The Indian vaccine industry is perched on a strong foundation of competitive advantage led by technical capability, noted Pushpa Vijayaraghavan, director, Sathguru Management Consultants.
 
“Therefore Indian vaccine industry has a great future and this is a successful Make in India sector. The country is already home to four companies with pneumococcal conjugate vaccine (PCV) in the pipeline. The industry needs to propel forward as a significant player in the Indian bio-pharma sector. We need the global recognition for the product pipeline and the technical complexity of the vaccines which makes the industry notable and poised for growth”, Vijayaraghavan told Pharmabiz in a telecon.

Recently Sathguru in association with CII released a White Paper on Vaccines which noted that India graduates from GAVI (Global Alliance for Vaccines and Immunization) support and begin self-financing its immunization programme. The government currently looks to expand the vaccine portfolio to address critical gaps in its immunization program with PCV and HPV (Human papillomavirus)

“The GAVI transition is based on certain economic criteria. India has been able to negotiate this transition because it is confident about implementing its robust immunization programme. The government is giving out an optimistic message on the adoption of vaccination by allocating its own budget for the same,” noted the Sathguru director.
 
The pipeline for PVC is quite robust with pre-clinical and clinical candidates for PCV from Serum Institute of India, Panacea Biotec, Biological E and Tergene Biotech. The Government has currently prioritized adoption of PCV and several initiatives rolling up to national adoption are encouraging. In the case of HPV, India’s pipeline is not as robust as PCV. It is an immediate priority to bolster the country’s pipeline of HPV vaccines and accelerate their path to market. While there isn’t clarity currently on HPV adoption timelines, we also look forward to the government next prioritizing the HPV vaccine adoption on a national basis, she said.

“We now need to accelerate the commercialisation and regulatory approval of these vaccines. Now this is getting extremely slow because of the current regulatory framework. This must be the country’s priority. Infrastructure for manufacture of vaccines is being created in the private sector,” she said.
 
Manufacturing of vaccines which are WHO approved is a robust landscape. The capability in terms of production capacity of vaccines is proved because the world depends on India for this. For public procurement, the world largely depends on GAVI, UNICEF and WHO. India’s Universal Immunization Programme accounts for 80 per cent of the India’s domestic demand for vaccines. The private sector vaccine marketing in India accounts for 20 per cent and are for not public health epidemics but people are prescribed to prevent certain diseases.
 
The key challenge for Indian vaccine industry is the large dependence on public health procurement. The companies also have to wait for 3 to 8 years of uncertainty which severely impact their capability to invest. The challenge is the dependence on public health procurement which impacts the capability to invest, she noted.