Pharma firms which challenged the Centre's decision to ban 328 fixed dose combination (FDC) drugs were Tuesday protected by the Delhi High Court from coercive action against them for the stock already in the market, provided they stop manufacturing the prohibited medicines.
Justice Vibhu Bakhru said the interim order would apply to the companies which have moved the high court and directed the Health Ministry to file an affidavit indicating the reasons for prohibiting manufacture and sale of the FDCs.
The court said it will test the government's assertion that the FDCs were risky to human health and listed the matter for further hearing on September 27.
It also asked the companies to give the batch numbers of the stock in the market.
The order came on a batch of pleas by several pharma majors including Glenmark, Wockhardt, Alkem Laboratories and Obsurge Biotech, challenging the Health Ministry's September 7 ban on 328 FDCs, which are two or more drugs combined in a fixed ratio into a single dosage form.
Coral Laboratories, Lupin, Mankind Pharma, Koye Pharmaceuticals, Macleods and Laborate have also moved the high court against the ban on their FDCs ranging from anti-inflammatory and pain killers to antibiotics and drugs for treating bacterial infections.
In a statement, Khaitan and Co partner Ajay Bhargava, who represented Glenmark, Lupin, Mankind, Coral and Koye, said: "The order will bring some respite to the pharma companies to protect them against coercive measures by the government in relation to the medicines which are already manufactured and in the distribution channel."
The court issued notice on each company's plea and sought the Centre's response by the next date of hearing, September 27.
Wockhardt had got the interim order in its favour on September 14 in respect of its anti-inflammatory medicine -- Ace Proxyvon and this relief was extended till the next date by the court.
Alkem moved the high court in respect of the ban on its anti-bacterial medicine Taxim and a painkiller which is a combination of the drugs diclofenac and paracetamol.
Apart from that Glenmark has challenged the ban on four of its FDCs -- two antibiotics, an ear drop and two anti-bacterial/antifungal medicines.
The court asked the ministry to file an affidavit indicating that the drug combination of each FDC was given in different dosages and they are not required to be taken together as part of one tablet or cream.
The direction came as the ministry, represented by Additional Solicitor General Maninder Acharya and central government standing counsels Kirtiman Singh, Amit Mahajan and Anil Soni, contended that in most cases one ingredient of FDCs was good by itself and there was no need for a patient to take the additional one, two or three drugs which were part of the medicine.
"One (drug) is good enough. There is no need to take two or three (drugs)," the ministry said, adding that taking FDCs could also lead to over or under medication apart from making a person resistant to all the ingredients of such medicines.
The government also said that "FDCs are an aberration" and not an accepted practice.
The court asked the ministry to say on affidavit that only one drug of a FDC was required and not all of them.
The Supreme Court had yesterday allowed sale of Piramal Healthcare's Saridon, GlaxoSmithKline's Piriton, Juggat Pharma's Dart and another drug.
The Health Ministry had earlier, through a notification of March 10, 2016, prohibited 349 FDCs for manufacture, sale and distribution under Section 26 A of the Drugs and Cosmetics Act, 1940. The notification was then contested by the pharma companies in the Delhi High Court and the Supreme Court.
The high court in December 2016 had quashed the ban on the FDCs, which was challenged by the Centre in the apex court.
The top court had in December last year set aside the high court order and referred the banned FDCs to DTAB for re-examination.
Complying with the apex court direction, an expert panel set up by DTAB, in its report to the Centre, had stated there was no therapeutic justification for the ingredients contained in 328 of the 349 FDCs, which may also involve risk to humans.
The board had recommended that it was necessary to prohibit the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 in larger public interest.
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