List of licensed vaccine manufacturing units in India and Conclusions

Box 1. List of licensed vaccine manufacturing units in India

There are number of licensed vaccines manufactures in India. These manufactures has installed capacity and are licensed for production or marketing of at least one or more vaccine in India. BCG Vaccine Laboratories, Guindy Institute of India Ltd, Pune Pasteur Institute of India, Coonoor Central Research Laboratory, Kasauli Haffkine Biological Product C Ltd., Mumbai Human Biologicals and Immunologicals, Hyderabad King Institute of Preventive Medicine, Chennai Pasteur Institute, Shillong Bio Vaccines, Hyderabad Dano Vaccines, Hyderabad Bharat Immunologocal and Biologicals Company Ltd, Bulandshahar Panacea Biotech Ltd, Delhi Bio-med (P), Ghaziabad Bharat Biotech International (L), Hyderabad Sanofi Pasteur India Pvt Ltd., Delhi Zydus Cadilla, Ahmedabad Chiron Behring Vaccine Lab. Ankleswar, Gujarat Sanofi (Aventis) Pasteur, New Delhi

Conclusions

 The evolution of vaccination efforts in India is far more complex than presented in this review and every single event merits a detailed analysis. Though preventive efforts from diseases were practiced in India, the reluctance, opposition and slow acceptance of vaccination have been the characteristic of vaccination history. The operational challenges keep the coverage inequitable in the country. The lessons from the past events have been analysed and interpreted to guide immunization efforts. There are many lessons learnt from the history from extending the benefits of immunization to every possible beneficiary in the country to achieve the stated policy goals.

Introduction of new antigens in UIP in India

Table VIII. Introduction of new antigens in UIP in India                           Milestone year 1985                 UIP launched with 6 antigens (BCG, DPT, OPV and measles). 1986-2001       No new antigen is added in UIP of India. 2002/03         Hepatitis B vaccine becomes the part of UIP in 14 metropolitan areas and 33 districts of the country. 2006-10         Japanese encephalitis (JE) vaccine added to the UIP in select endemic districts in phased manner. JE vaccination is initially done through mass campaign to cover 1-15 years of age group followed by administration in routine immunization schedule at the age of 16-24 months. 2007/08          Hepatitis B vaccination scaled up to cover 10 additional States of India. 2010                      Second dose of measles vaccine (MCV2) introduced in UIP in India; 21 States introduced vaccine in UIP at the time of DPT booster1 and rest 14 States started measles catch campaigns to cover 9 months to 9 years of age children. Japanese encephalitis vaccine campaigns completed in all identified 112 endemic districts of 15 States of India.  JE vaccine became part of the UIP in these districts. 2011                      Measles catch up campaign continued. Hepatitis B vaccine scaled up to the UIP of all 35 States and UTs in India. Haemophilus influenzae type b (Hib) vaccine introduced as pentavalent (DPT+Hib+HepB) vaccine in UIP of Tamil Nadu and Kerala States of India. 2012                        Measles catch up campaigns completed in 9 States of India and ongoing in remaining districts of 5 States of India. Plan for expansion of pentavalent vaccine in 6 additional States & UTs (Jammu & Kashmir, Haryana, Goa, Gujarat, Karnataka and Puducherry) of India.

Reports

                  Reported cases of major vaccine preventable diseases in India (1980-2010)

        Evaluated state-wise proportion of fully immunized children in India.

 Evaluated full immunization coverage by district in India

Timeline of polio eradication efforts in India

Table VI. Major milestone since launch of EPI in India (1978- till 2012)   1978                      Expanded Programme of Immunization (EPI) launched in India.   1980                     World declared smallpox free. It becomes the first disease to be eradicated from planet  1985                             Universal Immunization Programme (UIP) launched in 31 districts of India with a plan for expansion  to the entire country. 1986                             Immunization became one of the five National Technology Missions in India. 1988                            World Health Assembly passes a resolution to eradicate polio by the year 2000. 1989                             First comprehensive review of UIP in India conducted. 1990                              UIP universalized to cover the entire country. 1991                             Cold chain maintenance was taken over by the State governments. 1992                              UIP became part of Child Survival and Safe Motherhood (CSSM) programme in the country. Another international review of UIP in India conducted.   1995                     India conducted first National Immunization Day for Polio eradication.   1997                     UIP became part of Reproductive and Child Health (RCH) programme in India. National Polio Surveillance Project launched as WHO and the Government of India collaboration. 2000                             Border District Cluster Strategy for immunization strengthening in border districts implemented; Immunization Strengthening Project (ISP) implemented. 2001                             National Technical Advisory Group on Immunization (NTAGI) in India formed. 2004                             International review of UIP conducted.   2003/2004           First maternal and neonatal tetanus elimination (MNTE) validation done. 2005                            UIP became part of overall umbrella health programme National Rural Health Mission (NRHM) in India. First Multi Year strategic Plan (MYP) for UIP in India (2005-2010) released. National Adverse Events Following Immunization (AEFI) Surveillance and response operational  guidelines released. 2005/06                  The glass syringes in UIP were replaced by the policy of the use of auto-disable syringes   2006                            Country conducted first Immunization Weeks for improving coverage with UIP antigens in poor  performing districts. 2007/08                National, State and district level AEFI committees constituted. State and district level trainings in AEFI conducted. 2008                            Immunization Handbook for Medical officer released and trainings started. National Cold Chain Assessment conducted. 2009                            Guidelines for the involvement of private practitioners in UIP released. National Vaccine Wastage Survey Conducted. 2010                             India became the last country in the world to introduce measles second dose in the national immunization programme; 21 States provided MCV2 in routine immunization and rest of the States started  conducting measles catch up campaigns. 2011                             Last wild polio virus case reported from India. National Vaccine Policy of India released. Open Vial Policy was implemented for select vaccines in UIP. 2012                             Draft comprehensive Multi Year strategic Plan (MYP) for UIP (2012-2017) ready. Declared as Year of ‘Intensification of Routine Immunization’ in India. WHO removed India from the list of polio endemic countries.

Major milestone since launch of EPI in India (1978- till 2012)

Table VI. Major milestone since launch of EPI in India (1978- till 2012) Year                       Vaccination efforts 1978                      Expanded Programme of Immunization (EPI) launched in India.   1980                   World declared smallpox free. It becomes the first disease to be eradicated from the planet. 1985                                Universal Immunization Programme (UIP) launched in 31 districts of India with a plan for expansion  to the entire country. 1986                                Immunization became one of the five National Technology Missions in India. 1988                                World Health Assembly passes a resolution to eradicate polio by the year 2000. 1989                                First comprehensive review of UIP in India conducted. 1990                                UIP universalized to cover the entire country. 1991                                Cold chain maintenance was taken over by the State governments. 1992                                UIP became part of Child Survival and Safe Motherhood (CSSM) programme in the country. Another international review of UIP in India conducted.   1995                     India conducted first National Immunization Day for Polio eradication.   1997                      UIP became part of Reproductive and Child Health (RCH) programme in India. National Polio Surveillance Project launched as WHO and the Government of India collaboration. 2000                                Border District Cluster Strategy for immunization strengthening in border districts implemented; Immunization Strengthening Project (ISP) implemented. 2001                                National Technical Advisory Group on Immunization (NTAGI) in India formed. 2004                                International review of UIP conducted.   2003/2004           First maternal and neonatal tetanus elimination (MNTE) validation done. 2005                                UIP became part of overall umbrella health programme National Rural Health Mission (NRHM) in India. First Multi Year strategic Plan (MYP) for UIP in India (2005-2010) released. National Adverse Events Following Immunization (AEFI) Surveillance and response operational  guidelines released.   2005/06               The glass syringes in UIP were replaced by the policy of the use of auto-disable syringes only. 2006                                Country conducted first Immunization Weeks for improving coverage with UIP antigens in poor  performing districts. 2007/08                National, State and district level AEFI committees constituted. State and district level trainings in AEFI conducted. 2008                                Immunization Handbook for Medical officer released and trainings started. National Cold Chain Assessment conducted. 2009                                Guidelines for the involvement of private practitioners in UIP released. National Vaccine Wastage Survey Conducted. 2010                                India became the last country in the world to introduce measles second dose in the national immunization programme; 21 States provided MCV2 in routine immunization and rest of the States started  conducting measles catch up campaigns. 2011                                Last wild polio virus case reported from India. National Vaccine Policy of India released. Open Vial Policy was implemented for select vaccines in UIP. 2012                                Draft comprehensive Multi Year strategic Plan (MYP) for UIP (2012-2017) ready. Declared as Year of ‘Intensification of Routine Immunization’ in India. WHO removed India from the list of polio endemic countries.