US FDA weary of India PHARMA PILLS

The approval of several of Sun's key drugs in the United States, the drugmaker's biggest market, depends on the clearance on its Halol plant in the western Indian state of Gujarat. A warning letter issued by the US Food and Drug Administration (FDA) last year over violations found at the plant has already been hurting the company's sales.

http://timesofindia.indiatimes.com/business/india-business/Sun-Pharma-says-US-finds-more-concerns-at-Halol-plant/articleshow/55852291.cms

India Sun Pharma SHARES FALLS on US FDA grave CONCERNS

http://www.livemint.com/Companies/nHASkkiSlZrLArJ6mG0nMK/Sun-Pharma-shares-fall-as-much-as-46-after-FDA-inspects-co.html


#PREDATORindiaADMIN http://www.aljazeera.com/indepth/inpictures/2016/11/blind-kashmir-100-pellets-lodged-head-161124075129498.html

Blind in Kashmir with 100 pellets lodged in his head


The story of young Danish, who was shot by a pellet gun and suffered irreversible damage to his eyesight.


Srinagar, India-administered Kashmir - Danish Rajab, 24, used to work as a marketing executive for a company selling dairy products in the city of Srinagar in India-administered Kashmir. That was until the day his life changed forever.

The Kashmir valley has seen violent protests break out, triggered by the death of popular rebel militant commander, Burhan Wani on July 9. A curfew was imposed in most parts of the valley, almost immediately after his death, to contain the protests. Defying this curfew, people took to the streets in large numbers to protest against the killing.

On the evening of July 17, 2016, after the curfew had been lifted, Danish was hit by pellets in his face and eyes from a distance of about 10 metres, as he sat chatting with his friends at a tea stall near his house. He felt sharp pain and fell down with the shock. His friend, Aashiq, tried to lift him up. This was the last image that Danish saw.

The current unrest in the valley - which continues to this day even as the intensity has dwindled - has seen a new kind of injury inflicted by a new kind of non-lethal weapon, the pellet gun. Thousands have suffered damage to their eyesight as a result of pellet gun use by security forces to quell protests.

The pellet gun fires more than 500 sharp lead pellets at high velocity. Doctors say that even a single pellet entering the eye at that speed can cause grievous and irreversible damage.


http://www.ynetnews.com/articles/0,7340,L-4889373,00.html

http://www.ynetnews.com/articles/0,7340,L-4889373,00.html

HUMANITY HIJACKED by EMPATHY LESS PEOPLE
=======================================
https://twitter.com/sjsrana/status/806421350025871360

https://plus.google.com/117953276774098078497/posts/Wx5bMNmYiXQ?sfc=true

QUESTION your SOUL?
QUESTION your SENATORS?
QUESTION your DRUG & PILLS IMPORTERS?

Can US or WORLD so to speak TRUST #PREDATORindiaADMIN?


Even if #PREDATORindiaADMIN is providing huge PROFIT to US FDA or US admin by cutting costs, can there be PROFITS with PREDATORS?

FDA set for new Office and Regulations changes

John Jenkins is to retire from the FDA’s office for new drugs next year, with Janet Woodcock set to run the office in the interim, and comes after he hit out at the regulator for some of its decisions that led to the recent approval of Sarepta’s DMD med Exondys 51.

Another set of challenges lies ahead of the office is how to effectively cope up with influx of pills import that does not meet the standards or is sub-standard.

The issues that have been dealt in past with some lapses can't carry-on provided Trump taking all that matters seriously.

Major exporter of DRUGS and PILLS to N.America and elsewhere is already ramping-up the productions for exporting drugs to US and elsewhere, will there be policy shift in assessing and ascertaining quality and standard with increased complexity of drugs/pills cocktail of compounds as ingredients.

In a major crackdown since March this year, the drug regulators of seven states have alleged that 27 medicines — sold by 18 major drug companies in India including Abbott India, GSK India, Sun Pharma, Cipla and Glenmark Pharma — are of “substandard” quality, citing grounds such as false labelling, wrong quantity of ingredients, discolouration, moisture formation, failing dissolution test and failing disintegration test.

http://indianexpress.com/article/india/india-news-india/27-medicines-sold-by-top-firms-fail-quality-tests-in-seven-states-4398893/

Some of the key brands which were alleged to be substandard are: antipsychotic drug Stemetil and antibiotic drug Pentids from Abbott India, anti-bacterial medicine Althrocin by Alembic Pharma, migraine medication Vasograin by Cadila Pharma, popular cough syrup Ascoril by Glenmark Pharma, worm infection drug Zentel by GSK India, arthritis medication Hydroxychloroquine (HCQS) by Ipca Labs, anti-inflammatory medication Myoril by Sanofi Synthelabo, and Torrent Pharma’s hypertension drug Dilzem.


India admin rarely ARRESTS or level serious charges against establishments/corporations delivering sub-standard or wrong labeling of drugs/pills supplied to markets due to making more PROFIT by cutting-corners.

https://plus.google.com/117953276774098078497/posts/auGAtzf6cdU?sfc=true

Shadow Economy was fulling the industries now faces real challenge as PROFITS are bound to DIP further due to following impositions on Currency impacting DRUGS and PHARMA companies/corporations alike
https://plus.google.com/117953276774098078497/posts/auGAtzf6cdU?sfc=true


EU regulator recommends market suspension for dozens of generics
By Edwin Lopez | July 25, 2016
http://www.biopharmadive.com/news/eu-regulator-recommends-market-suspension-for-dozens-of-generics/423203/

The European Medicines Agency (EMA) recommended suspending sales of some generic drugs after a review found that data collected by a contract research company in India for their approval was unreliable.



The EMA's decision followed facility inspections by the Food and Drug Administration and World Health Organization which raised concerns over alleged data manipulation in the center's bioanalytical and clinical sites. Given the agencies' doubts over the center's data quality controls, the EMA concluded any bioequivalence studies conducted there were unacceptable unless backed by alternative studies.

We have been covering earlier,
Jeopardizing health care system sanity of US, US on road of perils of outsourcing?

https://twitter.com/sjsrana/status/756331869390635009

https://plus.google.com/117953276774098078497/posts/jTzhZnbjLFk

Now per latest objections raised by International Regulatory regarding india dubious drugs/pills details/data http://www.biopharmadive.com/news/eu-regulator-recommends-market-suspension-for-dozens-of-generics/423203/


The European Medicines Agency (EMA) recommended suspending sales of some generic drugs after a review found that data collected by a contract research company in India for their approval was unreliable.

The EMA's list included drugs made by some of the top generic drugmakers, including Teva Pharmaceutical Industries Ltd, Mylan NV and Novartis AG's Sandoz.

The recommendation comes after the U.S. Food and Drug Administration and the World Health Organization raised concerns about substitution and manipulation of patients' clinical samples by Semler Research Center Pvt Ltd. (bit.ly/2a0Lq4t)

https://plus.google.com/117953276774098078497/posts/E9hAqo3WeGp?sfc=true

The FDA asked drugmakers in April to repeat bioequivalence studies for drugs whose application used data obtained from tests conducted by Semler. (bit.ly/2a1PpRm)

https://plus.google.com/117953276774098078497/posts/E9hAqo3WeGp?sfc=true

He said that the FDA’s use of speedy reviews should be prospectively planned, “NOT as a ‘rescue’ for a failed program.”


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