New Delhi: India’s National Vaccine Policy, prepared under a court directive, calls for an investment push in vaccine development for so-called “priority diseases” by setting up a research fund, even as half the 26 million babies born every year fail to receive the full range of immunization against common, preventable diseases.
The draft policy, which comes in the midst of a legal standoff over a decision to introduce a new line of vaccines in the nation’s immunization programme, stresses on public-private partnership in areas of product development and building infrastructure for disease surveillance.
The document, penned by the government-constituted National Technical Advisory Group on Immunization, mentions that one of the biggest challenge in vaccine security is securing the right product, when “a majority of manufacturers are increasingly paying attention to the newer vaccines”.
“A majority of the vaccines research was being done in developed countries, and the focus was on vaccines against diseases which are prevalent in a developed country setting,” it says, stressing that the priority should be on local, preventable diseases such as pneumonia, diarrhoea, dengue, typhoid and cholera.
During the last decade, India has emerged as a vaccines hub, meeting 43% of global supply. Yet it trails behind smaller neighbouring nations in administering basic immunization to mostly poor children; Bangladesh, Nepal, Myanmar and Thailand have accelerated their vaccination drive and have achieved higher coverage than India’s 66% against diphtheria, whooping cough and tetanus, according to a 2009 World Heath Organization (WHO) evaluation survey.
A staple of six vaccines— diphtheria, whooping cough, tetanus, measles, polio and tuberculosis— form the core of the country’s public healthcare programme. The low rate of immunizing newborns and the government’s decision to roll out newer vaccines—for haemophilus influenzae type B (Hib), Pneumococcal conjugate vaccines and Rotavirus—has, however, polarized the medical fraternity and civil rights groups.
In 2009, a public interest litigation was filed in the Delhi high court opposing introduction of the pentavalent vaccine prior to carrying out epidemiological studies to ascertain disease prevalence among people.
Pentavalent, which is currently available in private clinics, is a combination of five drugs that include routine vaccines such as diphtheria, tetanus and whooping cough, as well as two new ones—Hib and hepatitis B.
At least nine petitioners, including a former health secretary and a member of the National Rural Health Mission, have accused the government of acting under pressure of vaccine manufacturers and international agencies such as WHO to push these new vaccines.
The purpose of having a policy is to make a comprehensive health assessment, says Pranav Sachdeva, the lawyer defending the petitioners. “The government now wants to make old vaccines unavailable without the new ones. What we are saying is introduce the new vaccines after establishing evidence of disease burden and carrying out cost-benefit analyses,” says Sachdeva.
The new policy says the newer vaccines can be considered to reduce costs and child mortality. At a WHO meeting in New Delhi recently, Union health minister Ghulam Nabi Azad said the pentavalent vaccine is being introduced in Tamil Nadu and Kerala, and the government’s aim is to “scale up”.
India spends a low 2.1% of the national health budget on routine immunization. At the heart of the debate lies India’s weakest flaw in providing healthcare services: shabby disease surveillance, delayed procurement, and the absence of any local standard for paediatric vaccination purchases.
Vishwa Mohan Katoch, director general of Indian Council of Medical Research, who assisted in drafting the policy, says “evidence of action” for vaccinating a population was hardly ever raised earlier.
“Evolution of procedures for disease surveillance is now coming from public perception and demand,” Katoch said. Without any robust disease registry other than cancer, mathematical models are generally used to estimate disease prevalence now.
At the concluding session of the WHO meeting in New Delhi, panellists comprising manufacturers and international funders blamed the government for not doing enough. Cyrus Poonawalla, chairman of Serum Institute of India Ltd, a leader in the estimated Rs 2,442 crore market, said the government lacks both accountability and commitment.
“They (India) must wake up and follow what others (countries) are doing,” said Poonawalla, whose company supplies 70% of the measles vaccine worldwide.
He criticized the ministry for not responding to his mails and overtures, like when he offered to give away 12 million doses of a combined measles-rubella vaccine for free.
According to a health ministry official who declined to be named, Poonawalla may be generous in offering free vaccines, but vaccination for rubella has not been approved by the government’s technical panel for him to push it as a combination product yet.