Misusing FSSAI licences, several Siddha drugs are marketed as herbal products by marketing cos in Chennai

Although the Food Safety and Standards Act (FSSA) was drafted carefully and it seems largely foolproof, certain provisions in the Act are alleged to be creating regulatory overlaps which may lead to a tussle between the regulators of the Drugs and Cosmetics Act and of the FSSA in the years to come if proper amendment is not carried out in the FSSA, observe enforcement officials in the directorate of Indian system of medicines (ISM), Chennai. According to officials in the ISM department in Chennai, the Food Safety and Standards Authority of India (FSSAI) is issuing licences to use individual herbs as ingredients for dietary supplements to many manufacturing companies which are engaged in the production and marketing of dietary supplements. They sell their food supplements made out of herbs and plants in the national and international markets. The ISM regulators are unable to inspect the manufacturing sites of these products, take samples and put them for testing because of FSSAI approval. The officials allege that this happens because of overlapping of provisions in the D&C Act and in the FSSA. They said it is high time for the Central government interfered in the matter and took measures for amendments in both the Acts. Taking advantage of these provisions, many marketing and manufacturing companies dealing in the production and sale of food and neutraceuticals companies in Tamil Nadu, bring out various brands of food supplements into the market using herbs. These herbs which are licenced by FSSA as food ingredients, have references in the Ayurveda, Siddha and Unani (ASU) pharmacopoeia as traditional ASU drugs. Talking to Pharmabiz, a senior officer in the ISM department, in anonymity, said even the Tamil Nadu Medical Service Corporation supplies these food supplements manufactured on FSSAI licence to the yoga & naturopathy wings attached to the ISM hospitals. “If any side effects or adverse reactions occur to the consumers of these herbal products, who will take responsibility of it? These FSSA licensed herbal ingredients are ASU drugs and they are prescribed by Siddha and Ayurveda practitioners under D&C Act. Power to grant licences for individual herbs by FSSAI authorities is only in the draft, it has not become an act. Even before it, the FSSA authorities have started giving approvals for individual herbs”, said another senior officer without wanting his identity to be disclosed. When contacted Dr. M Kannan, deputy director of FSSAI southern region, he said the act is in force since 2011 and approval is granted as per Schedule IV of the FSSA. Licences are issued for parts of specified plants and botanicals which are used for making food supplements. ‘Thippili Powder’ is a traditional drug prescribed by Siddha doctors for curing sputum production. But the drug is sold on FSSAI licence as a herbal product by Nellai Marketing Agency located at Valsaravakkam in Chennai. The company claims that it will have no side effects and cure dry cough, reduce lack of appetite and stomach ailments. ‘Kasthoori Manjal powder’ is also a Siddha drug ingredient used for various medicines for skin diseases. The Valsaravakkam located marketing company markets this on the approval of FSSAI as a herbal product. Indication is given on the outer cover that it can be used from infants to adults to make their skin soft and smooth. ‘Mudakathan’ is a popular Siddha drug used for arthritis. On FSSAI licence it is marketed by KCB company, operating from Thiruvallkkeni near Chennai. One of the most popular Siddha drug for cough and cold is ‘Nilavembu Kudineer’. It is also sold as herbal product in powder form by several marketers. Another Siddha drugs sold as herbal products in the market are ‘Maruthampattai powder’, ‘Kashaayam’, ‘Aloe Vera powder’, and a lot of medicinal products made in the form of powder. The ISM officials said even some big Siddha manufacturers in Tamil Nadu are also bringing out a host of herbal products into the market after taking food licence from the FSSAI.

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