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Obama Administration Issues New Rules to Combat Tax Inversions

Obama Administration Issues New Rules to Combat Tax Inversions | India Biotech & Pharma | Scoop.it
The Obama administration on Monday issued new rules to combat so-called tax inversions, intended to make the deals harder to accomplish and less profitable.
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Govt mulls price control on medical devices

Govt mulls price control on medical devices | India Biotech & Pharma | Scoop.it
The perception of a rise in corruption and lack of transparency in the health care sector could invite stricter norms and regulation. The government might cap the Maximum Retail Price of medical devices, mainly the ones meant for hospital usage such

Via TwoFour Insight Group
Amar Bhat's insight:

It is interesting to see how Govt views price controls as a way of controlling corruption, bribery and kickbacks. The regulators view all these activities as evidence of slack and excessively high prices in the system which they want to eliminate in order to bring down prices.  But is price control the right tool for this particular job?

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TwoFour Insight Group's curator insight, September 22, 2014 1:12 PM

Will setting the MRP result in aggressive growth of the local Indian industry to reduce the burden on imports?

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Govt withdraws NPPA's power to cap prices of non-essential drugs

Govt withdraws NPPA's power to cap prices of non-essential drugs | India Biotech & Pharma | Scoop.it
India has withdrawn the drug pricing authority's powers that allowed it to fix the prices of medicines not deemed essential, after its decision to impose price caps on more than 100 drugs in July triggered industry protests.

Via TwoFour Insight Group
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TwoFour Insight Group's curator insight, September 23, 2014 8:32 AM

Check out TwoFour Insight Group's client alert on this topic. www.twofourinsight.com.

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Venus Remedies eyes tie-ups for out-licensing drugs

Venus Remedies eyes tie-ups for out-licensing drugs | India Biotech & Pharma | Scoop.it
MUMBAI: Pharma firm Venus Remedies Ltd has targeted a turnover of Rs 1000 crore by FY'18, even as it eyes partners in Europe and the US for out licensing some of its drugs. "We are looking at...

Via TwoFour Insight Group
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New rules open door for firms to exit price-controlled drugs

New rules open door for firms to exit price-controlled drugs | India Biotech & Pharma | Scoop.it

Via TwoFour Insight Group
Amar Bhat's insight:

not much flexibility to self-determine which products you can sell on the market.

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TwoFour Insight Group's curator insight, September 19, 2014 10:34 PM

More flexibility for companies to discontinue products where there are 10 or more competitors and the company holds less than 1% market share. Will this be limited to scheduled drugs only?

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Health ministry to revise Schedule M-III for medical devices to make it harmonious with international standards

Health ministry to revise Schedule M-III for medical devices to make it harmonious with international standards

Via TwoFour Insight Group
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TwoFour Insight Group's curator insight, September 19, 2014 10:53 AM
The lack of a comprehensive regulatory system for medical devices in India not only impacts local production and availability of drugs, but also their price points as well as the export potential of local industry.
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Profits from medical devices used to bribe doctors? - The Times of India

Profits from medical devices used to bribe doctors? - The Times of India | India Biotech & Pharma | Scoop.it
A detailed investigation by the Maharashtra Food and Drug Administration (FDA) had exposed how drug eluting stents are sold at triple the price at which they are imported.
Amar Bhat's insight:

Just as the GSK China bribery case is winding down, looks like another similar story is heating up in India!

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GlaxoSmithKline Found Guilty of Bribery in China

GlaxoSmithKline Found Guilty of Bribery in China | India Biotech & Pharma | Scoop.it
GlaxoSmithKline said a Chinese court found its subsidiary in the country guilty of bribing nongovernment personnel and fined the company close to £300 million ($491.5 million), in what Chinese state media said was the largest ever corporate fine.
Amar Bhat's insight:

While GSK is finally seeing some resolution to this story, I wonder if the Chinese authorities will start to focus on other MNCs or other sectors in their efforts to clean out more corruption.

 

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Rite Aid Cuts Forecast on Lower Reimbursements, Generics

Rite Aid Cuts Forecast on Lower Reimbursements, Generics | India Biotech & Pharma | Scoop.it
Rite Aid Corp. reduced its full- year earnings forecast after it said lower reimbursement rates and higher costs for drugs hurt profit. The shares fell the most in more than five years.

Via TwoFour Insight Group
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TwoFour Insight Group's curator insight, September 18, 2014 9:37 PM

Imagine if India became a signatory to the GPA and the government procurement (e.g., VA) opened up for Indian companies...

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India, China biz delegates sign deals worth $3.4 bn

India, China biz delegates sign deals worth $3.4 bn | India Biotech & Pharma | Scoop.it
New Delhi, 17 SeptemberIndian and Chinese officials signed business deals worth $3.43 billion here on Wednesday.An agreement worth $2.2 billion was signed between Indigo Airlines and Industrial and Commercial Bank of China (ICBC) for leasing and

Via TwoFour Insight Group
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Natco Pharma, Orchid Chemicals get a strong dose of US FDA medicine

Natco Pharma, Orchid Chemicals get a strong dose of  US FDA medicine | India Biotech & Pharma | Scoop.it
Natco Pharma and Orchid Chemicals and Pharmaceuticals have received...

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TwoFour Insight Group's curator insight, September 17, 2014 7:57 PM

Another flurry of 483s in India...

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Cadila to take innovator drug to US, Europe markets | Latest News & Updates at Daily News & Analysis

Cadila to take innovator drug to US, Europe markets | Latest News & Updates at Daily News & Analysis | India Biotech & Pharma | Scoop.it
Cadila to take innovator drug to US, Europe markets - Cadila Healthcare will soon start filings for approval of its innovator drug Lipaglyn in advanced markets such as the US and Europe. The drug has current patients base of 50,000 in India within the first year of its launch.

Via TwoFour Insight Group
Amar Bhat's insight:

Cadila is one of the first Indian pharma company to develop a new, innovative drug for the relatively small Indian market. Now, they are ready for the big markets.  Good for them!

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TwoFour Insight Group's curator insight, September 16, 2014 12:24 PM

1st indigenously approved NCE by an Indian company...

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Pharma major AstraZeneca launches IT facility in Chennai

Pharma major AstraZeneca launches IT facility in Chennai | India Biotech & Pharma | Scoop.it
UK-based pharma and biopharmaceutical major AstraZeneca has launched its first Global Technology Centre (GTC) to develop its world-class IT capacity, in Chennai as part of its strategy to cut down its IT budget and improve operational efficiency and

Via TwoFour Insight Group
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TwoFour Insight Group's curator insight, September 16, 2014 7:12 PM

One by one, MNC pharma companies lowering IT costs by outsourcing to India or creating captive IT centers in India...

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NPPA Requires Pharma Firms to Post Data on New Online Database - TwoFour Insight Group

NPPA Requires Pharma Firms to Post Data on New Online Database - TwoFour Insight Group | India Biotech & Pharma | Scoop.it
NPPA, India's pharma price control regulator, has announced a new online database for companies to input pricing and market data.

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Stent Makers, Distributors Accused of Price Gouging, Bribery in India

Stent Makers, Distributors Accused of Price Gouging, Bribery in India


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TwoFour Insight Group's curator insight, September 22, 2014 1:38 PM
Stent Makers, Distributors Accused of Price Gouging, Bribery in India Courtesy of FDAnews  http://www.fdanews.com/articles/167277-stent-makers-distributors-accused-of-price-gouging-bribery-in-india Medical Devices / Commercial Operations Stent Makers, Distributors Accused of Price Gouging, Bribery in India Devices & Diagnostics LetterSep. 19, 2014  Manufacturers and importers of drug-eluting stents for the Indian market are coming under fire for allegedly conniving with distributors, to hike prices and, in some cases, bribe doctors to use their products.A Maharashtra state FDA study, reported by local media, claims a Medtronic stent was imported for $500, sold to a distributor for $1,100, and then parlayed to a hospital for $1,650. The profits were used for bribery.Medtronic told D&DL that it investigates all credible allegations of wrongdoing and takes appropriate disciplinary measures for engaging in conduct inconsistent with its policies or the law, as it does not “condone, nor tolerate, improper payments.”Abbott Vascular Devices and Johnson & Johnson were also named in the profiteering scheme, local media reports say. Abbott declined to comment, and J&J did not respond by press time.NPPA Asked to Step InThe Maharashtra FDA has reportedly asked the National Pharmaceutical Pricing Authority to bring devices under price control.The reports of price gouging are unusual, says Pramath Raj Sinha, an advisor to AdvaMed and head of the India practice of Albright Stonebridge Group. “Fortunately, for the patient, contrary to popular belief, prices of medical devices here are currently among the lowest in the world,” he says.For instance, Sinha says, sutures from both foreign and Indian manufacturers cost less than $1 U.S. And cardiac stents generally range between $250 and $3,700.Instead of looking at artificial price controls as a remedy, India should focus on how to increase the use of devices and create low-cost competition to drive prices down, says Vince Suneja, a founding partner at TwoFour Insight Group.India needs to establish regulations and a regulatory pathway so that patients and physicians have satisfaction and confidence in using medical devices, Suneja adds. A statutory code of ethics specific to devices would also help to foster understanding about devices, he says. — Jonathon Shacat 
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RLS to make India's first Remicade biosimilar for Epirus and Ranbaxy

RLS to make India's first Remicade biosimilar for Epirus and Ranbaxy | India Biotech & Pharma | Scoop.it
Reliance Life Sciences has been contracted to make the first Indian biosimilar of J&J’s Remicade (infliximab), though Epirus Biopharmaceuticals says it is looking to Fujifilm for its European supply.

Via TwoFour Insight Group
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TwoFour Insight Group's curator insight, September 23, 2014 10:21 AM

Epirus taking full advantage of India's low cost base with shifting manufacturing for the market to Reliance while taking advantage of Ranbaxy and/or Ranbaxy/Sun's commercial reach in the domestic market.  In addition, if the 351K pathway opens up for biosims in the US, Epirus will have both commercial and manufacturing lined up in advance. 

H. Fai Poon's curator insight, September 25, 2014 8:50 PM

Congrats to Fujifilm!

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Government to take measures to plug the gaps on quality of drugs, to includes new checks - The Economic Times

Government to take measures to plug the gaps on quality of drugs, to includes new checks - The Economic Times | India Biotech & Pharma | Scoop.it
The health ministry is also working out a pilot project to test the feasibility of bar-coding on drug packs to ensure authenticity of the product.

Via TwoFour Insight Group
Amar Bhat's insight:

Another positive step in India's attempt to bring its own regulatory system up to the global standards.

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TwoFour Insight Group's curator insight, September 23, 2014 10:18 AM

How much of this is driven by domestic concerns versus exports from India?

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Who is Richard Verma? 10 things you must know about the next US ambassador to India

Who is Richard Verma? 10 things you must know about the next US ambassador to India | India Biotech & Pharma | Scoop.it
President Barack Obama on Thursday nominated Rahul 'Richard' Verma as the new US envoy to India, making him the first Indian American in that position

Via TwoFour Insight Group
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Richard Verma Nominated as U.S. Ambassador to India

Richard Verma Nominated as U.S. Ambassador to India | India Biotech & Pharma | Scoop.it
President Obama’s nominee for ambassador to India is an Indian-American who served in the U.S. Air Force and in the State Department. Analysts say his appointment could help soothe strained U.S.-India ties.

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Some Indian Drug Makers Send Low-Quality Meds to Africa Deliberately?

Some Indian Drug Makers Send Low-Quality Meds to Africa Deliberately? | India Biotech & Pharma | Scoop.it
An analysis of 1,470 samples of two antibiotics and two tuberculosis drugs that were labeled as made in India, and then sold in Africa, India, and five middle-income countries elsewhere, found that more sub-standard drugs were purchased in Africa by the researchers.
Amar Bhat's insight:

Researchers find that un-registered pharmaceuticals in African countries, i.e. those drugs that have not received official approval to market in that country, are more likely to be substandard, adulterated.  Not a huge surprise.  

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Cipla licenses rights for innovative product to Salix

Cipla licenses rights for innovative product to Salix | India Biotech & Pharma | Scoop.it
Under the agreement, Cipla has granted Salix exclusive rights under certain patent applications in the 'Rifaximin Complexes' patent family controlled by Cipla, the company said in a statement...

Via TwoFour Insight Group
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TwoFour Insight Group's curator insight, September 18, 2014 9:29 PM

This time a typical arrangement whereby an Indian company licenses out its application/development to a commercial partner that has scale...

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India Value Fund buying 10% in Biocon's research arm Syngene for $62M | VCCircle

India Value Fund buying 10% in Biocon's research arm Syngene for $62M | VCCircle | India Biotech & Pharma | Scoop.it
Deal values Syngene at a premium to the recent transaction where Biocon bought back GE Capital's stake.
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US seeks to establish secretary-level group to address IPR concerns

US seeks to establish secretary-level group to address IPR concerns | India Biotech & Pharma | Scoop.it
Indian and US officials discuss agenda, modalities and dates for Trade Policy Forum meeting

Via TwoFour Insight Group
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TwoFour Insight Group's curator insight, September 18, 2014 10:12 AM

IPR remains a top priority for the US while what gets decided may have a direct impact on the EU-India pending trade agreement...

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Epirus' arthritis biosimilar approval in India shows its international focus

Epirus' arthritis biosimilar approval in India shows its international focus | India Biotech & Pharma | Scoop.it
Boston-based Epirus Bioscience has gotten the green light from regulators to market its Remicade biosimilar in India, teaming up with Ranbaxy to market the Johnson & Johnson analogue next year….
Amar Bhat's insight:

Interesting look at Epirus' strategy of seeking regulatory approval in India first, despite it being such a "small" market for biosimilars thus far.

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Indian Pharmaceutical Company to Invest $17M in Va. Plant

Indian Pharmaceutical Company to Invest $17M in Va. Plant | India Biotech & Pharma | Scoop.it
Monroe, Va. — The Indian pharmaceutical company Glenmark Pharmaceuticals plans to invest $17 million and open its first North American manufacturing facility in Monroe.

Via TwoFour Insight Group
Amar Bhat's insight:

Looks like Glenmark is hedging its bets by building in the U.S.  

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