The scientific panel for Functional Foods, Nutraceuticals, Dietetic Products of Food Safety and Standards Authority of India (FSSAI), which met on April 23, 2015 observed that the composition of nutrients in a range of pharma products offered by Juggat Pharma, an arm of Jagdale Industries Ltd, under the brand Mulmin (Mulmin Syrup, Mulmin Pro, Mulmin Plus Capsules and Mulmin Drops) were beyond national Recommended Dietary Allowance (RDA). Hence panel recommended the rejection of the product approval (PA).
As per the recommendations of the panel FSSAI decided to withdraw the No Objection Certificate (NOC) for all the products – Syrup, Drops, Pro and Plus Capsules and directed the company to stop manufacturing / sale/ distribution of the above products with immediate effect. In a letter dated June 19, 2015, the FSSAI directed to Jagdale Industries Ltd to recall all existing products from the market under intimation to it.
Juggat Pharma, a Bangalore based company noted that Mulmin Syrup and Drops are indicated to overcome hidden hunger, Substantially reduces diarrhea morbidity (even in HIV positive children), Dietary supplement to infants and children – vitamin deficiencies, Promotes Neuro Cognitive developments in children and As per UNICEF New York – Zinc (In Mulmin) promotes Appetite, Growth and Helps fight infection.
Observing the details submitted by the company for Syrup, it was asked to declare each ingredient in a proportion of the national RDA provided per serving size. Firm was also asked to revise the label declaration as per FSSR so as to be in compliance with food labelling regulations. The panel observed that applicant had reduced the composition of ingredients and also expressed the composition as % RDA. The panel further observed that the product was a combination of synthetic vitamins and minerals and label showed that the product was meant for children above five years. Hence panel recommended rejection of the PA.
In case of Mulmin Drops, the panel has asked the firm to submit safety information and rationale for pine bark addition to the product, including level of addition of minerals in the product. The panel at its latest meeting observed that the company has reduced certain nutrients like zinc in the process. The product, meant for children of 1 year, may have safety concerns for children if not supervised properly. The panel further observed that the product was a combination of synthetic vitamins and minerals. Hence recommended for rejection of the product approval.
The company noted that Mulmin Plus Capsules derived from dried Centella Asiatica (brahmi) leaf powder helps to manage mental and physical stress better, helps to boost Zinc level to improve immune response to viral and other infection, improves immune response, helps to overcome age related taste dysfunctions through Zinc, nutritional supplement for a healthy mind and body, helps to manage mild cognitive impairment and early onset dementia. The scientific panel of FSSAI observed that the rationale for adding extract derived from dried centell asiatica (brahmi) leaf powder is not clear and does not seem scientific. The synergistic effect of this combination is not known. Accordingly panel recommends for rejection of the product as applied.
The company noted that Mulmin Pro – a Milk Calcium Protein supplement with Multivitamins and Minerals in Strawberry / Vanilla Flavor is indicated for Pregnancy and Lactation, Growing children and adolescence, Sportsfolk, Post surgery, Osteoporosis and Geriatric patients. The scientific panel of FSSAI observed that applicant has used a terminology on the label ‘Milk Calcium Protein Supplement’ that was unscientific (as it is a preparation containing milk solids which include whey protein concentrate taken with milk). Further the claims made on the label are unsubstantiated and not scientifically justified. This forced the regulatory body to withdraw NOC given to the company.
The company noted that Juggat Pharma has recorded tremendous growth over the last four decades and it has become a symbol of success through planned diversification and innovative management. The company manufactures 33 pharma products.
With the most modern factory, conforming to Good Manufacturing Practice (GMP) standards as laid down by World Health Organization (WHO), Juggat Pharma manufactures Tablets, Liquid Orals, Capsules, Granules and Small Volume Parenterals. It has the facility for lyophilisation as well. The company noted that all its products undergo stringent quality assurance tests at every stage of manufacturing.