To Stop Illegal downloading Record labels, movie studios and ISP Join hands understand the Warning System adopted by ISP and Content Owners

It is very common that majority users of internet download movies, music and software’s
For personal use by doing this the user breaks the law as they do not purchase but they download it free of cost using P2P network or other websites.

Now in America to stop this downloading of illegal movies, music and television shows
ISP and Hollywood studios have signed a new agreement called as Copyright Alert System.



Which ISPs are participating in this agreement?
Some of the participating ISPs include Comcast, AT&T, Time Warner Cable, Cablevision, and Verizon.

Now after this agreement what will happen and how this warning system will work?

Few ISP already issue notices to customers when they find that the customer is using or doing illegal activity using his internet account.

But now ISP and industry has joined the hands to stop the illegal activities of internet user.
Now after this agreement all the ISPs will follow same procedure.

Exactly how this will?

A third-party will monitor file-sharing networks and collect the IP-addresses of suspected infringers.
These will then be added to a database and forwarded to the Internet provider who will send a corresponding copyright alert.

The owner of the content knows the IP address of the machine where pirated material is kept for downloading.

Your Internet Provider knows your IP address and your activities what you are doing on the internet.

Now the content owner will inform the ISP that this is the IP address where Pirated movies or pirated material is kept for downloading.

After this Your ISP will match your IP address and your activities and if ISP finds that
You downloaded movies from that IP address.

For doing this you will receive a First Notice or Initial Notice informing you that his or her internet account was allegedly used to share copyrighted content, and how to prevent this from happening in the future. The warning notice will include educational resources for how not to be a pirate.

After this they expect that you will stop downloading illegal material using internet service.

After getting this notice if you will ignore and keep downloading pirated material you will receive five or six times warning notices informing that stop your illegal activities.
Stop downloading illegal music or TV shows or Movies etc.

Each time a user is caught offering copyrighted material, that user will get an increasingly strident warning from his ISP.

First two warning notices will be same.
After 3rd notice you will be required to acknowledged that you have received a notice
Probably through a click-thru pop-up notice.

After 5 or 6 Notices ISP will start to take action against you.
What Action ISP will take –?

1. Digital Millennium Copyright Act already requires ISPs to have a termination policy in effect

2. temporary reductions of Internet speeds

3. redirection to a landing page until you contact your ISP to discuss the matter

4. if a copyright holder sues you for illegal downloading, the ISP can say it took measures to stop the activity and cannot be held liable for your activity

To stop this action or mitigation warning system allows the account holder internet customer who is accused of piracy to request an independent review but it will cost you $35.

Which ISPs are part of this agreement?
Participating ISPs include
1. AT&T
2. Cablevision
3. Comcast
4. Time Warner Cable
5. Verizon

Which Companies or Content Holders are Members of this agreement or who is backing this Plan?
Following are the companies and labels which are participating and backing this Plan.
1. Motion Picture Association of American
2. MPAA members like Walt Disney Studios
3. Motion Pictures
4. Paramount Pictures
5. Sony Pictures Entertainment
6. Twentieth Century Fox Film Corporation
7. Universal Studios
8. Warner Brothers Entertainment
9. Independent Film & Television Alliance
10. Recording Industry Association of America
11. RIAA members like Universal Music Group Recordings
12. Warner Music Group
13. Sony Music North America
14. EMI Music North America
15. American Association of Independent Music
16. And ISP

SM Suggestion –
If possible after getting first Warning Notice Contact immediately to lawyer if u can sue to get damages for this notice
Change the internet provider
Stop your illegal activities – Do not download anything

Reality views by sm –

Keyword - content material, copyright infringement, internet piracy, internet providers, internet supplier, ip addresses, isps, mpaa, Pirates, RIAA, time warner, cable, warning system, web entry, web providers, ‘Alert’

Former BJP Minister Katta Sumbramanya Naidu and his son Katta Jagadish Naidu charged in land scam

This land scam took place when Naidu was industry minister in 2007 in the Janata Dal (Secular)-BJP coalition government

Reason to file a charge sheet against them is that taking kickback of Rs.87 Crore for favoring an IT firm in allotment of 325 acres of land near Bangalore.


The Lokayukta had arrested Katta Jagadish in October 2010 on charges of trying to influence a witness. He is on bail now.

In December 2010, Lokayuta filed a police complaint against Naidu and his son, Katta Jagadish, a Bangalore corporator, and several others for involvement in the land and bribery scam.

The Lokayukta sought the governor's permission on July 4, 2011 to proceed with filing a chargesheet. The permission was necessary as the scam took place when Naidu was minister and at present he is an assembly member.

After getting the Permission from Karnataka Governor H.R. Bhardwaj, Karnataka Lokayuta (ombudsman) filed a charge sheet against Former BJP Minister Katta Sumbramanya Naidu and his son Katta Jagadish Naidu charged in land scam.

Charge sheet also includes the names of S.V. Srinivas, managing director of the IT firm ITASCA Software, and some officials of the Karnataka Industrial Area Development Board (KIADB).

Crime Happened in Year – 2007

What is the reason and delay for filing police complaint and charge sheet against them?

After how many years you think the final judgment will come in this case?

More than 50 Years or More than 25 Years?

Reality views by sm –

Keyword – News Politics Corruption BJP Minister Karnataka Naidu land scam kick back 87 Crore

Source – IANS

NGO CPIL Filed PIL against Kapil Sibal for favoring Reliance Communications and Reducing Penalty of Rs.650 Crore to only Rs.5 Crore

Know How Penalty of Rs.650 Crore became Penalty of Rs. 5 Crore Only

Centre for Public Interest Litigation (CPIL) has filed the application in the Supreme Court seeking CBI probe against Telecom Minister Kapil Sibal and Attorney General GE Vahanvati. Sibbal allegedly favored Reliance Infocom on the penalty over 2G licences, while Vahanvati bypassed rules to help former minister A Raja respectively.


Attorney General GE Vahanvati allegedly disregarded the Law Ministry in giving opinion to Raja on 2G spectrum when he was Solicitor General in UPA-I government.

The application filed by Centre for Public Interest Litigation (CPIL) alleged Sibal reduced the penalty to Rs. five Crore from Rs650 Crore against RCOM for violations in the Unified Access Service Licence (UASL) agreement.

The application filed in the Court says that Kapil Sibal abused his position as minister to over-rule the unanimous view taken by senior DoT officials including the Telecom Secretary, to benefit a private operator by closing the issue with only a penalty of Rs5 Crore instead of Rs650 Crore.
"This abuse of authority by him to benefit Anil Ambani controlled Reliance Infocomm needs a thorough investigation by the CBI

The application has attached documents to point that DoT officials said that Reliance group pay a penalty of Rs50 crore per circle for "violation of the terms and conditions of Universal Service Obligation Fund (USOF) agreement and UASL agreement by voluntary, unilateral and unauthorized switching-off/closure of services to subscribers from USOF sites without any notice."

The matter is likely to be heard on July 11

Universal Service Obligation Fund (USOF) is a fund used to subsidise rural telephony. Telecom operators can bid for providing this service, and even ask for subsidies.
But RCom bid aggressively for many USOF and later found them unviable and switched off without the USOF Administrator’s permission.

16 May, 2007
Under an agreement RCom had agreed to provide this service from base transceiver stations (BTSs) in 53 clusters (5,118 sites)

7 December 2010 –
RCOMM issued notice to that it was cutting off services with effect from the previous month (from November 22). The notice said that it was switching of all but 46 BTSs, and even these would be terminated in two or three months, and stop paying power and fuel bills to the infrastructure provider, Bharat Sanchar Nigam Ltd (BSNL).

21 December, 2010
USOF issued show cause notice to RCOM.
USOF rejected all the reasons and arguments given by RCOM to stop the service and break the agreement.
“RCL (Reliance Communications) is in clear violation of the licence agreement as well as USOF agreement leading to disruption of continuity of service.
Also there is no provision for USP (universal service provider that is RCom) to unilaterally exit on his own from discharge of its performance obligations and go scot-free without performing.”
The show cause notice proposed fine of Rs. 50 Crore for One Circle.
For 13 Circles it will amount to Rs.650 Crore.

In Following 13 Circles rural telecom operations under USOF were shut by RCOM
1. Andhra Pradesh
2. Bihar
3. Jharkhand
4. Gujarat
5. Karnataka
6. Maharashtra
7. Madhya Pradesh
8. Punjab
9. Rajasthan
10. Tamil Nadu
11. Uttar Pradesh (East)
12. Uttarakhand
13. West Bengal

After this show cause notice by USOF reliance wanted time of six weeks to reply and USOF said first start the services.

USOF administrators said Reliance Should pay fine of Rs.50 Crore per Circle for stopping the services.

Director (Telecom), Advisor (Finance), Member (Finance) and Secretary (Telecom) everyone recommended a fine of Rs.50 Crore for One Circle.

On 2 February, 2011, Director (Telecom) signs an internal order proposing a penalty of Rs. 50 Crore from RCom in one circle.

By 9 February, everyone up the chain, up to the Telecom Secretary, had signed on the internal order endorsing the Rs. 50-crore penalty.

On 16 February, RCom writes to Kapil Sibal.

After that Telecom Minister Kapil Sibal reduced the fine of Rs. 50 Crore per Circle to just few lakh Rupees.

RCOM unilaterally switched off its BTSs but Telecom Minister Kapil Sibal treated this action of RCOM as a mere “interruption” of service and lowered the penalty.

Kapil Sibal did not go for Rs.650 Crore fine and a fine, Penalty was charged based on the number of days of service disruption at Rs. 500 a day.
And in this way the fine of Rs.650 Crore became Rs. 5.49 Crore in 13 circles.

Government do not have money for the subsidies, Government is reducing the subsidies on gas by saying No Money

Then question is Why the Penalties of Rich Companies are reduced by Government?

What is the reason Penalty is reduced?

By doing so Who benefited Government of India Servants or the citizens of India?

Just Think Do Not Ignore


Reality views by sm –


Keyword - News Finance Contract RCOM Kapil Sibal Penalty Rs.650 Crore 5 Crore Penalty Reduced

Read the Warning Letter issued to Cadila Healthcare Limited by US Food and Drug Administration (USFDA)

Department of Health and Human Services
Public Health Service
Food and Drug Administration
Silver Spring MD 20993

Warning Letter

VIA UPS MAIL

WL: 320-11-015


June 21, 2011

Mr. Pankaj R. Patel
Chairman and Managing Director
Zydus Group
Zydus Tower
Satellite Cross Roads
Ahmadabad 380 015 India

Dear Mr. Patel:
During our January 17 - February 3, 2011 inspection of your pharmaceutical manufacturing facility, Cadila Healthcare Limited, located at Sarkhej Bavla N.H. No.8 A, Moraiya, Tal: Sanand, Dist. Ahmedabad, Gujarat, India, investigators from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211.

These violations cause your drug products to be adulterated within the meaning of section 501(a) (2) (B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a) (2) (B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

We have reviewed your firm’s response of February 10, 2011, and note that it lacks sufficient corrective actions.

Specific violations observed during the inspection include, but are not limited, to the following:

1. Your firm’s laboratory records fail to include complete data derived from all tests necessary to assure compliance with established specifications and standards [21 C.F.R. § 211.194].

For example,

a. Your microbiologists reported the MA 5 and MA 6 microbiological plates as “nil” while each plate contained one (1) colony forming unit (CFU).

On January 21, 2011, the FDA investigator observed the microbiological plates, MA 5 and MA 6, from air sampling locations in the Class 100/Grade A laminar air flow cabinet in the Microbiology Lab. Each microbiological plate contained one (1) CFU/m3.

Your microbiologists reported these microbiological plates as “nil” on your form FM/QC/252-9 Quality Control Department Record of Environmental Monitoring of Microbiology Laboratory.

However, the action limit for these sample locations is 1 CFU/m3 which requires an investigation per your procedure SOP/QC/049 entitled Environment Monitoring of Aseptic Area by Settle Plate, Air Sampling, Surface Sampling (RODAC Plate) and Personnel Hygiene for Viable Count.

The results as originally reported on your form FM/QC/252-9 would not have prompted an investigation.

b. The microbiological growth found on settle plate MS 4 was incorrectly identified and reported as a typical microorganism when compared against your firm’s library/photographs of typical environmental flora.

Your microbiologists identified the growth on the MS 4 plate as typical flora. However, the FDA investigator found that when compared with your normal environmental flora, the growth should have been reported as atypical since the microorganism identified is not included in firm’s library/photographs of typical environmental flora.

Your written procedure SOP QC/049 requires further identification of microbial growth not included in your firm’s library/photographs. The results originally reported on your form FM/QC/252-9 (typical flora) would not have prompted further identification.

Your response recognized that the microbiologists should have classified the MS 4 microorganism as atypical. Moreover, your response indicated that an investigation was performed and microbiologists were retrained. You stated that as part of your corrective actions two microbiologists will observe counts for three months to “rule out any possibility of erroneous reporting.”

However, during the inspection, the FDA investigator observed two microbiologists reading plates and recording data. Therefore, your corrective action plan does not adequately address the observation, nor does it appear to improve on current practices for reading plates and recording data. Additionally, the revised form used to document the microbiologist observation lacks appropriate identification of the microbiologist performing the task at the time of the final reading of the plates.

You are responsible for the accuracy and integrity of the data generated by your firm. We are concerned that trained microbiologists employed by your firm were unable to accurately identify microbial growth on environmental monitoring plates.

Additionally, there is no assurance that such errors have not occurred previously (during the manufacture of exhibit batches for application products pending with FDA). Provide a more comprehensive corrective action plan to ensure the integrity of all data used to assess the quality and purity of all drugs manufactured at your facility, including any registration lots.

Accurate and reliable microbiological data is essential to support the aseptic processing operations used during the manufacturing of sterile finished drug products intended for distribution in the United States.

Your response includes retraining documentation related to identifying environmental isolates as typical/atypical and observation of microbial growth, as well as retraining on SOP QC/049. According to information provided to the FDA investigators during the inspection, the Microbiology Laboratory is staffed by (b) (4) microbiologists. The training attendance sheets in your response do not include the same individuals.

For example, 10 QC personnel attended the training on observation and counting of colonies on environmental monitoring plates held on January 22, 2011; and, only 8 QC personnel attended the training on identifying typical/atypical environmental isolates during environmental monitoring plate observation.

Explain this discrepancy and provide documentation confirming that all employees have been retrained. Additionally, provide documentation of specific training offered to all employees regarding the importance of following CGMP, and ensuring that they accurately report all required tests.

2. Your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 C.F.R. § 211.113(b)].

For example,

a. Your firm’s environmental monitoring is inadequate in relation to personnel monitoring.

Our investigators found that gowns worn by operators working in the aseptic processing areas are only monitored (b) (4) per week. Additionally, gloves are only monitored at the (b) (4) the shift. We are concerned with the fact that operators performing critical operations may not be adequately monitored. Therefore, there is no assurance that your environmental monitoring program is capable of detecting all microbiological contaminants.

Since personnel can significantly affect the quality of the environment, a robust personnel monitoring program should be in place in order to be compliant with CGMPs. Your response indicates that SOP/QC/049 was revised to require additional monitoring of gloves after (b)(4) for personnel involved in aseptic connections on filling line and filtration activities apart from regular monitoring at the (b)(4) of the shift.

It is your responsibility to ensure that all personnel involved in aseptic processing are properly monitored on a daily basis, or in association with each lot. We acknowledge that SOP/QC/049 has now been revised to require sampling of gowns per (b) (4)/per (b) (4).

b. The technician performing the air sampling held the probe close to the HEPA filter face rather than (b) (4) as specified in section 4.5 of your written procedure SOP/QC/049.

During the inspection, the investigators were provided with retraining records for technicians performing active air sampling.

Your responses and corrective actions related to items 2a and 2b of this letter failed to indicate the disposition of exhibit batches that were manufactured during the time when personnel and air sampling monitoring was inadequate. Provide information on the disposition of these batches.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facilities. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. If you wish to continue to ship your products to the United States, it is the responsibility of your firm to ensure compliance with all U.S. standards for CGMP and all applicable U.S. laws and regulations.

Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. In addition, failure to correct these violations may result in FDA refusing admission of articles manufactured at Cadila Healthcare Limited located at Sarkhej Bavla N.H. No.8 A, Moraiya, Tal: Sanand, Dist. Ahmedabad, and Gujarat, India, into the United States. The articles are subject to refusal of admission pursuant to section 801(a)(3) of the Act [21 U.S.C. § 381(a)(3)], in that, the methods and controls used in their manufacture do not appear to conform to Current Good Manufacturing Practice within the meaning of section 501(a)(2)(B) of the Act [21 U.S.C. § 351(a)(2)(B)].

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Please identify your response with FEI #3002984011.

If you have questions or concerns regarding this letter, contact Alicia M. Mozzachio, Compliance Officer, at the below address and telephone number.

U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance
Office of Manufacturing and Product Quality
Division of International Drug Quality
White Oak, Building 51, Room 4234
10903 New Hampshire Ave
Silver Spring, MD 20993
Tel: (301) 796-3206
Fax: (301) 847-8741
Email: Alicia.Mozzachio@fda.hhs.gov

Sincerely,

/Steven J. Lynn/
Steven J. Lynn
Acting Director
Office of Manufacturing and Product Quality
Office of Compliance
Center for Drug Evaluation and Research

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Tag – News Health USFDA warning Cadila Letter