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 explained.
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 body said.
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 Fortis.
"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.