TRAI To Start Inspections To Monitor Quality Of Service

BENGALURU: The Telecom Regulatory Authority of India (TRAI) reinforcing the plans to initiate inspections to monitor the quality of service (QoS) in the cable industry and broadcasting. Speaking in TelevisionPost.com is GroundPost initiative on land in Bangalore, TRAI advisor Maharashtra, Karnataka, Kerala and Goa region Sibichen Dr K Mathew said that the regulator will soon come out with quality inspection service to control all aspects of the service, installation of decoders to compensate the consumer complaints to the choice of channels.

"This inspection will begin soon, and technical audits to control the quality of delivery. We will check what MSO (operator’s multi-system) broadcasters and LCO (local cable operators) are promising and if they are or are not meeting with them, "he said. TRAI has been patient for a long time and this is the moment when you will have to take a stand and enforce regulations. "This is the fourth year (after notification DAS) and now even people wonder why the regulator is not taking action in this sector," Mathew said. He added that TRAI monitors QoS and can reach financial disincentives as all regulation is in place. "But the regulator is being very patient. We know the industry, which has been totally disorganized, is slowly coming disaster," he said.

He also stressed that it is very necessary for scanning in Phases III and IV measurements. Speaking of Karnataka, said at least on paper seems digitization has been completed in Bangalore and Mysore. "We are not happy with damage repair system and must strengthen" he added. In general, in Karnataka, said 56.2 percent scanning is achieved, demonstrating that "we have to work hard and with good coordination, can reach 100 percent." In Maharashtra and Kerala, said, TRAI is receiving a very positive response. "In fact, in Kerala MSOs we met recently asked us not to let the deadline is extended." Concerns speaking of concerns digitization, said there are many of them.

"First, there is a lot of disagreement between the MSO, LCO, and broadcasters. Until and unless solve these problems is not going to achieve the goals." He added further that the cable and broadcasting is one of the best industries, and will win a lot of revenue. "But the biggest bottleneck is that there is absolutely no coordination between the MSO, LCO, and broadcasters," he said. "Until and unless appropriate agreements on services, revenue sharing, etc., how are you going to do business? There is no consensus about the little things like repairing STB.

Who will do the service?

But you must understand that it is important questions for consumers, "he said. The second concern, he said, is that which comes from the LCO or independent MSO that large companies are reducing prices. "Here we are in an open market economy. The question is how we can regulate pricing. The only condition is that we cannot have a fixed price which affect the consumer." Another area of concern is with respect to the STB. Dr. Mathew said that the transformation has occurred in the delivery platform television as the younger generation is consuming content not only on television but also on different screens. "But now is the time to turn the idiot box on the smart box".

He stressed that the government of India is giving much importance to the sector such as television helps provide not only entertainment but also information across the nation. The first step towards convergence is digitization. However, despite covering two phases of digitization, no one is happy with the achievement, mainly because of the challenges they face in Phases III and IV added. "We have to take lessons from Phases I and II, and create an appropriate work plan for the next phases.

The main reason for this bottleneck we are designing is the large geographic region of this country and the sector has been completely disorganized for several years. “He added that services are cheap and that India has one of the lowest for cable services in the consumer side rates.”They [consumers] get to see the channels at a much cheaper price. But the scope of increasing the quality and expansion is unlimited. But for that, you need more resources." In general, we often confuse scanning with putting local decoders in consumer. "That may be only 5 percent. While it starts with the STB placed in the homes of consumers, the second step is to record each consumer registered with the form request, where the consumer says what your choice is. Unfortunately, there are many procedural lapses in Phases I and II even.

Whenever there is a gap, the ultimate goal is not met, "he added. On expectations of TRAI, the regulator said everything you want is the choice for the consumer, the forms of CAF duly completed, and subscriber management system (SMS) instead. "Each MSO must have SMS in place, which means not only data of subscribers, but a proper grievance redress mechanism." "Unless you have a proper grievance redress mechanism for Phases I and II, we will fail in Phases III and IV. Does proper billing, call centers, procedures for repairing STB, refunds, displacement, etc., in the first two phases? Ultimately, the consumer should be allowed a smile while you are giving income, "he added. "The biggest challenge before entering the next two phases lies in the delay. We need to establish the correct process in Phases I and II, he said.

The Export (Quality Control And Inspections) Act, 1963- An Overview

Act 1963 ("the Act") Export (Quality Control Inspections) was enacted on 08/24/1963. As the name of the law indicates, is mainly used for quality control, pre-inspection of goods exported and actual trade in India. Under this law nearly 1000 major commodities such food for footwear, etc., were considered mandatory before export. Later stage, foodstuffs, agricultural and fishery products were exempt from prior inspection if the exporter has a genuine letter from overseas buyer showing their carelessness in the pre-inspection.



As this may be the State, the Council Export Inspection (EIC) that forms in Section 3 of the Act to ensure quality control, inspection and actual trade of goods that are exported. It has a President with 17 members appointed by the Central Government. EIC extends its role in the management of the elements related to food products. This advisory Council empowers and regulates the central government for taking steps to fulfill the purposes of this Act. EIC not only exercises powers of advice, but very much on the technical and administrative aspects. Central Government under the guidance of EIC international standards inspects the goods and use the appropriate mechanism to inspect the quality control.

EIC has control over several export Inspection Agencies (EIA) in the configuration in several states of our country through the Ministry of Commerce, Government of India under Article 7 of the Act. EIC made a trend setting in providing quality certification of export products through systematic inspection of products exported to international markets. Consignment wise inspections, certifications based Systems Food Safety Management in process quality control and Self-Certification are the main systems of inspections for certification.

EIC under this Act is a principal organ may constitute special committees if it feels necessary for the purposes of this Act. Similarly, consisting EIC Administrative, Technical and Standing Committees to perform their delegated functions. EIC is strengthening its functions and powers to permit effective trade in international markets through measures of quality control and pre-inspection systems. EIC extends its role in food and food related products.

This Act was amended in 1984 through the Export (Quality Control and Inspection) Amendment Act 1984. Under the Central Government may make appropriate necessary for effective export trade of India with the help of Council through notification in the Official Gazette. According to Article 6 of the Act, may notify any goods searching for quality control or pre-inspection before export or both. This government can declare or disclose the methodology of control and inspection of commodities that have on quality. Can take any number of standards specifications notified merchandise.

The Central Government may at any time refuse any number of commodity exports if it is not properly certified or breached in any specification that must be fulfilled for the export trade of India. You may cancel, suspend or modify certification if necessary. Any person aggrieved in subsection 3A may appeal within the time specified by the Central Government by notification in the Official Gazette. No appeal under decision under Article 6 of the Act.

The Central government has enormous powers under the intended quality control and inspection for efficient export trade in India. You can record the compliance of the standard specifications. It has powers to obtain information from exporting. Central to the approval of Parliament Government can finance through grants, loans, etc., to the Council to fulfill its role in this Act. He has power to enter, search, inspect and seize commodities.

Search and seizure under this Act shall be made in accordance with the Code of Criminal Procedure of 1973. There are various penal provisions for the unlawful act or omission of any. Recourse provisions are also available for previous criminal penalties. No one should be punished without the consent of the authorities of the Central Government. Similarly, there are no legal proceedings that may be taken against the board, officers and employees of the Central Government, if you have done something good faith within the scope of this Act. Last but not least, the central government you can frame any number of rules and regulations in good faith under this Act by notification in the Official Gazette.

Futec’s Online Inspection At Labelexpo India 2014

At Labelexpo India 2014 one of the main speakers of the inspection system was Futec showing his vision inspection systems with charge coupled device (CCD) image sensors to provide continuous online inspection technology to inspect multiple substrates. Futec units sold web surface inspection units printed surface inspection, thickness profiles units and labels inspection systems.



L - R: Krishnakumar Srinivasan, director of business development, GES; Yoshihiro Hasebe, managing director general, Futec; Takahiro Miura, general manager of product strategy, Futec; and Riju Earaly, regional sales manager, GES with online inspection system Futec at Labelexpo India .

One of the world's leading inspection technology has applications Futec paper, non-woven fabrics, plastic sheets, sheet metal, all forms of substrates for printed material such as paper, cloth, canvas, flexible films and cardboard. The inspection is performed before printing, during printing in the press, in the winding, laminating and cutting and is different for material control and inspection of print quality. The solutions are quality control systems related online production networks for high performance and are widely used in Japan and most of Southeast Asia.

The first inspection stage is the default optical inspection system on each substrate is different for different materials. For the role of failures include oil contamination, watermarks and tear paper or marks. For metal sheets are dents, bumps and uneven polishing or scratches while for films is the fisheye, gels, foreign matter, lumps, extra material and even pinholes. The optical conditions vary by type of material and the application process.

The printed web inspection systems are intended to inspect the quality of printing on a wide range of printed materials such as films and laminated flexible monocartons, corrugated, cardboard packaging, gravure, flexo and paper packages. Moreover there is the X-ray inspection is that the thickness of the film, aluminum foil and paper that is printed and is used in packaging. "The Indian market is opening up to sophisticated inspection systems and we have several customers in India with positive Tetra Pak packaging and India," says Yoshihiro Hasebe, managing director general, Futec, and Southeast Asia. "We are planning to increase our presence in India and have GES Infotek in Mumbai to market our products."

France, Germany Suspend Some Drug Approvals Over Indian Data

Regulators in France, Germany, Belgium and Luxembourg are suspending the marketing approval of 25 generic drugs due to concerns about the quality of the data from clinical trials conducted by India GVK Biosciences, said ANSM French watchdog on Friday.

The quality of pharmaceutical products from India has been this year, with regulators in Europe and the United States, citing problems ranging from data manipulation sanitation and banning the import of certain products from various companies.

"This decision is a precaution. Nothing in this stage has allowed to establish a real risk to human health or the lack of efficacy of these drugs," ANSM said on its website.

All drugs being suspended, several of which are made by Mylan and Abbott, has equivalent brand that can be used instead, so that patients do not have to stop treatment, he added.

MSNA and the German Federal Institute for Drugs and Medical Devices (BfArM) said they were investigating drug approvals based on clinical trials designed to demonstrate that these generic drugs are equivalent to the original branded versions made by GVK Bio between 2008 and 2014.

MSNA said it had alerted European authorities after they inspected the site GVK Bio in Hyderabad, India, and found "anomalies" in the way that electrocardiograms (ECG) were monitored during the bioequivalence studies.

He said the inspection raised serious concerns about whether the company studies comply with good clinical practice.

GVK Bio CEO Manni Kantipudi disputed the findings of the monitoring and ECG French said they were not an important component of drug efficacy.

GVK Bio ANSM concluded that conducts clinical research for domestic and foreign pharmaceutical, manipulated the ECG without taking into account the views of the company, said.

"We have agreed to redo the studies, I'm fine with that, but do not say it was not gross manipulation of the ECG," Kantipudi Reuters. He said the company had received board approval to spend $ 5.7- $ 6.5 million for further studies.

The European Medicines Agency (EMA) released a separate statement saying that "make a recommendation on whether the marketing authorizations for medicinal products concerned should be retained, modified, suspended or withdrawn across the EU." That recommendation is expected in January 2015.

The German control agency said it was investigating 176 approvals given 28 drug manufacturers. No name drugs or undertakings concerned.

BfArM said he was ordering pharmaceutical approvals which were found to have been based on trial data GVK stop distributing the drugs in question until they could provide details of new studies.

MSNA said several drug makers - who did not identify - had already offered to conduct new studies, if positive, could allow drugs on the market again.

Kantipudi of GVK Bio said the company has begun further studies for five to six of its customers. About 35 400 of the company's customers were affected by the regulator's decision Europoean said.

He said the Food and Drug Administration US Hyderabad inspected the plant in June, after the audit of the French regulator, and was satisfied with the data related to the ECG. No other regulator had he contacted the company since he added.

(Reporting by Maria Sheahan in Frankfurt, Ben Hirschler in London, Natalie Huet in Paris and Zeba Siddiqui in Mumbai, Editing by Mark Potter Spanish, Elaine Hardcastle, Lisa Shumaker & Kim Coghill).

Medicines Banned From The US And Canada Are On Sale In Australia

Prohibited drugs ... Drugs made at a factory in India are not imported into the US and Canada.

 

The safety of medicines in Australia are concerned here with lax regulation allowing the sale of drugs that are banned in the US and Canada.

Up to 20 medicines manufactured in India by the Canadian pharmaceutical company Apotex - which supplies a fifth of Australia generics - have been banned overseas because of "significant concerns".

But our medical surveillance is allowing them to Australia.

Checks by the US FDA found the company that makes antibiotics, blood pressure, asthma, pills and generic viagra was manipulating data quality tests.

He moved to prohibit imports from factories in April, Canadian regulators banned the products in September.

The pharmaceutical company that provides medicines make up about 18 percent of the market for generic drugs in Australia.



Questions loom ... FDA inspections of US pig factories Apotexc found deviations from good manufacturing processes. News Corp Australia Image Source: News Corp Australia

Canada regulator said it had "significant concerns" and "serious doubts" about data security and quality of the company's products.

The US FDA said it had "identified deviations from current good manufacturing process.

Our medical surveillance Therapeutic Goods Administration says it is aware of the US and Canadian stocks.

News Corp has learned that inspected the factory in India in late August, but did not ask Apotex suspend imports of medicines from India.

"There is no evidence to suggest that drugs manufactured by Apotex, Ranbaxy or other manufacturers coming to the Australian market, do not meet the quality standards required by the law of therapeutic goods," said TGA.

TGA Teva said inspected while the Candaian regulators in August.

The inspection identified problems with the handling of data quality testing company, said the TGA.

"His nature and the risk it poses to the quality and safety of the product does not justify the forced termination of the offer. The corrective actions were reviewed and found acceptable, pending an ongoing review of its implementation," the regulator said in a statement...




Suppliers tested ... the TGA says it has inspected the factories of India Apotex. Picture: Thinkstock Source: Thinkstock.

"The TGA will continue to rely on their own detailed analysis of information and in doing so, make decisions based on risk acceptability independent manufacturers to continue to provide, or initiate delivery to the Australian market," said TGA .

The TGA says neither the FDA nor Health Canada has begun withdrawing any product from Apotex, as a result of the findings of FDA inspection.

Apotex Corp News contacted but refused to provide an official comment.

The case has highlighted the supreme secrecy surrounding pharmaceutical factory controls by our regulator.

The TGA does not disclose the results of any of the controls. Often based on inspection reports and other regulators to approve a manufacturing plant.

Health Forum Adam Stankevicius Consumer chief said the case was disturbing and showed that it was time for the TGA released the results of its inspections of the factories that make our medicines.

"I hope the information of this type, especially when regulators are relying on overseas." He said.

"We have to have a high level of transparency about the information the TGA is relying in particular if it is out of step with other regulators," he said.

"Consumers should have access so they can see the necessary procedures have been followed to ensure your safety," he said.

The case also highlights the main problems with the new government plans to accept medicines and approved by regulatory agencies in other countries devices.

"If appropriate automatically accept devices and drugs approved abroad, the regulator must also implement security measures that are forbidden Australia would otherwise open to high levels of suspicious devices and it's a concern," he said.



Concerns raised over quality testing of medicines in Indian factories. News Corp Australia Image Source: News Limited

Health Canada says certain necessary medical products made by Apotex may be excluded from the ban on the condition they are tested by an independent third party.

The drugs included in the prohibition of Health Canada include:

Atenolol (angina and chest pain)

Candesartan (high blood pressure)

Irbesartan (high blood pressure)

Losartan (high blood pressure and stroke)

Methylphenidate (attention deficit hyperactivity disorder)

Metoclopramide (reflux)

Valganciclovir (CMV antiviral)

Valsartan (high blood pressure)

Tenormin (angina and chest pain)

Canadians Kept In Dark About Defective Drugs

Inspections American Canadian pharmaceutical companies reveal systemic problems that have jeopardized Canadian patients.

Installing Apotex Bangalore in India was criticized by the Food and Drug Administration of the United States for failing to report the results of unfavorable drug quality testing.

American patients were put at risk by prescription drugs that Canadian pharmaceutical companies sold with the knowledge that their products were defective, Star investigation has found.

Using records obtained through the United States freedom of information laws, the star also found other Canadian companies have:

Hidden altered and in some cases destroyed test data that showed their products were contaminated or potentially unsafe.
No evidence of side effects experienced by consumers take their drugs is reported.

Since 2008, more than 40 Canadian pharmaceutical companies, including Toronto-based Apotex generic giant, have been cited for serious violations of manufacture.

All these violations are detailed in the inspection reports provided to the star not Health Canada, but the Food and Drug Administration (FDA), which also inspects Canadian facilities.

The research found that the star as strict and transparent laws FDA enforces drug manufacturing, Health Canada leaves Canadians in the dark, keeping secret details of its inspectors found problems.

Meanwhile, medicines and ingredients banned drugs in the American market has been allowed by Health Canada at Canadian pharmacies.

The inspection documents obtained by the Star show:
In June, at a facility in Bangalore, India, which makes drugs bound for North America, Apotex employees did not report test results and records adulterated unwanted bacterial growth test.
Generic drug maker Taro Pharmaceuticals of Brampton drugs remained on the market despite evidence showing the company lots of drugs damaged before the expiration date on the label.
Cangene Corp., a drug manufacturer Winnipeg, could not tell the authorities of blood clots, fever and other side effects associated with their products.

The USA FDA inspects facilities in Canada and around the world where the ingredients of drugs and medicines for the American market are made. The regulator can ban drugs the American market or preventing a company introducing new products to the manufacturing and safety problems are fixed.

The FDA reports do not specify all the countries where drugs made by the companies inspected were sent. The star was found that many of these same drugs are also made for Canadian consumers, and factories are inspected Health Canada also.

There have been at least 19 Apotex inspections by the FDA since 2008, 16 of them resulting in conclusions called "objectionable" or noted as "repeated deficiencies." In one case, the FDA said the company could not defend "their legal obligation."

During an interview at a Toronto factory Apotex, and email correspondence, president and CEO Dr. Jeremy Desai and another manager did not question the conclusions of the FDA and told the star that is the signature fixing problems and their products are safe.

Desai told the Star "compliance is a journey" and his company has dealt with what he calls the "procedural lapses" identified by the FDA and has invested in improved data collection programs and staff training.


The Star found details of inspections that the FDA inspection dates and makes the results available to the public on its website. The American regulator has published dozens of online warning letters to Canadian companies, many of which detail the appalling conditions in drug manufacturing facilities.

A 2010 letter to Apotex revealed details of previous inspections of its facilities in Toronto, where American inspectors found the company antihistamine pills and distributed diabetes made with contaminated ingredients. Apotex recalled more than 600 lots of drugs made at its facilities in GTA Canadian and American markets.

In contrast, Health Canada does not tell the public the number of times it has been inspected Apotex individual facilities or other large drug companies.

LRQA Verifies National Stock Exchange Of India ‘Water Footprint’

LRQA has successfully completed an assurance engagement on the roof of the operational water footprint of the National Stock Exchange of India Limited (NSEIL) in Mumbai.

Commissioned by Emergent Ventures India (EVI), Prabodha Acharya and Ketan Deshmukh the LRQA Climate Change Services team in India began checking the water footprint prepared by management, including the green water footprint, footprint of blue water and gray water footprint as defined in the Manual for the Assessment of Water Footprint, published by footprint Network Water.



"The National Stock Exchange of India Ltd has a number of initiatives to use water and energy wisely, to promote sustainable development in the company. NSE recently got its water footprint verified to reiterate its commitment to reduce footprint carbon and water and follow best practices in sustainable development. Corporativos is essential that work to reduce business water footprint and NSE has taken many initiatives to achieve this goal... NSE is very conscious of its social responsibility and verification its water footprint by a credible agency is to contribute to a government mission to promote sustainable development in India Corporations step, "said Mahesh Haldipur, Head - Administration and Local NSEIL.

The verification work included:

      A tour of the site of installation NSEIL Exchange Plaza, Mumbai, and a review of the processes related to the management of water consumption data and records.

      Interviews with key personnel responsible for the management of water consumption data and information, and the preparation of the water footprint.

      Sampling of data sets - as part of the audit trail - and tracing the data back to the aggregate levels for the year 2012-13.

      Checking the water consumption data and information for the financial year 2012-13 includes Water Footprint.

The LRQA verfiers concluded that nothing had come to light to suggest that water consumption data and information presented in the Water Footprint were not materially correct.

However, it is recommended that NSEIL should continue to develop its systems and processes to collect, calculate and report water consumption data, particularly focusing on the implementation of a formal process for monitoring of wastewater discharged into the public sewer system, including QA / QC review; maintaining calibration records of all water meters; and expanding the scope of information to all facilities and buildings under NSEIL control.

"We are very pleased to have successfully verified the Footprint of Water Companies the NSEIL. Water demand and verification assurance is we grow in our market and LRQA is well positioned to further capitalize on this, thanks to the collective expertise of climate change and our service team of sustainability. "Said K Krishna Nair, Director of LRQA Business Center South West Asia.