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on whether the marketing authorizations for medicinal products concerned should be retained, modified, suspended or withdrawn across the EU."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.

Drive To Add FDA Drug Police In India Delayed

Five months after the main U.S. drug regulator promised to expand the office that oversees Indian companies that make the medicine to patients in the United States, an exodus of workers the effort cramps.

The offices of the Food and Drug Administration of India are being directed by Carl Sciacchitano, who is also advisor to the FDA for international scientific matters. The agency is looking for a new leader for the team after the departure of Altaf Lal a year after taking the job. Atul Agrawal, the security officer monitoring consumer, has also departed.



In February, FDA Commissioner Margaret Hamburg, visited India and expressed concern about the quality of generic drugs manufactured there. She promised then to increase to 19 from 12 the number of responsible for reviewing about 600 manufacturing plants local drug workers. Now, however, only eight employees are based there full time, said Christopher Kelly, a spokesman for the FDA.

The FDA "is in the final stages of hiring additional investigators" with the aim of expanding permanent office in time, Kelly said. Six employees are being rotated in three to four months at a time to help, said in an email.

Neither Lal Agrawal could not be reached for comment, nor has the agency refused to discuss the circumstances behind their departures, citing privacy rules. Lal Agrawal and returned to the U.S. Lal and left since the FDA said Kelly. Sciacchitano took over as acting director on June 1 and the FDA plans to find a permanent director "in the coming months," according to Kelly.
Prohibited plants

since the beginning of 2013, 25 plants in India have been added to the list of facilities prohibited from sending drugs to the U.S. Hamburg, the head of the FDA, visited India in early February and met with both drug manufacturers and health officials.

The amount of U.S. patients get medicines from India doubled to 12 percent in 2012 from 6 percent in 2008, becoming the second largest importer of drugs to the U.S. after Canada.

Prohibited plants include those run by Sun Pharmaceutical Industries Ltd. (SUNP), which is the largest drug manufacturer in India, Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt Ltd. (WPL) warning letters and inspection reports allege companies manipulated quality testing and operation of insanitary conditions.

Both Sun and Wockhardt recalled generic drugs for depression or high blood pressure earlier this year because the drugs fail to comply with the dissolution tests that indicate whether a generic absorbs the same as copying treatment brand reports according to FDA enforcement.

The Indian government authorized the FDA to hire additional staff in March 2013, Kelly said, after Congress passed a law in 2012 that created a program user fee funded by the manufacturers of generic drugs in part to help increase staff and FDA inspections in outposts overseas including India.
"Different Culture '

"It's hard to make people stay there for long periods of time," said Robert Pollock, senior advisor Lachman Consultants who previously served as acting deputy director Office of Generic Drugs FDA. "It's so different from the U.S. culture is so different.''

The agency conducted 111 inspections of drugs in India in fiscal 2013, less than 20 percent of manufacturers registered in the country, according to data provided by the FDA Kelly drugs. This is an increase of 72 in FY2010 and 98 in FY2011, even though it is below 141 in fiscal 2012.
The FDA has increased its collaboration with Indian regulators through workshops and shadowing exercises to bring them up to speed on the rules of the FDA and help with the supervision of the generic drug industry.

"There are only so many companies that can inspect regardless of the number of people we have in the country," Agrawal said, according to a transcript of an industry conference in San Diego last month. "And only so much information you can gather. Eventually, we will have to establish that entwined relationship between us and them that we trust them in the long term."

R&D, Quality Assurance Professionals To See Good Hiring This Year

MUMBAI: The year 2013 is likely to be a great day for professionals working in research and development and quality assurance is expected that consumer goods companies to hire 700 people in the field from January to April, according to a comprehensive personnel staffing and recruiting firm.

"It is estimated that approximately 700 new openings will be created in the period from January to April of professionals who possess skills Quality and R & D.



   "This is seen as an opportunity boom for people working in the traditional domestic tuning to expand their career graph and enhance it with better exposure and international opportunities available to multinational companies," said an analysis report trend posted by Gi Group.

Of the estimated numbers, about 20 percent are likely to be recruited for mid-level management and said. In explaining this sudden increase, Gi Group, India CEO Asim Handa said companies with key overseas market in the plan of the Asia-Pacific to build domestic manufacturing implementation in order to reduce excise taxes or import duties or export duties.

For most of these global manufacturers, India is emerging as a favorite destination for setting up a new unit, which will support its local distribution plan said.

The initial team that is built for a manufacturing set-up, especially in consumer goods, it has professionals in product development, quality control and assurance provider likewise said.

"Companies that plan to invest in India are looking for in the country becoming its supply center for other international destinations, courtesy of his supreme connectivity in the territory of Asia Pacific. Moreover, it is expected that investment announcements made the past to see the initial implementation in 2013 year, "Handa said.

According to the report, more will be held pan India talent search to recruit for key positions that are likely to give an opportunity for potential candidates to move their base to a new city.

Companies can identify ideal candidates for large national consumer giants and multinationals, with funding from their headquarters, are expected to offer a hike to 60 percent for the best candidate, and said, adding the increase is estimated to average 30 to 35 percent.
Many opportunities for staff are likely to open in the purchasing function well said.

North is likely to witness more openings for R & D, Quality and Acquisitions since most large companies plan to set up manufacturing plants in this part of the country.

It is expected that states like Tamil Nadu, Uttar Pradesh and Andhra Pradesh to witness relatively high openings in the field of Quality provided following configurations to support high-volume manufacturing.

For some of these companies, huge R & D configuration already exists in your office, so that more attention will be focused on meeting local operating standards, he added.

Indian Regulators To Shadow U.S. FDA On Plant Inspections

Indian regulators will be notified when the Food and Drug Administration U.S. is inspecting plants that produce generic drugs in the country, and join to observe the standards of the FDA.

The agreement between government officials in India and FDA Commissioner Margaret Hamburg came during his visit to India this week, the FDA said yesterday. Hamburg, who told Bloomberg News, last week that expanded inspections of overseas plants, also met in a closed session with 16 pharmaceutical companies and affiliated groups in India to discuss the quality of manufacture.



U.S. lawmakers are scheduled to listen to the doctors, researchers and patient advocates at a conference of 26 February on whether generics inferior leaks in the U.S. medical system abroad. Harry Lever, a cardiologist at the Cleveland Clinic, said he will tell them that generic drugs manufactured by companies based in India for heart failure often do not work as they should, opening questions about the FDA's ability to track growth of generics business of India.

"It's like taking a squad to fight a huge army," Lever said in a telephone interview, referring to the efforts of the FDA to inspect drug plants in India.

Lever said he is awaiting test results of samples sent to questionable drugs Preston Mason, a researcher at Brigham and Women's Hospital in Boston. Mason previously reviewed the generic versions of Pfizer Inc. (PFE)’s Lipitor 15 countries and factory waste sometimes rendered ineffective drugs were found.

Pills produced by U.S. generic manufacturer Mylan Inc. (MYL) and Actavis Plc (ACT) were not contaminated, as reported by Mason in his research published in the June issue of the Journal of Clinical Lipidology.


Charges collected

in 2012, the FDA gave it the power to collect fees from manufacturers of generic drugs, in part, to pay for increased inspections of facilities outside the U.S. While the Indian government has cleared the way for the FDA to increase the number of staff members at December 19, it is unclear how many are based today. The agency has refused to provide a number.

Congressional aides are watching how well the FDA ramps up inspections abroad and may raise the issue of the quality of medicines as part of an oversight hearing of the FDA in the Senate in the coming months, according to a staff member on the Senate Health, Education, Labor and pension Committee was not authorized to speak publicly about it.

Generic drug makers Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt Ltd. (WPL), whose executives were among those attending the meeting with Hamburg, has banned the sale of drugs in the U.S. plants from India due to quality problems. In the latest incident last month, a fourth installation Ranbaxy was banned from U.S. exports after FDA inspectors found drugs were re-evaluated to obtain favorable results after the initial analysis failed.

Third Party Inspection And Quality Assurance Services

TCR Engineering Services from its offices in Mumbai provides control and quality assurance services to help retailers, trading partners, importers and manufacturers assess product quality and meet the regulatory requirements of the industry vertical.

Independent quality assurance services of third TCR results in improving product quality, with a reduction in customer complaints, noncompliance and product recalls.

Equipment deployment TCR staff can also provide qualified NDT personnel for their projects control contracts with strong experience on the site and offshore.

The inspection team at the site covers all states of India. The pricing structure for services on-site inspection is set competitively and is based on man-day charges.

Our inspection services include:

Factory Audit
Service TCR Engineering Services Factory Audit verifies the ability of a manufacturer to meet contract conditions for terms of quality, quantity and delivery. These assessments are often tailor-made according to customer needs and requirements. By using this service, we eliminate the need for a client to be present at the site of the plant or factory of the manufacturer.

OEM Development
TCR Engineering Services with 32 years experience with a team possessing a strong engineering background. This team is ready to provide consultation on the basis of the latest technological advances, incorporating standards and existing national and international standards. TCR can help assist in the creation of a first prototype production, technical documentation, evaluation standards, establishing production and quality criteria and technical transfer to the supplier.

Collecting samples and the analysis of Coordination
Our inspectors can select a predetermined number of samples of the production in a factory and seal, label and send them to our material testing laboratory for testing according to customer needs. In the laboratory materials testing TCR Engineering Services, provide mechanical testing, chemical analysis, Positive Material Identification (PMI), Non Destructive Testing, Metallography, Corrosion Testing, Failure Analysis, Raw Material Inspection, Metallurgical Product evaluation, Engineering Research and Consulting.

Initial Production Inspection
The inspection of TCR Engineering Services can perform a visual inspection of products as available at the beginning of the production cycle against a client's instructions and Purchase Order specifications. The "Initial Production Inspection" when combined with a "Final Random Inspection" and other controls production line, helps in taking corrective action at an early stage of the production cycle. The inspection team will send progress reports to the client and keep them informed on the progress of production in relation to the delivery terms.

Production within Check
The inspection team performs a visual inspection of products throughout the production. The inspection team may subject some products for random testing materials. Service check-in production helps reduce the risk of failure Final random inspection.

Random inspection
Equipment inspection services TCR Engineering Services performs a final random inspection comprising of a detailed visual inspection of goods before shipment. It usually takes place on the premises of the manufacturer, on samples selected according to defined sampling procedures. The inspection criteria covering quality, quantity, marking and packing are based on customer specifications and reference samples, as expected. At the end of the final random inspection a detailed inspection report to the client and the inspection certificate issued to the supplier if all results are positive is sent.

Random inspection can be chosen as a standalone service or a stricter review of the production, service random inspection may be carried out in conjunction with the "initial check of production" and "In-Production checks." Following this inspection, a Certificate of Inspection TCR Engineering Services certifying product quality issue.

Loading Supervision
to further manage the delivery of the products, the inspection team TCR Engineering Services offers Loading Supervision which involves "the case," checking the container condition, identification of the loaded packing units with shipping previously inspected, counting the total number of shipping units and sealed packaging container. Service Loading Supervision is offered in conjunction with the Final Random Inspection.

USFDA Finds Quality Testing Flaws At Wockhardt’s Illinois Plant

FDA said unit of plant quality does not have documented procedures and some systems were not followed

Irregularities in testing similar products were also cited two warning letters issued to prohibited plants and Wockhardt in Chikalthana Waluj in Aurangabad, India. Photo: Kedar Bhat / Mint




Wockhardt Ltd, the manufacturer of generic drugs has faced quality problems at two of its plants in India, was quoted by the Food and Drug Administration (FDA) for testing lapses at a factory in Illinois.
FDA issued a Form 483 listing possible violations of the Act Food Drug and Cosmetic Act after inspecting facilities for drug Wochardt in Morton Grove, Illinois, more than 17 days between January and March, according to a document on the website of the agency.

Two of the facilities of the Indian drug maker based in Mumbai and are prohibited from exporting to the U.S. after FDA inspections reported similar violations. If Wockhardt ignores problems, recent observations could affect the company's offerings to its biggest market.

The facility generates more than half of Wockhardt's U.S. sales last quarter. U.S. Business Wockhardt fell 26% in the year ended March 2014 following the import restriction on the other two factories. The contribution of U.S. sales dropped to 45% of total revenue 51% last year.

Form 483, issued on March 26 and contains 12 observations, that unit of plant quality does not have documented procedures and some systems were not followed.

The Wockhardt factory in Illinois is the latest installment in India under scrutiny by the FDA. Four factories of India Ranbaxy Laboratories Ltd are prohibited from selling to the U.S. and this year the FDA put import restrictions on a plant Sun Pharmaceutical Industries Ltd.

Drug Testing

The document cited the specific practice of testing test and said the company has not established appropriate procedures designed to ensure that products conform to appropriate standards of identity, strength, quality and purity.

Irregularities in testing similar products were also cited two warning letters issued to prohibited facilities Wockhardt in Chikalthana and Waluj in Aurangabad, India, the document says, leading the agency to believe that the unity of quality business is not fully monitoring systems in their plants.

The FDA also cited evidence RAW data files that could be accessed and removed by anyone, and workers not trained in good manufacturing practices today.

"It's hard to say what kind of position will make the FDA," said managing director Murtaza Khorakiwala on 27 May call with analysts, referring to the last inspection. "But I think that, in our opinion, the inspection was not-I mean, it was not a negative inspection." Dominic D'Souza, a spokesman for Wockhardt in Mumbai, declined to comment Tuesday on the FDA document.

India To Up Drug Inspection Efforts To Address Quality, Regulation Concerns

MUMBAI (Reuters) - India will spend 30 billion rupees ($ 511 million) and double the number of drug inspectors in the next three years to meet the standards of global manufacturing, said the country's health regulator on Wednesday.



A number of import bans imposed by the Food and Drug Administration U.S. in major generic drug manufacturers in India due to failures in the processes of production in recent years have given rise to concerns about the quality of the drugs sold in other markets, particularly in India.

The government of India the number of inspectors from the Organization of Central Drug Standard Control (CDSCO) 500 1000 now, Drug Controller General of India will increase GN Singh said in a statement Wednesday.

The number of officials from state departments of regulation was increased to 3,000 from 800 now, he said.


“Reference System India (for drug testing and intellectual property) will be at par with global standards the most important two or three years and will even match the U.S. in three to five years," Singh said.

In India, the states regulate the manufacture and distribution of drugs, while CDSCO, which is the federal authority, is responsible for approvals of new drugs and clinical trials, drug imports oversees and coordinates the activities of state regulators.

The chronic shortage of inspectors has made it difficult for regulators to monitor Indian factories over 10 thousand drug manufacturing in India, catering to more than 200 countries.

Multiple state drug regulators told Reuters in April that the skeleton staff and the lack of sufficient drug testing laboratories had surrendered their departments equipped to carry out their duties.

Indian Drugmakers Must Know Quality-Control Rules, FDA Says

Indian companies that supply a quarter of the drugs used in the U.S. must assume responsibility for the quality control necessary to export their products, the main regulator of U.S. drug said while increasing inspections.

Reviews of Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, follow an eight-day trip to India to meet with pharmaceutical companies in the production quality. The U.S. is increasing scrutiny of generic medicines manufactured in India, and in the last nine months banned imports from four plants in Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt Ltd. (WPL)

The FDA will expand its offices in India, train regulatory officials of the nation and strengthen inspections of overseas plants, Hamburg said in an interview with Bloomberg TV India in Mumbai yesterday. Until recently, the U.S. I was not inspecting the manufacturers of other countries in the same frequency as in the U.S. Said Commissioner. That is changing, he said.

"If a company wants to do business in the United States, the responsibility lies with them to understand the rules and requirements," said Hamburg. “We want to work closely with business.”

During his trip, Hamburg agreed a plan that regulators from India will shadow FDA inspectors’ visits to the plant to observe the practices of the U.S. agency Bloomberg News reported on February 12.

In the interview of Mumbai, also urged the Comptroller General of India Drugs and other regulatory authorities in the country to attend international meetings to discuss the drug's safety.
‘Table’

"Very often, when convened meetings with my counterpart’s regulatory authorities around the world, India are not represented at the table," said Hamburg. "It's a loss for them; it's a loss for us. And the more I think India is playing a very important role in the global market, the more it needs to be on the table paper."

The FDA is the creation of an Office of Pharmaceutical Quality to improve control of the agency brand, generic and over- the-counter drugs, Bloomberg News reported Feb. 14. The agency is also talking directly with industry to develop the data may indicate that manufacturing plants are shifting rules and the need for inspection , said Janet Woodcock , director of the FDA Center for Drug Evaluation and Research .

Pharmaceutical companies in India provide 25 percent of drugs in the U.S. , According to Gaurav Pathak and Rao Shashikiran , analysts at Standard Chartered Plc in Mumbai.