India is developing guidelines that may mean probiotic strains will have to be backed by clinical trials conducted on Indian populations if they are to gain market approval. India’s small but growing probiotics market is dominated by strains from non-Indian companies and so the mooted guidelines suggest probiotics should be tested on local populations before they receive safety approval because of differences in Indian gut flora. The commercial probiotic cultures currently used in India are of foreign origin,” said the Indian Ministry of Health & Family Welfare-backed Indian Council of Medical Research (ICMR), which has been working on the guidelines. “Inherent differences in gut flora of Indian population are known to occur, hence it is imperative to carry out efficacy studies in Indian population prior to their use in the country. ”
The ICMR added that in addition to these kinds of trials, there was a supplemental need for India to develop specific, “indigenous probiotic strains for expressing optimal functionality”. “After a public debate, once the draft is finalised, we would send it to the Drug Controller General of India, department of biotechnology, Food Authority of India. We have tried to harmonise the standards with international norms as large section of probiotic products produced in the country is also exported,” NK Ganguly, ICMR former director-general, said in press reports.
The research group also proposed an adverse event surveillance system as part of the voluntary guidelines that have the potential to be mandatory at a later point in time. It noted that many probiotic products in India bore claims not backed by science and therefore said strict labeling controls were required. The Indian probiotics market is growing at about 40 per cent annually, according to Frost & Sullivan data, which valued the market at €17. 5m in 2007. Global probiotic leaders, Danone and Yakult, which have a 50-50 joint venture in India, welcomed the guidelines, There is lack of regulations in this area and it is important that guidelines for probiotic products are established to ensure product safety, quality, reliability for all companies introducing and producing probiotic food,” Yakult Danone India Private Ltd head of science, Neerja Hajela, told Indian news sources. “The draft guidelines have a provision for assessment of efficacy, safety and health claims made by the probiotic foods that are being launched in India and defined parameters required for a strain/product to be classified as a probiotic. ”