USFDA settlement to hit Ranbaxy by Rs 60/sh: Espirito Santo

Ranbaxy Laboratories said it has reached a settlement with the US Food and Drug Administration while setting aside USD 500 million to address its potential liability from a separate US Justice Department investigation.

Speaking to CNBC-TV18, Chirag Talati of Espirito Santo Securities said, the move is likely take Ranbaxy's debt up to USD 750 million after the settlement. "This will translate into an impact of Rs 60 per share on Ranbaxy," he added. 

However, Talanti said, the development is a sentiment positive and one can expect near-term strength in the counter. " The fair value for Ranbaxy is close to Rs 460 ." 

Q: What do you make of this development? What does it mean for the stock?

A: Ranbaxy has entered into the consent decree and this would translate into an impact of close to Rs 60 per share for Ranbaxy. But importantly, it will strike its balance sheet as it would take the net debt situation to USD 750 million. The provision that has been set aside is on the higher side, as we were looking at close to USD 300-400 million.

The press release is still a bit vague because all it says is that Ranbaxy will show its capabilities in data integrity and CGMP compliance as a part of the consent decree. We don't know whether products will review immediately from both the facilities particularly for the Paonta Sahib facility which has been under significant question mark.

At last conference call management did mention that they expect to take up the US run rate to USD 400 million from current USD 300 million post FDA resolutions. But what happens because of the consent decree is that regulatory and compliance cost will not disappear immediately. If you look at the past trend of the 25 consent decrees that were signed by the FDA in the last decade, only three have been taken off at this point in time.

So, one would still expect regulatory cost to be overloaded on Ranbaxy for the next few years. Overall it is sentimentally positive and it removes the big overhand from the stock. Importantly it should enable Ranbaxy to timely launch all it's upcoming first to fill opportunity. However, the key for Ranbaxy still remains its new product flow in the US and ability to rapidly scale its filings. But we are still short of details over there, so we look to see what the management has to say before taking a firm call. Sentimentally, it is very positive and removes a big overhang on the stock.

Q: From this level of Rs 395 what kind of upside can you justify?

A: We are looking at around Rs 460 as a fair value on the stock. Some of this will be saved up because of the penalty that has been set aside. But to look at an upside from more than Rs 460 is difficult to justify, until we get clarity on the kind of stabilised run rate that one can keep from Ranbaxy in a steady state environment.

Ranbaxy falls as US settlement provision to hurt earnings

Shares of Ranbaxy Laboratories fell over 3% on Wednesday morning after the drug maker said it has signed a consent decree with the US Food and Drug Administration [FDA] and also has separately set aside USD 500 million to cover any potential penalty from an investigation by the US Justice Department.

Analysts say the settlement with the US FDA is positive and a step forward in the direction of resuming exports from its Dewas and Paonta Sahib facilities. However, the penalty it will pay will hurt earnings and pressure balance sheet, they add.

In 2008, the US FDA had banned Ranbaxy from exporting 30 drugs from its facilities in Dewas, Madhya Pradesh and Paonta Sahib, Himachal Pradesh and also stopped marketing approvals for new ones following quality control and data reporting issues.

Ranbaxy on Wednesday said it has committed to further strengthen procedures and policies to ensure data integrity and comply with current good manufacturing practices.

"We are pleased to have resolved this legacy issue with the FDA as we begin the next chapter in Ranbaxy's history…While we were disappointed by the conduct that led to the FDA's investigation, we are proud of the systematic corrective steps we have taken to upgrade and enhance the quality of our business and manufacturing processes," said Arun Sawhney, CEO & MD.

"The USD 500 million penalty provision is a bit high, it will hurt earnings," Hitesh Mahida, healthcare analyst at PUG Securities told moneycontrol.com.

Ranbaxy recently launched a generic version of cholesterol lowering drug Lipitor in the US Market. This launch is seen as one of the biggest catalyst to its growth. Analysts are expecting Ranbaxy's copy of Lipitor to add Rs 25-30 a share to its earnings during its 180-days exclusive marketing period.

Mahida said if Ranbaxy does end up paying USD 500 million as penalty, then it would wipe out earnings from the Lipitor generic launch.

Other analysts like Chirag Talati of Espirito Santo Securities feel the penalty will hurt its balance sheet, while shaving off as much as Rs 60 a share from its EPS.

"Ranbaxy has entered into the consent decree and this would translate into an impact of close to Rs 60 per share for Ranbaxy. But importantly, it will strike its balance sheet as it would take the net debt situation to USD 750 million. The provision that has been set aside is on the higher side, as we were looking at close to USD 300-400 million," Talati told CNBC-TV18.

Talati expects regulatory costs will be overloaded on Ranbaxy for the next few years.

At 11:30 hrs, Ranbaxy shares were trading down 2% at Rs 387 on NSE.

CARE maintains fundamental grade of 3/5 on Elder Pharma

CARE Equity Research has come out with its report on Elder Pharmaceuticals Limited (EPL). The research firm has maintained the fundamental grade of 3/5 on the company, which indicates 'Good Fundamentals'.

Healthy growth in revenue

EPL posted consolidated revenue of Rs.331 crore in Q2FY12 – a y-o-y growth of 57.2 per cent. Of this, revenue of Rs.78 crore was from the recently acquired stakes in Elder Biomeda AD and Neutrahealth PLC. On a standalone basis the revenue for the company stood at Rs.252.8 crore - up 24 per cent, y-o-y. All therapeutic segments witnessed healthy growth in the quarter.

Three new product launches

EPL furthered its strategy to enhance its product portfolio through new launches in Q2FY12. The company launched three new products, one each in lifestyle care, anti-infectives and nutraceuticals segment in Q2FY12. The company is further expected to add 8 more products to its portfolio in H2FY12. New product launches would be a critical monitorable for sustaining the growth in EPL's top-line going forward.

Margins witness some pressure

EPL's margins witnessed some pressure in Q2FY12 when compared with Q2FY11. The same was primarily on account of higher raw materials, employee and other expenses. Consequently, net margins too witnessed a decline y-o-y, and stood at 5.8 per cent in Q2FY12. However, on a standalone basis the margins have witnessed a slight improvement.

Valuation

CARE Equity Research assigns valuation grade of 4/5 to EPL based on the Current Intrinsic Value (CIV) of Rs.434 as against Current Market Price (CMP) of Rs.349 indicating that shares of EPL have 'Moderate Upside Potential' at the CMP.

EBITDA growth continues; margins witness some pressure on consolidated basis On a consolidated basis

EPL reported an EBITDA of Rs.54.9 crore in Q2FY12 – up 31 per cent, y-o-y. EBITDA for H1FY12 stood at Rs.107.75 crore – up 35 per cent, y-o-y. Operating margins however, stood lower at 16.6 per cent, as against 19.9 per cent in the same quarter of the previous year. The drop in margins was on account of increased expenses in the current quarter over Q2FY11. Other expenses, materials cost & staff cost witnessed a rise of 72.9 per cent, 60 per cent & 64.7 per cent, respectively, y-o-y. The PAT margins too were lower with drop in operating margins and higher interest expenses. The increase in other income, which comprised primarily of interest income, insurance claims received and duty drawbacks restricted the extent of drop in net margins. On standalone basis, however, the company reported an improvement in both operating and net margins.

Which pharma cos will gain from the falling rupee? Find out

With nearly half of total revenues coming from exports, the recent sharp deprecation in rupee spells good news the pharma sector. The rupee has depreciated against the US dollar in recent months. It even breached the 54 mark against the US dollar on Thursday.

The total Indian pharmaceutical industry size is about USD 20 billion, with exports accounting for around USD 9 billion of that. Many Indian pharma companies have high exposure to western markets, especially US, for export of active pharmaceutical ingredients [API], formulations and intermediaries. So to that extent the companies will certainly cheer this rupee decline, say some analysts.

"The rupee depreciation will be positive for pharma companies. The full impact of this will be seen in the margins in the third quarter, which should get a boost," Hitesh Mahida, healthcare analyst at PUG Securities, told moneycontrol.com.

Sun Pharma , for instance, has a zero hedging policy and thus stands to benefit significantly, he says.

Exports account for around 70% for companies likeDr Reddy's , Aurobindo Pharma , Dishman Pharmaand Ranbaxy Laboratories . So as rupee depreciates, revenue will appreciate. Others likeDivi's Lab and Cipla too stand to gain.

However, not all companies will be able to digest this depreciation in rupee completely. Mahida points out that Ranbaxy has USD 700 million worth of forward contracts and so stands to loose to an extent.

Aurobindo too has USD 600 million in forex loans. So even as rupee depreciation will boost its revenue by 10% in the second half of this fiscal, impact on profit will be limited to 3%, according to a report by Deepak Malik and Ashish Thavkar of Emkay Global Financial Services.

"Divi's to benefit the most with 37% upside in earnings in the second half and 21% in FY12, followed by Dr. Reddy's, Cipla and Sun Pharma, which will see upside of 16%, 15% and 13% in the second half and 9%, 8% and 6% in FY12, respectively," the Emkay analysts said.

However, there will be limited or no benefits for companies like Cadila Healthcare , Glenmark andJubilant Life Sciences , since they have foreign exchange loans and that will increase their liabilities, the analysts say.

Emkay has raised full year earnings per share estimates for Divi's Lab by 21%, Dr Reddy's 9% and Cipla by 8% among others.

Pharma stocks have outperformed the broader market over the past several months on the back of the rupee depreciation and several companies announcing FDA approvals and drug launches in the US.

The CNX Pharma index is up about 1% in the last three months, while the Nifty index is down 6% over the period. The CNX Pharma index was trading flat over yesterday's close, while NSE Nifty was down about 1% in afternoon trade on Thursday.

Nachiket Kelkar
nachiket.kelkar@network18online.com

Orchid Chem to repay FCCB through ECB, borrows $100 mn

Orchid Chemicals is buzzing on the radar today on account of the USD 100 million debt that the company has raised through external commercial borrowing. K Raghavendra Rao, chairman and managing director, Orchid Chemicals spoke to CNBC-TV18 about the fund-raising and strategies of the company going ahead.

Below is the edited transcript of the interview. Also watch the accompanying video.

Q: Just take us through the details of the USD 100 million ECB that you have raised?

A: Yes we have got a sanction for USD 100 million of External Commercial Borrowings (ECB) which will be used to repay the bonds for USD 117 million which are maturing in February 2012. Of course, there is also a yield-to-maturity (YTM) also to be added to this which will come from internal accruals. So we are replacing dollars with dollars and borrowing also is less than the repayment. So we don't have any issue in repayment of bonds in February when they mature.

Q: What kind of terms did you get on the ECB?

A: These terms are better than the interest that is there on these bonds which we are going to repay. The bonds that are currently outstanding are having 7.25% to YTM on a five-year bond, and the rates and tenure both are better than 7.25% and the tenure is longer than five years.

Q: What about the foreign exchange issue and the rupee-dollar rate? Does that worry you about how things might pan out?

A: Actually it is a positive for us because we are a net value addition company in terms of dollar terms. Our P&L is USD 400 million of exports each year and a net of imports for the material cost that goes into that- we are net dollar-positive of at least USD 200 million year-over-year, whereas the bonds are maturing once in five years. So in five years, we would be having a net value addition of more than a billion dollar. Thus foreign exchange is beneficial for us if the rupee is weakening. The only thing is in terms of stating the accounts at the end of each quarter, we need to restate the balance sheet items, instead of the P&L accruals over a period of time. So in a couple of quarters, we will be able to off set the notional loss on account of bonds at any point in time because our P&L is very strong in terms of dollars.

Q: And the gap between the total FCCB amount and the ECB is easily met through internal accruals?

A: Absolutely yes.

Sell Orchid Chemical, says Sudarshan Sukhani

Sell Orchid Chemical , says Sudarshan Sukhani, s2analytics.com.

Sukhani told CNBC-TV18, "Orchid Chemical is been a big disappointment. First it fell went on breaking support levels, we went on giving sell signals in it and then in the Rs 140-150 range there was a suggestion that probably the worst is over. But it's not. It's ready to begin another leg of the decline that we have already seen. That's worrying because it's not the only stock that's saying okay, I am ready to fall more. But Orchid Chemicals is a short selling idea. I don't know whether it's going to stop even at that target of Rs 124. I suspect before the bear market ends we will see it in double digits."

Orchid Chemicals may rally upto Rs 200: Tulsian

Orchid Chemicals may rally upto Rs 200, says SP Tulsian, sptulsian.com.

Tulsian told CNBC-TV18, "Orchid Chemicals, if you see FCCB of USD 117 million dollars and that has been cause of worry for the market. If you see Q2 results had a provision of about Rs 82 crore on account of the exchange loss that got set off against the tax refund of the equivalent, so that did not impact much on the bottomline of Q2 on a consolidated or taking all this into account, but if you see now since the FCCB of about USD 117 million has been replaced, I don't think that now you really have any worry- if you see the business profile of the company, they are the largest integrated antibiotic manufacturing company. They have 3 Active Pharmaceutical Ingredients (API) plants. They are the cephalosporin makers, one of the largest cephalosporin makers in the country and very good product pipeline they have good filings in the Europe and US to the extent to the extent of about 80 products and they are into the formulations also. They have their two plants, strong R&D pipeline."

He further added, "If you take all this into account and in fact I would say that FY11 results have been stable and one can expect that kind of results to get repeated from FY13. I will give a pass to FY12 results, but FY11 had a topline of close to about Rs 1600 crore and they an EPS of close to about Rs 22-23 and if you recall at that time management was confident that probably they will be able to post an EPS of close to about 25-30, but I don't think that that is likely to happen, as I said that because of this tax refund, exchange, gain, losses and all that, but yes, one can expect that from FY13, the company is in a position to post the topline of close to about Rs 2000 crore with atleast the EPS of about 20 plus if not 24-25."

"So if I take all these things into account, again you don't have any downside fear. The stock technically also looks oversold. We had been seeing short covering in the stock for the last couple of days. So if you take that FY13 performance based on a topline of Rs 2000 crore and expected EPS of 20 plus atleast I think share has potential to move back to about Rs 200, which market will start factoring in probably in the next 6- 8 months time. So target of Rs 200 can be seen in about 8 month's time from hereon."

Seth`s view on Orchid Chemicals

Prashastha Seth, IIFL Private Wealth feels that investors should hold their position in Orchid Chemicals .

Seth told CNBC-TV18, "The problem with Orchid Chemicals is not the business, the business is doing okay, and the valuations are cheap 6-5 times earnings."

He further added, "There are two problems with the company; one was the FCCB which the company said it has sorted out with the new ECB loan and second is in terms of pledged promoter shares which is still an overhang on this stock and will continue to be an overhang on the stock till the market sentiment improves. So if somebody is a trader then in these market conditions he would exit some of these stocks but if one is an investor and can wait and bear the pain theoretically of promoters pledge holding being sold and so on and so forth then some of these stocks present decent opportunity."

"I think five-six time one year forward earnings I don't see how much one can go wrong from where you are at this point of time and even the market sentiment is such that one might again have to as is the case with other two companies you will have to bear an extended period of pain but if one can see through it once the tiding change which could happen in three-six months down the line you could reap benefits from where one is at this point of time."

ISO

The International Organization for Standardization (French: Organisation internationale de normalisation, Russian: Международная организация по стандартизации, tr. Mezhdunarodnaya organizaciya po standartizacii),[1] widely known as ISO, is an international standard-setting body composed of representatives from various national standards organizations. Founded on February 23, 1947, the organization promulgates worldwide proprietary industrial and commercial standards. It has its headquarters in Geneva, Switzerland.While ISO defines itself as a non-governmental organization, its ability to set standards that often become law, either through treaties or national standards, makes it more powerful than most non-governmental organizations. In practice, ISO acts as a consortium with strong links to governments.

Name and abbreviation

The organization's logos in two of its official languages, English and French, include the word ISO, and it is usually referred to by this short-form name. ISO asserts that ISO is not an acronym or initialism for the organization's full name in either official language; rather, the organization adopted ISO based on the Greek word isos (ἴσος), meaning equal — recognizing that the organization’s initials would be different in different languages, the organization's founders chose ISO as the universal short form of its name.[3] However, one of the founding delegates, Willy Kuert, recollected the original naming question with the comment "I recently read that the name ISO was chosen because 'iso' is a Greek term meaning 'equal'. There was no mention of that in London!".

ISO's main products are the International Standards. ISO also publishes Technical Reports, Technical Specifications, Publicly Available Specifications, Technical Corrigenda, and Guides.[9][10]

International Standards are designated with the format ISO[/IEC] [/ASTM] [IS] nnnnn[-p]:[yyyy] Title, where nnnnn is the number of the standard, p is an optional part number, yyyy is the year published, and Title describes the subject. IEC for International Electrotechnical Commission is included if the standard results from the work of ISO/IEC JTC1 (the ISO/IEC Joint Technical Committee). ASTM (American Society for Testing and Materials) is used for standards developed in cooperation with ASTM International. The date and IS are not used for an incomplete or unpublished standard, and may under some circumstances be left off the title of a published work.

Technical Reports are issued when "a technical committee or subcommittee has collected data of a different kind from that which is normally published as an International Standard".[9] such as references and explanations. The naming conventions for these are the same as for standards, except TR prepended instead of IS in the report's name. Examples:

* ISO/IEC TR 17799:2000 Code of Practice for Information Security Management
* ISO/TR 19033:2000 Technical product documentation — Metadata for construction documentation

Technical Specifications can be produced when "the subject in question is still under development or where for any other reason there is the future but not immediate possibility of an agreement to publish an International Standard". Publicly Available Specifications may be "an intermediate specification, published prior to the development of a full International Standard, or, in IEC may be a 'dual logo' publication published in collaboration with an external organization".[9] Both are named by convention similar to Technical Reports, for example:

* ISO/TS 16952-1:2006 Technical product documentation — Reference designation system — Part 1: General application rules
* ISO/PAS 11154:2006 Road vehicles — Roof load carriers

ISO sometimes issues a Technical Corrigendum. These are amendments to existing standards because of minor technical flaws, usability improvements, or to extend applicability in a limited way. Generally, these are issued with the expectation that the affected standard will be updated or withdrawn at its next scheduled review.[9]

ISO Guides are meta-standards covering "matters related to international standardization".[9] They are named in the format "ISO[/IEC] Guide N:yyyy: Title", for example:

* ISO/IEC Guide 2:2004 Standardization and related activities — General vocabulary
* ISO/IEC Guide 65:1996 General requirements for bodies operating product certification

[edit] Standardization process

A standard published by ISO/IEC is the last stage of a long process that commonly starts with the proposal of new work within a committee. Here are some abbreviations used for marking a standard with its status:[11][12][13][14][15][16][17]

* PWI - Preliminary Work Item
* NP or NWIP - New Proposal / New Work Item Proposal (e.g., ISO/IEC NP 23007)
* AWI - Approved new Work Item (e.g., ISO/IEC AWI 15444-14)
* WD - Working Draft (e.g., ISO/IEC WD 27032)
* CD - Committee Draft (e.g., ISO/IEC CD 23000-5)
* FCD - Final Committee Draft (e.g., ISO/IEC FCD 23000-12)
* DIS - Draft International Standard (e.g., ISO/IEC DIS 14297)
* FDIS - Final Draft International Standard (e.g., ISO/IEC FDIS 27003)
* PRF - Proof of a new International Standard (e.g., ISO/IEC PRF 18018)
* IS - International Standard (e.g., ISO/IEC 13818-1:2007)

Abbreviations used for amendments:[11][12][13][14][15][16][17][18]

* NP Amd - New Proposal Amendment (e.g., ISO/IEC 15444-2:2004/NP Amd 3)
* AWI Amd - Approved new Work Item Amendment (e.g., ISO/IEC 14492:2001/AWI Amd 4)
* WD Amd - Working Draft Amendment (e.g., ISO 11092:1993/WD Amd 1)
* CD Amd / PDAmd - Committee Draft Amendment / Proposed Draft Amendment (e.g., ISO/IEC 13818-1:2007/CD Amd 6)
* FPDAmd / DAM (DAmd) - Final Proposed Draft Amendment / Draft Amendment (e.g., ISO/IEC 14496-14:2003/FPDAmd 1)
* FDAM (FDAmd) - Final Draft Amendment (e.g., ISO/IEC 13818-1:2007/FDAmd 4)
* PRF Amd - (e.g., ISO 12639:2004/PRF Amd 1)
* Amd - Amendment (e.g., ISO/IEC 13818-1:2007/Amd 1:2007

Other abbreviations:[15][16][18][19]

* TR - Technical Report (e.g., ISO/IEC TR 19791:2006)
* DTR - Draft Technical Report (e.g., ISO/IEC DTR 19791)
* TS - Technical Specification (e.g., ISO/TS 16949:2009)
* DTS - Draft Technical Specification (e.g., ISO/DTS 11602-1)
* PAS - Publicly Available Specification
* TTA - Technology Trends Assessment (e.g., ISO/TTA 1:1994)
* IWA - International Workshop Agreement (e.g., IWA 1:2005)
* Cor - Technical Corrigendum (e.g., ISO/IEC 13818-1:2007/Cor 1:2008)
* Guide - a guidance to technical committees for the preparation of standards

International Standards are developed by ISO technical committees (TC) and subcommittees (SC) by a process with six steps:[13][20]

* Stage 1: Proposal stage
* Stage 2: Preparatory stage
* Stage 3: Committee stage
* Stage 4: Enquiry stage
* Stage 5: Approval stage
* Stage 6: Publication stage
Stages in the development process of an ISO standard[12][13][14][17][18][20] Stage code↓ Stage↓ Associated document name↓ Abbreviations↓ Description↓
00 Preliminary stage Preliminary work item PWI
10 Proposal stage New work item proposal NP or NWIP, NP Amd/TR/TS/IWA
20 Preparatory stage Working draft(s) AWI, AWI Amd/TR/TS, WD, WD Amd/TR/TS
30 Committee stage Committee draft(s) CD, CD Amd/Cor/TR/TS, PDAmd (PDAM), PDTR, PDTS
40 Enquiry stage Enquiry draft DIS, FCD, FPDAmd, DAmd (DAM), FPDISP, DTR, DTS (CDV in IEC)
50 Approval stage Final draft International Standard FDIS, FDAmd (FDAM), PRF, PRF Amd/TTA/TR/TS/Suppl, FDTR
60 Publication stage International Standard ISO TR, TS, IWA, Amd, Cor
90 Review stage ISO TR, TS, IWA, Amd, Cor
95 Withdrawal stage

It is possible to omit certain stages, if there is a document with a certain degree of maturity at the start of a standardization project - for example a standard developed by another organization. ISO/IEC Directives allow also the so-called "Fast-track procedure". In this procedure a document is submitted directly for approval as a draft International Standard (DIS) to the ISO member bodies or as a final draft International Standard (FDIS) if the document was developed by an international standardizing body recognized by the ISO Council.[13]

The first step - a proposal of work (New Proposal) is approved at the relevant subcommittee or technical committee (e.g., SC29 and JTC1 respectively in the case of Moving Picture Experts Group - ISO/IEC JTC1/SC29/WG11). A working group (WG) of experts is set up by the TC/SC for the preparation of a Working Draft. When the scope of a new work is sufficiently clarified, some of the working groups (e.g., MPEG) usually make open request for proposals - known as "Call for proposals". The first document that is produced for example for audio and video coding standards is called a Verification Model (VM) (previously also called a Simulation and Test Model). When a sufficient confidence in the stability of the standard under development is reached, a Working Draft (WD) is produced. This is in the form of a standard but is kept internal to working group for revision. When a Working Draft is sufficiently solid and the working group is satisfied that it has developed the best technical solution to the problem being addressed, it becomes Committee Draft (CD). If it is required, it is then sent to the P-members of the TC/SC (National Bodies) for ballot.

The CD becomes Final Committee Draft (FCD) if the number of positive votes is above the quorum. Successive committee drafts may be considered until consensus is reached on the technical content. When it is reached, the text is finalized for submission as a draft International Standard (DIS). The text is then submitted to National Bodies for voting and comment within a period of five months. It is approved for submission as a final draft International Standard (FDIS) if a two-thirds majority of the P-members of the TC/SC are in favour and not more than one-quarter of the total number of votes cast are negative. ISO will then hold a ballot with National Bodies where no technical changes are allowed (yes/no ballot), within a period of two months. It is approved as an International Standard (IS) if a two-thirds majority of the P-members of the TC/SC is in favour and not more than one-quarter of the total number of votes cast are negative. After approval, only minor editorial changes are introduced into the final text. The final text is sent to the ISO Central Secretariat which publishes it as the International Standard.[11][13]
[edit] ISO document copyright

ISO documents are copyrighted and ISO charges for copies of most. ISO does not, however, charge for most draft copies of documents in electronic format. Although useful, care must be taken using these drafts as there is the possibility of substantial change before it becomes finalized as a standard. Some standards by ISO and its official U.S. representative (and the International Electrotechnical Commission's via the U.S. National Committee) are made freely available

Members
A map of standards bodies who are ISO members
Key:
members
correspondent members
subscriber members
other places with an ISO 3166-1 code who aren't members of ISO

ISO has 162 national members,[2] out of the 204 total countries in the world.

ISO has three membership categories:

* Member bodies are national bodies that are considered to be the most representative standards body in each country. These are the only members of ISO that have voting rights.
* Correspondent members are countries that do not have their own standards organization. These members are informed about ISO's work, but do not participate in standards promulgation.
* Subscriber members are countries with small economies. They pay reduced membership fees, but can follow the development of standards.

Participating members are called "P" members as opposed to observing members which are called "O" members.
[edit] Products named after ISO

The fact that many of the ISO-created standards are ubiquitous has led, on occasion, to common use of "ISO" to describe the actual product that conforms to a standard. Some examples of this are:

* Many CD images end in the file extension "ISO" to signify that they are using the ISO 9660 standard file system as opposed to another file system - hence CD images are commonly referred to as "ISOs". Virtually all computers with CD-ROM drives can read CDs that use this standard. Some DVD-ROMs also use ISO 9660 file systems.
* Photographic film's sensitivity to light, its "film speed", is described by ISO 6, ISO 2240 and ISO 5800. Hence, the film's speed is often referred to as its "ISO number".
* Often, the flash hot shoe found on cameras is called "ISO shoe", as it was originally defined in ISO 518.

CE Certification

CE marking (also known as CE mark) is a mandatory conformance mark on many products placed on the market in the European Economic Area (EEA). With the CE marking on a product the manufacturer ensures that the product is in conformity with the essential requirements of the applicable EC directives.[1] The letters "CE" stand for "Conformité Européenne" ("European Conformity").

Meaning

Existing in its present form since 1993, the CE marking is a key indicator of a product’s compliance with EU legislation and enables the free movement of products within the European market. By affixing the CE marking on a product, a manufacturer is declaring, on ones sole responsibility, conformity with all of the legal requirements to achieve CE marking and therefore ensuring validity for that product to be sold throughout the European Economic Area. This also applies to products made in third countries which are sold in the EEA.

CE marking does not indicate that a product was made in the EEA,[3] but merely states that the product is assessed before being placed on the market and thus satisfies the legislative requirements (e.g. a harmonised level of safety) to be sold there. It means that the manufacturer has verified that the product complies with all relevant “essential requirements” (e.g. safety, health, environmental protection requirements) of the applicable directive(s) – or, if stipulated in the directive(s), had it examined by a notified conformity assessment body.

However, not all products must bear the CE marking. Only those product categories subject to specific directives that provide for the CE marking are required to be CE marked. CE marked products are bought not only by professionals (e.g. medical devices, lifts, machinery and measuring equipment) but also by consumers (toys, PCs, mobile phones and light bulbs).

Rules underlying CE marking

The manufacturer of a product himself affixes the CE marking to it, but has to take certain obligatory steps before the product can bear CE marking. He has to carry out a conformity assessment, set up a technical file and sign an EC declaration of conformity. The documentation has to be made available to authorities on request.

Importers of products have to verify that the manufacturer outside the EU has undertaken the necessary steps and that the documentation is available upon request. Importers should also make sure that contact with the manufacturer can always be established.

Distributors must be able to demonstrate to national authorities that they have acted with due care and must have affirmation from the manufacturer or importer that the necessary measures have been taken.

If importer or distributor market the products under their own name, they then take over the manufacturer’s responsibilities. In this case they must have sufficient information on the design and production of the product, as they will be assuming the legal responsibility when they affix the CE marking.

There are certain rules underlying the procedure to affix the marking:

* Products that are subject to certain EC directives providing for CE marking, have to be affixed with the CE marking before they can be placed on the market

* Manufacturers have to check on their sole responsibility, which EU directives they need to apply for their products

* The product may only be placed on the market if it complies with the provisions of all applicable directives and if the conformity assessment procedure has been carried out accordingly

* The manufacturer draws up an EC declaration of conformity and affixes the CE marking on the product

* If stipulated in the directive(s), an authorized third party (Notified Body) must be involved in the conformity assessment procedure

* If the CE marking is affixed on a product, it can only bear additional markings under the condition that they are of different significance, do not overlap with the CE marking and are neither confusing nor impairing the legibility and visibility of the CE marking

Self-certification

Depending on the level of risk of the product, the CE Mark is affixed to a product by the manufacturer or authorized representative who decides whether the product meets all the CE mark requirements. If a product has minimal risk it can be self certified where the manufacturer prepares a Declaration of Conformity and affixes the CE Marking to their own product. In doing this the manufacturer has to do several things:

1. Decide whether the product needs to have a CE mark and if the product applies to more than 1 directive it needs to comply with all of them.
2. Choose the conformity assessment procedure from the modules called out by the directive for the product. There are several modules available for the Conformity Assessment Procedures as listed below:

* Module A – Internal production control.
* Module A – Intervention of a Notified Body.
* Module B – EC type-examination.
* Module C – Conformity to type.
* Module D – Production quality assurance.
* Module E – Product quality assurance.
* Module F – Product verification.
* Module G – Unit verification.
* Module H – Full quality assurance.

These will often ask questions about the product to classify the level of risk and then refer to the "Conformity Assessment Procedures" chart. This shows all the acceptable options available to a manufacturer to certify the product and affix the CE mark.

Products which are considered to have a greater risk have to be independently certified by a notified body. This is an organization that has been nominated by a Member Government and has been notified by the European Commission. These notified bodies act as test labs and carry out the steps as listed in the directives mentioned above and then decided whether the product has passed. A manufacturer can choose their own notified body in any member state of the European Union but should be independent of the manufacturer and a private sector organization or a government agency.

Declaration of conformity

The DoC must include: manufacturer's details (name and address, etc.); essential characteristics the product complies; any European standards and performance data; if relevant the identification number of the Notified Body; and a legally binding signature on behalf of the organization.

Product groups

The EC directives for CE marking[4] affect the following product groups:

* Active implantable medical devices
* Appliances burning gaseous fuels
* Cableway installations designed to carry persons
* Eco-design of energy related products
* Electromagnetic compatibility
* Equipment and protective systems intended for use potentially explosive atmospheres
* Explosives for civil uses
* Hot-water boilers
* In vitro diagnostic medical devices
* Lifts
* Low voltage
* Machinery
* Measuring Instruments
* Medical devices
* Noise emission in the environment
* Non-automatic weighing instruments
* Personal protective equipment
* Pressure equipment
* Pyrotechnics
* Radio and telecommunications terminal equipment
* Recreational craft
* Safety of toys
* Simple pressure vessels

Misuse

Proximal location of CE mark and Made in China text. The European Commission is aware that CE marking, like any other mark, is misused. CE marking may sometimes be affixed to products which do not fulfil the requirements and conditions for its affixing or it is affixed to products for which the affixing is not foreseen. There are also cases where, whilst the product is in compliance with the applicable requirements the CE marking itself does not respect the formal requirements, namely the form of the CE marking or the dimensions and proportions prescribed in the legislation.

China Export

The CE symbol has been alleged or believed to stand for China Export or China Electronics because some Chinese manufacturers apply a very similar marking to their products.As Chinese exporters have used the CE logo incorrectly, the matter was raised at the EU parliament in 2008,and the Commission responded that they will look into trade-marking the logo, and are in discussion with Chinese authorities to ensure compliance with European standards.

Legal implications

There are mechanisms in place to ensure that the CE marking is put on products correctly. Controlling CE marked products is the responsibility of public authorities in the Member States, in cooperation with the European Commission. Citizens may contact national market surveillance authorities if the misuse of the CE marking is suspected, or if a product’s safety is questioned.

The procedures, measures and sanctions applying to counterfeiting of the CE marking vary according to the respective Member State's national administrative and penal law. Depending on the seriousness of the crime, economic operators may be liable to a fine and in some circumstances, imprisonment. However, if the product is not regarded as an imminent safety risk, the manufacturer may be given a second opportunity to ensure that the product is in conformity with the applicable legislation, before being obliged to take the product off the market.

How Google-Motorola will change tech: Four ways

Here are the top four ways that Googlerola will change the course of the tech industry.

1. The Android patent wars are over

Before Google bought Motorola, the Android ecosystem was in real danger of having innovation stymied by litigation. Microsoft, Oracle, and Apple were all bearing down on Google as well as Android partners Samsung and HTC over patent infringements. Motorola hadn't entered the fray yet, but with its long history in the wireless business there was the potential that it could use its treasure chest of patents to pile on to its chief Android rivals, Samsung and HTC.

On August 11, my ZDNet colleague James Kendrick posted, "If Motorola turns its patents on other Android phone makers the platform will implode." And, that was on top of the overall intellectual property issues with Android itself, which affects all of the Android device makers. The problem for Google was that it didn't have enough mobile patents to fight back. That's the way these things usually work. One big company typically says to another big company, "Yeah, we might be infringing you there, but you're infringing us over here" and then it turns into a draw. With Motorola's 17,000 patents on its side, Google has essentially put an end to the Android patent wars. There will still be some final skirmishes, but don't expect much carnage.

2. Vertical integration has won

While Google is pledging to keep Android an open ecosystem and claiming that it will run Motorola as a separate business, it's pretty clear that Google also wants to have the option of producing its own hardware devices so that it can build prototypes, concept hardware, and leading edge devices to demonstrate its vision and point its ecosystem partners in the right direction. Google wanted to do this with the Nexus One smartphone and we also saw Google's hardware itch in the CR-48 laptop running Chrome OS. Of course, Google didn't have the expertise or infrastructure in place to handle the hardware business.

With the Motorola Mobility acquisition, it will add over 19,000 new employees with supply chain, customer service, and hardware development skills. When Google wants to do its next leading edge Android device like the Nexus One, Nexus S, or Motorola Xoom, we have to assume that it's going to use its new hardware division to build it so that it can deliver exactly the device it wants and get it to market much more quickly.

With Apple's continued success in mobile, BlackBerry's large (albeit fading) market share, HP's new hardware/software unification with WebOS, and now the Google-Motorola deal, it's becoming clear that vertical integration is winning in mobile. Going forward, look for the latest, greatest, high-end devices to all be vertically integrated, while many of the low-cost, copy-cat devices will come to the market later and be made by mass market manufacturers like Samsung.

3. Mobile consolidation has begun

Over the past couple years, the arrival of new mobile platforms and the expansion of mobile vendors have given buyers lots of new choices in smartphones and now tablets. However, even in a fast-growing market like mobile, the good times can't last forever. In 2011, we've already seen BlackBerry and Nokia drastically losing momentum, Windows Phone 7 and WebOS struggling to gain market share, and Android and Apple increasingly hogging the spotlight.

Even within the Android ecosystem itself, there have been lots of new upstarts recently, including LG, Lenovo, Acer, and ASUS. All of them have been grasping for a piece of the expanding Android market, which has been dominated by the big three — HTC, Samsung, and Motorola.

However, leading up to the Google deal, Motorola was the only one of the Android vendors that lost market share in the smartphone market in Q2. Obviously, that's likely to change if and when Motorola morphs into the Google-branded Android devices. Nevertheless, Motorola's Q2 struggles are a sign that the Android market itself is already beginning to whittle down to fewer big players.

4. Google has to grow up

As a company, Google is only a little over a decade old. Despite its recent kerfuffles with government regulators and its dust-up with China, the company has lived a bit of an idyllic, Peter Pan existence. Its offices are like college campuses with free food, free transportation, and free personal services (cleaners, barbers, etc). Its employees are loosely organized, don't have to deal with a bunch of overbearing middle managers and bean counters (in most cases), and even get the ability to use work time to dabble with some of their own pet projects.

Because Google's search engine has been such a major cash cow, it has given the company freedom to hire lots of engineers and computer scientists and loosely organize them in this unique environment. However, with search under greater pressure than ever from the social web, it could finally be time for Google to grow up and act like an adult company that has to closely manage expenses and account for the value that each of its employees brings to the organization.

The Motorola acquisition could hasten the process, since it will add over 19,000 employees to a Google that currently has 29,000, and Motorola is a much more established company with traditional organizational standards. Of course, Google will talk about wanting to maintain its startup-like culture, but it will be interesting to watch and see if Motorola influences Google to become more of an accountable, grown-up company.

Why consumers won’t buy tablets (unless they’re iPads)

Can anybody besides Apple can make a tablet that can sell? That question rises yet again with word that the HP TouchPad is not selling well. If this is true, it puts the TouchPad in the same camp as all other tablets except the iPad. The line from the movie "if you build it they will come" has been proven conclusively to not apply to tablets, as HP is now discovering.

Why can't non-iPads sell? It's not like products such as Honeycomb tablets or the webOS-based TouchPad aren't acceptable to the market. They may not match the iPad in every area but by and large they are mostly functionally equivalent. It seems that all of the tablets don't appeal to the same market that is attracted to the iPad, which continues to sell as fast as Apple can make them.

The only way for any tablet maker to hit big sales is to break through the mainstream consumer market. Not the techies who follow the world of tablets looking for the Next Big Thing, but the regular folks who rarely buy technology items. These millions of folks are the ones who snatch up the iPad but aren't grabbing the competing products in Best Buy or other retailers. The iPod crowd, in other words.

If you think back to the prelaunch hype of the original iPad, Apple never aimed it at the techie crowd. They didn't go after the MacBook crowd nor even the iPhone crowd. They went after the audience that had been buying iPods by the hundreds of millions. The ones who didn't care if this new large iPod could replace their computer. The crowd that had no interest in whether the iPad could talk to their computer or iPhone. Regular people were the target for the iPad, and Apple's approach has proven successful with huge sales numbers.

Sure it helped that Apple had produced a solid product in the iPad, but those who remember the product originally launched remember it wasn't perfect. The tech world jumped on its shortcomings like it does all new products, but buyers didn't care. They weren't paying attention to the tech world. They were only paying attention to the message Apple put out to the public. The same message they used for years with the iPod, for this was the audience Apple wanted to reach.

This audience had been proving for years that if a product was simple, well designed and iconic, they would buy it. They are the crowd that not only lined up in Apple stores to buy the iPod, they were the crowd that shelled out big bucks for each new iteration of the gadget. The tech world laughed at the release of each new iteration of the iPod, as the same customers kept giving Apple money to get a slightly improved version of what they already had. The Apple faithful we called them.

Apple knew it needed to set the same tone for the iPad's message, and get the iPod crowd thinking about how "magical" the new tablet could be. That message was set out in all marketing Apple produced for the iPad. Every time you turned on your TV, you got the message; picked up print publications, you got the message; stepped outside and saw huge billboards, the message bombarded you. Remember the iconic iPod silhouette ads that made millions want the iPod? That same effect was created with the consistent iPad marketing from day one.

Apple didn't stop with just the marketing; it created a retail system that gave the same message. Whether prospective iPad buyers were visiting the Apple online store or a physical retail outlet, the message was front and center. The iPad was magical, the experience with it was everything a buyer could want, it was another iconic product in the vein of the iPod. This was the coup de grace from Apple, carrying the magical marketing experience right to the cash register.

This consistent marketing experience from Apple is something that competitors simply cannot reproduce. These companies are coming from a computer background for the most part, and they are set up to market new products to the audience that buys computers. That's why promotions around most Android tablets have tried to appeal to the tech-savvy crowd. Remember the early Motorola XOOM ads? Like virtually all tablet ads, they missed the iPad target market completely.

Even if companies producing Android tablets or HP with the TouchPad get the marketing message right to appeal to the iPod crowd, and I'm not sure they can, they still fall miserably short at the retail experience. Apple recognizes the importance of carrying the promotion all the way to the register, and competitors cannot do that. These companies either don't sell tablets themselves, leaving the important shopping experience to others, or their online retail operations are falling short at committing the buyer because these stores were designed for computer buyers.

If you don't believe that, simply visit hp.com and try to buy a TouchPad. It's in the Home & Home Office section, and the first thing you see is not magical marketing, it's a small sales page that compares the two models of the TouchPad. No pizazz, no marketing, just click to buy.

The same holds true for all online retailers selling tablets. They are designed for selling computers, and expect the customer to have some idea what they want coming in. Their sites aim to help you decide between competing products, which assumes some prior knowledge. There is no sales technique at play, simple point and click to buy. Or to leave, which is apparently what most customers are doing if sales numbers are accurate.

Physical retailers are even worse for non-iPads than the abysmal mixed online experience. Go in any Best Buy or other big box retailer that carries tablets and there's no telling what you'll find. Maybe there will be a counter with tablets scattered all over. Maybe some of them will actually work. The only consistent part of the retail buying experience for tablets is that the sales reps don't know much about any of the products, much less help you decide which one is right for you. They don't care, frankly, and that message gets through loud and clear.

The sad part of this whole tablet debacle is that many of the products not selling are quite good. They are no iPad, as we are all fond of saying, but they are decent products that would serve the market just fine. That market will never end up getting near them, unfortunately, and will certainly never be shown why they should buy one.

USFDA Classification of the Medical Devices

TITLE 21--FOOD AND DRUGS
MEDICAL DEVICES
PART 888 ORTHOPEDIC DEVICES

In this Document we can understand of how we can classify the medical devices.

Free Download for the non commercial and educational purpose only.

If you have any questions please comment below.

Manufacturing Rules for the Medical Devices in India

REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF MEDICAL DEVICES

Free download for the educational and noncommercial purpose only

These are the requirement from the Indian government to setup the shop in India.

India has the potential for the growth and has many good suppliers and cheaper labour.

The cost of production of the medical devices is very low as comparable to the other countries.

Only we need to conform to the rules mentioned in the MIII schedule of the GMP.

For Entire Indian GMP, please refer to the next post.

If you require any further information, comment below.

Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement

Orthopedic Devices Branch
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
U.S. Food and Drug Administration

For a number of years there has been increasing interest in surface treating orthopedic devices in an attempt to improve implant fixation. The purpose of this document is to recommend to manufacturers of orthopedic devices and sponsors of future premarket notifications (510k), Investigational Device Exemptions (IDE) applicatons, Premarket Approval (PMA) applications, reclassification petitions, and master files, importa nt information that should be provided to the Food and Drug Administration (FDA) in order to evaluate the substantial equivalence and/or safety and effectiveness of modified orthopedic implant surfaces that are in contact with tissue or bone cement (e.g., porous coatings).

Free download for noncommercial and educational purpose only

Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
March 2005
Clinical Medical

This document provides guidance to industry on good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data regarding drugs, including biological
drug products (excluding blood and blood components).2 Specifically, this document provides guidance on (1) safety signal identification, (2) pharmacoepidemiologic assessment and safety
signal interpretation, and (3) pharmacovigilance plan development.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.

Download the document for free educational and non commercial use only.

Best Webmail services on XAMPP system

1. RoundCube

RoundCube Webmail is a browser-based multilingual IMAP client with an application-like user interface. It provides full functionality you expect from an e-mail client, including MIME support, address book, folder manipulation, message searching and spell checking. RoundCube Webmail is written in PHP and requires a MySQL or Postgres database. The user interface is fully skinnable using XHTML and CSS 2.

2. Zimbra

Zimbra provides open source email and calendar groupware software, with a browser-based AJAX client to deliver a rich experience with a message conversation view and visual search builder that makes multi-gigabyte inboxes easier to use. They also integrate 3rd party applications as "mash-ups" via web services so you can view CRM data, maps, or anything else without leaving the context of a message.

3. Xuheki

Xuheki is a fast IMAP client which has a browser-based AJAX client so you can access it from anywhere to read your email. It has most features that you would expect from a fine "Mail User Agent". Xuheki is distributed under the terms of the GNU General Public License.

4. SquirrelMail

SquirrelMail is a standards-based webmail package written in PHP. It includes built-in pure PHP support for the IMAP and SMTP protocols, and all pages render in pure HTML 4.0 (with no JavaScript required) for maximum compatibility across browsers.

5. Atmail

AtMail, a free lightweight Ajax Webmail client software that is written in PHP that allow end user receive email via web browser and WAP devices. This webmail client software can be installed on variety platform like Windows and Linux. Plus more, it support various email technology like IMAP/POP3 mailboxes, and an optional email-server mode that uses Exim as the MTA.

Personally I have used the Squirrel mail, Round Cube and the Atmail on Xampp platform.I was successful in installation with the above with the mercury mail server in the concerned organization. Actually if Appearance is to be consider the Atmail is the great one,

if you consider installation procedure and all, the roundcube rocks.

But if functionality is considered then only and only squirrel mail.

It has useful plugins an d is open source and very easy for adapting the same for the organizational alteration and great customization to the interface.

You only require some knowledge of the CSS style sheet for the customization and understanding of the code with the squirrel mail.So if you value the functionality with no fancy features go for the Squirrel Mail.

I have not used Zimbra nor the Xuheki for any comparision.

Guidance on the vigilance system for CE-marked Medical Devices

Guidance on the vigilance system for CE-marked medical devices (Joint replacement implants)

This guidance document gives advice to manufacturers on the notification of adverse incidents involving joint replacement implants under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC. It is supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System.

This guidance sets out the Medicines and Healthcare products Regulatory Agency's (MHRA) views on the interpretation of the Medical Devices Regulations. It should not be considered to be an authoritative statement of the law in any particular case as it is intended as guidance only. Manufacturers and others should consult the legislation referred to, making their own decisions on matters affecting them in conjunction with their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions, misleading or other statements in the guidance whether negligent or otherwise. An authoritative statement could be given only by the courts.

Download for free personal,non commercial and educational purpose

If you have any more information for sharing please comment below for the same.

ISO 13485 2003 document

I have stumbled upon the actual document for the guidance for the people of medical device industry for their reference and educational purpose only.

If the document is required for any commercial purposes, please consider the same for buying.

Free download ISO 13485 2003 for non-commericial and educational purposes.

If you need any more information or if you have any information, please consider to provide me/ society the same.

ISO 13485:2003 Medical Device Standard Documented Requirements by Section

ISO 13485:2003 Medical Device Standard Documented Requirements by Section

During the conformation with the ISO standard we require various materials and we require to submit the documents to the regulatory authorities.

I have attached the List for ready reference for personal and educational purpose.

If you have any question for me comment below.

Material for ISO13485:2003

This is one good article which I would like to share with you all people for the ISO 13485.

Download the material related to the ISO 13485:2003 Free for personal and educational purpose only.

Please comment if you have any queries.

Sampling for Medical Devices

Sampling is that part of statistical practice concerned with the selection of a subset of individuals from within a population to yield some knowledge about the whole population, especially for the purposes of making predictions based on statistical inference.

Researchers rarely survey the entire population for two reasons (Adèr, Mellenbergh, & Hand, 2008): the cost is too high, and the population is dynamic in that the individuals making up the population may change over time. The three main advantages of sampling are that the cost is lower, data collection is faster, and since the data set is smaller it is possible to ensure homogeneity and to improve the accuracy and quality of the data.

Each observation measures one or more properties (such as weight, location, color) of observable bodies distinguished as independent objects or individuals. In survey sampling, survey weights can be applied to the data to adjust for the sample design. Results from probability theory and statistical theory are employed to guide practice. In business and medical research, sampling is widely used for gathering information about a population.

Ok now to the main point of the statistical sampling plan for the medical devices. The ISO standard for the sampling of the same is attached for your reference.

Download for free for only personal information and educational purpose only.


If you require any further help, please contact me.