wockhardt ltd. is a pharmaceutical and biotechnology company headquartered in mumbai , india .

the company has manufacturing plants in india , uk , ireland , france and us , and subsidiaries in us , uk , ireland and france .

it is a global company with more than half of its revenue coming from europe .

in 2011 – 2012 its uk and usa sales alone were us$ 475 million .

it has market presence in emerging markets such as russia , brazil , mexico , vietnam , philippines , nigeria , kenya , ghana , tanzania , uganda , nepal , myanmar , sri lanka , mauritius , lebanon and kuwait .

the company has a market capitalisation of over ₹ 211 billion ( us$ 3.3 billion ) and an annual turnover of ₹ 36 billion ( us$ 560 million ) .

it produces formulations , biopharmaceuticals , nutrition products , vaccines and active pharmaceutical ingredients ( apis ) .

the company employs over 8,600 people globally .

wockhardt hospitals is a subsidiary of the wockhardt group .

wockhardt

wockhardt stock price , share price , live bse / nse , wockhardt bids offers . buy / sell wockhardt news & tips and latest announcements - ndtv
–wockhardt receives us fda approval for antibacterial levofloxacin –wockhardt launches prostate drug flomax in the united states on day–1 . –wockhardt receives us fda approval for the generic version of toprol xl , a cardiac drug .
–wockhardt launches generic version of anti–ulcer drug prevacid . –wockhardt receives us fda approval for generic version of parkinsonism drug requip xl . –wockhardt receives tentative us fda approval for generic version of anti–psychotic drug geodon . –wockhardt receives us fda approval for generic version of parkinson ? s drug comtan .
2011 –wockhardt launches generic version of protonix tablets in the us . –wockhardt receives us fda approval for generic version of effexor xr capsules . –wockhardt launches three new products in three weeks , in the united states . –wockhardt receives tentative us fda approval for generic version of patanol® ophthalmic solution .
wockhardt ' s pinewood is the no . 1 branded generics company in ireland .
wockhardt reports growing q4 loss as fda issues skewer its u . s . sales
wockhardt is today amongst the top three indian pharmaceutical companies in profits and profitability .
wockhardt has received an untitled letter for a sterile injectables plant in india that wockhardt is trying to get approved by the fda to sell into the u . s .
wockhardt q3fy17 net sales at rs . 995 crore , ebitda at rs . 18 crore
the company history page lists out the major events in chronological order for wockhardt ltd .
wockhardt’s csr ( corporate social responsibility ) arm under wockhardt foundation has touched in a short period of time , 3 million lives through its various medical and social programmes and initiatives .
view detailed wockhardt share / stock price today . also key pivot points for daily support and resistance levels , along with the price - to - moving average action for wockhardt .
for further information about wockhardt ' s full shared mission and vision , please click here .
wockhardt hospitals is associated with partners harvard medical international , an international arm of harvard medical school , usa .
the award is accompanied with a certificate allowing wockhardt to use the trademark ` best enterprise’ for marketing purposes .
india - based drugmaker wockhardt was the subject of an fda warning letter noting that seven wockhardt facilities are considered out of compliance with current good manufacturing practices .
these repeated failures at multiple sites demonstrate your company ' s inadequate oversight and control over the manufacture of drugs ,
the fda wrote ; wockhardt said it is addressing the issues .
wockhardt is a business in transition . new and innovative business models are in motion to make the most of emerging opportunities . a new drive for growth today permeates every mind - set , process and techno - innovation within wockhardt .
wockhardt’s csr arm under wockhardt foundation has touched in a short period of time , 3 million lives through its various medical and social programmes and initiatives . the foundation is a movement of human values , social awareness and social development .
wockhardt newspaper advertisements confirming completion of dispatch of notice of postal ballot and postal ballot form to its shar . . .
india’s wockhardt has received an fda warning letter for a plant in the u . s . , making an even half - dozen warning letters for seven wockhardt plants , three of which have been banned from shipping to the u . s .
wockhardt has set up wockhardt biotech park a biopharmaceuticals manufacturing complex located at aurangabad , india . this complex comprises six manufacturing facilities developed as per usfda and emea standards . it has capacity to serve 10–15 % of global demand for major biopharmaceuticals .
his signature style is much evident in the management processes at wockhardt i . e . open culture , participative management practices , innovations , continuous improvement , speedy response , empowerment and enjoying one’s job - are all hallmarks of wockhardt ' s culture .
wockhardt has vast international expertise in the manufacture of pharmaceuticals and biopharmaceutical formulations as well as active pharmaceutical ingredients ( api ) .
this is the latest in a series of failures by wockhardt to meet the standards of not just fda but other regulators .
at wockhardt , we are looking at new ways of thinking , new ways of working and new ways to touch people’s lives .
wockhardt uk is one of the largest generic pharmaceutical companies in the uk and we pride ourselves on our long established heritage . over the years we have been known as weddel , cp pharmaceuticals and finally wockhardt in 2003 , becoming wockhardt uk in 2004 . since the acquisition of cp pharmaceuticals , annual uk turnover continues to grow and we now have a uk workforce of over 350 employees .
india’s wockhardt saw its losses widen last year as its burgeoning regulatory issues with the fda continue to chainsaw away at its finances .
wockhardt has also received the prestigious worldstar award in the field of packaging , this being the highest recognition in the world of packaging .
wockhardt reported a widened q4 loss , takeda penned a t - cell platform deal , and the fda approved mitsubishi’s als drug radicava .
wockhardt has been a ' business superbrand ' for two consecutive years - the only pharmaceutical & healthcare company in india to get this rare distinction .
seen here ( l - r ) wil goodheer , president of the international club of rector , dr . murtaza khorakiwala , managing director , wockhardt
wockhardt employees also had unofficial notebooks with records of sample preparation for oos investigations , route - of - synthesis experiments and scale - up data .
a keen disciple of ‘change management’ , dr . habil khorakiwala has single - mindedly steered wockhardt in becoming the first true healthcare group from india . his visionary and astute leadership resulted in wockhardt emerging as a leading pharmaceutical and biotech conglomerate , driven by research and strategic thinking on a global scale .
according to wockhardt’s md , dr . murtaza khorakiwala , strategic partnerships are a less capital - intensive way of moving into new territories or acquiring new capabilities . by finding partners with complementary skills , wockhardt endeavours to find smarter ways to grow and in turn create significant value for all its stakeholders .
wockhardt has embarked on a new and exciting phase of its growth journey . as a global healthcare company , wockhardt has proved its technical excellence by developing patented modified release formulations and other complex and challenging medical technologies . we are committed to the pursuit of excellence in business and in society .
it ' s strike three for india’s wockhardt , which has had a third plant in its home country banned from exporting to the u . s .
wockhardt’s core business is innovation . it uses science and technology to develop medicines and other products that improve the quality of millions people’s lives through better health .
the fda on friday added wockhardt’s bulk manufacturing plant in ankleshwar , india , to its import alert list , joining plants in waluj and chikalthana that the fda banned in 2013 . the alert does not say why the plant ' s products were banned but wockhardt has a history of manufacturing shortcomings at other plants .
you have talked about divestment of stake in wockhardt hospitals , sale of non - core businesses and restructuring of subsidiaries . isn ' t time running out ?
the losses were also due to wockhardt ' s long - term hedging instruments that were bought to reduce the interest costs for the company ' s loans .
wockhardt is a true indian multi - national company with a multi - ethnic workforce of 8600 wockhardt associates from 21 different nationalities globally . it has 3 research centres and 12 manufacturing plants , with businesses ranging from the manufacture and marketing of pharmaceutical and bio - pharmaceutical formulations , active pharmaceutical ingredients ( apis ) and vaccines .
wockhardt combined voting results of postal ballot ( remote e - voting and postal ballot forms ) pursuant to regulation 44 ( 3 ) of the s . . .
india’s wockhardt , which now has a record seven fda warning letters for its plants on three continents , appears to be reaching a breaking point with the agency .
the minority stake sale in wockhardt hospitals and restructuring of subsidiaries or other assets will act as a back - up or as an insurance plan for our working capital requirements and the proposed cdr plans . we are talking to multiple partners for wockhardt hospitals for selling a stake and will conclude the deal within a few weeks .
wockhardt was four times in a row , awarded the prestigious patent award by the government of india , for the ‘maximum number of patent filings and grants from india’ .
wockhardt was ranked 76th amongst the world’s top 100 pharmaceutical companies and only the 4th indian pharmaceutical company in this elite 100 group ( scrip 100 , 2011 edition ) .
due to global bovine insulin raw material unavailability , wockhardt has no choice but to discontinue the hypurin® bovine insulin range . unfortunately , despite our best efforts in trying to find an alternative supply of bovine insulin raw material , none has been found . wockhardt regrets any inconvenience this may cause but unfortunately the circumstances are beyond our control .
wockhardt combined voting results of postal ballot ( e - voting and postal ballot forms ) pursuant to regulation 44 ( 3 ) of the sebi ( li . . .
if you look at wockhardt as a pharmaceutical company , it was one of the best performing companies in the first nine months of 2008 , excluding foreign currency losses .
efforts by wockhardt to fix violations at drug plant in wrexham , wales are inadequate according to the us fda which detailed its concerns in a warning letter this week .
wockhardt works with partners to in - license products in india and out - license products into other regions by capitalising on these collaborative strengths to capture and penetrate new markets .
the agency is concerned about wockhardt’s responses to these matters . among other things , although wockhardt was made aware of a major product defect / problem during fda’s march 22 , 2013 inspection at a wockhardt facility located in biotech park , midc area waluj , aurangabad , india , you did not take appropriate actions to resolve the “trial” sample injection problem discussed above at the biotech park facility or elsewhere within wockhardt’s organization . senior management is responsible for ensuring the quality , safety , and integrity of your firm’s products . implementing adequate controls to prevent the manipulation of laboratory data , assuring timely investigation and resolution of product defects , and preventing distribution of defective products are all fundamental aspects of these responsibilities .
wockhardt ? s core business is innovation . it uses science and technology to develop medicines and other products that improve the quality of millions people ? s lives through better health .
considering the strong technical position of wockhardt on charts , i ' d advise investors to buy its stock with a target of rs 760 and a stop loss of rs 714 .
wockhardt is a true indian pharmaceutical multinational with full - fledged operations in several countries , including us , uk , ireland and france . in an exclusive interaction with the dollar business , dr . murtaza khorakiwala , managing director of wockhardt group , talks about the company’s innovative business models that are in motion to make the most of emerging opportunities across the globe .
wockhardt is the 4th company in the world to have developed recombinant insulin , wosulin - from concept to market stage . it also developed a patented delivery device ‘pen’ for wosulin injections .
wockhardt ltd . , incorporated in the year 1999 , is a mid cap company ( having a market cap of rs 7000 . 66 crore ) operating in pharmaceuticals and health care sector .
wockhardt is the 4th company in the world to have developed recombinant insulin , wosulin – from concept to market stage . it also developed a patented delivery device ? pen ? for wosulin injections .
dr . habil khorakiwala strongly advocates that the only way towards fast growth is to be ' customer focussed ' . this customer - centric approach has filtered down to every decision and action in wockhardt .
wockhardt incorporated in 1999 , is engaged the pharmaceutical and biotechnology segments . the company ? s 14 manufacturing plants are located in india , uk , ireland , us , and are compli . . .
the state–of–the–art biotech plant in aurangabad has six dedicated manufacturing facilities for biopharmaceutical bulk as well as recombinant formulations . the wockhardt biotech park has created its own benchmark in manufacturing recombinant products with world–class technology .
wockhardt is in the forefront of intellectual property creation with 1 , 733 patents filed till date , of which 228 patents have been granted . our capability and commitment in pursuing intellectual property has been recognised by the government of india for four years in a row , with an award for the maximum number of ‘patent filings and grants from india’ . wockhardt is determined to create benchmarks for a promising future .
wockhardt ? s subsidiaries are located in the us , uk , ireland and france . the company has market presence in formulations , bio–pharmaceuticals , nutrition products , vaccines and active pharmaceutical ingredients ( apis ) .
finding wockhardt a promising stock with surety of its delivering solid returns ahead , i ' d advise investors to buy its stock with an intraday target of rs 760 and a stop loss of rs 714 .
wockhardt ltd . ’s regulatory troubles continued apace this week , with the release of yet another warning letter from the fda , the second such letter this calendar year . the india - based . . .
wockhardt is in the forefront of intellectual property creation with 1 , 411 patents filed till date , of which 145 patents have been granted . our capability and commitment in pursuing intellectual property has been recognized by the government of india for three years in a row , with an award for the maximum number of ? patent filings and grants from india ? . wockhardt is determined to create benchmarks for a promising future .
the company holds strong position in leading markets such as europe and united states , which contributes 65 % to wockhardt ' s revenue . the company has two subsidiaries negma lerads , france and morton grove pharmaceuticals , usa .
wockhardt has proved its technical excellence by developing patented modified release formulations and recombinant biotechnology products . it has a multi–disciplinary r & d programme with more than 550 scientists , including over 100 doctorates , in the areas of :
the food and drug administration ( fda ) said wockhardt’s response to the inspection – which it received late last year - was ‘inadequate’ and advised it to hire a consultant to help it bring the facility up to code .
all of wockhardt ' s u . s . targeted manufacturing facilities are under some kind of fda oversight , but the indian generics maker got a new product approved for the u . s . market by using a contractor .
the beleaguered indian drug manufacturer wockhardt is in trouble again with the us food and drug administration ( fda ) , this time for destroying current good manufacturing practice ( cgmp ) documents , among a list of other major violations .
wockhardt has proved its technical excellence by developing patented modified release formulations and recombinant biotechnology products . it has a multi - disciplinary r & d programme with more than 607 scientists , including over 80 doctorates , in the areas of :
h abil khorakiwala , executive chairman of wockhardt , says he has seen many ups and downs in his business since he inherited drug trading firm worli chemicals many decades ago and transformed it into india ' s sixth largest drug company .
sitting in his plush ninth floor office at the wockhardt headquarters at the bandra kurla complex , khorakiwala , 66 , talks to shyamal majumdar and p b jayakumar on the reasons for seeking corporate debt restructuring , and the road ahead .
wockhardt aspires to create a healthier world . its strategic vision of ‘more & more with less & less’ has transformed into new ways of thinking , a new journey for growth , medical breakthroughs for patients and continuing value for all stakeholders .
wockhardt was hit with a seventh fda warning letter , china ' s fda chief pledged to speed up approvals of foreign drugs , and an indian court ruled on patent cases concerning copycats of herceptin and two on - patent bayer blockbusters .
wockhardt chairman habil khorakiwala last year told investors the company hoped to get those two plants again approved for u . s . exports in 2016 . the remarks came a day after the indian drugmaker reported that sales in the u . s . last fiscal year were off by 50 % . in its latest annual report , wockhardt reported that total revenues for the company were off about 6 % to $ 674 million but didn’t break out its u . s . sales .
new delhi : the us food and drug administration ( us fda ) has issued a warning letter to wockhardt for violating current good manufacturing practice norms , including its failure to ensure proper clothing for workers at its ankleshwar plant in gujarat .
the state - of - the - art biotech plant in aurangabad has six dedicated manufacturing facilities for biopharmaceutical bulk as well as recombinant formulations . the wockhardt biotech park has created its own benchmark in manufacturing recombinant products with world - class technology .
wockhardt uk are pleased to confirm to concerned patients that migril® tablets are fully available with good stock levels to ensure committed supply . patients should visit their healthcare professional to discuss treatment options . pharmacists can order migril® tablets from the usual wholesalers .
in the annual report , wockhardt noted that the fda had observations after inspection of four of its plants , including the ankleshwar facility , as well as its plants in chikalthana and waluj , where it said remediation efforts were still under way .
uly 22 - 31 , 2013 simultaneous inspections of your pharmaceutical manufacturing facilities , wockhardt limited ( fei 3002808503 ) located at l - 1 , m . i . d . c . area , chikalthana , aurangabad , maharashtra , india , and wockhardt limited ( fei 3004540156 ) located at b - 15 / 2 , m . i . d . c . area , waluj , aurangabad , maharashtra , india , investigators from the u . s . food and drug administration ( fda ) identifi
last month , the us drug regulator found seven violations of manufacturing standards at sun pharmaceutical industries ltd’s formulations plant in mohali , punjab . also , the us food and drug administration had issued a warning to wockhardt for violating current good manufacturing practice norms .
in the pharma space , wockhardt is a promising stock with surety of its delivering solid returns ahead , therefore needs to be bought around levels rs 725 - 720 wherein keeping a short - term target at rs 775 and a stop loss below rs 702 .
wockhardt has 3 research centres globally with over 607 scientists of which over 80 are doctorates . its multi - disciplinary research activities encompass pharmaceutical formulations , biopharmaceutical bulk and formulations , novel drug delivery system , new drug discovery programme and process engineering for active pharmaceutical ingredients .
wockhardt is a global pharmaceutical and biotechnology organisation , providing affordable , high - quality medicines for a healthier world . it is india’s leading research - based global healthcare enterprise with relevance in the fields of pharmaceuticals , biotechnology and a chain of advanced super speciality hospitals .
the u . s . food and drug administration ( fda ) inspected your drug manufacturing facility , wockhardt limited , plot no . 138 g . i . d . c . estate district bharuch , ankleshwar , gujarat , from december 7 to 15 , 2015 .
in a warning letter issued by the fda , products from morton grove pharmaceuticals , a wockhardt limited subsidiary , will still be available in the market but new approvals will be withheld until regulatory compliance issues are addressed . morton grove manufactures topical and oral liquid drugs .
tdb : could you give us some insights into the journey of wockhardt group ? dr . murtaza khorakiwala ( mk ) : wockhardt ranks amongst india’s leading pharma and biotech companies with a global footprint and a strong r & d focus . it traces its roots back to the 1960s when the khorakiwala family bought a pharma company that primarily manufactured medicines for common cold and cough . till 1992 , the company centred its operations towards becoming a major player in the indian pharma industry . thereafter , it concentrated on becoming a global drug maker .
in the letter to wockhardt chairman and group ceo habil khorakiwala , the us fda said inspectors during inspection from 7 to 15 december 2015 , found “significant violations” of current good manufacturing practice ( cgmp ) regulations for finished pharmaceuticals as well as for active pharmaceutical ingredients ( api ) .
wockhardt ' s facility in maharashtra , india , has received a good manufacturing practice certificate from the uk ' s medicines and healthcare products regulatory agency after it passed inspection requirements . the generics and antibiotics maker has previously been banned by uk and us regulators due to gmp violations .
tdb : what role have acquisitions played in wockhardt’s growth ? mk : acquisitions have helped wockhardt continuously strengthen its presence in the global market . in 1998 , we acquired merind , a former affiliate of merck sharp & dohme of us . this enabled the company to penetrate into new therapeutic areas like corticosteroids , psychiatry and neurology . the same year , wockhardt also acquired uk - based wallis laboratory . later in 2003 , it took over cp pharmaceuticals , another uk - based company , thereby gaining access to a large customer base of hospitals under the national health service ( nhs ) . largely due to these highly successful acquisitions , today , it is the largest indian pharmaceutical company in uk . expansion through acquisitions continued in 2004 when we acquired the brands , businesses and marketing infrastructure of esparma gmbh of germany , followed by the purchase of us - based morton grove and france - based negma laboratories . today wockhardt’s manufacturing facilities , with capabilities for both finished dosage formulations and active pharmaceutical ingredients ( apis ) , are spread across india , us and uk . the company has subsidiaries in us , uk and mexico , and marketing offices in africa , russia , central and southeast asia . such has been the diversification that india , which in 2000 contributed to about 78 % of wockhardt’s business , now contributes just about 32 % to the total revenue . the rest 68 % comes from overseas markets .
tdb : today antimicrobial resistance ( amr ) is being considered as a major problem globally . however , wockhardt is amongst the top pharma giants that have vowed to eradicate it . can you elaborate a bit more on this ? mk : today , globally , amr is responsible for more than 0 . 7 million deaths annually and the number is slated to increase to 10 million by 2050 . due to amr , the additional healthcare cost per year is approximately $ 4 billion , globally . moreover , it has resulted in a collateral damage – the ability of the global healthcare system to manage various surgeries , organ transplants , etc . , has been compromised . wockhardt’s drug discovery programme focuses on finding novel solutions to this growing threat and has achieved significant successes in fulfiling these needs . with five new drugs accorded qualified infectious disease product ( qidp ) status , wockhardt aspires for global leadership in antibiotics .
wockhardt ' s 12 manufacturing plants are located in india , uk , ireland , us , and are compliant to international regulatory standards including us fda and uk mhra . these manufacturing plants are multi - technology and can manufacture all the dosage forms including sterile products as well as products with lyophilised dosage forms .
dr . habil khorakiwala is the founder chairman & group ceo of wockhardt limited , a company he founded in the early 1960s . he holds a masters in pharmaceutical science from purdue university , and has participated in an advanced management programme at harvard business school , usa . he is also the recipient of an honorary doctorate from purdue university , usa .
headquatered in mumbai , india , wockhardt has full - fledged operations in the usa , uk , ireland and france . it also has its marketing presence in emerging markets of russia , brazil , mexico , vietnam , philippines , nigeria , kenya , ghana , tanzania , uganda , nepal , myanmar , sri lanka , mauritius , lebanon and kuwait .
wockhardt ltd is a global pharmaceutical and biotechnology organization providing affordable high - quality medicines for a healthier world . the company is india ' s leading research - based global healthcare enterprise with relevance in the fields of pharmaceuticals biotechnology and a chain of advanced super speciality hospitals . the company has twelve manufacturing locations and there are five locati . . . > more
the fourth plant was a new sterile injectables facility in shendra that wockhardt saw as its best shot at restoring a u . s . business devastated by the fda product bans . but the company earlier this year said the fda found issues during an inspection to determine if it was ready for u . s . approval . - find the import alert here
finally , we note again that the cgmp violations listed in this letter include similar violations to those cited in the wl 320 - 13 - 21 , issued on july 18 , 2013 . it is apparent that wockhardt is not implementing global and sustainable corrective actions . it is essential that your firm implement a robust quality system . we remind you that you are responsible for ensuring that your firm’s drug manufacturing operations comply with applicable requirements and produce acceptable quality drugs . fda strongly recommends that wockhardt’s executive management immediately undertake a comprehensive and global assessment of your manufacturing operations to ensure that your systems and processes , and ultimately , the drug products you manufacture , conform to fda requirements for safety , efficacy , and quality .
in addition , our investigator discovered that some of the “trial” injection data was not kept on the hplc hard drives because your firm deleted it . your firm’s management confirmed that the files were deleted as part of an internal audit conducted as a result of the march 2013 fda inspection at your nearby wockhardt limited facility located in waluj ( fei : 3005289335 ) .
the agency followed the earlier bans up with a warning letter that criticized the drugmaker for hiding failed testing results and manipulating tests to make it appear that drug batches had met fda standards when they hadn’t . the fda said wockhardt employees at the waluj plant had tried to destroy records and lied to inspectors about having giving them access to all drug manufacturing areas .
wockhardt incorporated in 1999 , is engaged the pharmaceutical and biotechnology segments . the company ? s 14 manufacturing plants are located in india , uk , ireland , us , and are compliant to international regulatory standards including us fda and uk mhra . these manufacturing plants are multi–technology and can manufacture all the dosage forms including sterile products as well as products with lyophilised dosage forms .
we are particularly concerned about your inability to implement a robust and sustainable quality system . the findings from our current inspections include repeat citations from fda’s inspection of the wockhardt waluj , aurangabad , india facility conducted in march 2013 . these repeated observations and citations indicate that your quality unit is not exercising its responsibilities and may not have the appropriate authority or ability to carry out its responsibilities .
law360 , new york ( march 7 , 2017 , 8 : 14 pm est ) - - the u . s . food and drug administration once again scolded drugmaker wockhardt for testing and record - keeping issues at a subsidary ' s plant , an issue that’s caused trouble for the drugmaker in the past , and chastised a washington smoked salmon maker for listeria found in its facility .
wockhardt ltd . key products / revenue segments include pharmaceuticals which contributed rs 2146 . 00 crore to sales value ( 93 . 40 % of total sales ) , licence fees which contributed rs 114 . 41 crore to sales value ( 4 . 97 % of total sales ) , sale of services which contributed rs 37 . 11 crore to sales value ( 1 . 61 % of total sales ) for the year ending 31 - mar - 2017 .
wockhardt’s founder chairman and group ceo , dr . habil khorakiwala says , “a decade ago , i saw a changing world that i believed would present us with large - scale future opportunities in the field of pharmaceuticals and biotechnology . we steered our business model to leverage our research capabilities in providing innovative solutions and by constantly upgrading our world - class manufacturing facilities . we ventured outside india systematically and positioned ourselves mainly in the european and the us markets , which currently generates over 76 % of our revenues . ”
tdb : medical tourism is gaining momentum in india . what can be done to make india more attractive to patients from across the world ? mk : india is not only price - competitive compared to other south - east asian countries but is also high on the skill index . this has resulted in a large influx of international patients , over the last quarter of a century . currently , a reasonable amount of business is coming to metros such as bengaluru , hyderabad , chennai , delhi and mumbai , largely from the third world countries . it is estimated that roughly 5 % of the business of high - end tertiary care hospitals in metros and tier i cities comes from global patients . at wockhardt hospitals , business from international patients is rapidly rising at a pace of 60 - 70 % every year . at our hospitals in south and north mumbai , international patients constitute a substantial portion of our business . wockhardt has been able to reach out to various under - served geographies and is also privileged to leverage the wockhardt brand and network . our clinical acumen and credibility makes us stand out from the crowd . the two major markets of medical value travel are the underdeveloped interiors of the african subcontinent and the middle east . this constitutes about half of the medical value travellers arriving in india . india must look at it as an activity of creating dollar tourism and follow programmes created by countries such as thailand . the issuance and of medical visas should be increased considerably and specific facilities should be created with help from the private sector to generate high - value medical tourism .
tdb : besides india and uk , which other markets are of importance to you and where are you looking to expand ? mk : when it comes to overseas markets , us contributes significantly , after uk . at the same time , emerging markets in asia , africa , cis and latin america – where wockhardt has a portfolio of more than 50 products with a strong network of more than 65 regional partners – are important as well . we are currently looking to expand into the fast - growing and strategically important emerging markets .
until all corrections have been completed and fda has confirmed corrections of the violations and your firm’s compliance with cgmp , fda may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer . in addition , your failure to correct these violations may result in fda refusing admission of articles manufactured at wockhardt limited ( fei 3002808503 ) located at l - 1 , m . i . d . c . area , chikalthana , aurangabad , maharashtra , india and wockhardt limited ( fei 3004540156 ) located in b - 15 / 2 , m . i . d . c . area , waluj , aurangabad maharashtra , india into the united states under section 801 ( a ) ( 3 ) of the act , 21 u . s . c . 381 ( a ) ( 3 ) . the articles may be subject to refusal of admission pursuant to section 801 ( a ) ( 3 ) of the act , 21 u . s . c . 381 ( a ) ( 3 ) , in that the methods and controls used in their manufacture do not appear to conform to cgmp within the meaning of section 501 ( a ) ( 2 ) ( b ) of the act , 21 u . s . c . 351 ( a ) ( 2 ) ( b ) .
none of the facilities inspected since june 2014 ( 33 months ago ) and subsequently receiving warning letters have had resolution . since gdufa , the nine resolutions done took an average of ~ 500 days post warning letter issuance . cadila healthcare’s moraiya unit ( 426 days ) looks poised to be resolved soon post its recent re‐audit that had no fda observations . while data suggests that sun pharmas’ halol unit ( 432 days ) and dr reddy’s ( 474 days ) are closer to resolution timeframe , the concern is that the warning letters are not easy to resolve . other facilities of listed companies under import alert due to inspections post gdufa include wockhardt’s 4 units , ipca’s units and sun pharma’s karkhadi unit , the edelweiss report added .
tdb : where do these five qidp designated drugs currently stand in the drug development cycle ? mk : the five qidp - designated novel antibacterial drugs ( wck 771 , wck 2349 , wck 4873 , wck 4282 and wck 5222 ) , are in advanced stages of clinical development . they belong to four different classes of antibiotics . each of these new antibiotics has a distinct mechanism of action , making them active against multidrug - resistant pathogens responsible for serious infections . wockhardt’s new antibiotics would be useful in the treatment of bloodstream infections , pneumonia , surgical wound infections , community respiratory infections and pneumonia caused due to ventilators . all these products have the potential to significantly reduce the mortality and morbidity attributed to life - threatening infections in both hospital and community settings .
failure to correct these violations and deviations may also result in fda continuing to refuse admission of articles manufactured at wockhardt limited , plot no . 138 g . i . d . c . estate district bharuch , ankleshwar , gujarat , into the united states under section 801 ( a ) ( 3 ) of the fd & c act , 21 u . s . c . 381 ( a ) ( 3 ) . under the same authority , articles may be subject to refusal of admission , in that the methods and controls used in their manufacture do not appear to conform to cgmp within the meaning of section 501 ( a ) ( 2 ) ( b ) of the fd & c act , 21 u . s . c . 351 ( a ) ( 2 ) ( b ) .
until all corrections have been completed and fda has confirmed corrections of the violations and your firm’s compliance with cgmp , fda may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer . in addition , your failure to correct these violations may result in fda continuing to refuse admission of articles manufactured at wockhardt limited located at biotech park , plot h - 14 / 2 , m . i . d . c . area waluj , aurangabad , india into the united states under section 801 ( a ) ( 3 ) of the act , 21 u . s . c . 381 ( a ) ( 3 ) . the articles may be subject to refusal of admission pursuant to section 801 ( a ) ( 3 ) of the act , 21 u . s . c . 381 ( a ) ( 3 ) , in that the methods and controls used in their manufacture do not appear to conform to cgmp within the meaning of section 501 ( a ) ( 2 ) ( b ) of the act , 21 u . s . c . 351 ( a ) ( 2 ) ( b ) .
tdb : what opportunities and challenges do you foresee for indian pharma companies in foreign markets ? mk : india is likely to gain its fair share of global opportunities that are currently emerging around biosimilars . indian biotech companies are building capabilities in development and manufacturing of biosimilars . the development of biosimilars is more challenging than the development of small - molecule generics due to the greater complexity of biological drugs and the complex manufacturing process . it is because of this inherent complexity that the production , approval and uptake of biosimilars follow a different trajectory than that of the existing generic drugs market . we recognised this opportunity early and went through the learning curve with high involvement and commitment . in fact , our products have been well received by clinicians as well as patients in over 25 countries around the globe . another area of opportunity for india is new drug discovery research . while it’s at a nascent stage , new drug discovery research by indian fraternity is gaining momentum on the global landscape . the indian pharma industry has reached mid - to - late - stage global clinical development in areas of diabetes , respiratory diseases , immunology and oncology . the global antibiotic scenario has deteriorated considerably due to rising resistance to existing medication , lack of new medicines and an increase in new resistant organisms . this became more complicated when most pharmaceutical majors distanced themselves from the anti - infective development research and moved towards the chronic illness space . against this backdrop , wockhardt discovery engaged itself in the pursuit of developing new antibiotics with the vision of targeting the realm of unmet medical needs . two decades of research yielded five major drugs . though very rewarding , new drug development is a lengthy , complex and expensive process , entrenched with a high degree of uncertainty .
limited located at biotech park , plot h - 14 / 2 , m . i . d . c . area waluj , aurangabad , india , investigators from the u . s . food and drug administration ( fda ) identifi
ed significant violations of current good manufacturing practice ( cgmp ) regulations for finished pharmaceuticals , title 21 , code of federal regulations , parts 210 and 211 , and documented that your firm withheld truthful information , and delayed and limited the inspection . these violations cause your drug products to be adulterated within the meaning of section 501 ( a ) ( 2 ) ( b ) and 501 ( j ) of the federal food , drug , and cosmetic act ( the act ) , 21 u . s . c . 351 ( a ) ( 2 ) ( b ) and 351 ( j ) , in that the methods used in , or the facilities or controls used for , their manufacture , processing , packing , or holding do not conform to , or are not operated or administered in conformity with , cgmp , and in that your drug products have been manufactured , processed , packed , or held in an establishment and the owner or operator has delayed , denied , or limited an inspection , or has refused to permit entry or inspection , respectively .
we have conducted a detailed review of your firm’s response of april 9 , 2013 and note that it lacks sufficient corrective actions .
1 . your firm repeatedly delayed , denied , limited an inspection or refused to permit the fda inspection . examples are as follows :
on march 18 , 2013 , an fda investigator identified the presence of torn raw data records in the waste area and asked one of your firm’s qa officers to remove these torn raw data records for the investigator’s review . this qa officer presented the fda investigator with approximately 20 paper records , none of which included raw data entries identified in the waste area earlier during the inspection . the fda investigator asked three times if there were any more records found in the waste area , and the qa officer responded to each question ,
no , this is all of the records” . the fda investigator then re - visited the waste area and found that the raw data records had been removed and placed in a different holding bag . these records included raw data testing worksheets from anti - microbial effectiveness studies , controlled master batch records for
)
, equipment calibration records , and stability protocol records . because you provided some , but not all , of the records requested by the investigator that fda had the authority to inspect , you limited access to or copying of records for the fda inspection . because you directed fda investigators away from the requested documents , and because the fda investigator was impeded by having to locate and reassemble torn records that fda had requested and had the authority to inspect , you delayed the inspection .
on march 18 , 2013 , an fda investigator identified the presence of unlabeled and partially labeled vials in the laboratory glassware washing area . when the investigator asked a qc analyst to describe the contents of these vials , the qc analyst immediately began dumping the contents of the vials into the drainage sink . the qc analyst stated that the content of the vials could not be determined . because you limited the direct observation by the fda investigator and prevented any determination of the contents of the unlabeled vials , you limited the inspection .
on march 19 , 2013 , an fda investigator interviewed the production head regarding his knowledge of the unofficial batch record forms being used to record the results for the visual inspection of drug products . the production head stated that he had only seen this unofficial defect data for
1 to 2 batches
. the fda investigator had an earlier conversation with two manufacturing operators , who stated that the production head had directed this practice throughout the manufacturing facility and regularly requested and reviewed the unofficial bmr visual inspection results . on march 21 , 2013 , the production head stated that he was fully aware of the practice of using unofficial batch record copies during the course of manufacturing operations . the production head acknowledged that he had provided inaccurate information in the previous instances . by stating that the data that existed was limited to one or two batches and that no other data existed , you provided some , but not all , of the records requested by the investigator that fda had the authority to inspect . additionally , you limited access to or copying of records for the fda inspection . because you denied the existence of records that fda had requested and had the authority to inspect in order to obstruct the direct observation of the requested documents , you delayed the inspection .
aseptic filling line for all products ( vials and pre - filled syringes ) produced for the u . s . market . however , the fda investigators later identified
aseptic filling line for pre - filled syringes manufactured for export to the u . s . market , in use since at least september 2009 . the area was operational and was an area of the inspection site that fda has authority to inspect . the fda investigator was impeded at the inspection site from properly performing the inspection in a reasonable manner . because you directed the fda investigator away from this production area , you obstructed the direct observation of the manufacturing process to an unreasonably short amount of time , and you limited the inspection . because the investigator only later discovered the existence of the area , you delayed the inspection .
# ( b ) ( 4 ) . the investigator repeated the request no less than six times on march 20 , 2013 , and again multiple times on march 21 , 2013 . the data was provided to the fda investigator during the close - out meeting of the inspection on march 22 , 2013 . you failed to produce the requested records within the timeframe requested by the investigator without adequate justification . by delaying the provision of requested data and documents until the last scheduled day of the inspection without reasonable explanation , you limited the ability of the investigator to review and analyze the documents to an unreasonably short amount of time and you delayed the inspection .
2 . your firm failed to prepare batch production and control records for each batch of drug product that include documentation of the accomplishment of each significant step in the manufacture , processing , packing , or holding of the batch ( 21 cfr 211 . 188 ( b ) ) .
for example , on march 18 , 2013 , the fda investigators found unofficial batch records for approximately 75 batches of injectable finished drug products torn in half in a waste area . these records contain data indicating that some batches failed to meet the in - process visual inspection specifications of not more than ( b ) ( 4 ) % defects , while the official batch records for these batches state that these batches had met the specifications . the uncontrolled documents indicate that up to 14 % of vials had defects including , but not limited to , black particles , fibers , glass particles , sealing defects , and volume variations . according to your firm’s procedures , a defect rate higher than ( b ) ( 4 ) % requires initiation of an investigation ; however , a senior production officer at your firm stated that no investigations are performed when this occurs .
your firm’s response indicates that these issues are for products not related to the u . s . market , and that they pertain solely to the formulation ( b ) ( 4 ) building . additionally , you indicate that the quality unit is not involved in the use of uncontrolled records . you also indicate that your firm re - inspected the batches referenced in the fda observation . you provided an affidavit from your senior production officer stating “each and every identified defect unit during in - process visual inspection was rejected and only good units were transferred to the next stage for 100 % visual inspection after filling . ”
your response is inadequate because your facility manufactures ( b ) ( 4 ) injection in pre - filled syringes for the u . s . market in the same formulation ( b ) ( 4 ) building where these torn records were observed . your response did not address why your quality unit is not performing its duty to control records used in the manufacture of your drug products . your investigation for the products listed in the form fda 483 was limited and failed to include all of the other drugs manufactured by your facility . your affidavit confirms that your firm uses unofficial visual inspection to remove the defective units from the production line without appropriate documentation and investigation .
the above examples raise serious concerns regarding the integrity , reliability and accuracy of the data generated and available at your facility . in your response to this letter , provide an independent and comprehensive evaluation of the extent of the deletion and destruction of records , a risk assessment regarding the potential impact on the quality of products , and a comprehensive corrective and preventive action plan . your submission should include a summary report of your evaluation of the data and records related to the manufacture ( including testing , holding , etc . ) of all drug products produced at your site . this evaluation should include a detailed investigation of other instances in which your operations and quality units failed to ensure proper testing of materials , review of laboratory results and production data . for all other instances of missing , inaccurate or unreliable tests results are found , describe these findings in your response to this letter . your investigation should assess the impact of all these incidents on the quality of the drug products manufactured and released into distribution , and explain the systemic actions that will be instituted to prevent these fundamental breaches of data integrity and management oversight in the future .
accordingly , you should include a detailed description of your plans to implement a robust quality system in your response to this letter . this remediation plan should describe the broader steps you will be taking to ensure direct corporate oversight over the quality and operations functions of this facility . this system should ensure sustainable compliance with cgmp , including the basic capability to prevent data manipulation and destruction of records .
3 . your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards ( 21 cfr 211 . 194 ( a ) ) .
for example , your firm’s laboratory records failed to include complete records of all stability testing performed . the fda investigators identified the practice of performing
trial
sample analysis for high performance liquid chromatography ( hplc ) analyses prior to collecting the “official” analytical data for stability testing . these “trials” were performed on multiple products , including ( b ) ( 4 ) tablets ( b ) ( 4 ) mg , ( b ) ( 4 ) mg / ( b ) ( 4 ) ml , and ( b ) ( 4 ) tablets . these trial runs were not recorded in the equipment use log , and sample preparation data associated with these analyses was destroyed , preventing any calculation or analysis of the resulting data . your response states that trial runs were conducted using only one of the ( b ) ( 4 ) hplc instruments located in the stability laboratory , which happened to be the one instrument that the fda investigators reviewed during the inspection . your response indicates that you have revised procedures and re - trained your staff .
additionally , your quality control hplc raw data files can be deleted from the hard drive using the common pc login used by all ( b ) ( 4 ) analysts . this deletion eliminates all records of sample injections and analyses . your response indicates that this deletion function is only available on the software used for one of ( b ) ( 4 ) sets of hplc instruments . you also indicated that you have changed the access control privileges such that laboratory analysts in a “user” role cannot delete or rename files .


closed communion is the practice of restricting the serving of the elements of holy communion ( also called eucharist , the lord 's supper ) to those who are members in good standing of a particular church , denomination , sect , or congregation .

though the meaning of the term varies slightly in different christian theological traditions , it generally means that a church or denomination limits participation either to members of their own church , members of their own denomination , or members of some specific class ( e.g. , baptized members of evangelical churches ) . see also intercommunion .

a closed-communion church is one that ( perhaps with exceptions in unusual circumstances ) excludes non-members from receiving communion .

this is the practice of all churches dating from before the protestant reformation and also of some protestant church such as some lutherans and baptists .

non elca lutherans in the us require catechetical instruction for all people , even members from other lutheran churches , before receiving the eucharist while some baptist churches require part membership while others even require full membership before participating in the communion service .

churches which practice open communion allow all christians to partake in the lord 's supper , with membership in a particular christian community not required to receive bread and wine , in contrast to pre-reformation churches , which hold that what is received in their celebrations ceases to be bread and wine .

closed communion

communion with restrictions : not closed communion , not close communion , not open communion—but biblical communion .
those who hold to close communion are opposed to both open and closed communion .
anabaptists have through history practiced “closed communion” or “close communion” . in “closed communion” , only members of that specific church will partake in communion together . “close communion” allows those of “like - minded faith” to also partake with the congregation .
although i personally favor closed communion , my church is not . i would say it practices close communion .
there are serious omissions from this article on the orthodox view of closed communion .
those who hold to close communion are opposed to both open and closed communion . these are “middle ground” christians .
the communion is closed to only being partook of by real christians . . . .
dr . moore’s first reason for a closed communion position is both unpersuasive and insulting .
and the american baptist association ( predominant among baptists in arkansas ) also practices closed communion .
closed communion is superior to open communion because it more effectively helps to protect and nurture the sanctity and industry of the church .
it’s not about bureaucracy ; it’s about god’s word . closed communion is the teaching of repentance .
i do not think closed communion is wrong , but neither do i think close is incorrect .
the purpose of the communion tokens , which were used primarily throughout the 19th century , was dependent on the practice of closed communion .
for further study of the terms “closed” and “close” see norman nagel’s closed communion : in the way of the gospel ; in the way of the law . concordia journal / january 1991 and paul mccain’s communion fellowship .
closed communion is nothing more than the acknowledgement of what god’s word says , namely that not everyone should commune .
< / font > [ / quote ] in west virginia , the american baptist churches - usa predominately practice open communion . there are a few that practice closed . most ifb ' s in west virginia are closed communion .
that ' s interesting , considering that there is a least one baptist church in greenville that practices closed communion .
the writer contends that closed communion is not merely a practice dictated by a certain theological view of the church . on the contrary : a church which practices closed communion as the beginning of its theological thinking for church management , and diligently follows all naturally occurring corollaries of the full doctrine of closed communion , will soon discover that a closed communion table favourably governs correct practices in all areas of church life , and will preserve the existence of the local church .
from a careful examination of the scriptures , it is evident that closed communion most closely adheres to the biblical pattern .
closed communion is a crucial practice for the church to follow because the gospel is at stake . this is why .
there are basically three policies of observing communion – open , close , and closed . open communion allows anyone to participate without distinction or qualification . close communion restricts the supper to those within the denomination or fellowship of a church based on specified standards of agreement . closed communion restricts participation to only the members of each local assembly .
the policy of a
closed communion
is nothing new ; in fact it goes back to the earliest christians . the
closed communion an issue ? seriously ? i can easily understand , and support closed communion . reasonable people wouldn’t want to bring down a lightning strike upon any church . consider what happened to st . peter’s basilica on the night pope benedict resigned .
• from a careful examination of the scriptures , it is evident that closed communion most closely adheres to the biblical pattern .
the point here is that the expression “closed communion” is not an adequate or faithful description of the ecclesiology that undergirds the traditional practice of communion . for in reality there is no such thing as “open” or “closed” communion – there is either communion or there is not . in other words , either there exists a communion of faith expressed in a common understanding of doctrine and worship , sacramental and spiritual practice , or such communion does not exist .
[ 2 ] communion : a family affair : why the orthodox church practices closed communion , a . james bernstein , conciliar press , 1999 , p . 2 - 3 .
world communion tokens - scotish communion tokens - lot of 5 . communion tokens 1843 - 1855 scottish ( nice grade ) . 5 pcs .
– to disobey the scriptures is a sin . the only way a church can be reasonably sure it is obeying the word of god in regard to communion is to practice closed communion .
• to disobey the scriptures is a sin . the only way a church can be reasonably sure it is obeying the word of god in regards to communion is to practice closed communion .
because the communion supper is a command , there are rules for doing it correctly , because if it is not done correctly , some or all of the four - fold purpose will be not be properly achieved . the correct way of conducting the communion supper is at a closed table . this is known as ‘closed communion’ .
who is worthy ? - a reflection on closed communion in lutheran churches | j . w . wartick -
always have a reason
i agree . in my opinion there are only two viable choices . open and closed .
especially in america today , the word “closed” carries negative connotations . one of the worst accusations possible is that of “ closed - mindedness . ” a politically correct culture will not tolerate anyone or anything that is closed , for to be so is de facto “bigoted” and “intolerant” .
this is the logic behind a closed communion . it is not an arbitrary or spiteful policy , but a necessary one for a divided christendom .
experience indicates that churches allowing open or close communion will not have the same level of spiritual zeal , holiness , and concern for the truth as those churches practicing closed communion . closed communion is an imperfect indicator of a church that has more than the mere form of godliness without any authority , for they are protecting the integrity of the lord ' s table by their restrictive communion policy .
dr . bob , can you expand on these , especially the differences between close and closed .
most bma churches practice closed communion . my personal conviction tends to lean toward open communion . what i would like to see is some ' clear ' scriptural evidence for closed communion . the standard answer i have recieved from most is
that is just the way we do it
, which falls way short of a valid answer to me .
my “tradition” was always close communion . i left the tradition and went with closed because i was convicted by bible study that my tradition was wrong .
the older churches , such as the roman catholic and the eastern orthodox exclude non - members from communion under normal circumstances . many conservative protestant communities also practice closed communion , including some conservative lutheran churches . the mennonites and the landmark baptist churches also practice closed communion , as a symbol of exclusive membership and loyalty to the distinctive doctrines of their fellowship .
therefore closed communion – referring to the long - standing tradition of communing only those who are members of a unified body – is becoming an ecclesial “sin . ” ironically , most of us would admit that a healthy society is built upon “closed” marriage .
i would appreciate it greatly if someone could show me how i am wrong on acts 20 . i have no desire to abandon my closed communion position . however , at this time i do not know how to reconcile acts 20 with closed communion without straining this chapter in lukeâ€™s second volume to theophilus .
one of the reasons why closed communion is seen in such a negative light today , is because our world doesn’t like to hear the word “no . ”
now that i realize my conclusions on various passages in the book of acts were probably wrong , i becoming more swayed by the idea of closed communion .
the crux of the issue of open or closed communion is whether or not the lord ' s supper should be made available to people outside of a local church ' s membership . the bible teaches that communion should only be taken by believers in jesus christ , but it stops short of instructing on how this relates to church membership . some churches only allow their own members to take communion ( closed communion ) . other churches allow any believer to take communion , regardless of church affiliation ( open communion ) . sometimes , this latter position is referred to as
close
communion , with the idea that
open
communion would be letting anyone take communion , saved or unsaved .
the problem many have closed communion is not the issue stated above . all would agree with this . this is a good first step . in fact , without knowing it , pastors who do this are actually , halfway , practicing closed communion . they have closed the lord’s supper to the impenitent . this is good , but incomplete . what most people take issue with is telling members of other denominations that cannot commune .
update : the above historical reasons for a closed communion table were written before i became orthodox . click here for a more recent post explaining the theological reasons .
my problem with closed communion is that there is some fear factor of polluting the assembly , and or some outside the faith might bring rebuke to the assembly .
perhaps it would be good to have those supporting closed communion to give scripture support for their view , just as the op did in support of that view .
my problem with closed communion is that there is some fear factor of polluting the assembly , and or some outside the faith might bring rebuke to the assembly . perhaps it would be good to have those supporting closed communion to give scripture support for their view , just as the op did in support of that view .
[ 1 ] closed communion may also refer to simply keeping communion closed to those who affirm what the book of concord teaches regarding the lord’s supper . there is a fine line between this practice and making the additions to the book of concord’s teaching as noted in this post . i am not addressing this less stringent variety here .
rule of faith and practice within the lord’s church . in the case of closed communion , this is our foundational basis and sole point of reasoning . we feel doctrinally constrained by new testament scripture to observe the lord’s supper and communion in this way . it is my purpose in this article to present scriptural evidence as the basis for our commonly questioned and heavily criticized practice of closed communion .
closed communion is not unique to the lutheran church missouri synod . it continues to be practiced by most of the world’s christians who are roman catholic and orthodox . at one time nearly all christian denominations in america practiced closed communion . this included almost all lutheran churches . now only the lutheran church missouri synod and a few small lutheran bodies continue this confessional practice . the expressions “closed” and “close” are often used interchangeably . the term “closed or close communion , ” means that only baptized and instructed christians , who are in complete agreement concerning the teachings of holy scripture , and confession of faith , commune with one another .
i have been lutheran all my life , but have never agreed with a closed communion . before one objects , neither do i believe that communion should necessarily be open to all . i am much more of the mindset that “close” communion is in line with what we see in 1 corinthians .
if by any chance your church practices denominational communion , as opposed to closed communion for members only , it is not the purpose of this article to find fault with your church . rather , we desire to show a better way .
these articles are about the historically , and more importantly , scripturally authentic church practice known as closed communion . the practice is also known as ‘restricted communion’ , and it is from the word ‘restricted’ that ‘strict baptist’ churches take their title .
in both close and closed communion , we give the bread and wine to only those who believe the same and dress the same as we do . closed communion requires that you believe the same as i –on pretty much everything . close communion is a little less rigid . basically , it says you must be mennonite . ( and for conservative groups , that includes only mennonites that wear a head covering . )
the reasons for the practice of close communion are often misunderstood by christians who have been accustomed to an “open communion” policy . in a tract entitled “why close communion ? ” the rationale for the practice of close communion is explained in this way :
those who characterize the traditional practice as “closed communion” may forget that a church’s communion of faith , and by extension its sacrament , is actually open to all who formally embrace it and unite themselves to it . this is certainly true of the orthodox church . it is “closed” only in the way a marriage or a family is closed . while love and hospitality is extended , there are reasonable limits to that hospitality , without which there is no real marriage or family .
closed communion has been practiced in the church since its foundation . it began in the early church , continued through the reformation , and has been passed onto us . it reflects a deep understanding of god’s rich and abundant grace given to sinners in christ’s body and blood . it also magnifies for us the richness of our relationship to each other in christ . the practice of closed communion is a confessional practice . in a day where anything goes , closed communion and the confession it represents , gives lutherans solid ground to stand on .
for a detailed examination of the practice of the early church regarding closed communion , see werner elert , eucharist and church fellowship in the first four centuries , trans . norman e . nagel ( st . louis : concordia , 1966 ) . elert shows conclusively that the church from the very beginning practiced closed communion , and confirms the universality of the practice .
i have been in both kind of churches and respect their view to keep it closed if they see thatbaptist board .
the exceptions listed above are just that : exceptions to a general rule . closed communion is still the norm , the church only relaxes the restrictions in extreme circumstances out of charity .
those churches which exclude certain people ( usually non - members ) from receiving communion are said to have a
closed communion
. in contrast , those which allow non - members to communicate are said to have an
open commmunion
.
the argument for closed communion is based on a desire to ensure that only believers partake in communion . since church members are already on record as having professed faith in jesus , the restriction helps prevent an unsaved person from participating in the ordinance .
withholding communion from someone who refuses to get baptized makes sense . withholding communion from someone who doesn’t dress like us does not .
closed – only members of that particular church are admitted to communion . the catholic church theoretically operates on a closed basis : doctrinally , only catholics are supposed to receive the elements , though in practice i have often been invited to join at mass , even though the priest knew i was not catholic .
my understanding ( though often flawed ) is that communion is for born again believers only . some churches have closed communion ( only for their members ) , which i believe is wrong . god will know who the true believers are and won ' t be fooled by pretenders who partake of communion
unworthily .
by
closed communion
we refer to the policy in which only members of a particular local church are allowed to partake of the lord ' s supper when celebrated in that church .
some may see this as a good argument against what you have written , but there is no way i would ever have become a lutheran if not for the practice of closed communion .
as far as the red herring , saying that churches connect because christ is their head is a great truth . what does it have to do with whether communion is closed or close ?
table fellowship in the lord’s supper has become one of the most debated issues in the church today . the decision to practice open or closed communion segments many congregations . christians of good will and conscious on both sides of the issue want to do what they feel is right . they want to do the christian thing . most of the time decisions of open or closed communion are made from an emotional standpoint . on the one hand there are people who want to open the communion table up to everyone because this would be the “loving thing to do” . on the other hand there are people who want to practice closed communion because that is the way lutherans have always done it . with little more than this for a foundation the argument for closed communion crumbles in a heap . it would seem to be better to open holy communion up to all in love . this , however , is the point . it is not more loving to practice open communion .
question : where is denominationalism found in the bible ? if it can be found in the bible , then close communion is the correct way , and both open and closed communions are wrong .
term , define it , and stick with it . so , for the duration of this article , when i refer to closed communion , you now know exactly what i am referring to .
question : where is denominationalism found in the bible ' ? if it can be found in the bible then close communion is the correct way , and both open and closed communions are wrong .
closed communion—it couldn’t possibly sound more negative . it implies judgement , exclusivity , and moral superiority—all qualities that a pluralistic , democratic and egalitarian society despises . and yet , without a doubt , the orthodox church is a closed communion : only those who are baptized members of the eastern orthodox church , who offer a regular confession and who fast and pray in preparation , may receive the eucharist .
this is a short version of why the lord ' s super is
closed
and not
close or open .
i agree . in my opinion there are only two viable choices . open and closed .
close
is a misnomer .
because of obvious administrative complications , a closed communion table can be managed best in numerically small church memberships , but , in much larger churches , only with difficulty , or perhaps not at all .
first , i feel it necessary to express a quick word pertaining to terminology . when it comes to how primitive baptists observe the lord’s supper and communion , some people refer to it as “closed” communion and some people refer to it as “close” communion . this is merely an issue of semantics and preference . so , for the purposes of
according to the historic christian teaching reflected in the early church fathers , admittance to holy communion means embracing the entire faith tradition of the body . before holy communion can be received , communion must already be achieved .
with the absence of any other reason for close communion , we should follow the clear teaching ; interpret the less plain in light of the plain . we should practice closed communion . we should exclude the lord’s table from everyone except those in the membership of our own church .
the catholic church teaches that catholics should only receive communion from other catholic churches , and non - catholics should not receive communion in catholic churches .
gradually , as the church of scotland moved away from closed communion and the practice of fencing the table church interiors changed to reflect this , and fenced communion tables were removed . in fact , despite having visited countless church of scotland churches over the years , i had never seen a fenced communion table , and i simply assumed they no longer existed .
the scriptures teach closed communion , certainly . but it seems like where we draw the line on who is “worthy” or not is pretty much based on our understanding of scripture - which universally is not uniform .
orthodox christians , who all follow the ancient tradition of ‘closed’ communion , find this latest development quite puzzling . the late metropolitan paulos mar gregorios of the malankara syrian orthodox church expressed the orthodox understanding of the issue :
i realize that those who are persuaded of the “closed” position feel very passionate about this . i have known a few who are anxious to dis - fellowship all who are not “closed” . but i’m trying to demonstrate here that we who are persuaded of the “close” position also have reasons , which we feel are legitimate . and we have some objections to the “closed” position , that at least we ourselves feel are relevant .
the “synod” does not practice open communion . the synod is not church . lcms has affirmed the practice of closed communion as well . sadly , pastors and congregations have not been faithful to scripture , the lutheran confessions , nor the lcms agreement in doctrine when practicing open communion . a faithful lcms affiliated congregation / pastor will mark and avoid erring layman / pastors at the communion rail and also refuse to commune them while seeking to gain their repentance and once again confess the unity of faith properly at the communion rail .
bro . mcgovern , am i to understand that you do not recognize the importance of biblical examples . there is no clear evidence for close communion , whereas the biblical example is always closed communion . i truly have not heard anyone that is close communion give any scriptural proof or biblical examples without stretching scripture . i do not vote in your church and you don’t in mine . a member has communion at their local church and do not need to be involved with another churches communion . it is a big issue .
franz pieper , christliche dogmatik three vols . ( st . louis : concordia publishing house , 1920 ) iii : 444 :
auch die apostolische kirche praktizierte nicht ' open ' , sondern ' closed communion ' .
i can only speak of the baptist church , having been in that church since my youth . some baptist churches have ' open ' communion and some have ' closed ' communion . open communion invites all who are baptized believers to participate . closed communion invites only those who are members of that local church body to participate . now a note : the word ' invite ' is tacit in most churches and it is left to the individual to decide his / her own conscience . i have never seen anyone denied the rite of communion . usually the preferred practice will be spelled out in the individual church ' s covenant for anyone who cares to ask for clarification .
the auction has finished , bidding is closed . if you won any items an email will be sent to you with invoice & payment information .
i have received my first communion by accidentally taking communion but then having a bishop tell me it was okay to consider it a first commun . . .
the lutheran church generally also participates in closed communion , requesting that all participants in communion administered from a lutheran church be baptized members of a lutheran church . there are numerous synods within the lutheran church , and some of them may even require that participants be members of that specific synod of lutheran churches .
it was not until the beginning of the 20 th century that open communion became anything more than highly unusual . anglicans and episcopalians , lutherans , baptists , reformed presbyterians , and methodists all practiced closed communion at least until that time . [ 2 ] that means for close to 1 , 900 years the sharing of communion between christians of differing faith was quite exceptional . [ 3 ]
there exists full and formal communion among all the 23 churches of the catholic communion , the largest of which is the roman catholic church . so for example any roman ( latin ) catholic can receive communion in a melkite church , and any melkite catholic can receive communion in an armenian catholic church or a maronite church , and a maronite can receive communion in a roman ( latin ) church .
the problem is not simply that roman catholics practice ‘closed’ communion , whilst protestants all follow a policy of ‘open’ communion , as there are several protestant churches ( such as the brethren and some lutheran churches ) who have a very strict ‘closed’ discipline , whilst rome herself opens her altars to orthodox , assyrians christians and members of the polish national catholic church . in recent years participants at large ecumenical gatherings have found themselves offered ‘eucharistic hospitality’ at catholic altars , a form of once - off gesture to those not normally permitted to receive communion .
while canvassing the community for my church , i met a couple who were not interested in us because they believe in closed communion . this was even though they were not going to any church because they couldn’t find one suitable .
answers to the questions concerning communion practices , including the practice of closed communion , must be given in accordance with the scriptures as expounded in the lutheran confessions . therefore , it is necessary to lay the groundwork for the discussion by noting the basic principles of interpretation by which the lutheran church operates , so that these principles can then be put to use in answering questions concerning communion practices .
why can’t lutherans take catholic communion ? | russell e . saltzman | first things
the true body and blood of jesus christ truly given in communion ? check .
we thank you for respecting our communion practice and the scriptures which teach us .
writing , and in order to be consistent and avoid confusion , i will now define what i mean by “closed communion” and that will be the term and definition in which i will use throughout this article . this is meant solely for the clarity of this article only and is not an effort to standardize primitive baptist terminology . for this article , i choose the term “closed communion” and define it to mean the following : primitive baptists maintain that only believers baptized into a primitive baptist church may partake in the ordinance of the church known as the lord’s supper and / or communion . in other words , only those baptized believers of like faith and order may participate together in this church ordinance . another reason i personally prefer the term “closed” over “close” is that later in this article we will contrast the two different ideas of open communion versus closed communion . obviously , it logically makes more sense to contrast the opposites “closed” and “open” rather than the opposites “close” and “far” ( or “distant” ) . again , this may seem like a silly distinction to some , but for the purposes of this article and to be clear , it is expedient that we chose
the practice of closed communion gives the lutheran church the opportunity to witness to the world . from this practice , as questions arise , we can communicate to our friends and neighbors the richness of god’s grace on the issues of the lord’s supper , alter and table fellowship , christian unity and inclusiveness , and the meaning of a common confession of faith . the purpose of this paper is to gain a better understanding of the practice of closed communion as a foundational tool for catechesis . the questions to be considered are : what are its scriptural roots ? how was it practiced in the history of the church ? what do our confessions say ? finally what makes the contemporary practice of closed communion difficult ?
all of this is to convey that the practice of “closed” communion is not personal or vindictive . christians of other confessions are not excluded from holy communion based on a judgment of their personal faith , sincerity , or sanctity . rather they hold to a different christian tradition and are united to a different christian body .
5 . church discipline can override communion privileges . however , that is a disciplinary issue , made in consequence to specific actions that need correction . closed and close communion deny participation rights of some believers even when there have been no disciplinary actions taken . this is not the biblical standard as presented in these verses .
some of those who would abandon closed communion see it as a custom which served the church well in the past , but which has outlived its usefulness . they suggest that in a pluralistic culture such as ours the practice causes offense and thus distracts from the good news the church is called to proclaim . it becomes necessary , then , to examine the nature of the practice of closed communion to determine if it is a man - made custom which may be abandoned in view of current circumstances , or if in fact it is a practice which is derived from the very nature of the lord ' s supper . in other words : is closed communion a man - made option or a divinely instituted necessity ?
one of my biggest struggles on my journey into orthodoxy was the closed communion table . it seemed quite unfair that someone else could deem who was worthy to take communion , and who was not . infants and children in the church could partake of it , but i as a christian and inquirer into orthodoxy could not .
lot 327 features a canada east beauharnios communion token from the church of scotland . from the bob merchant communion token collection , only three examples are known to exist .
world communion tokens - new zealand communion tokens , port chalmers , b . 5713 ; tapanui ; waihola ; warepa ; wellington , b . 7142 . 5 pcs .
the question of open or closed communion is one that each individual church must decide . however , scripture reveals the lord ' s supper can be and most likely should be left open for all believers who are in right standing with christ .
by communing with somebody from outside of our own communion , not only do we reinforce a sinful fellowship , we deliberately have communion with what we understand as error . i like to use the term communion and not use the term fellowship at all . if we are in communion with somebody who is in another communion with satanic arts , then we too , have deliberately entered into communion with those satanic arts . “insistence that people be missouri synod” is both too narrow a protocol and too wide a protocol . it is too narrow because the missouri synod is in communion with many other lutheran synods around the world . and then there are synods that ride the fuzzy line like the lutheran church of australia . it is too wide because within the missouri synod , there are a great many who deliberately and persistently violate their own pledges to confessional practices on communion . closed communion is beautiful . iron sharpens iron . when our brothers and sisters of other christian communions also practice closed communion , we are able to sharpen each other and learn from each other . when we blindly blend , neither stands for anything or communicates anything . neither offers the other anything .
although i personally favor closed communion , my church is not . i would say it practices close communion . my view is closely tied to church discipline . for example , we could disfellowship someone for flagrant sin , yet under open communion could not deny him participation in the lord ' s supper . that ' s a pretty extreme example , and not likely to happen , but you can see the implications .
communion is more than just a personal or individual act between god and the communicant .
) . this verse clearly reveals the importance of taking communion in the proper spirit .
originally posted by bender99 : in my opinion communion should be opened to all believers .
at a solemn tridentine mass , the host is displayed to the people before communion .
“the more doctrines you believe the less people you will have communion fellowship with . ”
may the lord bless your administration of holy communion and may it be a true communion in the body and blood of christ by the work of the spirit through faith .
this view is from the balcony , and shows the communion table between the pews .
and 12 , both of which talk about the universal body of christ is 1 corinthians chapter 11 . there is no scriptural basis to claim that the corinthian church practiced closed communion as a basis for discounting the message of this chapter . the context of chapters 10 and 12 requires otherwise . this chapter explains how to conduct communion .
historically , christians share communion ( the sacrament ) with those they are in communion ( the state of unity ) with . now the difference between how the various traditions — catholic , orthodox , anglican and protestant — understand communion ( unity ) impacts how they practice
holy communion has never been free . the eucharist , and real communion , comes with the price of monogamy , of standing for and within a tangible faith community and tradition .
great question . it’s not a lack of charity at all ; it is a biblical mandate . that’s the bottom line : what does scripture say about who should receive communion , and what that act signifies ( in the corporate sense ) ? several christian groups have closed communion : not just catholics ( missouri synod lutherans come to mind ) .
i feel like it is appropriate , as one who , at this time , still holds to closed communion ( and thus hopes that i am wrong on acts 20 ) , to mention that some of us who are closed make arguments that are quite poor on acts 20 . i have read literature arguing for closed communion that says that there is no scriptural evidence that there was a church at troas , and also argues that there is no evidence from church history for a church in that city for centuries . unless i am in the dark about something ( which is very possible ) , both of these contentions seem extremely poor to me . ( by the way , sometimes kjv - only churches that are closed reproduce arguments for closed communion that are based on corruptions in the critical text , such as â€œweâ€ for â€œthe disciplesâ€ in acts 20 : 7â€”it is easier to say that there is no church in troas if one believes the nasv rather than the preserved word of godâ€”anyway , here are my reasons for thinking there was a church in troas , and for the fact that church history supports this ) :
this is my quick answer : if the ordinance is for the local church then that would mean that each local church partakes of this ordinance privately , meaning closed . at our church , we do not call it
closed
but
covenant
communion . only those who have made the
covenant
to be faithful to christ and his
local
church are able to partake of the lord ' s supper .
anyone conscious of a grave sin must receive the sacrament of reconciliation before coming to communion .
all that is to say that depending on which lcms church one visits , where one is located , etc . , all play a factor in whether one would see lutherans practicing closed communion or not . incidentally , i’ve never heard the gospel preached in a lutheran church that practices open communion . not sure if there is a correlation there or not .
although the media usually seems to criticize the catholic church for having a closed communion , this is not entirely fair since she is not the only christian church with such a policy . the eastern orthodox also have a closed communion ; they only permit orthodox christians to receive in their churches and forbid their own members from communicating in any other church ( even a catholic one ! ) . some protestant churches have similar rules , only allowing those who accept jesus as their savior to participate in their
lord ' s supper
.
it should be clear from the above that , according to martin luther’s own criteria for shared communion , modern day evangelicals would be prohibited from receiving communion in the catholic and orthodox communions .
world communion tokens - new zealand communion tokens , east taieri , 1864 ; invercarcill . b . 3357 ( 2 ) ; kaihiku , b . 5441 ( 2 ) . 5 pcs .
closed communion means not everyone who worships at praise lutheran receives the bread and wine , christ’s body and blood , during the lord’s supper . not , that is , until they’ve been faithfully instructed and confirmed in the very same faith that is taught here . god desires us all to have the same mind concerning his teaching ( 1 cor . 1 ) before receiving his gifts at the table ( 1 cor . 10 - 11 ) . closed communion is a reflection of our unity in doctrine and common confession and witness before the world .
the lutheran church teaches that after the blessing by the pastor , the bread and wine also become the body and blood of jesus . it ' s both body and bread , wine and blood , at the same time . this is why lutherans also practice closed communion .
too often , closed communion is spoken of as the end of a long process undertaken by an individual and not part of the process undertaken by god . this shifts the focus away from the purpose and efficacy of the sacrament and toward the personal faith of the recipient .
let me try and explain one assertion in the post is that if one practices close communion he is â€œredefiningâ€ the church . if this point were true , i believe there would be a clear verse ( s ) teaching against close communion . why ? because of the importance of the local church . ( i in no way believe in a â€œuniversal church . â€ i in no way think that closed communion in any way suggest a belief in universal church . )
it is unlikely and improbable that those who observe open or close communion will obey this command .
– there is no proof in the new testament that paul ever observed communion with any church .
lcms frequently asked questions doctrinal issues - the lord’s supper / holy communion ( accessible here ) .
• there is no proof in the new testament that paul ever observed communion with any church .
“i’m for vestments , weekly communion , crucifixes , elevation and everything associated with traditional lutheranism . ”
world communion tokens - new zealand communion tokens , west taieri , b . 7165 ( 2 ) ; whangarie ( 2 ) ; launcestown , b . 4155 ( australia ) . 5 pcs .
the church i grew up in was primitive baptist old school and our communion was closed and only opened to those who were of our same faith and order . . . these other churches were know as sister churches and as tc stated they were of our church family . . . our communion was open only to our church family , even the lords supper and feet washing . . . there are other who have stated for open and some for close and others for closed . . . each body of believers have their own way of how they conduct communion in their churches , i told you mine . . . whenever and by what mode we take communion we must keep in mind one thing , the reason for it . . . brother glen
anyone who desires to receive christ in eucharistic communion must be in the state of grace . anyone aware of having sinned mortally must not receive communion without having received absolution in the sacrament of penance .
1 ) the uoc - kyiv patriarchate has been vigorously seeking inter - communion with as many other “non - canonical” orthodox churches as possible . at present , it is in communion with the following :
the relevance for today ' s churches remains . in all instances , communion should be taken only by believers who have examined themselves before the lord . if a person has not made a profession of faith or is unwilling to take communion in a worthy manner , he or she should refrain from taking part in the lord ' s supper . if a believer is visiting a church which practices closed communion , it is best to refrain from partaking , so as not to give offense .
so we have two options . open , allowing people we don ' t know determine who we unite with , or closed , limiting participation to our own , known , church family .
here , i’d like to examine this practice of some lutheran churches , often referred to as “closed communion . ” [ 1 ] what do the actual lutheran confessions say about who may receive the lord’s supper ? that is the question which must be asked by any claiming to be lutheran .
a true seeker of bible truth and practice , need to earnestly seek to understand the practice of this closed communion . when we hold to the restrictions placed upon the lord’s supper by our master , we are defending the “faith which was once delivered to the saints” ( jude 3 ) .
in the end , closed communion is not merely the unpleasant practice of an exclusive church . it is a challenge for all of us to ask 1 ) who is jesus ? and 2 ) what is communion ? i invite you to take these questions forward in your thoughts . may they goad you to a richer encounter with the crucified and risen christ and his living body on earth .
at the communion rail one is saying “i believe the same thing as is taught at this altar .
exceptions to this may be made under special circumstances . if you are a member of another communion of believers , please remain seated during holy communion unless you have spoken with the pastor before the service .
i am doing some historical research on my denomination ' s ( general association of general baptists ) position on open communion . i am interested in knowing if any other group represented here affirms open communion .
russian true orthodox church – metropolia of moscow ( in communion with and originating from the uao ) .
communion tokens of the united states of america
by autence a . bason , greensboro , nc
if you happened to be in attendance when we held the lord ' s supper , then you were gently told it is our conviction from the word of god to observe closed communion . that is , we believe the lord ' s supper is limited to the membership of each local church .
as a baptist , i believe in the priesthood of the believer . closed communion denies the priesthood of the believer , it denies the protocol god established in this chapter , and it denies the oneness of all believers with all believers in christ and christ in all believers , as jesus taught in
in today ' s earlier post i introduced the concepts of closed , close , and open communion and fencing the table . i realized that i never explicitly explained how we fence the table at redeemer and thought it would be a good idea to explain that in a follow - up post .
close
is a misnomer . if a door is
almost closed
it is still open . it can be open a little or open a lot but it is still open .
i have believed in closed communion for years , and i would still say that i believe in it . however , i donâ€™t have a good answer on acts 20 . i started studying that passage out for the purpose of dealing with seventh day adventists , and in the course of my study , my way to explain the passage in a closed communion consistent method was shaken . i think it was the lordâ€™s supper in acts 20 , and this is why ( from my study ; i hope the greek / hebrew fonts turn out okâ€”and i have changed footnotes to things in brackets ) :
closed communion in a divided christendom is a modest restatement of the historic position of our church body , as this was formulated by dr . c . f . w . walther in his essay on communion fellowship delivered to the missouri synod ' s western district convention in 1870 . ( 15 ) readers of this essay will note that the commission has expressed itself much more mildly than did dr . walther .
if you , like me , have struggled with the idea of having a closed communion table , then i would say that firstly you are not alone . i have no desire to make someone feel guilty for thinking that way nor am i condemning those who have a very open practice in their church .
to come to communion is to confess openly before everyone the true christian unity we enjoy under god’s word .
– if this cannot be proven then open and close communion cannot be proven as a new testament practice .
communion is a package deal . it does not happen without reference to the tangible life of the community . it is not an isolated moment where i “take” communion on my own terms , without reference to the community , its corporate faith and life , its tradition . such a communion never existed in the historical church .
• if this cannot be proven then open or close communion cannot he proven as a new testament practice .
comprehensive directory of world communion tokens
by 0 . d . creswell nadin - davis numismatics , 1985
bell said among the top highlights of this spring’s auction is material from the bob merchant communion token collection .
world communion tokens - new zealand communion tokens , longbush , b . 4442 ; oamaru , b . 5355 ; north taieri , b . ( 2 ) ; north dunedin , b . 5312 . 5 pcs .
world communion tokens - new zealand communion tokens , north dunedin , b . 5312 ; otago , b . 5259 , stock ( 2 ) ; otepopo , 1864 ; port chalmers , b . 5713 . 5 pcs
no you should not take communion . the catholic and orthodox churches have closed communion as such - it would be a sin for you a protestant to receive communion at an orthodox or catholic church as the chalice is reserved for those who are members and have been to confession , fasted and prayed and to approach the cup is to claim that about yourself . like wise i as an orthodox christian can not take communion at a catholic or protestant church . whether or not a protestant christian can take communion at an other protestant church would depend - on the teaching of their church and the one they are attending . if you read 1 corinthians 11 : 29 you will see treating communion with out respect is a sin - for he that eateth and drinketh unworthily , eateth and drinketh damnation to himself , not discerning the lord ' s body .