The Supreme Court on Monday allowed the sale of three of the 328 fixed dose combination drugs that the government had banned last week, The Economic Times reported. The exempted drugs include the painkiller Saridon, Piriton Expectorant and Dart, whose manufacturers said they have been producing them since before 1988. Fifteen such drugs that are being produced since before 1988 were exempted from the government ban.
On Wednesday, the Ministry of Health and Family Welfare banned the manufacture, sale and distribution of 328 fixed-dose combination drugs with immediate effect, and placed certain conditions on six others. Fixed-dose combination drugs, popularly known as FDCs, are medicines that are a cocktail of two or more drugs. The government cited an advisory board’s recommendation that there was no “therapeutic justification” for their ingredients and they may pose health risks.
Around 6,000 brands with a combined market size of between Rs 2,000 crore and Rs 2,500 crore are likely to be affected, according to News18. On Friday, the Delhi High Court allowed pharmaceutical major Wockhardt to sell its anti-inflammatory medicine, which is on the list, till Tuesday.
On March 10, 2016, the Central Drugs Standard Control Organization issued a notification prohibiting the manufacture, sale and distribution of 344 Fixed Dose Combinations of drugs. It later added five more. The Delhi High Court set aside the order in December 2016 after the pharmaceutical industry moved against it. The Supreme Court overruled the ruling a year later after the central government’s appeal.
In its notification, the government exempted 15 of 349 drugs and restricted the sale of six. The government said: “The Drugs Technical Advisory Board recommended, amongst other things, that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings. The board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under section 26A of the Drugs and Cosmetics Act, 1940 in the larger public interest.”