Minutes of The Meeting - Brain Storming meeting on Indian Pharmacopoeia Veterinary Monographs on dated 23rd - 24th Jan, 2013 at IPC, Ghaziabad.
A meeting was held on 23-24 January 2013, at R. S. Iyer Hall, Indian Pharmacopoeia
Commission, Ghaziabad to discuss the issue of IP Veterinary Monographs, for the next
edition of IP 2014. The meeting was attended by more than 50 (Fifty) participants from
various parts of India, both from government sector and also from Industry. The list of
participants is annexed as Annexure - II
The meeting started after registration of the delegates and their introduction with the
welcome address and a brief note about Indian Pharmacopoeia Commission by Dr. R. M.
Singh, PSO, IPC. He had then introduced Dr. Rishendra Verma, Chairman, IP Veterinary Drug
Monographs, who had appreciated the audio-video presentation about IPC. He in turn
welcomed all the delegates, and briefed about various activities of Indian Pharmacopoeia
Commission, and the task about bringing out a New edition of Indian Pharmacopoeia, 2014,
which includes new and updated Veterinary Monographs.
Mr. Venkatakrishnan, Ex-Drugs Controller Kerala, had briefed about the periodicity of
publishing Indian Pharmacopoeia, which is a standard legal document, for all the
pharmaceutical products that are manufactured, marketed for sale, or exports for both
human beings and for animal health.
Dr. Tripathi, Director, NIAH, Bhagpat, who had attended the meeting for the first time had
emphasised about the importance of including veterinary diagnostics, improvement in
standardisation, quality control, and quality of the monographs.
Dr. Verma had urged all the stakeholders to follow the guidelines and standards as given in
Indian Pharmacopoeia for all practical reasons. He also said, the standards presented in the
Indian Pharmacopoeia, veterinary section, are in line with the standards mentioned in any
other leading world pharmacopoeias. Dr. S. B. Tatavarthy, emphasised to make available all
reference standards, that are required and related to veterinary monographs, for practical
implementation. Stakeholders expressed that lack of microbial reference cultures
availability is hampering their work, and in this connection Dr. Nishant had said that IPC is in
the process of concluding an MOU with IMTECH Chandigarh, for the microbial reference
cultures. In addition he also said, that efforts are underway to provide all the reference
cultures mentioned in the Indian Pharmacopoeia to the stakeholders in the near future.
Dr. P. V. Kanitkar, Member Scientific Body of IPC had elaborated about Indian
Pharmacopoeia, which had been published in 3 volumes earlier, and now will be published
in 4 volumes that includes a separate volume for veterinary monographs. He also said that
those who want to include new veterinary monographs are welcome to do so, and should
forward such new monographs to IPC within the next 7days. He also stressed to submit the
reference standard, impurities and API for the new monograph.
Dr. Reddy spoke about the reference serum, vaccines and seed material required for the
preparation of various veterinary medicines. Dr. Jeetendra, spoke about the stake holders
responsibilities, to meet and match the world standards in veterinary products. It was also
decided during the discussions to constitute a separate sub group for all the new veterinary
chemical monographs, which includes stakeholders from the industry and IPC officials. Dr
Rishendra Verma, elaborated on the various aspects of the safety test, requirement of the
post-mortem and safe disposal of the animals. He also urged the stakeholders to follow the
CCPA guidelines for breeding of the animals. He further initiated the discussion on New
Veterinary vaccines, mixed vaccines, live and inactivated vaccines, and the stakeholders
expressed their views on the topic. Dr. Tatavarty stated that no government is using the
combined vaccines and said that such type of irrational and irrelevant vaccines should be
weeded out. However he stated that stakeholders can manufacture the combined vaccines,
if the market exists for such products. Dr. Verma stated, that there is need for limiting
combinations in poultry vaccines, and to reduce immune system loading, and to minimise
load of stress to the animal.
Dr Rishendra Verma, initiated the discussion on revised veterinary vaccines, and urged the
stakeholders for their comments, and the house adopted all the existing vaccines as such.
Further he took up the new veterinary diagnostic monographs, new veterinary appendix. He
further took up the issue of evaluation of safety of immunosera, and need for separate
guidelines to clinical research. He took up the issue Brucella Melitensis, and B. Abortus
vaccine, and other vaccines at length and invited comments from the stake holders, on the
related vaccines. Then the topic concentrated on Canine vaccines and the need for quality
control in production of these vaccines. He further initiated the discussion on the cell
culture for production of veterinary vaccines. He also stated that this is an important and
neglected area where there is scope for developing indigenous technology, and to avoid
imports. He also initiated discussion on source of cell lines, sequencing, traceability and the
PCR techniques and molecular characterisation. Dr. Tatavarthy had stated that, the
necessary infrastructure exists and he can extend cooperation for cell culture, and
production of vaccines. Dr. Bhattacharya, had stated, that manufacturing is not a problem
but marketing poses several hurdles.
Dr. Rishendra Verma, then took up the issue initial draft prepared by Indian Pharmacopoeia
Commission, which includes Chemical & Biological Monographs general chapters, and new
veterinary surgical material monographs. In poultry vaccines, he gave more emphasis on
selection of SPF flock, one after another. In addition discussions were more on quality
control of vaccines, use of preservatives in vaccines, batch testing, sterility testing, labelling,
storage, and transportation. Use of addition of food grade dyes also came for discussion,
and all the stakeholders actively participated in the proceedings.
He further initiated discussion on the individual monographs, and took up the issues related
to canine vaccines, rabies vaccines, anthrax spore vaccine, black quarter vaccine,
enterotoxaemia, clostridium vaccines, Brucella vaccine, swine fever vaccine, FMD vaccine
and Blue tongue vaccine, vaccines related to sheep and goat and also on mycoplasma. The
issue of dose also came for active discussion from the stakeholders. All the stakeholders
including Dr. Piruthvi Raj, Dr. Smita Mahajan and others participated in the discussion and
unanimously accepted that it should be 2/5th the dose. The stake holders had actively
participated in the discussions on all these issues and some of the suggestions made by the
stakeholders had been accepted for incorporation in the coming edition of Indian
Pharmacopoeia. In addition, the stake holders actively took part on Brucella control
programme, and Dr. Srenivasulu Kilari elaborated at length various steps need in this
direction. The issue of import of vaccines in this connection also came up for discussion. Dr.
Verma had explained that government is committed to Brucella Eradication programme in
the coming 12th five year plan.
On the second day, Dr. G. N. Singh, Secretary-cum-Scientific Director,& Drug Controller
General (I), had addressed the gathering, and gave an emotional talk on the general
scenario, on the importance of Indian Pharmacopoeia’s coming edition (IP- 2014), and also
informed the gathering about the 2nd World Pharmacopoeia meeting going to be held in
India for the first time during April 18-20th 2013. He also stressed the point that the whole
world is watching us and the country should take lead in providing quality medicines at
affordable cost to the world at large.
Dr. Dey had suggested for inclusion of aqua vaccines in the coming edition of Indian
Pharmacopoeia. Dr. Sreenivasulu Kilari had suggested to involve WHO and OAU in this work
and to seek their help in finalising future strategies
Dr. Rishendra Verma further emphasised that two monographs namely ”Equine Herpes
Virus Vaccine (Inactivated) and Equine Influenza Vaccine(Inactivated)” to put on hold till he
checks up the monograph with NRC. The final decision he will convey to Indian
Pharmacopoeia Commission later. In addition to the above, he also stated that he will
convey the final decision on monographs related to Swine Fever Vaccine Lapinized ( Living)
and Swine Fever Vaccine (Live prepared in Cell culture), very soon.
Later the house agreed unanimously to the suggestions made by the stakeholders for
incorporation of the changes in existing monographs and inclusion of new Monographs in
the next edition of Indian Pharmacopoeia, and the list is attached as Annexure - I. The
stakeholders had also agreed to provide new veterinary monographs for inclusion in the
coming edition of Indian Pharmacopoeia within the stipulated period.
After the marathon brain storming session, Dr. Rishendra Verma, thanked all the
stakeholders for their active participation, suggestions, and cooperation in upgrading the
veterinary monographs. He also expressed his happiness and said that the coming edition of
Indian Pharmacopoeia 2014, will be really a good one with all the salient features, in
comparison with the leading world pharmacopoeias.
Dr. Nishant A. Dafale thanked all the stakeholders and Dr. Rishendra Verma for sparing time
for this brain storming session, in the national cause.
Dr. Raman Mohan Singh, thanked the august gathering for attending the brain storming
session on finalising the much needed veterinary monographs. He also appaulded Dr.
Rishendra Verma, for taking lead role, sparing his valuable time, energy in coordinating and
cooperating in finalisation of the Veterinary Monographs for the coming edition of Indian
Pharmacopoeia 2014, in the national interest.
Annexure –II
The following eminent Scientists, dignitaries and stake holders and staff of the Indian
Pharmacopoeia Commission attended the meeting. The list includes:
1.
Dr Rishendra Verma, Joint Director, NDRI, ICAR.
2.
Dr. D. S. Shivdekar Scientific Adviser
3.
Dr. D. K. Dey, C. E. O M/s Globion (I) Pvt Ltd,
4.
Dr. K. C. Verma M/s Biomed,
5.
Dr. Padmaraj
6.
Dr. S. S Tongaonkar, Consultant, Veterinary Biologicals,
7.
Dr. Nitin Bhatia, AGM (T), M/s Intas Animal Health ,
8.
Dr. Shankaraiah, Sr.Manager, M/s V. Animal Health,
9.
Dr. Thirunavukarasan, Research Assistant, Institute of Vet.Preventive Medicine,
10.
Dr. Johnsi Koruth Assistant Research Officer, IVPM,
11.
Dr. S. B. Tatavarthy, Joint Commissioner, A. H,
12.
Dr. Manoj Sood, Associate Director,
13.
Dr. Tapas Bhattacharya, G. M, M/s Biovet Pvt Ltd,
14.
Dr. P. V. Kanitkar, Director, Plant Operations, M/s Pfizer Ltd,
15.
Mr. C. B. Raju, Executive Director (T), M/s Brilliant Biopharma Ltd,
16.
Mr. Ashok . K. Saxena, Vice President, M/s Brilliant Biopharma Ltd,
17.
Dr. Prem Sagar, Scientist In charge (R&D), M/s Brilliant Biopharma Ltd,
18.
Mr. Girish Juneja, Senior Manager, CQA, M/s Mankind Pharma,
19.
Dr. Hari Sen Naik, G. M, M/s Indo Vac Pvt Ltd,
20.
Dr. V. Vijayan, Resident Director, M/s Indo Vac Pvt Ltd,
21.
Dr. B. Piruthvi Raj Kumar, Assistant Vice President, QC, M/s Globion India Pvt Ltd,
22.
Dr. Smita Mahajan, Manager,(R. A) M/s Pfizer,
23.
Dr. Udai Singh Deputy Director, B. P. Institute, Lucknow,
24.
Dr. G. H. Reddy, Joint Director, VBRI, Hyderabad,
25.
Dr. Bala Rajeswara Reddy, D. D, VBRI, Hyderabad,
26.
Dr. Sandeep Singh, Assistant Director, NIAH, Bhagpat,
27.
Mr. S. S. Venkateswarlu
28.
Dr. B. N. Tripathi, Director, NIAH, Bhagpat,
29.
Mr. Subhas K. Sharma, QC Manager,
30.
Dr. Ripil, Manager- Regulatory, M/s Merck (I) Pvt Ltd,
31.
Dr. Sanjay Gavakare, G. M, M/s Ventri Biologicals,
32.
Dr. Santosh Despande, G. M, M/s Ventri Biologicals,
33.
Dr. Kishore Motwani, Head (T), M/s Zydus AHL,
34.
Dr. Swapnil Kubal, A. G. M, QC, M/s Ventri Biologicals,
35.
Dr. D. B. Bhandari, A. G. M, M/s Ventri Biologicals,
36.
Dr. Jeetendra Verma, G. M, M/s Eli Lilly Asia,
37.
Dr. Sreenivasulu. Kilari, Associate Director R&D, M/s MSD- AH,
38.
Dr. Rama Mohan Singh, Principal Scientific Officer, IPC,
39.
Dr. Jai Prakash, Principal Scientific Officer, IPC,
40.
Dr. Nishant. A. Dafale, Senior Scientific Officer, IPC,
41.
Dr. Robin Kumar, Senior Scientific Officer, IPC,
42.
Mr. Anuj Prakash, Senior Scientific Officer, IPC,
43.
Mrs. Menakshi Dahiya, Senior Scientific Officer, IPC,
44.
Mr. Alok Sharma, Scientific Officer, IPC,
45.
Dr. S. C. Mathur, Scientific Officer, IPC,
46.
Mr. K. K. Singh, Library& Information Officer, IPC,
47.
Dr. P. K. Saini, Scientific Assistant, IPC,
48.
Mr. M. K. Pandey, Scientific Assistant, IPC,
49.
Mr. Piyush kumar Pharmacopoeial Associate, IPC,
50.
Mr. L. M. Vijaya Prasad,Ex-Senior Scientist, & P.S. to Director, IPC.
51.
Mr. Venkatakrishnan Ex-Drugs Controller, Kerala, had also attended the meeting as a
special invitee.
Annexure-I
Following New Veterinary Monographs suggested during the meeting on 23rd-24th Jan 2013 at
IPC.
Veterinary Vaccine Monograph
1.
Bluetongue Vaccine, Inactivated
2.
Brucella Melitensis (Strain Rev. 1) Vaccine, Live
3.
Brucella Abortus (Strain19 Vaccine) Live
4.
Canine Adenovirus Vaccine, Inactivated
5.
Canine Adenovirus Vaccine, Live
6.
Haemorrhagic Septicaemia Alum Precipitated Vaccine
7.
Laryngotracheitis Vaccine, Live
8.
Old Adjuvant Vaccine against Pasteurellosis in Sheep and Goats
9.
Swine Fever (Lapinized) Vaccine
10.
Swine Fever Cell Culture Vaccine
Veterinary Chemical Monograph
1.
Albendazole Veterinary Oral Suspension
2.
Amoxicillin Veterinary Oral Powder
3.
Carprofen
4.
Cloprostenol Injection
5.
Closantel Sodium Dihydrate
6.
Co-trimazine Tablets
7.
Decoquinate
8.
Decoquinate Premix
9.
Deltamethrin
10.
Deltamethrin Pour-on
11.
Diclazuril
12.
Enrofloxacin
13.
Febantel
14.
Febendazole Granules
15.
Fenbendazole Oral Suspension
16.
Fenbendazole Veterinary Oral Paste
17.
Fenbendazole Veterinary Oral Powder
18.
Flunixin Meglumine
19.
Ivermectin Pour-on
20.
Ivermectin Veterinary Oral Paste
21.
Sulphadimidine
22.
Sulphadimidine Injection
23.
Sulphadimidine Tablets
24.
Xyaline Hydrochloride
Veterinary Diagnostic Monograph
1.
Avian Tuberculin Purified Protein Derivative (PPD)
Veterinary Immunosera Monographs
1.
Clostridium Novyi Alpha Antitoxins
2.
Clostridium Perfringens Antitoxins
3.
Clostridium Perfringens Beta Antitoxins
4.
Clostridium Perfringens Epsilon Antitoxins
5.
Clostridium Tetani Antitoxin (Tetanus Antitoxin)
Veterinary Surgical Materials Monographs
1.
Sterile Catgut in Distributor
2.
Sterile Non-absorbable Strands in Distributor
3.
Sterile Linen Thread in Distributor
4.
Sterile Poly (ethylene terephthalate) Suture in Distributor
5.
Sterile Polyamide 6 Suture in Distributor
6.
Sterile Polyamide 6/6 Suture in Distributor
7.
Sterile Braided Silk Suture in Distributor
Veterinary Appendix
1.
Terminology Used in Monographs on Biological Products
2.
Cell Cultures for the Production of Veterinary Vaccines
3.
Veterinary Liquid Preparations For Cutaneous Application
4.
Intrauterine Preparations
5.
Veterinary Oral Pastes
6.
Veterinary Immunosera
Following Veterinary Monographs proposed by stakeholders and their detail monograph
will be provided by them within 7 days.
Addition of New Proposed Monographs
1.
Albendazole Bolus
2.
Bruseline Acetate
3.
Buparvaquone Injection
4.
Cefodoxime Protoxime Tablets/Dry Syrup
5.
Cefoperazone Intramammary
6.
Cefquinome Sulphate Injection-USP
7.
Ceftriofur Sodium, Crystalline Injection
8.
Ceftrizoxime Injection
9.
Cephelexin Injection
10.
Ceptrioxane + Tazobactam Injection
11.
Ciprofloxacin + Tinidazole (to be added in Intrauterine)
12.
Colistin Sodium + Cloxacillin Intramammary
13.
Diaminazine Diaceturate
14.
Doramectin Injection
15.
Fipronil Spray
16.
Isofluperidone Injection
17.
Isometamedium Chloride Injection
18.
Levofloxacin + Ornidazole (to be added in Intrauterine)
19.
Levofloxacin Injection
20.
Marbofloxacin
21.
Meloxicam + Parcetamol Injection
22.
Moxidectin Injection
23.
Tolfenamic Acid Injection/Bolus
Following changes suggested in existing Monographs.
S.
No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
Monograph
Anthrax Spore Vaccine
(Page 2707, Spore count)
Avian Infectious Bronchitis
Vaccine
(Page 2708, In embryonated
eggs. Line3)
Change From
To
Determine the number of
viable spores by plate count.
The number of live spores is
not less than 80 per cent of the
stated on the label. The spore
count must be not less than 10
million spores per dose.
The vaccine when plated on
suitable media should show
10 million viable spores per
cattle dose and 5 million
spores per sheep dose.
10 dose
2/5th dose
Avian Spirochaetosis Vaccine,
Inactivated
(Page 2709)
Blackquarter Vaccine
(Page 2710, Potency, Line 4)
Add Inactivation test
28 days
Fowl Cholera Vaccine,
Inactivated
(Page 2724)
7 days
Add Inactivation test
Inclusion Body Hepatitis
(IBH) Vaccine, Inactivated
(Page 2727)
Test for Inactivation
Line 6
Add two passage in bracket
after fertilized eggs
Line 10
Ten dose
2/5th dose
IBD Vaccine, Inactivated
(Page 2728, Test for
Inactivation, Line 1)
10 dose
2/5th dose
Infectious Chicken Anaemia
Vaccine , Inactivated
(Page 2730, Test for
Inactivation, Line 1)
10 dose
2/5th dose
Infectious Coryza Vaccine ,
Inactivated
(Page 2731)
Add Inactivation test
Potency (Line 1)
Delete SPF Chickens (2.7.7)
Add before observe – or the
dilution at which 70 per cent
of unvaccinated birds get
infected or show clinical
signs or coryza.
10. Marek’s Disease Vaccine,
Live
(Page 2732, Line 2)
Strain or strains
11. Ranikhet Disease Vaccine,
Inactivated
(Page 2735, suggested method
of haemagglutination inhibition
test, Para 3, Line 3)
12. Reo Virus Vaccine,
Inactivated
(Page 2737, Inactivation)
Serotype (s)
After five fold add in
bracket (1/25th, 1/ 50th and
1/100th dose).
10 doses
2/5th dose