|Year : 2018 | Volume
| Issue : 1 | Page : 116-118
Survey of probiotic preparations and labeling practices in Indian market
Vikas Chandrashekhar Ghattargi, Swapnil H Kalam, Sumeet S Pandit, Shrikant P Pawar, Yogesh S Shouche
National Centre for Microbial Resource, National Centre for Cell Science, Pune, Maharashtra, India
|Date of Web Publication||2-May-2018|
Dr. Yogesh S Shouche
National Centre for Microbial Resource, National Centre for Cell Science, Pune - 411 021, Maharashtra
Source of Support: None, Conflict of Interest: None
A cross-sectional survey was conducted across 320 chemists shop in Pune city for their availability and labeling practices. The questionnaire revealed the data about the most sold probiotic preparations, their mode of sale, and their available forms such as tablet, capsule, and sachet. Top ten probiotic preparations were evaluated for labeling practice as per the existing regulations of the Indian Council of Medical Research-Department of Biotechnology, Indian guidelines. Majority of probiotic preparations were listing the best before date, viability, probiotic organisms, net quantity, and batch number, but none of them mentioned the health claims.
Keywords: Available forms, mode of sale, most sold, questionnaire, survey
|How to cite this article:|
Ghattargi VC, Kalam SH, Pandit SS, Pawar SP, Shouche YS. Survey of probiotic preparations and labeling practices in Indian market. Indian J Med Microbiol 2018;36:116-8
|How to cite this URL:|
Ghattargi VC, Kalam SH, Pandit SS, Pawar SP, Shouche YS. Survey of probiotic preparations and labeling practices in Indian market. Indian J Med Microbiol [serial online] 2018 [cited 2018 Nov 15];36:116-8. Available from: http://www.ijmm.org/text.asp?2018/36/1/116/231684
| ~ Introduction|| |
The UNFAO/WHO, 2001 defines “Probiotics are live microorganisms that when administered in adequate amount confer a health benefit.” An effective probiotic should consist of a large number of viable cells at the time of injection and must survive during packing, transportation, and storage moreover should be metabolically active in gut. Microbes used as probiotics are generally lactic acid producers.
Probiotics have been associated with variety of health benefits, namely, antagonistic effects against gut pathogens by antimicrobials production, modulation of immunological, respiratory and gastrointestinal functions, short-chain fatty acid production as well as essential vitamins and lowering serum cholesterol,,, Moreover, they have the potential to offer alternative to effects of pharmacotherapy such as antibiotic-associated diarrhea and treat symptoms of chronic disease (NEC and IBS-Irritable Bowel Syndrome). Thus, the ingestion of probiotics to improve health is increasingly common.
The objective of this study is to find the most sold probiotic preparation (directed for treatment of disease conditions) across the chemist shop to understand the probiotic demand across Pune, India. We also made an attempt for evaluation of the labeling practices of top ten probiotic preparations.
| ~ Materials and Methods|| |
A total of 320 chemist shops across Pune city were directed for this study, the voluntary nature of participation and the intended use of the research, for scholarly purposes was stated before. The questionnaire was assessed through the personal interview by a structured questionnaire [Table S1]. The first column contained a list of probiotic preparations, second had mode of sell, and third had most sold. The ranking was given as 1, 2, and 3 for least sold, moderately, and most sold, respectively. The last column was for available forms (tablet, capsule, sachet, and others) of the probiotic preparations.
Evaluation of labeling practices of probiotic
We adapted the Indian Council of Medical Research (ICMR) Department of Biotechnology guidelines to evaluate the labeling requirements of probiotic preparations indented for medical purpose. The preparation should have genus, species, and strain designation according to the International Nomenclature, minimum viable numbers of each probiotic strain, evidence-based health claims and storage conditions, and minimum effective quantity of probiotic. Data analysis was conducted using the Microsoft Excel and Statistical Package for the Social Sciences (SPSS release 17.0.0, SPSS Inc., Chicago, IL, USA).
| ~ Results|| |
Out of the 350 shops only 3 chemist shops had all preparations, 5 chemist shops had 20 preparations (56%); 53 chemist shops had 15 preparations (42%); 143 shops had 10 preparations; and 108 shops had 5 preparations. The top ten most sold probiotic preparations are in the order of Vibact, Nutrolin B, Rinifol, Econorm, Sporlac, Vizylac, Becelac Forte, Flora-BC, Bifilac, and Gut-OK [Figure 1]. The probiotic preparations least sold in the market were Pro-sig (2%), Imm-4 (2%), and Hepolac (2%). Four preparations, namely, Entrelac-Z, Labale, I-lac, and Enbolac were available in 5 chemist shops surveyed [Figure 1]. Except Abigut, Binifit, and Pro-sig preparations all others were sold on the basis of prescription and over-the-counter (OTC). The ratio for a prescription to OTC was found to be 91:3. About 44% of preparations were sold both by prescription as well as OTC [Figure 1].
|Figure 1: (a) The top ten most sold probiotic preparations, (b) The distribution of other probiotic preparations, (c) Mode of Sale of Probiotic preparations. Where p is prescription, o is over-the-counter and po is both combinations, (d) Available forms of Probiotic preparations. Where t is tablet, c is capsule, s is sachet and o is other form being sold. The others are shown in combinations|
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Most of the probiotic preparations were sold in the form of capsule while the preparations were least available in other syrup form, while some were sold in multiple forms such as tablet and sachet [Figure 1]. The ratio for tablet, capsule, sachet, and other forms such as syrup was found to be 4:24:5:1, respectively. Nutrolin B was the only one preparation available in all four forms such as tablet, capsule, sachet, and syrup. Seven preparations viz. Nutrolin B, Rinifol, Sporlac, Vizylac, Becelac Forte and Flora-BC had content labeled as Lactic Acid Bacillus. These product labels did not mention the species or strain of the content as per the ICMR guidelines. Only Sporlac and Econorm mentioned the content to species level, i.e., Lactobacillus sporogenes and Saccharomyces boulardi, respectively. The other additives mostly consisted of Pyridoxine Hydrochloride IP, Nicotinamide IP, Cyanocobalamin IP (added as Mannitol Triturate), and Folic acid IP commonly present in almost all the probiotic preparations. Labeling of probiotic preparations containing multiple microbial contents such as Vibact, Bifilac, and Gut OK had mentioned the microbial content to its strain level, i.e., Streptococcus faecalis T-110 JPC, Clostridium butyricum TO-A, Bacillus mesentericus TO-A JPC, and lactic acid Bacillus (Lactobacillus sporogenes).
| ~ Discussion|| |
Market survey across Pune city was conducted to gain insights for the most sold from the chemist shops and to know the labeling practices. In the current study, we identified the most sold probiotic preparations by structured questionnaire at chemist shops. The questionnaire revealed the figures about the most sold probiotic preparations. Vibact was the most commonly available product, being offered by 75% of the chemists, followed by Nutrolin B, Rinifol, and Econorm which were available in 71%, 71%, and 67% of the chemist's shops, respectively. All preparations were available only in 1.6% chemist shops. The questionnaire publicized the probiotic preparations were sold mostly on the prescription.
Most of the probiotic preparations were sold in the form of capsule while syrup containing were Rinifol, Nutrolin B, and Flora-BC. Among the most sold (top ten); three preparations: Vibact, Bifilac and Gut OK were ployculture while Nutrolin B, Rinifol, Econorm, Becelac Forte, Flora BC, Sporlac and Vizylac were monoculture.
Efforts were taken for directing the labeling practices of only most sold probiotic preparations in the market. The microbial content and their count were mentioned, along with other contents and its concentrations. The analysis of the survey revealed that the probiotic preparations are labeled according to the old nomenclature. While all of the labels mentioned the name(s) of microorganisms, very few drugs had dosage stated on the label. The colony forming units (CFU) was also not mentioned on the labels for five of the supplement. No other contents were mentioned in the labels in these probiotic preparations. All the probiotic preparations mentioned the dosage, storage, manufacturing date, expiry date, and manufacturing license number in its labeling.
Financial support and sponsorship
This study was supported by the National Centre for Microbial Resources and National Centre for Cell Science.
Conflicts of interest
There are no conflicts of interest.
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