Government flouts Delhi HC order to ban 5 FDCs, affected companies seek stay
Mumbai, July 07, 2017:
Despite Delhi High Court order on 344 fixed dose combinations (FDCs) ban wherein it stated that the Drugs Technical Advisory Body (DTAB) and the Drugs Consultative Committee (DCC) constituted under the Drugs Act should be consulted before imposing a ban on drugs, the government has again banned five FDCs without taking advice of the statutory bodies on irrationality of the drugs invoking sharp response from pharmaceutical industry.
Three firms-- Mankind Pharma, Akum Drugs & Pharmaceuticals Ltd. and JB Chemicals and Pharmaceuticals Ltd had filed a petition in the Delhi High Court seeking a stay on the ban. Though the petition was rejected by the court’s vacation bench of Justice Sanjeev Sachdeva, the drug makers are hopeful that the regular bench of high court will definitely consider their issues and grant a stay on the ban as it did in 344 FDCs ban case.
The government in its reply on June 30 stated that as per the Drugs and Cosmetics Act, it can impose a ban on drugs without consultation of DTAB and DCC. “We have given opportunity to innovators of the drugs to present their views before banning the medicines. Despite approval, we can ban drugs after finding that medicines have no therapeutic value and it is risky to people. The said FDCs have not been approved in developed countries and they are no longer needed for well-being of the country's people.”
The next hearing is slated to take place on July 13, a day after the Supreme Court's hearing on 344 FDCs ban.
Said a spokesperson of one of the affected companies, “There is no empirical evidence suggesting adverse affect of five FDCs banned by the Union health ministry early June. We have not been given hearing opportunity before the ban. Unlike the 344 FDCs ban which were approved by the state drug regulators, the five FDCs had received DCGI approval. The government had not consulted DTAB and DCC before imposing the ban as per the Delhi High Court direction. It should have followed the process specified by the court to impose the ban on drugs. There is a robust amount of medical literature indicating efficacy of these FDCs.”
The FDCs ban does not augur well for Indian pharma industry which is one of the rapidly growing industry in the world. It reflects uncertainty over policy decisions in the country. This is against Prime Minister's “easy of doing business” initiative. It may affect investors' sentiments in pharma sector in future, he added.
Acting on a subject expert committee recommendation, the Union health ministry banned combination of nimesulide with levocetrizine, combination of ofloxacin with ornidazole injection; combination of gemifloxacin with amboroxol; combination of etodolac with paracetamol last month.
The committee was set up by the government to look into the therapeutic efficacy of several FDCs available in the market. The panel suggested that these FDCs are irrational and may cause risk to consumers.