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By , , ET Bureau | Updated: Nov 16, 2017, 04.38 PM IST

Government need not consult statutoryboard to ban combo drugs: Supreme Court

NEW DELHI: The Supreme Court onWednesday said the central government neednot consult the statutory board on drugsbefore banning any fixed-drug combinations,an observation that goes against a major legalplank of companies battling against a ban on344 such products. Fixed-dose combinations (FDCs) are cocktaildrugs of two or more therapeutic ingredientspacked in a single dose.

A central government notification banning the 344 fixed-dose combinations in 2016 wasset aside by the Delhi High Court in December. The government had banned thesecombinations in public interest, claiming they were unsafe and "irrational". The ban had hit several popular brands like Corex, Saridon, D’Cold Total and Vicks Action500 Extra, prompting pharma companies to submit over 500 petitions at around 10 highcourts, with Delhi receiving a sizeable chunk. The government challenged these in the top court on the ground that the ban wasnecessary in public interest, prompting the top court to stay the order. Pharma companies such as Glenmark NSE -0.60 % , Pfizer NSE -1.79 % and Procter & Gamblehad contended that the principle of natural justice required some kind of hearing fromstakeholders before the government can take a call on a technical subject like this one.

Samanwaya Rautray Prabha Raghavan

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Before prohibiting fixed-dose combination drugs, the government must consult thestatutory bodies provided for in the Drugs and Cosmetics Act, the companies had arguedbefore a bench of Justices RF Nariman and Sanjay Kishan Kaul. “Otherwise the power would be unfettered, unlimited,” senior advocate Abhishek ManuSinghvi had said. “This cannot be done without consulting the stakeholders. Public safety,public risk can only be assessed on the basis of expert inputs.” In the absence of an emergency, such a consultation should be made mandatory, he hadargued. Justice Nariman, however, said such consultations were not specified in Section 26A of theact, which defines the power of the Central government to regulate the manufacture andsale of drugs and cosmetics in public interest. “If we hold otherwise, we will neither be reading the law up or down but reading in, which islegislating,” Nariman said. Justice Kaul also said the arguments would have beenappealing had the subject matter been anything but drugs. The court said it was with the government on this legal point. The companies will now likelyargue the other legal points against the ban at the next hearing, scheduled for Dec 6. "Arguments on December 6 will look at how many FDCs can be excluded from the banand how many we are not able to justify entirely," a lawyer involved in the case told ET,speaking on the condition of anonymity. The industry is positive about the court's decision to allow further arguments in this case. “The judge is open to hearing a little bit from our side as well, which is positive," said RKSanghavi of pharmaceutical lobby group Indian Drug Manufacturers Association. The association on Wednesday submitted a list of around 175 FDCs out of the original listof 344 that it had determined were not only safe for consumption but needed for specificpatients, he said. This list excluded the FDCs approved before 1988 and those already approved by theDrug Controller General of India, he added. "The judgment will definitely have an impact depending on how much commercials are atstake and more importantly on the patients' dependency on such FDCs, especially incases of chronic diseases," said Ashish Prasad, partner at Economic Laws Practice.

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The impending ban had sent hospitals into a panic-

buying mode.

India's oxytocin ban delayed by a month asDelhi HC hears cases against it

NEW DELHI: The Delhi High Court hassuspended the health ministry’s restrictions onprivate companies making and sellinglifesaving drug oxytocin for a month while ithears petitions opposing the move. The courtwill hear the case next on September 12, itsaid on Friday. “This is an interim move for the court toprovide enough room to hearing all thearguments in this case,” a lawyer present incourt said on condition of anonymity.

Oxytocin is a hormone drug used to induce labour in pregnant women and prevent post-partum bleeding. The curbs were aimed at preventing illegal supply and misuse of the drugin cattle. The restrictions would have been effective from September 1 and would have limited theproduction and sale of oxytocin in the country to state-owned Karnataka Antibiotics andPharmaceuticals Ltd

Prabha Raghavan

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9/4/2018 combo drugs: Government need not consult statutory board to ban combo drugs: Supreme Court - The Economic Times

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Pharmaceuticals Ltd. According to the court order, statutory bodies Drugs Technical Advisory Board and DrugsConsultative Committee raised concerns that emphasise that prohibition or restricted saleof oxytocin “would not be in order.” As many as 116 inspections to track illegal sales of oxytocin have resulted in prosecutionin 12 instances in the past four years and the figures suggest that only two out of 112licensed manufacturers have had their permits suspended, according to the order. Thedetails of seizures conducted suggest that abuse of the drug is widespread only in regionsincluding Bihar and West Bengal, Justices S Ravindra Bhat and AK Chawla said in theorder.

“The materials disclosed to the court also show that when the discussion to restrict thedomestic sale of oxytocin was taken in February 2018, KAPL, as a matter of fact, was noteven licensed to manufacture the drug,” they said, adding that the company was issued alicence in April 2018. Mylan is one of the companies that has opposed the ministry’s plan in court. Pfizer hasstopped manufacturing the drug and planned to exhaust its inventory of the product withintwo months, ET reported on July 26. ET had also reported then that the impending move had sent hospitals into a panic-buyingmode. The size of the oxytocin market was about Rs 50 crore in the 12 months ended July2018, with Pfizer capturing an over 40% share, according to pharmaceutical marketresearch firm AIOCD PharmaTrac. Patient activist group All India Drug Action Network has also filed a petition, which is beingheard along with the pleas of Mylan subsidiary BGP Products Operations Gmbh and NeonLaboratories. “KAPL’s ability to single-handedly produce an emergency drug for the entire country andensure the supply all over India while maintaining a cold chain… is untried and untested,”AIDAN said in its petition, a copy of which ET has reviewed. “A slight disruption or problemin functioning of the supply chain would mean unnecessary maternal deaths.” Oxytocin is considered a lifesaving drug and is included in the National List of EssentialMedicines of 2011 and 2015 as well as the WHO Model List of Essential Medicines. About four women die every hour in India from complications developed during childbirth,with heavy blood loss from haemorrhaging being “a major factor,” AIDAN said in thepetition, citing data from the Registrar General of India. ET’s queries to Mylan, Neon Laboratories and AIDAN remained unanswered by press timeon Friday.

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1Government need not consult statutoryboard to ban combo drugs: SupremeCourt

2India's oxytocin ban delayed by amonth as Delhi HC hears cases againstit

3 Gland Pharma seeks pitches frominvestment bankers to go public 4 Domestic pharmaceutical players eye

Bharat Serums acquisition 5Glegeinh