Minutes of the meeting of Expert Group on Production of Vaccines

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Tyler Stone
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1 Minutes of the meeting of Expert Group on Production of Vaccines A meeting of the expert group on Expert Group on vaccines constituted by Sec. DHR) and DG ICMR was held at ICMR Hqs. on 21 st Jan The list of participants is in Annexure 1. Issue: Whether our laboratories can produce DPT+ Hep.B vaccine and JE vaccine as then these vaccines would be available from them at cheaper rate Indian public and private sector manufacturers of childhood vaccines were invited to attend the meeting and make presentations on current production capacity and proposed plans for manufacture of DPT+Hep.B and JE vaccines. The following table summarizes the presentations S.No Manufacturer Vaccine Production capacitydoses/year Remarks 1. CRI, Kasauli DPT 40 million Potential to increase DT 20 million Potential to increase TT 40 million Potential to increase Hep B Possibility of procuring Hep.B component from other manufacturers and bottling and blending at CRI JE - mouse brain 5 lakh Can be increased to 20 lakhs 2 Pasteur Institute, Coonoor JE vero cell Hib DPT 40 million Research in progress Have potential to manufacture DT 15 million TT 30 million DPT+Hep B+ Hib Technical team visited to modify infrastructure to produce the combination. Report awaited JE mouse brain (requires 3 doses) Training of staff for production and testing completed 3 BIBOL OPV 600 million 1

2 4 Biological Evans DPT, Hep.B, JE 50% surplus utility available which can be utilized for manufacture of these vaccines. Time line would be about 3 years for new vaccines DTP 80 million 80 million (Proposed) DTPH 40 million 20 million (Proposed) TT 310 million 110 million(proposed) Penta 10 million 20 million(proposed) JE 20 million 20 million(proposed) Hep.B 20 million 30 million(proposed) Hib - 30 million(proposed) 5 Panacea Bulk Hib-TT conj. 50 million Bulk Hep.B 50 million Bulk Diphtheria toxoid 50 million Bulk TT 50 million Bulk wpertussis 50 million EnicvacHB (Hep.B) Ecovac4(DTwP- Hep.B) Easyfour (DTwP-Hib) Easyfive (DTwP- HepB-Hib) OPV(tOPV, bopv1&3,mopv1,m OPV3) 6 Bharat Biotech International Ltd. JE Hep.B bulk D,T & P ComVac3 (DTPw) ComVac4-HB(DTP- Hep.B) ComVac5(DTPw- Hep.B (liquid) & 20 million (proposed) 25 million Technology obtained from NII, propose to develop in 18 months Long term agreement with suppliers of bulk as per requirement 2

3 7 Shanta Biotech lyophilised ComVac5 (DTwP- Hep.B & Hib) liquid vaccine JE Verocell Proposed 50 million TT (SHANTT) 300 million Hep-B (SHANVAC B) Hib (SHANHIB) DTP (SHANTRIP) Tetra (SHANTETRA) Pentavalent (SHAN5) JE 200 million 100 million 300 million 300 million 100 million By end of year No plans Conclusions: 1. DTP-Hep.B a. As of December 2009, no public sector vaccine manufacturing units, were producing (DPT+Hep.B) combination vaccine in India. CRI, Kasauli which would have an installed capacity of 40 million doses of DPT, can procure and blend it with Hep.B and bottle it for use in India. Pasteur Institute, Coonoor can make upto 40 million dose of DPT, there is a proposal to produce Hep.B also in future. b. In private sector Biological E (produces individual and Combination DPT 80m; and Hep.B 20 m); Panacea (produces DPT+Hep.B and is WHO pre-qualified); Bharat Biotech (combo DPT+ Hep.B) 20 md/year; and Shanta Biotechnics (comb DPT+Hep.B) produce the DPT + Hep B vaccines 2. JE a. Public Sector: CRI Kasauli used to produce 5 lakh doses of mouse brain derived JE vaccine (not used anymore as given in 3 doses), Pasteur Institute Coonoor can also produce, training of staff has been completed. BIBCOL can also produce but does not have infrastructure b. Private Sector: Panacea working with Indian strain provided by NII, proposed time line of 18 m, installed capacity of 20 md /yr (in vero cell); Biological E SA w derived JE vaccine, capacity 20md/yr; Bharat Biotech working with Indian strain 3

4 provided by NIV, awaiting DCGI approval for clinical trials, 50 million doses of vero cell vaccine Point for consideration of Core Committee Encourage public sector investment in combination vaccines (Quadrivalent + Hibseperately; or pentavalent) to ensure affordability and vaccine security for the masses. Make a policy about approving a generic technology which can lead to production of affordable and commercially viable vaccines. 4

5 Annexure 1 List of participants: 1. Dr. V.M.Katoch, Sec.DHR and DG, ICMR 2. Dr. Lalit Kant, Head (ECD), ICMR 3. Dr. Sudhanshu Vrati, NII, New Delhi 4. Dr. S.D.Seth, New Delhi 5. Dr. Veena Mittal, NCDC, Delhi 6. Dr.K.R.Mani, Pasteur Institute, HP 7. Dr.B.Sekar, Pasteur Institute, Coonoor 8. Sh. C.B.Benjwal, BIBCOL 9. Dr. Rakesh Sinha, Biological E Ltd 10. Dr. PVVS Murthy, Biological E Ltd 11. Sh. M.Raghuram, Shanta Biotechnics Ltd 12. Sh. Ganesh Kumraj, Panacea Biotech Ltd 13. Dr. Kapil Maithal, Panacea Biotech Ltd 14. Sh. Milind V Galgalkar, Panacea Biotech Ltd 15. Dr.Ratnish, Bharat Biotech, Hyderabad 5

Snapshot - Indian Pharma Industry. Indian Pharmaceutical Market ~US $ 18bn Import ( )US$ 2.7 Bn

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