decide fate of over 334 banned combination Supreme Court ... · 8/29/2018 Banned Medicines: Supreme Court asks drugs advisory body to decide fate of over 334 banned combination medicines

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FDCs are cocktail drugs that contain two or more

therapeutic ingredients packed in a single dose.

Supreme Court asks drugs advisory body todecide fate of over 334 banned combinationmedicines

NEW DELHI: The Supreme Court has askedthe country’s technical advisory body on drugsto decide on the fate of more than 300combination medicines banned by thegovernment between March 2016 and June2017. The order is a potential relief to drugmakers who have argued that the governmentdid not consult statutory bodies provided for inthe country's drug regulations before banningthese drugs. Companies can make and sell the 349contested fixed dose combination drugs

(FDCs) while Drugs Technical Advisory Board (DTAB) deliberates on the issue. At the same time, the court also clarified that this order is specific to two of thegovernment's ban notifications due to “peculiar facts” of the cases. In an order dictated in open court on two government notifications banning these FDCs, aSupreme Court bench of Justices Rohinton Fali Nariman and Sanjay Kishan Kaul onThursday said it was setting aside the ban on 15 such drugs which were manufactured inIndia before 1988. However, if it chooses to, the government can carry out further inquiry on whether thesedrugs should continue to be marketed in the country, the court suggested. For the remaining 334 FDCs, the court suggested that DTAB should decide whether themanufacture and sale of these drugs should be regulated, restricted or outright banned,and submit a report with its recommendations to the government within six months.

The bench will pronounce its official judgment on Friday. FDCs are cocktail drugs that contain two or more therapeutic ingredients packed in a

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single dose. While 344 of the contested drugs are currently available in the market as the Delhi HighCourt in December last quashed the ban on them imposed in March last year, the otherfive FDCs banned in June, too, can now return to the market. The Supreme Court bench said DTAB or a sub-committee it sets up should heararguments by the drug industry as well as patient group All India Drug Action Network(AIDAN), which is in favour of the ban notifications, before preparing its report. The government is expected to carefully consider this report, “apply its mind” andaccordingly either maintain or modify its ban notifications, according to it. The Kokate committee — the government’s expert committee that had studied the FDCsand declared them “irrational” — was not clear as to the reasoning behind its decision, itobserved. The top court last month said the government does not have to consult statutory bodieslike DTAB before banning FDCs as such consultations were not specified in Section 26A ofthe Drugs and Cosmetics Act. The government had used Section 26A, which defines itspower to regulate the manufacture and sale of drugs "in public interest", to ban thesedrugs last year on a separate expert committee's recommendation. “The judgment means that the government need not mandatorily consult DTAB to prohibitthe manufacture and sale of FDCs it finds irrational and can use expert committees like theKokate committee,” said S Srinivasan, a member of AIDAN. “Earlier, the Delhi High Courthad quashed the ban only on the reasoning that DTAB was not consulted, but now thegovernment has been empowered to act fast,” he said. “The only drawback is that sixmonths seems too short a deadline to achieve all this,” he added. AIDAN’s counsel Colin Gonsalves told the court on Thursday that there are 40,000contested and debated FDCs in India, while any well-regulated country allows 500 FDCsat most. Lawyers representing drug makers said the decision is a victory for the industry. “The court has referred the matter for a fresh look to decide if the drugs require to bebanned under Section 26A of the Drugs & Cosmetics Act,” said Ashish Prasad, partner atEconomic Laws Practice, who represented Indian Drug Manufacturers Association (IDMA),Federation of Pharma Entrepreneurs (FOPE) and Confederation of Indian PharmaceuticalIndustries (CIPI) during the proceedings. Archana Sahadeva, associate partner at Singh & Singh Law Firm, who represented drugmakers such as Cipla, MacLeods, Alembic and Microlabs, said, “This means that theprocess will now be more transparent.” The 300 plus contested drugs include popular brands such as Corex, Phensedyl, D’ColdTotal, Vicks Action 500 Extra and Saridon.

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PTI | Aug 29, 2018, 11.21 AM IST

Glenmark inks licensing pact for genericTiotropium Bromide dry powder inhaler inWestern Europe

NEW DELHI: Glenmark PharmaceuticalsEurope has entered into a strategic, exclusivelicensing agreement for marketing genericTiotropium Bromide dry powder inhaler, usedin the treatment of chronic obstructive

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Pharma Glenmark Pharmaceuticals Pulmonary Disease Tiotropium Bromide

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Tiotropium Bromide DPI is a generic version of

Boehringer Ingelheim's Spiriva Handihaler.



in the treatment of chronic obstructivepulmonary disease, in Western Europe. Glenmark Pharmaceuticals EVP & BusinessHead of Europe and Latin America AchinGupta said, respiratory is a core area of focusfor Glenmark and this deal shows ourcommitment to increase product offeringswithin this segment.

"There is significant opportunity in the inhalers market and we believe that this deal willgive further impetus to Glenmark's growth in Europe," he added. This is the second inhalation product in-licensed by Glenmark for the European marketafter Fluticasone/Salmeterol dry powder inhaler, the company said. Tiotropium Bromide DPI is a generic version of Boehringer Ingelheim's Spiriva Handihaler. Quoting IQVIA data, Glenmark said Boehringer Ingelheim's Spiriva Handihaler recordedsales of USD 724 million in the European Union in the 12 month period ended March2018.

Shares of Glenmark Pharma were trading 0.85 per cent higher at Rs 648.85 on BSE.

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USFDA Lupin Gabapentin Tablets Postherpetic Neuralgia Seizures

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PTI | Aug 28, 2018, 02.22 PM IST

Lupin's tablets are generic version of Pfizer Inc's

Neurontin tablets in the same strengths.



Lupin gets USFDA nod to market itspostherpetic neuralgia drug

NEW DELHI: Drug firm Lupin today said it hasreceived approval from the US healthregulator to market its generic Gabapentintablets used for treatment of postherpeticneuralgia in the American market. The company has received final approval tomarket its Gabapentin tablets USP in thestrengths of 600 mg and 800 mg from theUnited States Food and Drug Administration(USFDA), Lupin said in a statement. The company's tablets are generic version of

Pfizer Inc's Neurontin tablets in the same strengths, it added. As per the IQVIA MAT June 2018 data, Gabapentin tablets USP, 600 mg and 800 mg hadannual sales of around USD 180.7 million in the US, Lupin said. The product is "indicated for the treatment of postherpetic neuralgia in adults andadjunctive therapy in the treatment of partial onset seizures, with and without secondarygeneralisation, in adults and pediatric patients 3 years and older with epilepsy."

Shares of Lupin were today trading at Rs 910.75 per scrip on BSE, up 0.34 per cent fromits previous close.

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By , ET Bureau | Aug 28, 2018, 09.42 AM IST

T he health minister's statement on Monday suggest

that the government may wait to take action in this

matter.

India's health ministry still 'deliberating' onfindings on J&J's faulty hip implants, saysJP Nadda

NEW DELHI: The government is yet torelease the findings of an expert committeethat reportedly found US drug giant Johnsonand Johnson guilty of concealing informationrelated to faulty hip implants that haverendered several Indian patients withpermanent disabilities. This is because thehealth ministry is currently still "deliberating"on the committee's report, said health ministerJP Nadda during a media briefing on Monday. The expert committee reportedlyrecommended that each affected patient

Prabha Raghavan

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Health Ministry Luni Coleone Patients Jagat Prakash Nadda India

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receive compensation of Rs20 lakh and is said to have submitted its report in February thisyear. However, the findings of this committee and its recommendations have not beenmade public. Meanwhile, officials close to the development have said that the health ministry hasaccepted the recommendations and is coordinating with states to set up committees to findany aggrieved patients that have not come forward to claim damages. These committeesare expected to advertise for patients to approach them and, depending on physical andclinical data, the committee is expected to ascertain to what extent the hip implants havecaused damage to the patient. Subsequently, a central committee is supposed to takethese findings and suggest a compensation for the patient that J&J will have to pay up,officials earlier told ET. Yet, the health minister's statement on Monday suggest that the government may wait totake action in this matter. "We share your concerns, however we are still deliberating upon the matter," said Naddain response to queries on why the report had not been made public and why no stringentaction has been taken in this matter yet even though the committee's findings had beensubmitted six months ago. J&J, through subsidiary DePuy Orthopaedics, had issued a global recall of the implantsystem, called ASR Hip System, in 2010 after it received "new information" from the UKNational Joint Registry, a J&J spokesperson earlier said.

Reportedly over 4,500 patients in India had received this implant, and J&J is said to havereported over 100 serious adverse events to the Central Drugs Standard ControlOrganisation between 2014 and 2017.

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PTI | Aug 27, 2018, 01.45 PM IST

Lupin's product is a generic equivalent of Bayer's

Beyazs tablets.

Are you a Business Owner? Get Your FreeBusiness Listing on Economic Times. Connect with us

Lupin launches contraceptive drug in the USmarket

Drug maker Lupin today launchedDrospirenone, Ethinyl Estradiol, LevomefolateCalcium tablets and Levomefolate Calciumtablets, used to prevent pregnancy, in the USmarket. The company has launched the product in theUS after having received approval from theUS Food and Drug Administration (USFDA)earlier, Lupin said in a BSE filing. Approval was granted in the strengths of 3mg/ 0.02mg/ 0.451 mg and 0.451 mg.

Lupin's product is a generic equivalent of Bayer's Beyazs tablets. Quoting IQVIA MAT June 2018 data, Lupin said Drospirenone, Ethinyl Estradiol andLevomefolate Calcium Tablets and Levomefolate Calcium Tablets had annual sales ofapproximately USD 80.8 million in the US.

Lupin shares were trading 0.38 per cent up at Rs 910.60 apiece on BSE.

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ET Bureau | Aug 27, 2018, 11.36 AM IST

The nature of the inspection – whether it is a PAI (pre-

approval inspection) or a GMP (good manufacturing

practices) could not be ascertained

USFDA conducts inspection of SunPharma’s Halol site: Sources

The U S Food and Drug Administration(USFDA) is conducting an inspection at SunPharma’s Halol facility in Gujarat. The siteproduces multiple dosage forms – fromtablets to ointments to injectables – and wascleared by the US drug regulator in June,almost three years after a comprehensiveremediation process was initiated. The nature of the inspection – whether it is aPAI (pre-approval inspection) or a GMP (goodmanufacturing practices) – could not be

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practices) – could not be ascertained.



ascertained. When contacted, Sun Pharmasaid it had no comment to offer. The USFDA inspection at Halol in 2015 had resulted in 23 observations – a set ofdeficiencies in the manufacturing processes. The next inspection in 2016 resulted in nineobservations and the last one conducted in February this year had cited threeobservations. Interestingly, earlier this month Sun Pharma had announced a product recall of 5,215 unitsof 10 ml vials of testosterone cypionate injections from the US market. The product wasmanufactured at Halol. The reason for the recall cited in media reports was the presenceof particulate matter – organic and inorganic compounds detected in vials of the product.

But it is unclear if the current inspection is actually triggered by the same recall or it is asmaller one only to approve a product or a few products. Pre-approval inspections areconducted if the USFDA intends to examine a site for approval of a single or a fewproducts.

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PTI | Aug 24, 2018, 11.30 PM IST

A regulatory filing Lupin had said that the USFDA had

completed inspection of the Nagpur facility without

making any observations



Lupin gets EIR from USFDA for Nagpurfacility

Drug firm Lupin on Friday said it has receivedan establishment investigation report (EIR)from the US health regulator after thesuccessful inspection of its Nagpur facility.The plant was inspected by the United StatesFood and Drug Administration (USFDA) inMay 2018, Lupin said in a filing to BSE. Commenting on the development, Lupin MDNilesh Gupta said, "The successfulcompletion of the Nagpur facility inspection isa positive development as we continue ourjourney to meet and exceed international

regulatory standards." Earlier in May, in a regulatory filing Lupin had said that the USFDA had completedinspection of the Nagpur facility without making any observations. Shares of Lupin were onFriday trading at 903 per scrip on BSE, down 0.07% from its previous close.

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Pranab Mukherjee to hold nationalism class in Nagpur


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By , TNN | Aug 24, 2018, 10.18 AM IST

The use of branded combination medicines instead of

generic ones added almost a billion dollars in just one

year to the cost of the US federal insurance programme.

US Medicare could have saved $1 billion bysubstituting branded drugs, says study

The use of branded combination medicinesinstead of generic ones added almost a billiondollars in just one year to the cost of the USfederal insurance programme, according to astudy published in the Journal of theAmerican Medical Association (JAMA). Thestudy said promoting generic substitution byeducating doctors on prescribing habits andthrough rational substitution policies couldoffer substantial savings to the drug benefitprogramme. The revelation is significant for India since

Indian pharma companies supply 40 per cent of generic drugs consumed in the US. In 2016, the difference between what the Medicare drug benefit program spent on brandedcombination drugs and the estimated amount it would have spent for the same number ofdoses of generics was $925 million, concluded the study. The study conducted by doctors

t B i h d W ' H it l d H d M di l S h l l d d t f th

Rema Nagarajan

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decide fate of over 334 banned combination Supreme Court ... · 8/29/2018 Banned Medicines: Supreme Court asks drugs advisory body to decide fate of over 334 banned combination medicines