Proposal for Vaccine and Vaccination Policy for control of Animal Diseases in India/ भारत की पशु रोग नियंत्रण के लिए नई प्रस्तावित टीकाकरण नीति

Proposal for Vaccine and Vaccination Policy for Control of Animal Diseases in India

The problems of vaccines and vaccinations are complex in the livestock sector and cannot be solved without educating livestock owners, veterinarians, society and having the social and political will. For the success in controlling and eradicating vaccine-preventable diseases involvement of whole society is must, but the question, the really difficult one, is how to involve all stakeholders, how to build the confidence and hunger to succeed. In October 2018, MoS for Department of Dairying, Fisheries and Animal Husbandry under the Ministry of Agriculture and Farmers’ Welfare called a meeting for the draft of more efficient vaccine and vaccination policy. In part, the new policy has been implemented experimentally in Haryana. However, only future may tell either the policy will be adopted or not, accepted by various state governments of not, practised by veterinarians and livestock owners or not and yield desirable results or not. The direct losses estimated based on spillover reports indicated that average annual economic losses due to HS, FMD, Brucellosis, PPR, classical swine fever were in tune of Rs. 5255 crores (2014), Rs. 20000 crores (2016), Rs. 20400 crores (2015), Rs. 2417 crores (2016), and Rs. 429 crores (2016), respectively. It indicated that farmers incur almost Rs. 50,000 crores direct loss every year due to the five fully preventable (with vaccination) diseases. The Government of India along with state government spend equally good amount of funds on vaccination and almost one lakh crore rupees are wasted every year due to our legacy to hide the disease, due to substandard vaccines, inefficient vaccination, ill-education of livestock farmers and above all the political will (https://www.researchgate.net/publication/332865437_Foot_and_Mouth_Disease_Control_Program_FMD-CP_Corruption_Syndicate_of_India; https://www.researchgate.net/publication/332103614_Indian_Disease_Disseminating_Research_Institute_IDDRI). The caucus of corruption operating at all levels starting from politicians, policymakers, sub-standard vaccine producers, quality control officers, purchasers, suppliers, vaccinators and livestock owners ends up with this huge loss in the era when we just have two and half year to fulfil the dream of doubling the farmers income.

To counter the problems the following is proposed

1.    Multivalent (bivalent, trivalent and polyvalent vaccine should be given preference over monovalent vaccines to cover more than one disease prevalent during control programmes to save money, time and other expenses and also to reduce the burden on implementing agencies (veterinarians and livestock workers).

2.     Vaccines should be purchased through global tender and producers must use seed strains of Indian origin only preferably supplied by the National Vaccine Seeds Centres (IVRI, PDFMD etc.).

3.    All the vaccine batches must be sampled as per rule by competent people like drug inspectors, and before dispatch, the samples must be coded at the level of the sampler. Coded samples should be dispatched to any of four centres (selected) for testing using scientific randomization.

4.    Vaccine quality testing must not be done by any of the vaccine seed supplier or technology provider (like the Indian Veterinary Research Institute or any other such institute involved in vaccine technology development).

5.    At the selected Centres (preferably 4 State Veterinary Universities from different regions having required facilities) following Characters of Vaccines need to be tested as per international standards, not only as per Indian Pharmacopeia, for each and every batch, needs no animals

·         Antigenic mass

·         Sterility for killed vaccine & freedom from any extraneous organism in a live vaccine

·         Innocuity (harmlessness)

·         Freedom from any non-inactivated virus or bacteria in an inactivated or live vaccine

·         Emulsion stability for oil-adjuvanted vaccine

·         Self-life

For randomly selected 5% batches (out of those passed in non-animal tests) testing in target animals (at CCS NIAH, Baghpat) for

·         Safety

·         Potency/ immunogenicity/ protection power

No Vaccine batch should be released for use without completion of the testing and it should be done within a specified period (21-30 d1ys).

6.       Implementing agencies: State animal husbandry/ veterinary services/ Animal health NGOs

7.       Sero-monitoring agencies should monitor seroconversion in the sample collected randomly (as per NIVEDI, Bengaluru protocol) by the implementing or any other independent agencies using DIVA tests. Sero-monitoring should be done at all State or Central Veterinary universities excluding those four involved in vaccine quality testing.

8.       Case/ outbreak reporting should be the responsibility of KVKs/ Farmers/ NGOs/ village panchayats etc. Reporting must be associated with a reward like promotion/ increment/ monitory support etc.

9.       Investigation of all the reported outbreak should be the responsibility of RDDL and CDDLs and all the positive cases/ virus isolates should be submitted to PDFMD (in case of FMD) and other National virus/ bacterial or pathogen seed centres for fingerprinting and monitoring antigenic variation or pathogen evolution so that Seeds used in vaccine production can be modified/ changed in time. In case of any kind of vaccine and vaccination failure investigation must be conducted at priority by the concerned RDDL/ CDDL.

10. In cases (outbreaks after vaccination) of the vaccine failure, the producer company must be made responsible to meet all the losses to farmers, expenses on vaccination, and on three consecutive failures of vaccines, the company must be debarred, blacklisted for all of its products. In the cases of Vaccine failures (outbreaks after vaccination) the head of the vaccine quality testing team for the specific batch or batches must be terminated and prosecuted and his team members must be demoted and punished.

11. In the case of vaccination failure (at the implementing agencies end/ farmers end) appropriate administrative action must be taken to ensure proper implementation of the vaccination programme(s).

12. Approval/ release of the vaccines to be used in Disease Control programmes and for animal use: All the vaccine seeds/ vaccines properly evaluated for their safety and efficacy in Indian conditions through first, second and third phase clinical trials yielding sufficient data be approved/ released for the animal use in India.

13. The chairmen and secretaries of the committees responsible for approval/ release of vaccines already in the market without any or insufficient data relating efficacy/ safety/ potency and clinical trials must be appropriately punished and put for criminal prosecution at the earliest. The members of such approving or releasing committees may also be punished appropriately.  

14. The agencies/ companies selling/ marketing unapproved vaccines and related medicines in India must be blacklisted and brought under criminal prosecution.

15. Up-gradation and strengthening of state Biologicals Production units through the provision of GMP facilities, training, new vaccine technologies and vaccine seeds free of cost at a subsidized cost to create healthy competition in the market for better quality products.
As an alternative, the vaccine producers and suppliers be given responsibility to deliver the vaccines to the end-users in required storage and use conditions, often saying the failure of cold chain at users end, and made responsible for losses to farmers in event of vaccine and vaccination failure through the accountability settlement process.

Hindi Version 

भारत की पशु रोग नियंत्रण के लिए नई प्रस्तावित टीकाकरण नीति

१. जहाँ उपलब्धता है एवं आवश्यकता है वहां एकाधिक रोगों की रोकथाम हेतु संयुक्त टीकों का प्रयोग किया जाए जिससे कि टीकाकरणमें होने वाला व्यय एवं समय बचाया जा सकेगा.

२. रोगों के टीकों की उपलब्धता वैश्विक टेंडर के जरिये निश्चित की जाए परन्तु सभी निर्माताओं को भारत में प्रभावी एवं प्रामाणिकवैक्सीन सीड    समान भाव पर राष्ट्रीय वैक्सीन सीड सेंटर (भा. पशु चिकित्सा अनुसंधान संस्थान एवं अन्य) से उपलब्ध कराया जाए.

३. सभी वैक्सीन के सभी बैच के योग्य अधिकारियों  द्वारा नमूने लिए जाएँ तथा उनकी कोडिंग करके ही विभिन्न जांच केंद्रों को भेजे जाएँ.

४. वैक्सीन की जांच की अनुमति किसी भी वैक्सीन सीड एवं टेक्नोलॉजी देने वाले संस्थान को ना दी जाए.

५. सभी वैक्सीन नमूनों के जांच तीन या चार चयनित (देश के विभिन्न भागों में स्थित पशु चिकित्सा विश्व विद्यालयों में) निम्न लिखितगुणों के लिए अंतर्राष्ट्रीय एवं भारतीय मानकों के अनुसार कराई जाए.

·         एंटीजेनिक द्रव्यमान

·         मृत जीवाणुओं/ विषाणुओं से निर्मित वैक्सीनों के लिए स्टेरिलिटी और जीवित जीवाणुओं/ विषाणुओं से निर्मित वैक्सीनों के लिए किसीअन्य जीवाणु / विषाणु  से मुक्ति लिए.

·         संभावित हानिकारक कारकों से मुक्ति हेतु.

·         मृत जीवाणुओं/ विषाणुओं से निर्मित वैक्सीनों में क्रियाशील या जीवित जीवाणुओं/ विषाणुओं की उपस्थिती से मुक्ति हेतु.

·         यदि वैक्सीन तेलीय एडजुवन्ट युक्त है तो उसकी इमल्सन शक्ति एवं स्थायित्व के लिए

·         वैक्सीन की स्थिरता (selflife) के लिए

जो वैक्सीन उपर्युक्त मानकों पर खरे हों उन्हें वैज्ञानिक तौर पर रैंडम विधि द्वारा ५-१०% चयन करके उपयुक्त पशुओं मेंराष्ट्रीय पशु स्वास्थय संस्थान बागपत में निम्नलिखित गुणों के लिए जांचा जाए.

·         सुरक्षित होना

·         प्रभावी होना

कोई भी वैक्सीन बैच बिना जाँच पूरी हुए प्रयोग के लिए ना रिलीज किया जाए. सभी जांच एक माह के अंदर ही पूर्ण की जाएँ.

६. राष्ट्रीय रोग नियंत्रण में टीका कारण की जिम्मेदारी राज्यों के पशुपालन एवं पशुचिकित्सा विभागों, एवं NGO के माध्यम से सुनिश्चितकी जाए.

७. सेरोमॉनीटरिंग का कार्य सिर्फ उन संस्थानों के माध्यम किया जाए जो किसी अन्य कार्य जैसे सीड या टेक्नोलॉजी प्रदान करने, वैक्सीनोंकि गुणवत्ता की जांच या टीकाकरण के कार्यों में ना लगे हों (जैसे कि पशुचिकित्सा महाविद्यालयों द्वारा) DIVA विधि द्वारा कराई जाए.इस कार्य के नमूने पशुचिकित्सकों द्वारा NIVEDI बेंगलुरु द्वारा निर्धारित वैज्ञानिक विधि द्वारा इकट्ठे किये जाएँ.

८.रोगों के होने की सुचना देने का कार्य कृषक, कृषक संस्थाएं, ग्राम पंचायतें, और कृषि विज्ञान केंद्रों को दिया जाए. रोगों की सूचना देनेवालों को यथायोग्य पुरस्कार का प्रावधान हो.

९. रोगों के प्रकोप की सभी सूचनाओं की जांच RDDL एवं CDDL एवं अन्य नैदानिक प्रयोगशालों से त्वरित गति से कराई जाए, और उनसेविलगित जीवाणुओं/ विषाणुओं को फिंगरप्रिंटिंग और संजोने के लिए रिफरेन्स केंद्रों एवं वैक्सीन सीड रखने वाले संस्थानों को दिया जाएजिससे की जीवाणुओं/ विषाणुओं में आने वाले परिवर्तनों का आंकलन करके यथासमय वैक्सीनों के सीड्स में परिवर्तन किया जा सके.

१०. यदि कहीं रोग का कारण वैक्सीन में कमी होना पाया जाये तो वैक्सीन निर्माताओं को सम्पूर्ण हानि (पशुओं में, टीकाकरण आदि में)भरपाई  के जिम्मेदार ठहराया जाए, तथा त्वरित एवं प्रभावी तरीके से भरपाई कराई जाए , तथा तीन बार ऐसा होने की स्थिति में सम्बंधितनिर्माता कंपनी को आने वाले समय में वैक्सीन निर्माण से प्रतिबंधित किया जाए. साथ ही इन मामलों में प्रयुक्त वैक्सीन को गुणवत्ता मेंपास करने वाली  संस्था/ टीम के अध्यक्ष को निलंबित और कार्य मुक्त करते हुए कानूनी कार्यवाही की जाये, इन मामलों में सम्बंधितजांच टीम के सदस्यों पर भी यथायोग्य दंडात्मक कार्यवाही की जाए.

११. यदि कहीं रोग का कारण टीकाकरण में कमी को पाया जाए तो टीकाकरण के लिए जिम्मेद्दार लोगों पर दंडात्मक कार्यवाही की जाएतथा कमियों को दूर करने के उपाय किये जाएँ.

१२. वैक्सीन या वैक्सीन सीड्स के रिलीज या प्रयोग के लिए प्रमाणित करने से पूर्व उनके प्रमाणीकरण के लिए आवश्यक दस्तावेज जैसेकि प्रथम, द्वितीय एवं तृतीय स्तर के क्लीनिकल ट्रायल के सफलता सम्बन्धी दस्तावेज, पूरी तरह योग्य समितिओं द्वारा जांचे जाएँ.सभी प्रमाणीकरण के लिए आवश्यक दस्तावेज जनसूचना हेतु संबधित वेबसाइट पर हरसमय उपलब्ध होने चाहियें.

१३. बाजार में यदि कोई वैक्सीन या औषधी बेचीं जा रही या प्रयुक्त हो रही है जिसके प्रमाणीकरण के लिए आवश्यक दस्तावेज नहीं हैं तोप्रमाणीकरण के लिए जिम्मेदार समिति के अध्यक्ष एवं सचिव पर कड़ी दंडात्मक कानूनी कार्यवाही की जाए.

१४. इस तरह के घटिया प्रामाणिक एवं अप्रमाणिक वैक्सीन और दवा उत्पादक एवं विक्रेता संस्थानों / कंपनियों पर दंडात्मक कानूनीकार्यवाही के साथ ही उन्हें तात्कालिक प्रभाव से इस व्यापार में निरुद्ध किया जाए.

15. राजकीय वैक्सीन उत्पादक इकाइयों का  वैक्सीन टेक्नोलॉजी, वैक्सीन सीड्स निशुल्क या रियायती दरों पर उपलब्ध कराकर, उन्नत तकनीकों में ट्रेनिंग देकर तथा GMP सुविधाएँ विकसित कराकर  उन्नतिकरण और सुदृढ़ीकरण. इससे स्वस्थ प्रतिस्पर्धा का विकास करने एवं अच्छी गुणवत्ता के वैक्सीन उपलब्धता में सहयोग मिलेगा. 
विकल्प के तौर पर वैक्सीन निर्माता एवं प्रदाता कंपनियों को ही किसान के पशुओं तक वैक्सीन पहुँचाने की जिम्मेदारी दी जाए जिससे हर बार वैक्सीन के फेल होने पर उनका यह कहना कि वैक्सीन को सही ढंग से रक्खा नहीं गया या लगाया नहीं गया, बंद हो सके, साथ ही वैक्सीन और टीकाकरण के फेल होने पर उनकी नियमानुसार जिम्मेदारी निश्चित की जा सके. 

हम विज्ञान के नाम पर किस तरह से अपने देश के साथ गद्दारी और धोखा करते हैं देख कर शर्म आती है

जागो किसान, जागो पशुपालक, जागो पशुचिकित्सक, देर होने से पहले, वरना ठगे से रह जाओगे और माँगते रहना भीख नेताओं से, सरकार से, संसार से

Wakeup farmers, wakeup Vets, be truthful to the Nation.

RTI information revealed that in NDRI Karnal Triovac vaccine for HS, FMD and BQ has been in use in the last 10 years. But we are not recommending it for use in Farmers, animals. moreover why IVRI is bluffing that there is no data on the multivalent vaccine. The similar vaccine is also used in all military dairy farms, LUVAS, CIRB & GLF Hissar. Why IVRI is conducting experiments on this vaccine? Why already available data on the use of FMD HS BQ vaccine can't be taken available in the same organization i.e., ICAR or why data can't be provided for analysis? There appears to be something fishy. It needs investigations; it is the mere waste of time and money.

This vaccine is in the market for decades but has never been tested for quality, safety and potency at IVRI, the only approved vaccine quality testing centre. What does this indicate? Vaccines and drugs of some big companies are never sampled and tested. It is the democracy of India. That is why we need to change the vaccine and vaccination policy.

https://azad-azadindia.blogspot.com/2018/10/proposal-for-vaccine-and-vaccination.html

If multivalent vaccines (Trivalent, FMD+HS+BQ or Bivalent FMD +HS) were not approved, then Punish the Producer and Seller of such vaccines for decades, forgetting how big the names are behind this heinous act to bluff the poor farmers and livestock owners of India.

If such multivalents were approved, without sufficient data (for which now IVRI is trying to generate data under a multimillion project), let those traitors be hanged for approving the vaccines without safety and efficacy data for those vaccines.

If you can't do anything be ready to be bluffed, live in hell, be cheated, be poor, and be beggars.