Immunization has played an integral role in improving children’s health and survival in India. The Ministry of Health and Family Welfare has been consistently working towards reducing the mortality rates from vaccine-preventable diseases through its Universal Immunization Programme (UIP). Immunization doesn’t just save medical costs, but also yields indirect economic benefits like educational attainment, enhanced productivity. The unimmunized individuals are also offered protection through “herd immunity” by many vaccines.
India has made significant progress towards reducing child deaths and has set multiple child health targets to achieve. The government of India has taken multiple steps to accelerate child survival, including strengthening the routine immunization (RI) programme of the country. Since 1990, the child mortality rates of the country have declined by 58%. So far, Vaccines have successfully eradicated smallpox and polio from the country. Measles have brought to an all- time low and tetanus has been reduced to a large extent. As of 2013, 18 states were estimated to have eliminated maternal and neonatal tetanus. Over the years, India has seen progress in expanding immunization coverage, with nationwide coverage of the third dose of the diphtheria-tetanus-pertussis (DTP) vaccine increasing to an estimated 72% in 2012 from 60% in 2003.
The industry stands on remarkable success that exemplifies “Make in India” while the road ahead calls for strategic maneuvering and funding. The global foothold is consistently strengthened which is crucial to remain successful, however, the need of the hour is to evaluate the evolving domestic market landscape.
Vaccines have transformed public health throughout the world, for children particularly, the burden of vaccine-preventable diseases in India is still substantial and hence the usage of this powerful tool is still not optimal in our country. The Indian healthcare industry presents new vistas of growth, provided, challenges in terms of policy barriers, lack of awareness and affordability issues, are successfully tackled. Some of the challenges can be explained as -
Technical Challenges: -
Technology has been a conspicuous obstruction in the case of few emerging vaccines. Hence, this results in significantly higher product risk, higher than it has been in all previously developed vaccines.
IP Policies: - We need stringent IP policies and an ecosystem where research is prized and not just encouraged. Hence, at the end its not only a question of sustained industry competitiveness, it is a question of appropriate and active public response to a critical national need.
Regulatory Challenges: -
Many a times procedural hold-ups delay product development and launch, which in turn have proven truly expensive – not only to the industry but to the country as such. While the industry stakeholders have now begun a constructive dialogue to wash out certain regulatory delays, the magnitude of the problem calls for a collaborative approach that is as aggressive as it can be.
In a wake to address the regulatory issues of Indian vaccine industry, Union Health Ministry has recently announced that it will be forming an expert group to examine regulatory issues for Indian vaccine industry. "Indian vaccines manufacturers should accord prime importance to meeting domestic demand, upscale research and development related work, and also take initiatives in developing critical vaccines such as Pneumococcal conjugate vaccine (PCV) and Human Papillomavirus (HPV) vaccines" said Union Health Secretary C K Mishra. The expert group will work towards speedy resolution of issues in time-bound manner without compromising critical aspects like quality, patient safety and patient management.
More of such initiatives and planned multi-stakeholder approach is required for conquering challenges of complex emerging vaccines that lie ahead. It is critical that policymakers and regulators alike, maintain the pace in such efforts and work in full force to help India win over the next set of public health challenges.