Supreme Court Asks Drugs Advisory Body to Decide Fate of Over 334 Banned Combination Medicines - the Economic …

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By Prabha Raghavan, ET Bureau | Updated: Dec 15, 2017, 12.31 PM IST Save

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NEW DELHI: The Supreme Court has asked the country’s technical advisory body on drugs to decide on the fate of more than 300 combination medicines banned by the government between March 2016 and June 2017. The order is a potential relief to drug makers who have argued that the government did not consult statutory bodies provided for in the country's drug regulations before banning these drugs. FDCs are cocktail drugs that contain two or more therapeutic ingredients packed in a single dose. Companies can make and sell the 349 contested 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 the government's ban notifications due to “peculiar facts” of the cases.

In an order dictated in open court on two government notifications banning these FDCs, a Supreme Court bench of Justices Rohinton Fali Nariman and Sanjay Kishan Kaul on SPOTLIGHT Thursday said it was setting aside the ban on 15 such drugs which were manufactured in Power Mess India before 1988.

However, if it chooses to, the government can carry out further inquiry on whether these drugs should continue to be marketed in the country, the court suggested.

For the remaining 334 FDCs, the court suggested that DTAB should decide whether the manufacture 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.

Drinking traditions around How Indians Are Earning the World. Online Fix it yourself, HC tells govt on LiveInStyle Careertimes power mess The court said that while govt can issue directives to RBI, it is expected to do so if The bench will pronounce its official judgment on Friday. there are sufficient grounds. Government to hold talks on seeking RBI relief for stressed power firms FDCs are cocktail drugs that contain two or more therapeutic ingredients packed in a The next 15 days will test the fate of https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/sc-asks-drugs-advisory-body-to-decide-fate-of-349-banned-combi… 1/19 8/29/2018 Banned Medicines: Supreme Court asks drugs advisory body to decide fate of over 334 banned combination medicines - The Economic … y single dose. India's bankruptcy fight

While 344 of the contested drugs are currently available in the market as the Delhi High Court in December last quashed the ban on them imposed in March last year, the other five 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 hear arguments by the drug industry as well as patient group All India Drug Action Network Are you an Advertising & Marketing Agency? Get Your Listing on Economic Times (AIDAN), which is in favour of the ban notifications, before preparing its report. CREATE FREE LISTING The government is expected to carefully consider this report, “apply its mind” and accordingly either maintain or modify its ban notifications, according to it. Most Read Most Shared Most Commented

The Kokate committee — the government’s expert committee that had studied the FDCs In volte-face, IIT directors now say coaching not and declared them “irrational” — was not clear as to the reasoning behind its decision, it bad

observed. Reliance Jio inches closer to Bharti Airtel in terms of revenue market share

The top court last month said the government does not have to consult statutory bodies Asia's richest banker may acquire rivals after RBI's like DTAB before banning FDCs as such consultations were not specified in Section 26A of rebuff the Drugs and Cosmetics Act. The government had used Section 26A, which defines its Bankers race to resolve Rs 3.8-lakh-crore bad power to regulate the manufacture and sale of drugs "in public interest", to ban these assets before Monday deadline drugs last year on a separate expert committee's recommendation. Google, Paytm Mall to invest Rs 3,500-4,000 crore in Kishore Biyani's Future Retail “The judgment means that the government need not mandatorily consult DTAB to prohibit More » the manufacture and sale of FDCs it finds irrational and can use expert committees like the Kokate committee,” said S Srinivasan, a member of AIDAN. “Earlier, the Delhi High Court had quashed the ban only on the reasoning that DTAB was not consulted, but now the Industry Top Trending Terms

government has been empowered to act fast,” he said. “The only drawback is that six Reliance Jio Bankruptcy Vodafone Idea IIT months seems too short a deadline to achieve all this,” he added. India's 1st Drone Policy SpiceJet Airtel offers Netflix Subscription Indian Railways AIDAN’s counsel Colin Gonsalves told the court on Thursday that there are 40,000 IIM Executive Programme ZEE channels RBI contested and debated FDCs in India, while any well-regulated country allows 500 FDCs at 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 be banned under Section 26A of the Drugs & Cosmetics Act,” said Ashish Prasad, partner at Economic Laws Practice, who represented Indian Drug Manufacturers Association (IDMA), Federation of Pharma Entrepreneurs (FOPE) and Confederation of Indian Pharmaceutical Industries (CIPI) during the proceedings.

Archana Sahadeva, associate partner at Singh & Singh Law Firm, who represented drug makers such as Cipla, MacLeods, Alembic and Microlabs, said, “This means that the process will now be more transparent.”

The 300 plus contested drugs include popular brands such as Corex, Phensedyl, D’Cold Total, Vicks Action 500 Extra and Saridon.

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Glenmark Pharmaceuticals EVP & Business Bankers race to resolve Rs 3.8-lakh-crore bad assets before Monday deadline Head of Europe and Latin America Achin Gupta said, respiratory is a core area of focus Google, Paytm Mall to invest Rs 3,500-4,000 crore in Kishore Biyani's Future Retail Tiotropium Bromide DPI is a generic version of for Glenmark and this deal shows our Boehringer Ingelheim's Spiriva Handihaler. commitment to increase product offerings More » within this segment. Industry Top Trending Terms "There is significant opportunity in the inhalers market and we believe that this deal will Urjit Patel Jet Airways Starbucks vs Sardarbuksh give further impetus to Glenmark's growth in Europe," he added. Power assets India's 1st Drone Policy SpiceJet Airtel offers Netflix Subscription Johnson & Johnson This is the second inhalation product in-licensed by Glenmark for the European market Airport security check Discarding medicines after Fluticasone/Salmeterol dry powder inhaler, the company said. Indian Railways Smart Coaches

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

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

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Yet, the health minister's statement on Monday suggest that the government may wait to take action in this matter.

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Reportedly over 4,500 patients in India had received this implant, and J&J is said to have GO TO ET PRIME → reported over 100 serious adverse events to the Central Drugs Standard Control Organisation between 2014 and 2017.

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The U S Food and Drug Administration Most Read Most Shared Most Commented (USFDA) is conducting an inspection at Sun Pharma’s Halol facility in Gujarat. The site In volte-face, IIT directors now say coaching not produces multiple dosage forms – from bad

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Bankers race to resolve Rs 3.8-lakh-crore bad The nature of the inspection – whether it is a assets before Monday deadline The nature of the inspection – whether it is a PAI (pre- PAI (pre-approval inspection) or a GMP (good Google, Paytm Mall to invest Rs 3,500-4,000 crore approval inspection) or a GMP (good manufacturing manufacturing practices) – could not be in Kishore Biyani's Future Retail practices) could not be ascertained https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/sc-asks-drugs-advisory-body-to-decide-fate-of-349-banned-combi… 9/19 8/29/2018 Banned Medicines: Supreme Court asks drugs advisory body to decide fate of over 334 banned combination medicines - The Economic … practices) – could not be ascertained. ascertained. When contacted, Sun Pharma More » said it had no comment to offer.

Industry Top Trending Terms The USFDA inspection at Halol in 2015 had resulted in 23 observations – a set of deficiencies in the manufacturing processes. The next inspection in 2016 resulted in nine Urjit Patel Jet Airways Starbucks vs Sardarbuksh observations and the last one conducted in February this year had cited three Power assets India's 1st Drone Policy SpiceJet observations. Airtel offers Netflix Subscription Johnson & Johnson Airport security check Discarding medicines Indian Railways Smart Coaches Interestingly, earlier this month Sun Pharma had announced a product recall of 5,215 units of 10 ml vials of testosterone cypionate injections from the US market. The product was manufactured at Halol. The reason for the recall cited in media reports was the presence of 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 a smaller one only to approve a product or a few products. Pre-approval inspections are conducted if the USFDA intends to examine a site for approval of a single or a few products.

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Lupin gets EIR from USFDA for Nagpur

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Drug firm Lupin on Friday said it has received Most Read Most Shared Most Commented an establishment investigation report (EIR) from the US health regulator after the In volte-face, IIT directors now say coaching not successful inspection of its Nagpur facility. bad

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Commenting on the development, Lupin MD Bankers race to resolve Rs 3.8-lakh-crore bad Nilesh Gupta said, "The successful assets before Monday deadline A regulatory filing Lupin had said that the USFDA had completion of the Nagpur facility inspection is Google, Paytm Mall to invest Rs 3,500-4,000 crore completed inspection of the Nagpur facility without a positive development as we continue our in Kishore Biyani's Future Retail making any observations journey to meet and exceed international More » regulatory standards."

Industry Top Trending Terms Earlier in May, in a regulatory filing Lupin had said that the USFDA had completed inspection of the Nagpur facility without making any observations. Shares of Lupin were on Urjit Patel Jet Airways Starbucks vs Sardarbuksh Friday trading at 903 per scrip on BSE, down 0.07% from its previous close. Power assets India's 1st Drone Policy SpiceJet Airtel offers Netflix Subscription Johnson & Johnson Airport security check Discarding medicines 0 Indian Railways Smart Coaches Comments

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The use of branded combination medicines Most Read Most Shared Most Commented instead of generic ones added almost a billion dollars in just one year to the cost of the US In volte-face, IIT directors now say coaching not federal insurance programme, according to a bad

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through rational substitution policies could Bankers race to resolve Rs 3.8-lakh-crore bad offer substantial savings to the drug benefit assets before Monday deadline The use of branded combination medicines instead of programme. Google, Paytm Mall to invest Rs 3,500-4,000 crore generic ones added almost a billion dollars in just one in Kishore Biyani's Future Retail year to the cost of the US federal insurance programme. The revelation is significant for India since More » Indian pharma companies supply 40 per cent of generic drugs consumed in the US.

Industry Top Trending Terms In 2016, the difference between what the Medicare drug benefit program spent on branded combination drugs and the estimated amount it would have spent for the same number of Urjit Patel Jet Airways Starbucks vs Sardarbuksh doses of generics was $925 million, concluded the study. The study conducted by doctors Power assets India's 1st Drone Policy SpiceJet t B i h d W ' H it l d H d M di l S h l l d d t f th Airtel offers Netflix Subscription Johnson & Johnson https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/sc-asks-drugs-advisory-body-to-decide-fate-of-349-banned-com… 12/19 8/29/2018 Banned Medicines: Supreme Court asks drugs advisory body to decide fate of over 334 banned combination medicines - The Economic … at Brigham and Women's Hospital and Harvard Medical School analysed data from the Airtel offers Netflix Subscription Johnson & Johnson prescription drug coverage programme in the 2011-16 period for 1,500 medications that Airport security check Discarding medicines Indian Railways Smart Coaches accounted for the highest total spending reported by Medicare in 2015.

Medicare is a federal health insurance programme for those over 65 and for certain others such as younger people with disabilities and those with end-stage renal disease.

"For the 10 most costly brand-name combination drugs, the cumulative potential reduction in spending between 2011 and 2016 was estimated at $2.7 billion. Taking into account possible rebates from manufacturers at the average rate reported by Medicare, potential savings would have been estimated at $2.1 billion in total," stated the study.

The study cited the case of the antihypertensive drug Exforge, a combination of amlodipine and valsartan, that cost $8.21 per pill in 2016 compared to $0.96 for its generic constituents. It noted that with 5,036 beneficiaries prescribed Exforge in 2016, the estimated potential reduction in reported spending on just this one drug could have been How much is Ola really worth? $6.8 million. Similarly, the Medicare-reported price in 2016 for Duexis was $20.26 per pill compared to $0.28 for its generic constituents, ibuprofen and famotidine. For the 5,907 Is India's smartphone revolution beneficiaries prescribed Duexis in 2016, the estimated saving could have been $23.4 stalling? million. Flood monitoring needs a climate-change update The researchers pointed out that while the prices of branded drugs have increased GO TO ET PRIME → considerably in recent years, those of generic drugs has continued to decrease, which could explain the huge price difference and hence saving in cost.

The authors cited several studies to also point out that though combination products are said to reduce a patient's pill burden and improve adherence, no clear connection between combination products, improved adherence and improved clinical outcomes has been established.

The US has the highest per capita spending on prescription medications among industrialised countries and high drug costs have been a cause for concern for patients, doctors and policymakers.

(This article was originally published in The Times of India)

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Drug Administration (USFDA) indicates Bankers race to resolve Rs 3.8-lakh-crore bad closure of the audit of the plant, Dr Reddy's assets before Monday deadline In an earlier filing on June 2, 2018, the company had Labs said in a BSE filing. Google, Paytm Mall to invest Rs 3,500-4,000 crore said that the audit of the Srikakulam plant (SEZ) by in Kishore Biyani's Future Retail USFDA had been completed with no observations. In an earlier filing on June 2, 2018, the More » company had said that the audit of the Srikakulam plant (SEZ) by USFDA had been completed with no observations. Industry Top Trending Terms

Shares of Dr Reddy's Labs were trading at Rs 2,467.05 per scrip on BSE, up 2.26 per cent Urjit Patel Jet Airways Starbucks vs Sardarbuksh from the previous close. Power assets India's 1st Drone Policy SpiceJet Airtel offers Netflix Subscription Johnson & Johnson 0 Airport security check Discarding medicines Comments Indian Railways Smart Coaches Are you a Business Owner? Get Your Free Business Listing on Economic Times. Connect with us Register Now https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/sc-asks-drugs-advisory-body-to-decide-fate-of-349-banned-com… 14/19 8/29/2018 Banned Medicines: Supreme Court asks drugs advisory body to decide fate of over 334 banned combination medicines - The Economic … eg ste o

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segment in Brazil Are you an Advertising & Marketing Agency? Get Your Listing on Economic Times PTI | Aug 23, 2018, 01.59 PM IST

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Drug maker Lupin today said it has entered Most Read Most Shared Most Commented the prescription dermatology segment in Brazil with the launch of two products Fillerina In volte-face, IIT directors now say coaching not and Recrexina in the country. Fillerina is a bad

high-end anti-aging technology that Reliance Jio inches closer to Bharti Airtel in terms of https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/sc-asks-drugs-advisory-body-to-decide-fate-of-349-banned-com… 15/19 8/29/2018 Banned Medicines: Supreme Court asks drugs advisory body to decide fate of over 334 banned combination medicines - The Economic … e a ce J o c es c ose to a t te te s o incorporates a deep action innovative revenue market share

formulation to fill wrinkles and expression Asia's richest banker may acquire rivals after RBI's lines. Recrexina, on the other hand, is a hair- rebuff

growth formulation which stimulates natural Bankers race to resolve Rs 3.8-lakh-crore bad hair growth in active and partially inactive assets before Monday deadline Lupin today said it has entered the prescription follicles. Google, Paytm Mall to invest Rs 3,500-4,000 crore dermatology segment in Brazil with the launch of two in Kishore Biyani's Future Retail products Fillerina and Recrexina in the country. "The launch of Lupin high-end skin science is More » a recognition of Lupin Brazil's capabilities within the pharmaceutical market, and with the launch of Fillerina and Recrexina, we look to executing on our capabilities in this sector Industry Top Trending Terms and address the dermatological needs of the market," Lupin Latin America President Martin Mercer said in a statement. Urjit Patel Jet Airways Starbucks vs Sardarbuksh Power assets India's 1st Drone Policy SpiceJet The dermatology segment is a rapidly growing portion of the Brazilian pharmaceutical Airtel offers Netflix Subscription Johnson & Johnson market, he added. Airport security check Discarding medicines Indian Railways Smart Coaches

"The establishment of this new division to cater to Brazil's fast growing dermatological segment will further strengthen our presence in the region and serve to drive our future expansion plans," Mercer said.

Valued at USD 28 billion, Brazil is the world's sixth largest pharmaceutical market, driven by growing public health expenditure and increasing household income.

The dermatology segment in Brazil is worth USD 1.5 billion and growing at 10 per cent (CAGR) is one of the fastest growing segments in the country.

Lupin Brazil clocked sales of BRL 157 million during 2017-18 making it the largest Indian company in Brazil by volume and second largest by value. How much is Ola really worth? The Mumbai-based company entered Brazil through the acquisition of Medquimica Is India's smartphone revolution Industria Farmaceutica SA in 2015. stalling?

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India has decided to focus on 20 key brands Asia's richest banker may acquire rivals after RBI's to drive growth in identified therapy areas," rebuff

GSK India spokesperson said in an e-mailed Bankers race to resolve Rs 3.8-lakh-crore bad response. assets before Monday deadline As part of its growth plans the company is also planning Google, Paytm Mall to invest Rs 3,500-4,000 crore to aggressively expand its field force. As part of its growth plans the company is in Kishore Biyani's Future Retail

also planning to aggressively expand its field More » force.

Industry Top Trending Terms "We will drive growth by increasing our field force by 30 per cent, from our current base," the spokesperson added. Urjit Patel Jet Airways Starbucks vs Sardarbuksh Power assets India's 1st Drone Policy SpiceJet Recently, while announcing the company's quarterly results, GlaxoSmithKline Airtel offers Netflix Subscription Johnson & Johnson Pharmaceuticals MD A Vaidheesh had said: "... we are evolving our commercial operating Airport security check Discarding medicines Indian Railways Smart Coaches model to invest resources on key products and patients/consumers to drive growth for our company".

Id tifi d th i ill l b t d b i t l fi ld f d i th f https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/sc-asks-drugs-advisory-body-to-decide-fate-of-349-banned-com… 17/19 8/29/2018 Banned Medicines: Supreme Court asks drugs advisory body to decide fate of over 334 banned combination medicines - The Economic … Identified therapies will also be supported by incremental field force during the course of the year, he had said.

The company currently sells around 130 prescription drugs, vaccines and non prescription products in India.

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