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हरियाणा फार्मेसी काउंसिल चुनाव 2013 में उम्मीदवारों को प्राप्त वोट

    नाम                               प्राप्त वोट

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धानेश अधलखा             6883

रोहित खंडूजा                      6104

राजकुमार छाछरोली     5394

यशपाल सिंगला              4863

सोहनलाल कंसल              4686

कृष्णचंद गोयल             4500

(Winner 6 Candidate)

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अनिल कुमार----------    4020

अमित कुमार ------------3555

संजय कुमार ------------3488

सुरेन्द्र जाखड़ ------------3207

कुमार गौरव ------------2950

सतीश विज ------------2815

जोगिन्द्र सिंह ------------2622

बीबी सिंगल -------------2204

राज सिंह        -------------1395

नंद किशोर -------------483

सरोवर आनंद ------------458

हेमन्त कुमार ------------284

ओमप्रकाश रोहिल्ला---  268

जयनारायण शर्मा ------258

रामचंद्र -----------------147

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Madras HC upholds govt's order banning manufacture, sale of dextyropropoxyphene (22/10/13)

Mumbai, 22 Oct 2013: Madras High Court (HC) in its recent order has directed Wockhardt Ltd to restrain from manufacturing, marketing and selling the drug dextyropropoxyphene under the brand name Proxyvon and Spasmo Proxyvon against the writ petitions filed by the company to get interim stay of operation of the notification on the ban. HC passed the order taking in view of the recommendations of Drugs Technical Advisory Board (DTAB).

Wockhardt Limited and its distributors had requested for a judicial review in respect of the notification issued on May 23, 2013 by the Government of India to ban the manufacture and sale of the drug till the drug is proved safe, rational and efficacious through a well designed, multi-centric, statistically powered clinical trial in India. The drug has been banned in the US, UK, Canada and New Zealand considering the fact that the benefits of the drug do not outweigh its risks in recommended doses. 

DTAB in its 60th meeting on October 10, 2011 accepted the recommendation made by the sub committee constituted to examine Fixed Dose Combination (FDC) that clinical trial should be conducted with the drug dextyropropoxyphene to establish its safety and efficacy.The deliberations in the said meeting and the follow up action taken thereafter resulted in issuing the impugned notification.The petitioners wanted interim stay of all further proceedings pursuant to the notification dated May 23, 2013. The HC did not grant interim stay of operation of the notification and has issued notices to the Government of India and Drugs Controller General of India (DCGI) to continue with the ban and get details of the inventory of drugs stored at the warehouses of the company.

The petitioners have contended that the Government has not taken any expert opinion before the suspension of drug. As per the petition, Wockhardt Ltd has been manufacturing and selling these drugs for the last forty years without any complaint. The abrupt action taken by the government of India resulted in substantial loss not only to the manufacturer but also to the distributors.

As per the contentions made by the Government of India against the petitioner, the court is not an expert to decide as to whether a particular drug is dangerous in nature and it is unfit for human use. It is for the expert committee entrusted with the said task to decide the issue. The experts have taken a decision to suspend the drug for the time being till a close study is conducted with regard to its adverse affects on human beings.

The counter affidavit filed by the Drugs Controller General of India (DCGI) shows that the expert body has arrived at a conclusion that dextyropropoxyphene and its formulations need to be examined and evaluated with respect to its safety aspect.

As per the HC order, the company and its distributors have also been directed to inform the DCGI and concerned State Drug Controllers about the stocks available with them and details of warehouses where the drugs are stored.

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Himachal Pradesh High Court stays Drug Controller General of India's order on combination drugs            (7/10/13)

NEW DELHI, 7 OCT 2013: The government's efforts to weed out 'potentially unsafe' combination drugs for which pharma companies have not taken the central drug regulator's permission by September 30 has run into a wall.
The High Court of Himachal Pradesh on September 27 granted an interim stay on Drug Controller General of India's (DCGI's) directive of July which intended to dub all those combination drugs as 'illegal' for which drugmakers have not filed safety and efficacy data with the central drug regulator by September 30.
The court was hearing an appeal of a member of Himachal Drug Manufacturers' Association. "Some of these drugs are being marketed for over two decades with no adverse impact recorded in the country. Isn't that proof of safety?" said SL Singla, general secretary of Himachal Drug Manufacturers' Association.Drug experts say India has had no scientific mechanism to measure side effects of drugs. "Why can't the government constitute an expert panel which can identify dubious combination drugs and study their safety and efficacy instead of going after all combination drugs?" Singla asked.Combination drugs constitute 46% of the country's Rs 70,000-crore drug market but many of these have not been tested for safety and efficacy and are termed 'irrational' by drug experts. Also, a large chunk of this is being sold with the state drug controllers' consent, but the central drug regulator is kept out of the loop.In January, the DCGI had asked the state drug controllers that drugmakers must submit safety and efficacy data for combination drugs to the central regulator within 18 months. If pharma companies fail to do so, the sale of these drugs would be forbidden in the country, it said.In July, the central drug regulator came out with a similar directive but preponed the deadline to August 30, which it later extended by a month. The central drug regulator said in its July order that despite its January notice, only a few drugmakers have come forward to prove the safety of the combination drugs that they are selling.But the court has noted that the drug regulator has 'unilaterally altered' the deadline without citing any 'exceptional reasons' for doing so. Drugmakers, especially small and medium scale players, are arguing that such an approach to prohibit sale of combination drugs is unfair and would hurt their business."How can these drugs, which have been approved by the state governments, be considered illegal? In that case, is it the fault of the drug manufacturer or the state drug regulator, which cleared its sale?" another small scale drugmaker said, requesting anonymity.The government is battling another case in Madras High Court since 2007 against drugmakers, where it is trying to convince the court why it's necessary to withdraw 294 'irrational' combination drugs from the market.The government renewed its efforts to phase out 'irrational' combination drugs this year after a parliamentary panel last year criticised the regulator for not acting on such potentially 'unsafe' drugs flooding the market.

Economic Times

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Illegally operating drug factory sealed

SHIMLA: The drug controlling authority of Himachal Pradesh raided a pharmaceutical unit in Sirmaur district and found out that illegally manufactured drugs were being supplied to government hospitals of Chhatisgarh, Tripura and Uttar Pradesh. Following the raid, the authority sounded national alert to alert other state governments. A couple from Ambala in Haryana who were running the unit were booked by police on Sunday night. 

The raid carried out at Vardhman Pharmaceutical in Kala Amb area started on Saturday morning and continued till late Sunday. 700 boxes of spurious drugs were seized and the illegally running factory was also sealed. According to sources, Vardhman Pharmaceuticals had started operation from the industrial area of Kala Amb on December 24, 2004 after obtaining a license to manufacture drugs. The license was never renewed after 2009 but production continued without informing the authorities concerned. 

Based on a complaint lodged by the Drug Controlling Authority, a case was registered by police against M C Jain and his wife Meenakshi Jain. The company was in the name of Meenakshi Jain while M C Jain was having its power of attorney, officials added. 

Himachal Pradesh Drug Controller Navneet Marwaha said that 700 boxes of injections, tablets, capsules and syrups were seized from the unit that was closed on record since 2009. Marwaha said few days back they got information about some clandestine activity taking place in this unit after which the unit was kept under surveillance with the help of police. He said the main gate of the unit used to remain closed and was being opened only for few hours during the day while production work was being done during night. 

"We raided the premises on Saturday morning and found the unit functioning. Drugs, mostly antibiotics which comes under lifesaving drugs category, were being manufactured by around 30-32 people," he said. 

The Ambala couple was also running a dairy and raids conducted by Haryana Drug Controller also resulted in recovery of some more drugs. 

Himachal Pradesh caters to around 40 to 50% drug demand of the country. Last year, the drug controlling authority had suspended the license of seven manufacturing units after drugs manufactured by them failed quality test.

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Nurses can distribute medicines at sub-centres and primary health centres        

Jaipur, 25 Sept 2013: JAIPUR: Reacting to the long-pending demand of nurses for the right to distribute medicines, the health department, referring to Drug and Cosmetic Act 1945, clarified that nurses can distribute medicines to patients at sub-centres and primary health centres (PHCs).The order issued on Tuesday by medical and health services director (health) Dr BR Meena pointed out that in Schedule 'K' drugs section 23, there is a provision that 1) multipurpose workers attached to primary health centres/sub-centres, 2) community health volunteers under the rural health scheme, 3) nurses, auxiliary nurse, midwives and lady health visitors attached to urban family welfare centres/PHCs/sub-centers can distribute medicines in Schedule K.But the letter has not mentioned if nurses at community health centres, district hospitals, satellite hospitals, dispensaries, and hospitals attached to medical colleges are authorized to distribute medicines.Nurse leader Rajendra Rana said, "It is for the first time, the government has clarified that there is a provision in the Drug and Cosmetic Act that nurses can distribute medicines at sub-centres and PHCs. It is a good step taken by the government as at sub-centres and at most PHCs, nurses are administering medicines to patients."Rana said that at some district hospitals and community health centres, nurses are distributing medicines without any authority.He said that out of the 14,481 health centres, the nurses will now be eligible to distribute medicines in 12,701 sub-centers and 1,649 PHCs.


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रैनबैक्सी के मोहाली प्लांट पर बैन की दिलचस्प वजह
(रॉयटर्स) वॉशिंगटन-दवा कंपनी रैनबैक्सी लैबोरेटरीज के एक प्लांट की विजिट के दौरान पिछले साल यूएस इंस्पेक्टर्स को टैबलेट में एक 'काला रेशा' मिला था। डॉक्युमेंट्स के मुताबिक, यह किसी कर्मचारी के बाजू का बाल हो सकता है। यह और क्वालिटी से जुड़ी दूसरी चिंताओं के कारण यूएस फूड एंड ड्रग एडमिनिस्ट्रेशन ने पिछले हफ्ते कंपनी के मोहाली प्लांट को लेकर इंपोर्ट अलर्ट जारी किया था। यूएस एफडीए का कहना था कि सेल्स के हिसाब से भारत की सबसे बड़ी दवा कंपनी ने अपने यहां मैन्युफैक्चरिंग क्वालिटी को मेंटेन नहीं किया है।
रैनबैक्सी में जापान की कंपनी दाइची सैंक्यो की 63.5 फीसदी हिस्सेदारी है। कंपनी की सेल्स में अमेरिकी बाजार का कंट्रीब्यूशन 40 फीसदी से ज्यादा है। कंपनी ने एफडीए जांच पर तत्काल कोई टिप्पणी नहीं की है। इंपोर्ट अलर्ट की वजह से रैनबैक्सी एफडीए रेगुलेटेड दवाएं मोहाली प्लांट में नहीं बना पाएगी। ही उन्हें उस समय तक अमेरिकी मार्केट में बेच पाएगी, जब तक कि कंपनी का मेथड, फैसिलिटी और कंट्रोल अच्छी मैन्युफैक्चरिंग स्टैंडर्ड के मुताबिक हों। मोहाली प्लांट पर लगी पाबंदी के बाद सोमवार को रैनबैक्सी के शेयर 30 फीसदी से ज्यादा गिरे थे। अब रैनबैक्सी के भारत में सभी तीनों प्लांट पाबंदी के दायरे में गए हैं। इन प्लांट्स से ही अमेरिका को दवा की सप्लाई की जाती थी। यूएस एफडीए ने पिछले साल सितंबर और दिसंबर में प्लांट की जांच की थी।
डॉक्युमेंट्स में कहा गया है कि जांच के दौरान एफडीए ने पाया कि टैबलेट में जो 'काला रेशा' है, शायद वह मशीन के नोजल हेड पर लगा टेप का हिस्सा या कर्मचारी के बाजू का बाल है, जो मशीन लोडिंग के दौरान गिर गया। रैनबैक्सी ने मंगलवार को कहा था कि वह एफडीए इंपोर्ट अलर्ट के डिटेल्स की समीक्षा करेगी और जल्द से जल्द इस मुद्दे को सुलझाने की खातिर जरूरी कदम उठाएगी। रैनबैक्सी ने जारी बयान में कहा है, 'यूएसएफडीए ने रैनबैक्सी के मोहाली प्लांट का दौरा 2012 में किया था। जांच में कुछ चीजें सामने आई थीं। कंपनी का मानना है कि उसने मोहाली प्लांट में आगे कई सुधार किए हैं।' कंपनी मोहाली प्लांट से पिछले साल नवंबर से अमेरिकी मार्केट में दवाओं का एक्सपोर्ट नहीं कर पा रही है। पिछले साल नवंबर में कंपनी ने कोलेस्ट्रॉल घटाने वाली दवा लिपिटॉर के जेनेरिक वर्जन को रिकॉल किया था। एंजेल ब्रोकिंग के सेक्टर एनालिस्ट सरबजीत कौर का कहना है कि मोहाली प्लांट से अमेरिकी शिपमेंट पर लगी पाबंदी अप्रत्याशित है, क्योंकि यह प्लांट नया है और रैनबैक्सी के द्वारा फाइल की गई नई जेनेरिक दवाओं में इसकी 50 फीसदी के करीब हिस्सेदारी है।


कैडिला हेल्थकेयर (Cadila Healthcare) ने भारत में उतारी दवा

कैडिला हेल्थकेयर (Cadila Healthcare) ने भारत में नयी दवा पेश की है। कंपनी ने देश की पहली एनसीई (NCE) दवा लिपाग्लाइन (Lipaglyn) को बाजार में उतारा है। इस दवा का इस्तेमाल मधुमेह के इलाज में किया जाता है। एक गोली की कीमत 25.90 रुपये रखी गयी है। 
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अमेरिकी दवा प्रशासन ने रैनबैक्सी को जारी की चेतावनी
नई दिल्ली
-रैनबैक्सी लैबोरेटरीज को एक और झटका लगा है। अमेरिकी खाद्य एवं दवा प्रशासन (यूएसएफडीए) ने कंपनी के पंजाब के मोहाली संयंत्र में उत्पादित दवाओं के बारे में महत्वपूर्ण अलर्ट जारी किया है। यह अलर्ट मौजूदा बेहतर विनिर्माण व्यवहार के उल्लंघन के लिए जारी किया गया है। यूएसएफडीए की वेबसाइट पर उपलब्ध सूचना में हालांकि अलर्ट जारी करने का कारण नहीं बताया गया है।इसमें कहा गया है कि एफडीए की जांच में यह तथ्य सामने आया है कि कंपनी द्वारा मौजूदा बेहतर विनिर्माण व्यवहार नहीं अपनाया जा रहा है। इस बारे में संपर्क किए जाने पर रैनबैक्सी के प्रवक्ता ने कहा कि अभी तक यूएसएफडीए से हमेंकिसी तरह की सूचना नहीं मिली है। हम इस बारे उससे जानकारी लेने का प्रयास कर रहे हैं। कंपनी की वेबसाइट के अनुसार मोहाली संयंत्र में खाने वाली ठोस दवाओं का उत्पादन होता है।इस साल मई में रैनबैक्सी भारत में अपनी दो इकाइयों में कुछ मिलावटी दवाओं के विनिर्माण तथा वितरण के मामले में दोषी पाई गई थी और कंपनी ने अमेरिकी अधिकारियों को जुर्माने के रूप में 50 करोड़ डालर अदा करने की सहमति दी थी। इससे पहले यूएसएफडीए ने 2008 में रैनबैक्सी के मध्य प्रदेश के देवास तथा हिमाचल प्रदेश के पोंटा साहिब संयंत्र में उत्पादित 30 जेनेरिक दवाओं के आयात पर प्रतिबंध लगाया था। यह प्रतिबंध विनिर्माण नियमों के उल्लंघन के लिए लगाया गया था।

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री-लेबलिंग के लिए फार्मा कंपनियों को मिलेगी मोहलत  

नई दिल्ली-सरकार फार्मा कंपनियों को इसेंशियल ड्रग्स को री-लेबल करने के लिए एक महीने की मोहलत दे सकती है। ड्रग प्राइस कंट्रोल ऑर्डर (डीपीसीओ) 2013 के तहत कंपनियों को जरूरी दवाओं की कीमत रिवाइज करके मार्केट और डिस्ट्रिब्यूटर्स तक भेजने के लिए 29 जुलाई तक का वक्त मिला था। अब सरकार इसे एक महीने और बढ़ा सकता है। 
एक अधिकारी के मुताबिक, इसका यह मतलब नहीं है कि फार्मा कंपनियां इन दवाओं को पहले की तरह ऊंची कीमत पर बेचती रहेंगी। अधिकारी ने कहा, 'नए डीपीसीओ के तहत दवा कंपनियांे को रिवाइज्ड प्राइस लिस्ट टे्रडर्स के पास भेजनी होगी।' यह राहत सिर्फ 151 दवाओं के पहले सेट के लिए ही है। इस मामले में नोटिफिकेशन आने के बाद इंडस्ट्री ने कहा था कि कीमतों में बदलाव अगले बैच से लागू किया जाए, लेकिन सरकार ने उसकी मांग खारिज कर दी। 

फार्मा डिपार्टमेंट के टॉप अधिकारियों, फार्मा डिपार्टमेंट के सेक्रेटरी और नेशनल फार्मा प्राइसिंग अथॉरिटी के चेयरमैन ने बुधवार को दवा कंपनियों के साथ मीटिंग की। इसमें नए डीपीसीओ को लागू करने की मुश्किलों पर चर्चा की गई। यह बैठक ऐसे समय में हुई है, जब कई फार्मा कंपनियां नए ड्रग प्राइस कंट्रोल ऑर्डर को अदालत में चुनौती दे रही हैं। ड्रग प्राइस कंट्रोल ऑर्डर के तहत सरकारी नोटिफिकेशन के 45 दिनों के भीतर सभी जरूरी दवाओं की कीमतें रिवाइज होनी चाहिए। 

पिछले 15 दिनों में करीब दर्जन भर फार्मा कंपनियां और दो इंडस्ट्री बॉडी (इंडियन ड्रग मैन्युफैक्चरर्स एसोसिएशन और कन्फेडरेशन ऑफ इंडियन फार्मा इंडस्ट्री) ने दिल्ली हाई कोर्ट में सरकारी नोटिफिकेशन के 45 दिनों के भीतर सभी जरूरी दवाओं की कीमतें रिवाइज करने के ऑर्डर को चुनौती दी है। बैठक में शामिल होने वाले इंडियन ड्रग मैन्युफैक्चरर्स एसोसिएशन के सेक्रेटरी जनरल दारा पटेल ने कहा, 'फार्मा डिपार्टमंेट के सेक्रेटरी ने हमारी बातें सुनीं। उन्होंने कहा कि नए ड्रग प्राइस रिजीम का फायदा कंज्यूमर तक जल्द से जल्द पहुंचना चाहिए।' उन्होंने हमें भरोसा दिलाया कि फिलहाल दवा कंपनियों के खिलाफ सख्त कार्रवाई नहीं की जाएगी। हालांकि, उन्होंने यह भी कहा कि कंपनियां डीपीसीओ को आसानी से लागू कराने के लिए रिवाइज प्राइस लिस्ट स्टॉकिस्ट और डिस्ट्रिब्यूटर को भेजे। कोर्ट ने भी सरकार को कहा है कि वह उन कंपनियों के खिलाफ कोई कार्रवाई ना करे, जिन्होंने कोर्ट का दरवाजा खटखटाया है। हालांकि, अदालत ने कंपनियांे को भी यह कहा है कि वे जरूरी दवाओं की रिवाइज प्राइस लिस्ट डिस्ट्रिब्यूटर को भेज दें। 
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ग्लैक्सो फार्मा (Glaxo Pharma) की बिक्री मामूली घटी
9-8-2013

पिछले साल की समान अवधि में यह 164 करोड़ रुपये रहा था। इस तरह कंपनी के मुनाफे में 30% की गिरावट आयी है।
अप्रैल-जून 2013 तिमाही में कंपनी की कुल कामकाजी आय भी 2% घट कर 645 करोड़ रुपये हो गयी है, जबकि बीते वर्ष की इसी तिमाही में यह 660 करोड़ रुपये दर्ज हुई थी।
इस दौरान कंपनी की शुद्ध बिक्री 2% घट कर 637 करोड़ रुपये रही है, जो कि पिछले साल की समान अवधि में 652 करोड़ रुपये रही थी।शेयर बाजार में कंपनी के शेयर भाव में गिरावट का रुख है। बीएसई में दोपहर 1:31 बजे 2.37% के नुकसान के साथ 2,335.25 रुपये पर है  
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शासुन फार्मा को 6.6 करोड़ रु का घाटा



वित्त वर्ष 2014 की पहली तिमाही में शासुन फार्मा को 6.6 करोड़ रुपये का घाटा हुआ है। वित्त वर्ष 2013 की पहली तिमाही में कंपनी को 13.8 करोड़ रुपये का मुनाफा हुआ था।

वित्त वर्ष 2014 की पहली तिमाही में शासुन फार्मा की बिक्री 13.5 फीसदी घटकर 216.7 करोड़ रुपये रही। वित्त वर्ष 2013 की पहली तिमाही में कंपनी की बिक्री 250.6 करोड़ रुपये रही थी।
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प्लेथिको फार्मा के खिलाफ ईडी की जांच शुरू

फार्मा कंपनी प्लेथिको फार्मा के खिलाफ एनफोर्समेंट डायरेक्टोरेट ने जांच शुरू कर दी है। उसे शक है कि यहां सत्यम जैसा बड़ा घोटाला निकल सकता है। कंपनी पर आरोप है कि वो सत्यम की तरह बढ़ा-चढ़ा कर टर्नओवर दिखा रही है। यही नहीं कंपनी पर गैरकानूनी तरीके से टर्नओवर करने के साथ ही मनी लॉन्डरिंग के भी आरोप हैं।प्लेथिको फार्मा जांच के घेरे में आ गई है। कंपनी पर मनी लॉन्ड्रिंग के गंभीर आरोप लगे हैं जिसके तहत कहा गया है कि विदेश में प्रोमोटर कंपनियों को गलत तरीके से रकम भेजी गई है।जांच में कंपनी के कांडला पोर्ट से एक्सपोर्ट में फेमा के उल्लंघन का मामला सामने आया है। वहीं आरोप हैं कि कंपनी ने 670 करोड़ रुपये के बजाए टर्नओवर 1550 करोड़ रुपये दिखाया है। कंपनी पर बैलेंसशीट में गड़बड़ करके शेयर चलाने का आरोप लगा है।जांच में आरोप लगाए गए हैं कि प्लेथिको फार्मा ने 2004-05 में अपनी ही रूस की कंपनी रेजलोव का टेकओवर किया था। रेजलोव को प्रोमोटर के रिश्तेदार ही चलाते हैं। रेजलोव के लिए दिए गए 1.5 करोड़ डॉलर की रकम गैर कानूनी ढ़ंग से दी गई। इसके अलावा प्लेथिको फार्मा ने अपनी ही दुबई की कंपनी ट्रीकॉन में हिस्सेदारी ली और ट्रीकॉन के 20 फीसदी के हिस्से के लिए 2 करोड़ डॉलर दिए।
इसके अलावा प्लेथिको की दुबई सब्सिडियरी को प्लांट के लिए 4 करोड़ डॉलर भेजे गए जबकि दुबई सब्सिडियरी के कागजात जाली हैं और प्लांट की जमीन के लिए भी कारार नहीं हुआ है।
इन आरोपों पर प्लेथिको फार्मा का जवाब है कि कंपनी ने टर्नओर बढ़ाकर नहीं दिखाया है और कुल कारोबार में सभी सब्सिडियरीज का टर्नओवर शामिल किया है। प्लेथिको ने फेमा कानून का उल्लंघन नहीं किया और सभी निवेश नियमों का पालन किया है।
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एफआईपीबी ने फार्मा के 6 प्रस्ताव मंजूर किए

नई दिल्ली : विदेशी निवेश संवर्धन बोर्ड यानी एफआईपीबी ने दवा क्षेत्र में 855 करोड़ रपये के 6 प्रस्तावों को मंजूरी दी जिसमें फ्रेसेनियस काबी का एक प्रस्ताव शामिल है।सूत्रों ने कहा कि आर्थिक मामलों के सचिव अरविंद मायाराम की अध्यक्षता में हुई एफआईपीबी की बैठक में सिंगापुर स्थित दवा कंपनी फ्रेसेनियस काबी के प्रस्ताव को मंजूरी दे दी। कंपनी 349 करोड़ रुपये का एफडीआई लाएगी।एफआईपीबी ने लोटस सर्जिकल के 150 करोड़ रपये, कैलिक्स केमिकल्स एंड फार्मा के 200 करोड़ रुपये और सिंगापुर स्थित स्मिथ एंड नैफ्यू के 142 करोड़ रुपये के प्रस्तावों को भी मंजूरी प्रदान की।
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भारतीय फार्मा कंपनियों ने अमेरिकी नियम तोड़े तो होगी कार्रवाई

नई दिल्ली। नियमों के पचड़े में लगातार फंस रहीं भारतीय फार्मा कंपनियों को अमेरिकी दवा नियामक एफडीए ने कड़ी कार्रवाई की चेतावनी दी है। नियामक ने कहा है कि दूसरे देशों में गंदगी, कीटनाशक और कीड़े पाए जाने पर ज्यादा ध्यान नहीं दिया जाता। मगर कंपनियों ने अमेरिका में उत्पादन गुणवत्ता पर ध्यान नहीं दिया तो उन्हें परेशानी का सामना करना होगा।एफडीए के प्रवक्ता क्रिस्टोफर सी. केली ने बताया कि भारत से पूरी दुनिया को सस्ती एवं गुणवत्तापूर्ण दवाएं मिल रही हैं। हम बस इतना चाहते हैं कि वे अमेरिकी नियमों को समझे और उसी हिसाब से उत्पादन करें। कई भारतीय कंपनियां अमेरिकी नियमों का पालन कर रही हैं। जब भी हम कोई शिकायत उठाते हैं तो वे उसका समाधान लेकर सामने आते हैं। दूसरी कंपनियों को भी उत्पादन गुणवत्ता पर ध्यान देने की जरूरत है। उन्होंने कहा कि लगातार ऐसी गलतियां करने वाली कंपनियों को कड़ी कार्रवाई से बचना मुश्किल होगा। भारतीय दवा कंपनियों के लिए अमेरिका दूसरा सबसे बड़ा बाजार है। एफडीए ने पिछले कुछ महीनों में कई भारतीय दवा कंपनियों को चेतावनी दी है, उन्हें दवा वापस लेने का आदेश दिया है और जुर्माना भी लगाया है। इसी महीने दो कंपनियों वॉकहार्ट और फ्रेसेनियस कबी को चेतावनी पत्र भेजे गए हैं।होस्पाइरा हेल्थकेयर और आरपीजी लाइफ साइंसेज को चेतावनी पत्र मई में भेजे गए थे। पिछले हफ्ते एफडीए ने दुनियाभर की 15 कंपनियों पर कार्रवाई शुरू की थी। इनमें गुजरात की अमृताम लाइफ केयर भी शामिल है। कंपनी की डायबिटीज की आयुर्वेदिक दवा की बिक्री को अवैध ठहराया गया है। इसके अलावा रैनबैक्सी, कैडिला, डॉक्टर रेड्डीज लैब, सन फार्मा, ग्लेनमार्क और अरबिंदो फार्मा पर विभिन्न मामलों में कार्रवाई चल रही है।
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शक के दायरे में भारतीय फार्मा कंपनियां

नई दिल्ली। अब फ्रेसेनियस काबी अमेरिकी ड्रग रेगुलेटर के शक के दायरे में आ गई है। अमेरिकी एफडीए ने फ्रेसेनियस काबी को बंगाल के यूनिट को लेकर चेतावनी जारी की है। अमेरिकी एफडीए ने कंपनी से अतिरिक्त जानकारी और सुधार की मांग की है। कुछ ही दिन पहले यूके के ड्रग रेगुलेटर ने वॉकहार्ट के औरंगाबाद के करीब वेलुज प्लांट पर इंपोर्ट अलर्ट जारी किया था।रैनबैक्सी ने अमेरिकी एफडीए के साथ ड्रग सेफ्टी के झूठे दावे के मामले को 2880 करोड़ रुपये में निपटाया है। कंपनी के पोंटा और देवास प्लांट में गड़बड़ी सामने आई थी। वहीं, कंपनी के खिलाफ भारत में मिलावटी दवा बेचने के कोई सबूत नहीं मिले। हैरानी की बात है कि भारतीय ड्रग रेगुलेटर को कोई गड़बड़ी नहीं मिल रही है।कॉनेक्सस सोशल रिस्पॉन्सिबिलिटी सर्विसेज के मैनेजिंग पार्टनर, केवल हांडा का कहना है कि 97 फीसदी अमेरिकी कंपनियों का ऑडिट किया जाता है और 7 फीसदी ही विदेशी कंपनियां का ऑडिट किया जाता है। रैनबैक्सी मामले के बाद अंतर्राष्ट्रीय कंपनियों की ओर रवैया कड़ा हो गया है। लेकिन, ऐसा नहीं है कि सिर्फ भारतीय कंपनियों को ही निशाना बनाया जा रहा है।
केवल हांडा के मुताबिक भारत में कंपनियों ऑडिट ठीक से नहीं किया जाता है। देश और विदेश में जेनेरिक दवाओं के एप्रूवल में काफी फर्क है। इसके अलावा एक्सपोर्ट और घरेलू बाजार के लिए बनाई दवाओं के लिए अलग-अलग स्टैंडर्ड इस्तेमाल किया जाता है, क्योंकि घरेलू बाजार में दवाओं की कीमतें कम है।
केवल हांडा का मानना है कि इस तरह के मामलों से घरेलू फार्मा सेक्टर के निवेश पर असर पड़ सकता है। विदेशी निवेशकों के मन में सवाल उठेंगे कि वो जिस घरेलू कंपनी में पैसा लगा रहे हैं या करार कर रहे हैं उसकी दवाओं की क्वॉलिटी में कोई खामी तो नहीं है।
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एल्डर फार्मा का कारोबार खरीदेगी सनोफी-कार्लाइल!

सनोफी एसए की भारतीय इकाई और कार्लाइल समूह भारत की एल्डर फार्मास्युटिकल्स के देसी दवा कारोबार खरीदने के लिए अलग-अलग बातचीत कर रही है। इस प्रगति पर नजर रखने वाले सूत्रों ने कहा कि ये कंपनियां 40-50 करोड़ डॉलर में सौदा कर सकती हैं। सूत्रों ने कहा कि सौदे पर अगले महीने के शुरुआत में हस्ताक्षर हो सकते हैं। इस अधिग्रहण से सनोफी इंडिया लिमिटेड (फ्रांस की सनोफी की स्थानीय इकाई) को भारतीय जेनेरिक बाजार में अपने कदमों का विस्तार करने में मदद मिलेगी, जिसका योगदान 13 अरब डॉलर के देसी दवा उद्योग की बिक्री में 90 फीसदी से ज्यादा है।
सनोफी और कार्लाइल ने इस पर टिप्पणी करने से इनकार कर दिया, जबकि एल्डर फार्मा ने भी कोई टिप्पणी नहीं दी। एल्डर फार्मा ने 11 जुलाई को कहा था कि बोर्ड ने कंपनी के कारोबार के पुनर्गठन को मंजूरी दे दी है और इसके तहत कर्ज घटाने के लिए पूंजी की उगाही, संपत्ति की बिक्री या अन्य रणनीतिक कदम उठाए जा सकते हैं
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