India is on the
threshold of launching an oral vaccine for diabetes that would
replace the current practice of insulin injections, promising
relief to millions in the country suffering from the
debilitating health condition.
The Andhra Pradesh-based pharmaceutical company Transgene Biotek
Ltd is currently doing research and pre-clinical trials of the
vaccine in collaboration with the Indian Institute of Chemical
Technology (IICT), Hyderabad.
"We have made considerable progress in the drug development
process. The new vaccine will be administered in liquid form,"
Prakash V. Diwan, chief of pharmacology of IICT, told IANS.
Diwan, however, said they would not like to divulge details
about the development. "It's too early to give further details."
With nearly 40 million diabetes patients, India is home to over
20 percent of the total cases worldwide. Experts believe that
given the changing lifestyles, the disease could take on an
endemic status soon.
Health Minister Anbumani Ramadoss had told IANS earlier that pre-clinical
trials of the oral vaccine were at an advanced stage and "by the
second half of 2008 there will be some reason to smile".
The oral insulin vaccine has shown a reduction in blood glucose
levels comparable to that of the injectable insulin, officials
said. Once taken, the benefits would persist for almost 24 hours
and help in better management of diabetes.
However, experts involved in the research said they would go for
a "toxicological test" of the drug in "animal mammals because of
the safety factor".
"The clinical trial will have two phases - in phase one the drug
would be tested on animal mammals and on phase two on humans.
Nearly 200 to 250 mammals of two separate categories would be
put under the toxicological test," said a researcher associated
with the new vaccine, requesting he not be named.
In the second phase, the drug would be tested on at least 20
humans. "Once successful, the drug would be tried on around 100 patients from different parts of India and probably from some
European country. It would help in containing the disease faster
and more effectively. The cost of treatment would also go down
as the drug would be an indigenous product," the researcher
According to the World Health Organisation (WHO), an estimated
180 million people worldwide suffer from diabetes. Nearly 1.1
million succumbed to the disease in 2005. Almost 80 percent of
diabetes deaths occur in low and middle-income countries, the UN
Diabetes, which can lead to several complications like kidney
failure, gangrene in the leg leading to amputations, heart
problem and skin related problems, is growing at the rate of
over 50 percent in India, say officials. In India, the mortality
rate is over five percent of the total number of cases reported
every year. Anoop Mishra of the Fortis Group of Hospitals said
an oral vaccine would greatly help patients. "It would make the
treatment process easier and help in containing the disease,"
said Mishra, director and head of the department of diabetes at
"Indians are genetically predisposed to such ailments. And when
they change their food habits the chance of being affected by
diabetes and heart problems increases. A lot of children are now
turning diabetic," Mishra added.
According to one estimate, a diabetes patient spends nearly Rs.15,000
on treatment a year. If the problem leads to other health
related problems, the amount rises four-fold. The loss of
working hours also results in revenue loss.