No coercive steps against drug firms for FDCs in market: Delhi HC

The Delhi High Court on Tuesday issued a notice on the writ petitions filed by pharma majors such as Glenmark, Lupin, and Mankind, among others challenging the ban on close to 40 products out of the 328 fixed dose combinations (FDCs), directing that no coercive steps be taken against petitioners and their stockists or dealers for the existing stock already in circulation. 

The matter came up before the single judge bench of the Delhi High Court of Justice Vibhu Bakhru. The court said no coercive steps be taken by government agencies as overnight recall of drugs from across the country is difficult. Meanwhile, the Centre has been directed to file an affidavit explaining reasons for the findings. The companies have been directed to file a statement of stocks in circulation. 

The matter will be taken up for hearing again on October 9. Around five pharma firms had filed writ petitions in the Delhi High Court challenging the September 7 notification by the Ministry of Health and Family Welfare prohibiting the manufacture and sale of 328 FDC drugs. 

Of this Glenmark has challenged the ban on four of its FDC drugs, Lupin for 14 and Mankind Pharma for 17, apart from some drugs from Coral Laboratories and Koye Pharmaceuticals. 

FDCs are two or more drugs combined in a fixed ratio into a single dosage. 

Ajay Bhargava, partner at law firm Khaitan and Company that has filed the petition on behalf of the firms, 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 that are already manufactured and in the distribution channel.”  The notification had come in on September 7 and many pharma firms received it on September 13. 

Earlier, the HC had allowed pharma major Wockhardt to sell its Ace Proxyvon tablets (a banned FDC) used for treatment of painful rheumatic conditions. This was after the company reasoned it had not been provided with the Drugs Technical Advisory Board report, based on which the decision was taken.

It had claimed the only reason given in the September 7 notification was that the combination had no therapeutic value.

In a March 2016 notification, the health ministry had banned manufacture, sale and distribution of 349 FDCs. The notification was then contested by the pharma companies in the Delhi High Court and the Supreme Court. After the HC had quashed the ban, the decision was challenged in the Supreme Court. Last December, the Supreme Court had set aside the HC order and referred the banned FDCs to the DTAB for re-examination.

In its report, an expert panel set up by the DTAB had stated that there was no therapeutic justification for the ingredients contained in 328 of the 349 FDCs, which may also pose a risk to humans. The board had also recommended prohibition of manufacture, sale or distribution of the 328 FDCs.

In its petition challenging the ban of Candibiotic ear drops, Glenmark noted: "It is pertinent to mention that the individual components of the Subject FDC is being sold in the market for the past several decades. That it is pertinent to mention that the Subject FDC has been in production from the period, as mentioned in the table above, under license granted by the State Drug Controllers." 

It also mentioned that Candibiotic Ear drops has been sold widely and is also being exported to more than 15 countries, including regulated markets like Russia, Ukraine, and Vietnam, among others. Glenmark also claimed that to the best of its knowledge, there has been "no serious adverse events or any serious complaints" received by the company with regard to the safety and efficacy of the Subject FDC, till date.