U.S. - India Life Sciences Trade
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TROUBLE WORSENING FOR EXPORTERS

TROUBLE WORSENING FOR EXPORTERS

Via TwoFour Insight Group
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At least the domestic market is growing?

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TwoFour Insight Group's curator insight, September 10, 2014 10:00 AM

Indian pharmaceutical exports declining with US market is still largest destination - 25%.  GDUFA's inspection requirements cause concerns for Indian industry. 

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Indian Patients Suffer from India's Weak Pharmaceutical Patents

Indian Patients Suffer from India's Weak Pharmaceutical Patents | U.S. - India Life Sciences Trade | Scoop.it
India’s recently elected Prime Minister, Narendra Modi, will visit the U.S. later this month. One of the sticking points in the U.S.-India relationship is weakness in India’s laws governing intellectual property (IP). Indian growth will continue to lag as long as this persists: Researchers have demonstrated the positive relationship between IP protection and a county’s prosperity.

One of India’s weak spots is patent protection for new prescription drugs. New research also shows, counter-intuitively, that this limits patients’ access to new medicines Indian patients and Indian medical innovation will benefit when India improves its patent law to the highest global standard.

Via TwoFour Insight Group
Connecting the US/India Life Sciences Dots by VHS@TwoFour Insight Group's insight:

Is this a case of lack of IP protection in India or pricing pressures and lack of appropriate health insurance products  either in the public or private sector. 

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TwoFour Insight Group's curator insight, September 10, 2014 10:24 AM

Over 5 years prior to launching new drugs in India after approval in the U.S. - study shows half of the drugs approved by USFDA between 2000 and 2009 in India not launched within 5 years. 

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Pharma firms go to court over new price controls

Pharma firms go to court over new price controls | U.S. - India Life Sciences Trade | Scoop.it
According to figures from AIOCD Pharmasoftech, out of the total Indian pharmaceutical market of Rs.75,690 crore, scheduled products under Price Control amount to Rs.9,746 crore or 13 per cent.

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Connecting the US/India Life Sciences Dots by VHS@TwoFour Insight Group's insight:

Does the filing of this lawsuit essentially suggest that the major Indian generic players are not confident in their ability to reduce their COGS for these additional products to main profit margins and/or don't believe that the price controls will result in greater volume, thus an increase in top line revenue?

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CDSCO Issues Clarifications on Medical Devices - TwoFour Insight Group

CDSCO Issues Clarifications on Medical Devices - TwoFour Insight Group | U.S. - India Life Sciences Trade | Scoop.it
India does not have a separate Act that mandates how medical devices should be regulated. CDSCO issues new regulations for medical devices,.

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Another Order by DCGI. This time directly impacting medical device companies. 

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FDA Denies Horizon Pharma's CP on Vimovo (esomeprazole magnesium; naproxen) ER - Tabs

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Dr. Reddy's is the direct beneficiary of this ruling as they have already secured final approval for the product.   Other pending ANDAs by Mylan, Watson, Lupin, and Anchen will also benefit from the FDA ruling. 

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FIR move against drug company - The Times of India

FIR move against drug company - The Times of India | U.S. - India Life Sciences Trade | Scoop.it
BMSICL GM (finance and administration) Tripurari Sharan said on Friday they had gone with a letter to the Gandhi Maidan police station to lodge FIR.

Via TwoFour Insight Group
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Filing a FIR with the local police station is one thing, but the drug regulators have sufficient powers to withdraw the licenses of these companies as well as seek prosecution of people with knowledge within the company. 

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DU scientists find cure for drug-proof TB - The Times of India

DU scientists find cure for drug-proof TB - The Times of India | U.S. - India Life Sciences Trade | Scoop.it
Delhi University scientists, led by Rup Lal from the zoology department, have managed to produce an antibiotic that works even against multi-drug-resistant TB.

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Perhaps this will start a trend of more discoveries taking place at the Indian University level...

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Teva Files Citizen Petition with the U.S. Food and Drug
Administration (FDA) Regarding the Complexity of COPAXONE® (glatiramer
acetate) Following the Agency’s Guidance

Teva Files Citizen Petition with the U.S. Food and Drug <br/>      Administration (FDA) Regarding the Complexity of COPAXONE® (glatiramer <br/>      acetate) Following the Agency’s Guidance | U.S. - India Life Sciences Trade | Scoop.it
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Govt needs to invest $5bn a year for next 5 years in biotech: PwC

Govt needs to invest $5bn a year for next 5 years in biotech: PwC | U.S. - India Life Sciences Trade | Scoop.it
Ahead of the Budget, global consultancy firm PwC says government needs to invest up to USD 5 billion (around Rs 30,000 crore) each year for the next five years to enable biotech sector to become a USD 100 billion industry by 2025.
As part of the

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Connecting the US/India Life Sciences Dots by VHS@TwoFour Insight Group's insight:

$100 billion biotech industry in India by 2025 - a little too ambitious, considering - (1) the initial growth will come in the biosimilar or follow-on biologics space for the US market, which still has lacks a clear pathway; (2) any pathway in the US will have to face considerable disparity between states on substitution, which will act as a barrier; and (3) at a minimum, the sale of these biosimilars /follow-on biologics will require considerable investment into a sales force, which will also act as a barrier to entry unless Indian companies can find marketing partners with brand-pharma MNCs that have established sales force...

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Zydus Cadila loses two popular brands - The Economic Times

Zydus Cadila loses two popular brands - The Economic Times | U.S. - India Life Sciences Trade | Scoop.it
Dulcolax and Buscopan had been present for the past many decades in India, initially through an agreement that Boehringer Ingelheim had with drug firm German Remedies.
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With no review by either the Center or State FDAs of the tradename being used by companies for pharmaceutical products despite the Center coming very close in 2012 to prohibit state licensing authorities to implicitly approve trade names in manufacturing & loan licenses, confusion over similar sounding, etc names continues in India.  The only remedy available is the Magic Remedies Act, which at least allows the regulators to monitor the use of names to ensure that they are not misleading, etc. 

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TN govt opens 10 Amma Pharmacies to sell medicines 10 to 20 % discount

TN govt opens 10 Amma Pharmacies to sell medicines 10 to 20 % discount

Via TwoFour Insight Group
Connecting the US/India Life Sciences Dots by VHS@TwoFour Insight Group's insight:

If the term pharmacy is being used correctly, thee cooperatives Kerala and Tamil Nadu will allow be able to both compound and dispense medicines requiring a prescription under Schedule H or H(1) as well as Schedule G to the D&C Act.  In addition, it will be interesting to see how the drop shipment to these pharmacies from manufacturers will be perceived by the retail distribution trade associations in the state.  The impact will probably be more on manufacturers versus these pharmacies. 

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Medical gizmo makers target young Indians in lifestyle mess - Hindustan Times

Medical gizmo makers target young Indians in lifestyle mess - Hindustan Times | U.S. - India Life Sciences Trade | Scoop.it
Medical gizmos are now helping youngsters resolve a lifestyle mess created by sedentary desk jobs, affection for speed and bingeing on junk food. And there are now key customers for medical device makers.

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Great opportunity for medical device companies looking to untag the Indian market.  

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Govt asks drug inspectors to keep vigil on sale of banned drugs - Hindustan Times

Govt asks drug inspectors to keep vigil on sale of banned drugs - Hindustan Times | U.S. - India Life Sciences Trade | Scoop.it
The Punjab health department has restructured the drug de-addiction cell and rationalised the human resource requirement of each district as per requirement.

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Considering that the requirement for a prescription is dependent on which schedule the particular drug falls under, hope that the Punjab health department is able to act appropriately...

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South-East Asia Region health ministers ink pact to eliminate kala-azar

South-East Asia Region health ministers ink pact to eliminate kala-azar

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Supply opportunity for small to medium size companies in this market?

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TwoFour Insight Group's curator insight, September 10, 2014 10:02 AM

WHO procured free supply of medicines to treat kala-azar until 2016...

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National Pharmaceutical Pricing Authority : Price Notification - Drug Shortage


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Mfgs failing to provide monthly supply reports to NPPA.  With price monitoring cells in States as another initiative of NPPA, it appears that there will be further oversight provided by NPPA that industry should be aware of. 

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TwoFour Insight Group's curator insight, September 10, 2014 10:30 AM

NPPA issues order under DPCO par 29 to manufacturers... 

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Kiran Mazumdar-Shaw urges PM Narendra Modi to cure pharma sector

Kiran Mazumdar-Shaw urges PM Narendra Modi to cure pharma sector | U.S. - India Life Sciences Trade | Scoop.it
Open letter: Asks for tax exemptions, review of forced price discounting of drugs

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While I don't disagree with anything Ms. Shaw has requested of the PMO, I would argue that the fastest way to ensuring a ROI and eliminating the substandard medicines competition is by creating a central, appropriately resourced regulatory structure and authority that would be in a position to enforce one standard for all drugs manufactured and/or available in the Indian market. 

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CDSCO Attempts to Further Clarify on Clinical Trials - TwoFour Insight Group

CDSCO Attempts to Further Clarify on Clinical Trials - TwoFour Insight Group | U.S. - India Life Sciences Trade | Scoop.it
India's drug regulator, CDSCO, attempts once again to clarify its regulations for clinical trials. However, few will likely be satisfied.
Connecting the US/India Life Sciences Dots by VHS@TwoFour Insight Group's insight:

Interesting impact on both innovators and generics. 

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Hospira Inc.: Hospira Completes Acquisition of Orchid's Active Pharmaceutical Ingredient Manufacturing and R&D Facility

Hospira Inc.: Hospira Completes Acquisition of Orchid's Active Pharmaceutical Ingredient Manufacturing and R&D Facility | U.S. - India Life Sciences Trade | Scoop.it
An independent investment publication of Interviews with Company CEOs, Money Managers, and Wall Street Analysts.

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Connecting the US/India Life Sciences Dots by VHS@TwoFour Insight Group's insight:

With one of the last major generic specialty companies to vertically integrate into India coupled with recent 483s at other Hospira facilities, Hospira should be prepared for significant oversight by USFDA since the majority of these products will be targeted for the US market. 

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Health care sector needs watchdogs to protect people’s interest

Health care sector needs watchdogs to protect people’s interest | U.S. - India Life Sciences Trade | Scoop.it
Flood water entered Malda medical college & hospital after heavy rainfall in Malda, West Bengal. PTI Photo
Anubha Moghe underwent a laproscopic knee surgery. She had a medical insurance from a private insurance company with a cover for Rs 5 lakhs. The surgical procedure costs were predicted to be Rs 1.4 lakhs by the private hospital....

Via TwoFour Insight Group
Connecting the US/India Life Sciences Dots by VHS@TwoFour Insight Group's insight:

This is just one of the examples of where the current insurance industry needs to continue to grow and develop.  At a minimum, the Indian IT industry should partner with the government and insurance industry to ensure that every pharmacy is equipped with an electronic billing system so that out-patient drugs can be covered under health insurance. 

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Saturday Morning Catch-Up - 05 July 2014

Saturday Morning Catch-Up - 05 July 2014 | U.S. - India Life Sciences Trade | Scoop.it

Via Amar Bhat, TwoFour Insight Group
Connecting the US/India Life Sciences Dots by VHS@TwoFour Insight Group's insight:

It was another action packed week in India with an interesting idea by some pharmaceutical manufacturers to bypass wholesalers and retailers and instead have physicians dispense their medicines to patients.  A very old practice in the majority of the world where markets have frowned upon physicians prescribing and dispensing medicines to avoid conflicts and serve public health. 

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Why invite bids for CGHS medicines by brand: HC asks Centre - The Economic Times

Why invite bids for CGHS medicines by brand: HC asks Centre - The Economic Times | U.S. - India Life Sciences Trade | Scoop.it
The Delhi High Court has asked the Centre reasons for inviting bids for supply of CGHS medicines from drug manufacturers on the basis of brand names instead of their chemical composition.

Via TwoFour Insight Group
Connecting the US/India Life Sciences Dots by VHS@TwoFour Insight Group's insight:

Shouldn't the court first ask how does CGHS confirm that the generic drugs are equivalent to the brand name drugs (as well as the brand name drugs themselves to the "new drugs" under Rule 122 of the D&C Rules or "patent or proprietary drug") in terms of safety, effectiveness and purity? 

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Saturday Morning Catch-Up - 28 June 2014

Saturday Morning Catch-Up - 28 June 2014 | U.S. - India Life Sciences Trade | Scoop.it

Via TwoFour Insight Group
Connecting the US/India Life Sciences Dots by VHS@TwoFour Insight Group's insight:

It was a packed week in the Indian life sciences sector.  First, on the retail side, we continued to see the unfortunate, yet fortunate trend of increased enforcement of establishments holding themselves out as "pharmacies" or "chemists and druggist", but not employing or having registered pharmacists supervising the dispensing of medicines that require a prescription from a registered medical practitioner.  Second, we saw the advocacy by the industry on the budget process kick-off with it firing on all engines.  Typically, in the past, the requests were limited to exemptions for essential medicines and devices and export subsidies, but this year they also include areas such as exemptions for retention and physician samples from excise tax.  Third, we also saw a disturbing event at a hospital where patients were given drugs that were labeled for veterinary use.  According to reports, the hospital was exonerated from any wrong doing and focus is now on the manufacturer.  A classic case of misbranded drug?  Finally, a new coalition was launched to supposedly counter the advocacy efforts of the Multinational Pharmaceutical Industry ("PhRMA") in the areas of quality, intellectual property rights, etc.  How the Indian industry believes this will be effective will be interesting to monitor.  When it comes to pharmaceuticals, the industry is heavily regulated and USFDA has been pretty much immune to such international pressure as patient safety becomes paramount over anything that the U.S. Congressional members may take up as a cause.  Also, with the generic drug industry being a highly regulated commodity market, the purchasers of these products are also not swayed by any negative image of Indian generic drugs. The purchasers are able to squeeze additional discounts out of companies along with requesting shelf-stock adjustments to mitigate any situation of a drug being withdrawn, recalled, etc.  As a result, the effectiveness of the coalition will be interesting to watch.

 

 
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TwoFour Insight Group's curator insight, June 28, 2014 12:07 PM

a lot of activity this past week in India ranging from certain pharmacies continuing to lose their licenses, requests for relief in the budget, expansion of a new type of pharmacy, hospital using medicine labeled for veterinary use to a new Coalition being created to "fix" the image of the Indian generic drug industry. 

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GDUFA fee: 86 generic drug approvals voluntarily withdrawn

GDUFA fee: 86 generic drug approvals voluntarily withdrawn | U.S. - India Life Sciences Trade | Scoop.it
Drug companies in the US are carefully evaluating their portfolios to give away approvals for those products that are not commercially viable, as these approvals are not free anymore...

Via TwoFour Insight Group
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It appears that any satisfaction by USFDA of withdrawal of these products is short lived as they will now to have focus on the purchasers of these drugs, which most likely have not been recently inspected by USFDA, thus will be characterized as "higher risk", thus needing an inspection soon.   Hope these buyers are prepared for inspections and how best to respond to 483s, etc. 

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Novartis India launches Voltaren Emulgel for body pain

Novartis India launches Voltaren Emulgel for body pain

Via TwoFour Insight Group
Connecting the US/India Life Sciences Dots by VHS@TwoFour Insight Group's insight:

It will be interesting to see if Novartis is able to enjoy the 4 pseudo market exclusivity under Rule 122 of the D&C Rules, 1945 or whether there will be competition via approvals through the various state FDA's for competitive products. 

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FDLI Webinar on Doing Business in India: Pharm Reg Developments on at 11:00am (EST) tomorrow


Via TwoFour Insight Group
Connecting the US/India Life Sciences Dots by VHS@TwoFour Insight Group's insight:

Tune in tomorrow...I will be covering everything from clinical trial litigation to use of brand names for drugs in India...

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