Saturday, May 27, 2017

बढ़ते कदम: भारत ने घटिया (substandard) और नकली (counterfeited) दवाएँ एवं वैक्सीन बनाने में सबको पछाड़ा: How India become Number one?

How India become Number one?
बढ़ते कदम: भारत ने घटिया (substandard) और नकली (counterfeited) दवाएँ एवं वैक्सीन बनाने में सबको पछाड़ा
To keep an eye on officially declared substandard drugs in India, keep an eye on https://cdsco.gov.in/opencms/opencms/en/Notifications/Alerts/
Do you know who are producing NSQD Antibiotics in India? Download here full list (Jan 2013 to March 2018) of Producers Antimicrobial drugs of non-standard (Substandard) Quality. https://www.researchgate.net/profile/Bhoj_Singh/post/How_serious_is_the_problem_of_Substandard_Antibiotics_old_in_India

To Read in English:
1. https://www.researchgate.net/publication/317715214_Why_India_Failed_to_Penalize_those_Responsible_for_the_Circulation_of_Substandard_Medicines_and_Vaccines_while_China_Succeeded?_


दुनिया में लगभग 200 बिलियन डालर का घटिया और नकली दवाओं एवं वैक्सीन का धंधा है और एशिया में बिकने वाली 30% दवाएँ नकली या घटिया हैं. और भारत में बिकने वाली हर पाँच गोलियों के पत्तों में में से एक नकली है. इन दवाइयों से हर वर्ष लगभग 5% धनहानि देश को होती है और ये धंधा रोज ब रोज असली दवाइयों के व्यापार से भी ज़्यादा तरक्की कर रहा है, लगभग 10% की दर से.
दो वर्ष पहले के सर्वे से पता चला है कि एशिया घटिया और नकली दवाइयों का सबसे बड़ा उत्पादक है. भाई एशिया तो शायद चीन, परंतु चीन तो भारत के सामने बच्चा निकला. कुल 75% हिस्से के साथ भारत पहले, 7% हिस्से के साथ ईजिप्ट दूसरे और चीन तीसरे (6%) स्थान पर है. चलो भारत ने कहीं तो चीन से बाजी मारी.
नकली दवाइयों और वैक्सीनों से हर वर्ष लगभग 10 लाख लोग काल के गाल में समा जाते हैं, शायद किसी भी युद्ध या आतंकवाद से ज़्यादा. तो देखा भारत के एक दाव ने कैसे ठिकाने लगा दिया युद्धप्रिय और आतंकवादी देशों को, तभी तो भारत महान है.
भारत के स्वास्थ्य मंत्रालय की माने तो भारत में 5% दवाएँ चोर दरवाजे वाली एवं 0.3% नकली हैं. दिल्ली के चाँदनी चौक में भागीरथ पैलेस इन नकली और घटिया दवाइयों का विख्यात अड्डा है. भारत के दवाइयों के 40,000 करोड़ के बाजार में 20% हिस्सा सिर्फ़ इन्ही नकली और घटिया दवाइयों का है.

भारत में क्यों फल फूल रहा है नकली और घटिया दवाइयों का धंधा: भारत दुनिया के हर देश को बढ़िया से बढ़िया और उत्तम दवाएँ उपलब्ध कराता है परंतु अपने नागरिकों को क्यों नहीं.  भारत की कुछ नामी दवा कंपनियों के CEO ने एक अंतरंग बातचीत में बताया था कि भारत में उच्च गुणवत्ता की दवाएँ एवं वैक्सीन सप्लाई करने में सबसे बड़ी बाधा मनुष्य्यों एवं पशुओं के स्वास्थ्य बजट का नगण्य होना है. दूसरा बड़ा कारण है सरकारी खरीदारी में गुणवता पर एल-1 का भारी होना. और भी कई कारण हैं जैसे कि कुकरमुत्तों की तरह बढ़ती दवा कंपनियों की तादाद, कमजोर नियमन तथा उससे भी बुरा क़ानूनों का लागू होना, दवाइयों की बढ़ती कीमतें, टैक्स दर टैक्स, बिना लाइसेन्स के डाक्टरी, बिना प्रेस्क्रिप्सन के दवाइयों की बिक्री, जनता की अज्ञानता, क़ानून की कमज़ोरी, क़ानून की बदलती व्याख्याएँ, लंबी क़ानूनी प्रक्रिया, न्याय में देरी, न्याय में अन्याय, न्याय में धन-बल, बाहू-बल और राजनीतिक बल का बढ़ता प्रभुत्व, धर्म-जाती-समुदाय आदि से बदलता न्याय का स्वरूप आदि. और इन सबसे बढ़कर हमारा लंगड़ा लोकतंत्र जिसमें हर बुरा काम करने की आज़ादी है और हर भला काम करने में अड़ंगे हैं, जहाँ हर अच्छा और बुरा काम कराने की फीस लगती है. भारत के स्वास्थ्य मंत्रालय ने भी इसे स्वीकार किया कि ड्रग एवं कास्मेटिक एक्ट को प्रभावी ढंग से लागू करने में तमाम बाधाएँ है, परंतु उनसे कोई (परंतु कौन) पूछे कि भाई ऐसे क़ानून को बदलने में क्या बाधा है.

घटिया और नकली दवाएँ और वैक्सीन बनाने एवं बेचने वालों को सज़ा के मामले में भारत के बढ़ते कदम:  अभी कुछ दिन पहले ही एक मुँह पका खुर पका रोग (FMD) की वैक्सीन बनाने वाली कंपनी के उत्पाद के काफ़ी नमूने घटिया स्तर के पाए गये, उसपर कार्यवाही क्या हुई: हरयाणा सरकार ने उसके ऑर्डर कैंसिल कर दिए, पूरे भारत में एक छोटा सा राज्य, कंपनी को क्या सज़ा हुई, कुछ नहीं.
तीन साल पहले भारत में FMD वैक्सीन बनाने वाली सभी कंपनियों के नमूने खराब गुणवत्ता के मिले थे पर कार्यवाही वही ढाक के तीन पात. लीपापोती, जाँच और जाँच में पहली जाँच को ग़लत सिद्ध करना आदि.
केरल के कन्नूर जिले में (2003) घटिया रैबीज वैक्सीन सालों लगती रही, लोग बचने के बजाय मरते रहे, जाँच में घटिया पाए जाने पर भी ना बनाने वाले, ना खरीदने वाले और ना लगाने वालों का बाल बांका हुआ परन्तु कितने ही भारत के बांके असमय ही काल-कवलित हो गये.
सन् 2013 में पता लगा की हिमाचल के एक सरकारी अस्पताल में पिछले 5 साल में लगभग 8000 लोग घटिया ऐंटी-बायोटिक लगने के चलते स्वर्ग सिधार गये, किसी का कुछ बिगड़ा क्या, आपको पता हो तो बताना शायद स्वर्गवासी आत्माओं को कुछ शांति मिले.
अरुणाचल प्रदेश में और मध्य प्रदेश में हज़ारों करोड़ की 33 नकली दवाएँ वर्षों तक खरीदी गईं, ज़रूर कोई तगड़ी प्लानिंग होगी, परंतु जाँच के बाद भी क्या हुआ, राम जाने.
सन्  2016 में CDSCO ने बताया कि 6 नामी कंपनियों (सिप्ला, इप्का लैब्स, एल्केम लैब्स, मॉरीपेन लैब्स, अब्बोट और सनोफि) की 181 दयाएँ घटिया पाई गईं, पर किया क्या. कंपनियों ने बाजार से अपनी घटिया दवाएँ वापस मंगाकर भारत की जनता पर भारी ऐहसान किया.
पिछले एक दशक में कितनी ही बार घटिया और नकली दवाओं के चलते कितने ही लोग मारे गये, कितनी ही बार ऐसी दवाएँ देश के हर कोने में पकड़ी गईं पर हुआ क्या, किसी को पता नहीं क्योंकि जब तक न्याय मिलेगा तब तक तो न्याय की तलाश में भटकने वाले इस दुनिया से विदा हो चुके होंगे.

भारत में नकली और घटिया दवाइयों के व्यापार कंट्रोल के लिए मशहूर गुजरात मॉडेल: गुजरात मॉडेल खूब सराहा गया है भारत के चहुमुखि विकास के लिए, फिर नकली दवाइयों के लिए क्यो नहीं. सरकार का कहना है कि इस मॉडेल के प्रयोग से जल्दी ही भारत नकली और घटिया दवाइयों से मुक्त होगा. गुजरात में 2013-14 में 567, 2014-15 में 516 और 2015-16 सिर्फ़ 448 नमूने ही नकली दवाइयों के थे जो पकड़े गये. भाई काफ़ी तरक्की की है, पर पकड़ के क्या किया, सज़ा मिली क्या किसी को या फिर 2116 का इंतजार है, तब तक तो वैसे ही रामराज्य आ जाना है.

भारत में अपराधी क्यूँ बच निकलते हैं: क्या क़ानून कमजोर हैं? क्या क़ानून का डर नहीं है? कि कोई क़ानून लागू करने वाला नहीं हैं? या कोई क़ानून मानने वाला नहीं है? भारत के क़ानून में नकली दवाइयों का धंधा करने के लिए कम से कम 10 साल की सज़ा है और मृत्यु दंड का भी प्रावधान है. परंतु आपकी जानकारी में है क्या कोई केस (इसके बावजूद कि भारत नकली दवाइयों के धंधे में दुनिया में नंबर वन है) जब किसी नकली दवा निर्माता या विक्रेता को फाँसी की सज़ा मिली हो या 10 साल की जेल हुई हो (पता चले तो ज़रूर बताना, मन को तसल्ली होगी). भारत की संसद ने भी (2012) माना कि भाई भारत में करप्सन एक गंभीर समस्या है जिसका कोई हल दूर तक नज़र नहीं आता जिसके चलते अपराधी हर फंदे को ऐसे चबा जाते हैं जैसे चुन्गम चबा लिए हों.
जिस देश में संसद पर हमला करने वालों को, दिन और रात आतंक फैलाने वाले दरिंदों को बचाने के लिए वकीलों की फौज हर वक्त हाजिर हो और सुप्रीम कोर्ट रात को 12 बजे भी खुलने को तैयार हो, वहाँ तेरे मेरे भारतजन की कौन बिसात है, भाई यहाँ हमेशा से गद्दारों का राज रहा है और रहने वाला भी लगता है.
सरकार को पता है कि नकली दवाइयों को बनाने वाले, बेचने वाले कौन हैं और दिल्ली में ही सरकार की नाक के तले बैठे हैं परंतु पता नहीं सरकार को कार्यवाही करने में क्यूँ  शर्म आ रही है, शायद वे सरकार के भी जेठ हैं, या कहीं खुद सरकार ही तो नहीं हैं. क्या भारत में कोई ईमानदार बचा ही नहीं या ईमानदारी एक ढकोसला है या ईमानदारी कमजोर है या फिर कुछ और ही राज की बात है.

नकली दवाइयों के धंधे में पिछड़े चीन का हाल: सन् 2016 में चीन में नकली दवाइयों के धंधे में लिप्त 202 व्यपारियों को और 357 उनकी सहायता करने वाले अधिकारियों को कठोर कारावास की सज़ा दे दी गई. शायद आज़ाद भारत के संपूर्ण इतिहास में भी इस धंधे में लिप्त इतने लोगों को सज़ा ना मिली हो. पिछले वर्ष ही (शर्मा, 2016) डेली मेल में लंदन और दिल्ली से एक खबर छपी थी कि भारत में ईमानदारी की सज़ा कैसी होती है, नकली दवा बनाने वालों का नाम उजागर करने वालों का क्या हश्र होता है और नकली को असली सिद्ध करने वाले कैसे रातों रात कुलपति बनकर देश में शिक्षा और विज्ञान को दिशा और दशा देते हैं.
सन् 2007 में चीन के खाद्य और स्वास्थ्य विभाग के मुखिया (झेंग झीयाऊ) को दो महीने की सुनवाई के बाद सीधे फाँसी की सज़ा इसलिए दे दी गई क्योंकि उन्होने बिना टेस्टिंग के ही कई कंपनियों की दवाइयों को बिकने दिया था. इससे उन्हे अंतरराष्ट्रीय स्तर पर एक न्यायशील राष्ट्र और सही दवाएँ बेचने वाले राष्‍ट्र की छवि बनाने में सहयोग मिला. अपनी छवि को और सुधारने के लिए चीन अमेरिका और ब्रिटेन से भी दवाइयों की गुणवत्ता सुधारने के लिए सहयोग बढ़ा रहा (वैसे भारत जैसी कोई दोस्ती उसकी ना अमेरिका से है ना ब्रिटेन से). फिर भी चीनी लोगों ने कहा कि चीन में क़ानून कमजोर है इतने सारे लोगों की जिंदगी से खेलने वाले को इतनी आसान मौत. दूसरी तरफ मेरा भारत महान है जिसके वैक्सीन टेस्ट करने वाले संस्थान ने ना जाने कितने हज़ार नमूने बगैर जाँच के ही पास कर दिए, कितने हज़ारों की जाँच अधूरी की या ऐसे की कि हर फेल भी पास हो जाए (सिंह, 2016), जैसे कि बिहार में अपना नाम ना लिख पाने वाले भी पिछले दिनो परीक्षा में टॉप कर गये थे. परंतु यहाँ तो हाल ही निराला है, हर वैक्सीन पास करने वाला जाने कितनों को पछाड़ कर सबसे आगे अजेय होकर क्या से क्या हो गया. मेरा भारत महान है, महान था, महान रहेगा. जय हिंद, चलो कहीं तो हमने दुनिया में नंबर वन पाया. वैसे भारत एक और काम में भी नंबर वन है, खाल खींचने में, जैसे कि दूध उत्पादन, चमड़ा उत्पादन, बड़े बड़ों की खाल खींच डाली है. परंतु इसके बारे में फिर कभी.

सन्दर्भ:

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2.       Hays J. 2012. DRUG MAKERS, VACCINES, FAKE DRUGS AND DRUG SAFETY IN CHINA. http://factsanddetails.com/china/cat13/sub83/item2275.html

3.        http://m.timesofindia.com/city/thiruvananthapuram/Anti-rabies-vaccine-substandard-KGPA/amp_articleshow/40090240.cms

4.       Indian Ministry of Health and Family Welfare (Government of India). 2003. A Comprehensive Examination of Drug Regulatory Issues, including the Problem of Spurious Drugs.
5.        Ossola A. 2015. The fake drug industry is exploding, and we can’t do anything about it. http://www.newsweek.com/2015/09/25/fake-drug-industry-exploding-and-we-cant-do-anything-about-it-373088.html
6.       Parliament of India. 2012. The Functioning of the Central Drugs Standard Control Organisation (CDSCO).
7.       Pharmaletter (2008) Largest Fake Drug Haul in Europe from India. http://www.thepharmaletter.com/file/60856/largest-fake-drug-haul-ineurope-from-india.html PSI

8.       PTI. 2003. Anti-rabies vaccine substandard: KGPA

9.       Sharma Dinesh C. 2016. How India punishes those who exposes corruption. http://www.dailyo.in/politics/foot-and-mouth-disease-br-singh-whistle-blowers-scam-veterinary-scientist/story/1/10929.html

10.    Singh, BR et al. 2014. Testing of FMD Vaccine (intended to be used under FMD-CP of Govt of India) at CCS NIAH, Baghpat (UP) India. https://www.researchgate.net/publication/267705649_Testing_of_FMD_Vaccine_intended_to_be_used_under_FMD-CP_of_Govt_of_India_at_CCS_NIAH_Baghpat_UP_India?_iepl%5BviewId%5D=sTqGzucwKlnEjnpx39jeyqXz&_iepl%5BprofilePublicationItemVariant%5D=default&_iepl%5Bcontexts%5D%5B0%5D=prfpi&_iepl%5BtargetEntityId%5D=PB%3A267705649&_iepl%5BinteractionType%5D=publicationTitle

11.    Singh, BR. 2016. Treachery with India: vaccine testing at ICAR-IVRI. https://www.blogger.com/blogger.g?blogID=6638451428693957679#editor/target=post;postID=4152191037779192738;onPublishedMenu=allposts;onClosedMenu=allposts;postNum=24;src=postname

12.    Southwick N. 2013. Counterfeit Drugs Kill 1 Mn People Annually: Interpol. http://www.insightcrime.org/news-briefs/counterfeit-drugs-kill-1-million-annually-interpol

13.    The Pharma Letter. 2016. Indian government moves to tackle substandard drugs. https://www.thepharmaletter.com/article/indian-government-moves-to-tackle-substandard-drugs

14.    Verma S., Kumar R. and Philip P.J. 2014. The Business of Counterfeit Drugs in India: A Critical Evaluation. International Journal of Management and International Business Studies. 4, 141-148. https://www.ripublication.com/ijmibs-spl/ijmibsv4n2spl_04.pdf.

15.    WHO. 2006. Counterfeit Medicines: an update on estimates. http://www.who.int/medicines/services/counterfeit/impact/TheNewEstimatesCounterfeit.pdf.

Monday, May 8, 2017

Why the Department of Agriculture and Farmers Welfare, New Delhi is silent over the ongoing corruption in Animal Disease control?

Why the Department of Agriculture and Farmers Welfare, New Delhi is silent over the ongoing corruption in Animal Disease control?

चुप सी क्यों लगी है, अजी कुछ तो बोलिये---मुंह पका खुर पका कण्ट्रोल प्रोग्राम क्यों १५ साल से झूला झूल रहा है, यदि केंद्रीय पशुपालन विभाग ये किसान-पशुपालकों को बता भी देगा तो वे उसका क्या बिगाड़ लेंगे, पशुपालकों के नाम पर कितने लोग घोटालेबाज और घोटाला पालक बन गए इससे पशुपालकों को फर्क भी क्या पड़ता है? फिर भी जानकारी होने में नुक्सान क्या है? शायद मन दुखी हो, या मन खुश हो, पर ये तो जानने के बाद ही पता चलेगा कि आप-------.

Department of Animal Husbandry, Dairying, and Fisheries, Ministry of Agriculture and Farmers Welfare, New Delhi is cheating livestock owner and administrators by saying that in Uttar Pradesh there is no Foot and Mouth Disease since several years. The truth is, FMD has devasted not only livestock owners in several districts (Bulandshahar, 2015) but also the government farms as Indian Veterinary Research Institute, Izatnagar (2016) and Military Dairy Farm, Meerut (2016). But in recording everything has been dumped.
  केंद्रीय कृषि मंत्रालय का पशु पालनडेरी और मतस्य पालन विभाग कैसे और कबसे धोखा दे रहा है देश कोमुंह पका खुर पका रोग के प्रकोप हर वर्ष होते हैं परन्तु विभाग कहता है पिछले कई वर्षों से उत्तर प्रदेश में ये रोग है ही नहींगौ अनुविश्व विद्यालय मथुरा भी कह रहा है कि ये रोग २०१५ में बुलंदशहर में फैला (https://www.researchgate.net/publication/316356043_Investigation_of_FMD_Outbreak_in_District_Bulandsahar_Uttar_Pradesh_India)भापशु चिकित्सा अनुसंसंस्थानबरेली में (https://www.researchgate.net/publication/306324222_Epidemiology_and_Statistics_of_Indian_Veterinary_Research_Institute_Dairy_during_Foot_and_Mouth_Disease_FMD_Outbreak_in_January-February_2016?_iepl%5BviewId%5D=R424kXdyu1TbQGqcFb7NeFiP&_iepl%5BprofilePublicationItemVariant%5D=default&_iepl%5Bcontexts%5D%5B0%5D=prfpi&_iepl%5BtargetEntityId%5D=PB%3A306324222&_iepl%5BinteractionType%5D=publicationTitle), और मिलिट्री डेरी फार्म मेरठ में भी ये रोग २०१६ में फैलापरन्तु पशु पालनडेरी और मतस्य पालन विभाग दिल्ली कहता है कि प्रमें ये रोग कई वर्षों से नहीं हुआ.
कैसा खेल है किसानो को धोखा देने का और घटिया वैक्सीन के निर्माताओं को लाभ पहुंचाने कापरन्तु यहाँ तो यहाँ, प्रधानमंत्री ऑफिस में भी सुनने वाला कोई नहीं.
Deceivers of India: Deceiving by GOI Committee and False Affidavit in High-Court
After proper testing when CCS NIAH Baghpat reported that the vaccine used under FMD control program (FMD CP) of Government of India is of substandard quality (https://www.researchgate.net/publication/267705649_Testing_of_FMD_Vaccine_intended_to_be_used_under_FMD-CP_of_Govt_of_India_at_CCS_NIAH_Baghpat_UP_India?_iepl%5BviewId%5D=NlTGk5bgqVrLhfkuDcN0CJMx&_iepl%5BprofilePublicationItemVariant%5D=default&_iepl%5Bcontexts%5D%5B0%5D=prfpi&_iepl%5BtargetEntityId%5D=PB%3A267705649&_iepl%5BinteractionType%5D=publicationTitle), the GOI committee was constituted by Indian Council of Agricultural Research on 10th November 2014, chaired by Dr. Gaya Prasad, members were Dr. B. Pattnaik and Dr. Ravinder Sharma (Annexure 1). Retesting of the disputed vaccine was done at Standardization Division of IVRI, Izatnagar. Testing completed on 6th February 2015 (Annexure 2 at point 4). The report from Standardization Division was submitted on 7th February 2015 (Annexure 3).

Forgery by the Committee:
The GOI committee submitted its report on 12th January 2015, mentioning that all old and fresh batches of the vaccine passed in the testing at IVRI (Annexure 4, page marked 52, Point 1 para 2).
The GOI Expert Committee report was deposited by the First Respondent no. 1  (Annexure 5) in a PIL at High Court Allahabad, Lucknow Bench (PIL 12586 of 2014 (M/B) as Annexure CA-9 quoting that the report has been accepted by DG, ICAR (Annexure 6)
              By the documents it is clear that the GOI expert committee lied in their report and submitted the report 25 days before testing was completed. The report was submitted to Court i.e., tried to bluff the Honorable Court too.
At IVRI, report was written three times (Annexure 7), two times before compelition of testing (on 6th February 2015). Retesting of disputed FMD vaccine batches at IVRI is itself another big scam in vaccine testing. As per RTI information (Annexure 8)
a.        Samples tested at CCS NIAH were not tsted by the committee.
b. Reserve copy of the samples tested at CCS NIAH available at IVRI, Bengaluru was also not tested by the committee.
c. Defying all the rules, samples were collected a fresh directly providd by the producers of substandard vaccine rather than collection from state depots where vaccins were available, or from State veterinary Hospital where vaccine was being used or from the market.
d. Samples, if collected, were collected by unauthorized persons from inappropriate sites (directly from producers).
e.         Samples were never received at IVRI, Izatnagar as under RTI, IVRI failed to provide any proof of sample receipts in writing and also failed to show the samples physically.
f.         The samples were tested at IVRI, Izatnagar (an unauthorized place the to test quality of FMD vaccine) instead of IVRI, Bengaluru.

The GOI expert committee also approved addition of enrofloxacin (a fluoroquinolone) as preservative in FMD vaccine intended to be used in dairy animals. The parent company producing enrofloxacin prohibits its use in growing and dairy animals (https://www.researchgate.net/publication/303685698_Use_of_Enrofloxacin_as_Preservative_in_FMD_vaccine?ev=pubitem-pub_supplemented&_iepl%5BviewId%5D=LdonVvGtL3L40IMiq0A92vd508Paq1jwaFx4&_iepl%5Bcontexts%5D%5B0%5D=pdppi&_iepl%5Bdata%5D%5Bmilestone%5D=experimentMilestoneClickedToPublicationFromRelatedWithFulltext&_iepl%5BinteractionType%5D=publicationView). This prohibited because in age below 14 years in human it causes permanent damage to joints, ligaments, tendons and nerves and a child exposed to this drug may start to have epilepsy and he or she can never be an athlete. Probably it may be one of the reasons that India with 130 crores of people has no International athlete.

Why for this all criminal conspiracy? To bluff the country! To cheat the livestock owners of India! To benefit the traitors (supplying substandard vaccines) of India! To cripple the young India! Is it not terrorism? But, no body is ready to hear even the honest Government of India.

भारत के गद्दार: भारत सरकार की विद्वत समिति द्वारा धोखा और उच्च न्यायालय में जूठा हलफनामा
कुछ लोग कहते हैं कि सरकार के पास बहुत बड़े बड़े काम है, पर इस मुंह पका खुर पका रोग वैक्सीन घोटाले को छोटा मत समझो, सरकारी आंकड़ों के अनुसार मुंह पका खुर पका रोग से हरवर्ष 22 हजार करोड़ रुपये का चूना पशु पालकों को लग रहा है

उचित जाँच के उपरांत जब चौ. च. सिंह रा. पशु स्वा. संस्थान (CCS NIAH) बागपत द्वारा राष्ट्रीय मुंह पका खुर पका रोग नियंत्रण कार्यक्रम (FMDCP) में प्रयुक्त घटिया वैक्सीन को जब घटिया कहा (https://www.researchgate.net/publication/267705649_Testing_of_FMD_Vaccine_intended_to_be_used_under_FMD-CP_of_Govt_of_India_at_CCS_NIAH_Baghpat_UP_India?_iepl%5BviewId%5D=NlTGk5bgqVrLhfkuDcN0CJMx&_iepl%5BprofilePublicationItemVariant%5D=default&_iepl%5Bcontexts%5D%5B0%5D=prfpi&_iepl%5BtargetEntityId%5D=PB%3A267705649&_iepl%5BinteractionType%5D=publicationTitleतो उसके विरुद्ध भारत सरकार ने एक विद्वत समिति का गठन किया. जिसका अध्यक्ष डा. गया प्रसाद तथा सदस्य डा. बी पटनायक एवं डा. रविंदर शर्मा बनाये (Annexure 1). घटिया वैक्सीन की जाँच भा. पशु. चि. अनु. सं. संस्थान इज्जतनगर बरेली में जैव मानकीकरण विभाग में ६ फरवरी २०१५ तक हुई (Annexure 2)विभाग ने ७ फरवरी को अपनी रिपोर्ट ईमेल द्वारा डा. गया प्रसाद को भेजी (Annexure 3). यहाँ तक सब कुछ सही प्रतीत होता है.
समिति का खेल: समिति ने अपनी रिपोर्ट भा. पशु. चि. अनु. सं. संस्थान  की रिपोर्ट पहुँचाने से २५ दिन पहले ही १२ जनवरी २०१५ को जमा कर दी.  इस समिति की रिपोर्ट को इलाहाबाद हाई कोर्ट की लखनऊ पीठ में लंबित जनहित याचिका में मुख्य  अभियुक्त के नुमाइंदे द्वारा सबूत के तौर पर यह कहकर जमा कर दी कि इस रिपोर्ट को मान्य कर लिया गया है.  जबकि अभी भी यह रिपोर्ट विभाग में ही जांच के दायरे में है. इसके द्वारा पशु पालको को हानि और घटिया वैक्सीन निर्माताओं को लाभ के अलावा माननीय उच्च न्यायालय को भी धोखा दिया गया (Annexure 4, 5, 6).
भा. पशु. चि. अनु. सं. संस्थान में कि गई जाँच भी अपने आप के घोटाला है. वैक्सीन के ना तो वो नमूने जो CCS NIAH बागपत में टेस्ट किये गए थे और दुबारा टेस्टिंग के लिए उपलब्ध थे. नाही उन्ही बैच के वो प्रतिरूप जो भा. पशु. चि. अनु. सं. संस्थान बेंगलुरु में रखे गए थे टेस्ट किये गए. सभी नियमों को टाक पर रखकर नए उन नमूने की जाँच का नाटक किया गया जो सीधे कंपनियों द्वारा उपलब्ध कराये गए थे.जनसूचना अधिकार से प्राप्त जानकारी से पता चला कि सैंपलिंग उन लोगों से करवाई गई जो कानूनन सक्षम नहीं थेवहां से करवाई (सीधे कंपनी से सैंपल लिए) जहाँ से नहीं होनी चाहिए थीउस ढंग से करवाई जो कानूनन गलत है. और तो और उसकी जाँच वहां करवाई जहाँ जांच की ना सुविधा थी ना ही वो प्रयोगशाला उस जाँच के लिए अधिकृत थी (सिर्फ भा. पशु. चि. अनु. सं. संस्थान की बेंगलुरु प्रयोगशाला में ही इस वैक्सीन कि जांच करने की मान्यता है. (Annexure 7, 8).
इस वैक्सीन में एनरोफ्लोक्सासिन नामक एंटीबायोटिक को संरक्षण के लिए मिलाने को  इस विद्वत समिति ने अपनी इस रिपोर्ट में उचित बताया है. जबकि इस दवा को बनाने वाली कंपनी कहती है कि इसे संरक्षक के तौर परदुधारू पशुओं मेंबढ़वार कि आयु में नहीं दिया जा सकता क्योंकि इसके प्रभाव से १४ वर्ष की आयु से काम के बच्चों में जोड़ों और स्नायुओं को इतना नुक्सान पहुंचता है कि उन्हें मिर्गी दौरे आने शुरू हो सकते हैं और उनकी दौड़ने की छमता समाप्त हो जाती है . वैसे इस ग्रुप की और इस दवा के बच्चों में प्रयोग के और भी बहुत से नुक्सान हैं (https://www.researchgate.net/publication/303685698_Use_of_Enrofloxacin_as_Preservative_in_FMD_vaccine?ev=pubitem-pub_supplemented&_iepl%5BviewId%5D=LdonVvGtL3L40IMiq0A92vd508Paq1jwaFx4&_iepl%5Bcontexts%5D%5B0%5D=pdppi&_iepl%5Bdata%5D%5Bmilestone%5D=experimentMilestoneClickedToPublicationFromRelatedWithFulltext&_iepl%5BinteractionType%5D=publicationView). शायद यही कारण है कि १३० करोड़ आबादी वाले देश में एक भी अंतर-राष्ट्रीय स्टार का एथलीट नहीं है. परन्तु गद्दारों को यही तो चाहिए कि देश बर्बाद हो जाये आने वाली पीढ़ियां बर्बाद हो जाएँ.

   क्या यह एक आपराधिक साजिस नहीं हैएक आतंकवादी गतिविधि नहीं है इस देश के पशु पालकों को बर्बाद करने की और इस देश की आने वाली पीढ़ियों को पंगु बनाने कीफिर आसमा चुप हैये जमी  चुप हैचुप है सारा जहाँ, और भारत की ईमानदार सरकार चुप है. है कोई पूंछने वाला.

https://www.researchgate.net/post/Should_the_truth_of_FMD_vaccine_testing_at_Indias_Premier_Indian_Veterinary_Institute_be_disclosed#573490274048540ac307fa2d
The truth of the Enquiry into retesting of the FMD vaccine failed at CCS NIAH, Baghpat by the Committee headed by Dr. Gaya Prasad (ADG-AH, ICAR, New Delhi) and his team.

The report deserves condemnation being tyrannical based on unfounded claims and imaginations. The report is prepared with the malicious intent to benefit the firms producing sub-standard FMD vaccine and to ruin the animal husbandry of the Country. It was expected that the committee constituted by the MoS Dr. Sanjeev Balyan will examine the facts scientifically and methodologically in evaluating the quality of the vaccine and its testing at CCS NIAH (https://www.researchgate.net/publication/267705649_Testing_of_FMD_Vaccine_intended_to_be_used_under_FMD-CP_of_Govt_of_India_at_CCS_NIAH_Baghpat_UP_India?_iepl%5BviewId%5D=K8Tgvg91tuiBZfi8pvTvJOgW&_iepl%5BprofilePublicationItemVariant%5D=default&_iepl%5Bcontexts%5D%5B0%5D=prfpi&_iepl%5BtargetEntityId%5D=PB%3A267705649&_iepl%5BinteractionType%5D=publicationTitle) , but the committee became tyrannical and acted in biased state and based their report on some assumptions with mal-intent.
The committee has created their report on the basis of following assumptions:
A.    CCS NIAH, Baghpat Director has worked in its own interest with having no right to test or order to test the vaccine and published it without permission.
B.     Emulsion Stability of FMD vaccine is not required as per IP.
C.     The samples tested at CCS-NIAH, Baghpat were faulty.
D.    Sterility test and other tests were done meticulously at IVRI, Izatnagar and IVRI Bengaluru.
E.     Tests were not conducted by the scientific staff at CCS NIAH, Baghpat.
F.      Dr. BR Singh released the report to the public without authorization?
The pointwise facts about the assumptions of the committee are:
A.      CCS NIAH Baghpat Director has worked in its own interest with having no right to test or order to test the vaccine and published it without permission. If it is so then my queries are:
1.      Why at all FMD vaccine vials from each batch to be released were coming under DADF order and MOU to CCS NIAH, Baghpat since last several years?
Ans:
a. It is because the institute’s primary mandate is to test the biologicals including all vaccines in animals and to ensure their quality. The facts can be seen at DADF records and website (http://dahd.nic.in/dahd/WriteReadData/Directorate%20of%20Animal%20Health.pdf.). The institute has been created with the sole purpose of vaccine testing. Is to do mandated work one needs an order again and again?
b. The orders to test the FMD vaccine exist and were provided to the committee but the committee has intentionally ignored the facts to benefit the faulty vaccine manufacturers (the document was sent to Dr. G Prasad on his email on 11th December 2014 and for which he acknowledged the receipt too). The orders of Shri RS Rana (JS, DADF) issued through D.O. No.3-15/2013-NPRE –NIAH- dated 15th March 2013, were sent by DADF F. No.50-03/2014-LDT (NIAH) dated 12-06-14 with the sign of Dr. Akhilesh Kamal, Director (I & C) at DADF.
c. If there were no orders and permission to test the vaccine, why the reports of vaccine testing have been submitted by the earlier director to DADF?
d. If the Institute has the only role to act as postmaster to direct/ deliver the vaccine samples to IVRI, Bengaluru, then why this facility was created after investing around 2000 million rupees about a decade ago and investing several million every year for maintenance and running this institute, it could have been done by a clerk sitting at Krishi Bhavan.
e. Why the scientific staff (Dr. Shinjini Sharma, Joint Director) at CCS NIAH, Baghpat was trained for FMD vaccine testing for months together at IVRI, Bengaluru?
f. If DADF did not know that CCS NIAH, Baghpat is testing the vaccine what they discussed in their letter F. No. 53-67/2010-LDT (LH) and our letter F.No. 5-1-2012-CCSNIAH Dated 03-0902104, already submitted to the committee.? It was nothing but about modalities of testing stability and sterility of vaccine using IP protocol and to get 20 vials for testing sterility.
g. At: http://dahd.nic.in/dahd/WriteReadData/Directorate%20of%20Animal%20Health.pdf. Downloaded on 24-4-15; see what in its publication on official website of DADF write about CCS NIAH, Baghpat and described it at B as: National Veterinary Biological Products Quality Control Centre, Baghpat, and again about its functioning writes: The National Institute of Animal Health has been established at Baghpat, Uttar Pradesh to undertake the testing of vaccines and biologicals for their quality.  The Institute has started functioning and is carrying out the following activities. • The virology laboratory is functional with facilities for testing of quality assurance of FMD vaccine by way of testing of serum samples by LPB-ELISA and sterility of vaccines. Institute has tested the FMD vaccine by sterility, safety and potency test.
B. Emulsion Stability of FMD vaccine is not required as per Indian Pharmacopeia (IP).
1. If emulsion stability is not required for FMD vaccine then:
Why at all the vaccine is made in emulsion form?
Ans:  It’s because of the scientific fact that emulsified FMD vaccine provides better and longer immunity
If so, why IP is silent over emulsion stability testing, of the FMD vaccine?
Ans: The IP is not silent over emulsion stability, for emulsions IP recommends it in general introduction but specifically not mentioned everywhere where so ever emulsion vaccine testing is discussed.
After all, IP is not a God-Book, it is based on scientific knowledge and scientific advancement over the years that is why it has been revised dozens of times in previous years. An addition and deletion in IP are always possible on the basis of scientific facts, advancement, and requirement of the country.
2. Why the committee and FMD vaccine producers are so particular to avoid of emulsion stability testing of FMD vaccine and its non-mentioning in IP?
Ans. The stable emulsion can be made only at certain fixed ratio of different aqueous (water) and oil components and requires standard procedures to make it a stabilized emulsion. If the emulsion made in excess of water it may not stay for long. And if the emulsion stability is made mandatory (through it must be) then the producers may lose their freedom to add water into the vaccine ad-lib. The IP revising committee is also constituted with the representatives of manufacturers and same favored official lobbying to have the desired protocols to benefit the corporate at the cost of the nation’s wealth and economy.
C. The samples tested at CCS-NIAH, Baghpat were faulty: The committee was pretty sure and knew the fact that the vaccine samples of different batches available for re-testing and those tested as CCS NIAH, Baghpat were of substandard vaccine batches released in the field. If it is not, then:
1. Why the committee has not gone to test/retest the samples collected systematically and available at CCS NIAH, Baghpat, stored under the recommended environment? For retesting results of those samples only which were tested by the team at CCS NIAH, Baghpat would have been authentic to say that the report of CCS NIAH was wrong.
2. Why the substandard batches released in the field were not recalled, and why samples of the same batches were not collected from some of the field depots with State Animal Husbandry Departments?
3. Why the committee has not gone to test the samples of the same batches sent to IVRI, Bengaluru which were stored under so-called cGMP and GLP facility?
4. Why the committee has not rapidly acted to confiscate the vaccines available in the depots of firms and depots at State Govt which would have lead to legally authentic sampling?
     The committee has not opted any of the above more ethical and legally acceptable procedures to collect the samples because the committee knew well about the substandard of the vaccine batches released. They knew that the vaccine producers were at fault but due to one or other reason (Needs to be investigated) they wanted to benefit them at the risk of Nation and public money (an anti-national act). The committee collected the samples from the firms giving them sufficient time, a novel alternate to defy the entire legal and truthful inquiry. Now the question is:
Why the committee opted for an illegal and unethical route for collecting the samples from the firms giving then two weeks of time?
The reply lies in the following facts:
The vaccine tested by the committee was not of the same batches as those tested at CCS NIAH, Baghpat. The batches released for field use were substandard. The committee wanted to give the opportunity to the firms to produce good quality samples; with labels of the same batch numbers as released to market (the labels and vials are made/ procured by the firm(s) itself and can be printed in the desired number at their will). Even if the labels would have been provided by some fool proof honest authority still then it is possible to produce them in the same way as the fake currency in the market. In this case of involving, hundreds of the crores of rupees production of a few labels would have not been impossible.
   The way out for future for these types of discrepancies are that in future to avoid disputes samples should be systematically collected from ready to dispatch batches in triplicate. Two sets of samples should be given for testing to two independent agencies and third should be stored in suitable coffers of the third party (not related to the firms, supplier, purchasers, testing agencies and DADF).
   If the committee was truthful; why it again chose to give the samples to re-test to the same agency i.e., IVRI? Earlier it was tested and passed at Bengaluru lab and then given for retesting to IVRI, Izatnagar lab, but both are one and the same, under control of the same authority, the same Director. It is because the committee targeted to malign the image of IVRI only.                                                        
D. Sterility test and other tests were done meticulously at IVRI, Izatnagar and IVRI Bengaluru.
The facts are:
1-   Yes, the testing at IVRI was either not done or if done it was done with honesty with all meticulous procedures. Dr. R Verkatramnan, in charge IVRI Bengaluru lab honestly accepted in the meeting with MoS on10th November 2014 that he has never tested vaccine samples for emulsion stability and not tested any batch in the year 2014 due to one or other reason even for sterility too. But the batches were released for use by the DADF without the requisite testing. The major point of inquiry would have been: why people at DADF favored the firms, without the report from Dr. R Verkatramnan? In this case, neither IVRI nor Dr. R. Venkarramnan is at fault but some big game players sitting in DADF at Krishi Bhavan, the implementers of FMD-CP, needs to be interrogated.
2-    Even if Dr. R. Verkatramnan would have desired to test the samples for sterility it would have not been possible without defying the IP protocol (IP 2014, 2.2.11 page 59-66) which requires at least 20 vials of vaccine to perform sterility test of any commercial batch but he has never been given more than 3 to 5 vials by DADF for testing vaccine.
3-   The testing at Izatnagar lab was not of the same sample as of those tested at CCS NIAH, Baghpat but of the freshly produced good quality vaccine, procured directly from the firms on the directions of the committee. For such type of retesting no legal system can permit except if the system is of tyrants.
E.       Tests were not conducted by the scientific staff at CCS NIAH, Baghpat. The foolproof document of involvement of all scientific staff in vaccine testing and falsehood of Dr. Gaya Prasad is with me signed by all the staff. Though it was also produced earlier to the committee but as the committee has hidden the other vital facts they might also have hidden this one. The question is who pressurized the staff at CCS NIAH, Baghpat to tell lies or submit lies with the committee?
F.       Dr. BR Singh released the report to the public without authorization. In this context a lot has been explained (details are also there in attachment above "Credibility of the report by the th...committee appointed by MoS (1).pdf") and evidence were submitted to the committee by email (on 27-11-2014 with simultaneous submission to Director IVRI, the receipt of the same was acknowledged by Dr. Gaya Prasad on the same day) and the document was also handed over in person and also to authorities in the meeting with MoS on 10th November 2014. However, I could not understand at first why those facts were hidden by the committee. And now I can understand well why the committee was against the recording of the proceedings despite my repeated requests, the committee was not honest at the heart and was predetermined to malign my career. Even to present the papers related to reporting of FMD testing permission was granted and my tour was approved by the Director IVRI (dated 29th October 2014), much before the report come into light. If the Director CCS NIAH, Baghpat has no right to interact with media about vaccine testing and achievements of the Institute then what action was taken against the earlier director (Dr. BN Tripathi) who interacted with media and gave interviews in December 2013 and January 2014, published in Dainik Jagran?
G.      Now let us see some more foolish claims of the committee:
The committee claimed that the vaccine vials were stored in a refrigerator at 4-8C in CCS NIAH that is why results were wrong they would have been correct if stored in a walk-in cold room. The committee probably not has even a single qualified microbiologist or they were forced to forget their knowledge. It is impossible to enter a microbe in properly sealed bottle irrespective of minor differences in storage conditions, and a sterile product can not turn non-sterile if stored under different storage conditions.
If it is essential then why the producer has not mentioned it on the vials of the vaccine? Probably because of the mal-intention to keep the disease in India and because vaccine in actual practice cannot be stored in walk in cold chambers. And if not then what is the reply for:
If the cold chamber is so much needed to store FMD vaccine instead of refrigerators than under visionary FMD-CP program how many cold rooms have been built at district level at district veterinary offices where the vaccine is stored before vaccination. If they have not built cold room then
a.    Either they are bluffing in the report or
b.      They are bluffing the FMD-CP (and wasting the country’s money), or
c.    They have mal intention for ensuring the failure of FMD-CP so that their market can sustain forever.
The committee claimed that all companies producing FMD vaccine in question have cGMP and GLP approved quality control laboratories. The question is who recommended for that certificate, is not the same committee or its members? Bad luck, it does not prove that by merely having good labs they may produce good vaccine too.  It is like a claim made by a paranoiac of having the very good capability to hear and exceptionally good eyesight, but what they hear and see, any psychologist can tell.
The inquiry report claimed that sterility testing at IVRI Bengaluru was done scrupulously on a random basis, while reality is that even after claimed 40 years of experience in FMD, the in-charge of the lab probably has never tested sterility as per IP for a single batch. I am confident because they have never received more than 5 vials of a batch in past years, while minimum requirement for a commercial batch is 20 vials as per IP.
Therefore a fresh enquiry is earnestly required to find the truthfulness of biased committee and also the following facts:
1.    What were the intentions of Dr. G Prasad (ADG AH, ICAR) and other members of the committee behind producing malicious, fraudulent and anti-national report through hiding the facts and assuming the unfounded things as facts, synthesizing the falsehood?
2.    Why the committee was constituted only of those members who are in one or other way  associated with the vaccine producing firms (given them cGMP compliance clearance, recommending them for vaccines to be produced or  imported)?
3.    Why the foul players of FMD-CP implementation (DADF) are trying to use IVRI as escape goat?
4.    What benefits the chairman and members of the committee got from DADF and from the vaccine producing firms in last 5-6 years? How many committees and at how many times committees were headed by the same chairman? Do many of those were not associated with FMD-CP? Why in majority of the cases of FMD vaccine failure in different parts of India Dr. G. Prasad was the chairman to investigate the reasons and he always found the faults of the vaccinators?
5.    Why the MOU by DADF for FMD vaccine testing was signed with IVRI, while functional (http://dahd.nic.in/dahd/WriteReadData/Directorate%20of%20Animal%20Health.pdf.) and state of art facility (examined and found suitable by none but Dr. R Venkanvamnan; certified on 9th September 2009) was available with DADF at CCS NIAH, Baghpat. If trained staff was not there, it could have been taken from ICAR on deputation as I was taken or the staff could have been got trained within a month as Dr. Shingini Sharma (one of JD of CCS NIAH) was trained. It was probably to escape from their liabilities!
6.    Who drafted the faulty MOU for testing the vaccine at IVRI, Bangaluru with the provision to provide only 5 vials for testing sterility while it is not possible as per IP Standards?
It might be due to the fact that same people at higher post sitting in Krishi Bhavan had it in their mind that if on any day their wrong deeds are caught or FMD-CP fails then –they can easily blame on IVRI for not providing the proper technical support in terms of proper vaccine testing.
Therefore, it appears to be a premeditated scheme to devise such a biased and ruthless anti-National report to deceive the nation and blame the honest scientist(s) of IVRI to save some black sheep in the system.
6. The biggest question Is, Why the Report was submitted by the committee 25 days before of so called retesting at IVRI, Izatnagar, a non-authorized place for testing FMD vaccine quality?

7. The still bigger question is, why the department (Ministry of Agriculture and Farmers Welfare, New Delhi) has not taken any action against the committee that prepared and submitted the fabricated report despite all the facts available and submitted to the department.

How the honesty of enquiry committee to test the credibility of our report on FMD Vaccine quality can be entrusted when everything is mala-fide?. Available from: https://www.researchgate.net/post/How_the_honesty_of_enquiry_committee_to_test_the_credibility_of_our_report_on_FMD_Vaccine_quality_can_be_entrusted_when_everything_is_mala-fide [accessed May 9, 2017].