The office of the Drugs Controller General of India (DCGI) has asked all the companies marketing formulations containing probiotics as dietary supplements to obtain drug licenses within three months. All state drug control authorities have been instructed to refrain from giving manufacturing licenses to formulations containing probiotics under the Prevention of Food Adulteration Act. The instruction comes in the wake of the government decision to consider all probiotics formulations as drugs and not food supplements.
In a directive issued to state drug control authorities, the DCGI has observed that formulations containing lactobacillus organism are being marketed both as drugs and dietary supplements by several companies in the country. The companies promoting the formulations as dietary supplements are doing so after obtaining licenses from the local health authorities. Taking serious note of this situation the DCGI has warned against promoting these products as dietary supplements.
Recently, the Central Committee for Food Safety (CCFS), a statutory body under PFA Act, had opined that these probiotic preparations in capsule / tablet / sachet doses forms and having therapeutic claims need to be regulated as drugs. Probiotics are known to play beneficial role in Traveler's diarrhoea, antibiotic associated diarrhoea, infantile diarrhoea, inflammatory bowel disease, irritable bowel syndrome, colon cancer etc.
Lactobacilli used as probiotics include lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus cellobiosus, lactobacillus crisputus, lactobacillus curvatus, lactobacillus fermentum, lactobacillus GG, lactobacillus johnsonii, lactobacillus plantarum and lactobacillus salivarus.