was appointed to probe efficacy of 349 FDCs.
While a ban was proposed on 343 drugs, the board suggested restricted use with respect to six drugs. The DTAB
recommendations were submitted to the health ministry which has issued a draft notification to ban the drugs.
Aggrieved by the government decision, companies moved the court. Abbott manufactures Phensedyl and Tixylix and the products had annual sales of Rs 2.8 billion and Rs 0.56 billion respectively. Incidentally, Phensedyl is the largest selling fixed-dose combination drug in the domestic market.
The companies argued that the Supreme Court
in its December 2017 order had referred 329 drugs to the DTAB
for further review. Fifteen pre-1988 approved drugs were not on the review list as the court had set aside government notifications banning their sale.
The Supreme Court
on Friday disposed of the applications holding that the DTAB
appointed panel did not have the mandate to review these fifteen drugs. However, the government is free to carry out fresh investigations if it chooses to ban pre-1988 drugs, it said.
In March 2016 the ministry of health implemented a ban on 349 FDCs
based on recommendations of Chandrakant Kokate committee that found these drug combinations to be irrational and posing health risks. Last December the Supreme Court
referred the matter to the DTAB
for a review on drug makers' pleas.
The market size of the 343 FDCs
is estimated to be around Rs 20-22 bn at the moment and constitute around 2 per cent of total domestic market. An FDC drug is one which contains two or more active ingredients in a fixed dosage ratio.