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Many nutraceuticals in market classified as drugs : sub-committee of DTAB

 

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As per sub committee of Drugs Technical Advisory Board (DTAB), many nutraceuticals which are being sold as food products contain considerable amount of drugs. And such product may be withdrawn from market and they will sell as drugs instead of food.

The Hon’ble High Court of Patna had desired that DTAB may give opinion in respect of component of ingredients of certain Neutraceuticals and its effect on the human body if consumed as a food and as to whether the products would fall under the classification of "drugs" under the Drugs and Cosmetics Act, 1940 or under the Prevention of Food Adulteration Act as "Food". Then DTAB constituted a sub-committee to examine the matter in detail.

The sub-committee submitted a report to DTAB in its meeting held on 18th august 2015. The committee opined that authorities shall implement the enforcement on the product standards as per the principles (for withdrawing or approving the products). It was also generally accepted by the Committee that the fixed Dose Combinations of vitamins and minerals which are given in schedule 'V' shall be considered as generally safe as was opined in various expert Committees on the subject. Whenever there is additional ingredients, than those given in schedule V, including some of herbal ingredients, a separate and conscious view has to be taken about safety and efficacy of drug.

As per sub-committee the some of the ingredients present in the products like Ferradol (Pfizer); Revital (Ranbaxy Laboratories); Beneficial capsules, CSN Capsules and DSN Capsules (Shreya Life science); A to Z (Alkem Laboratories); Kidvit Z (Ceza Formulations); Resource Diabetic and Resource Renal 2.0 (Drytech Process) fall under the range as prescribed under schedule V of the Drugs and Cosmetics Rules, 1945 either in prophylactic or in a therapeutic dose. The Committee recommended that the products shall be classified as drugs.

The Committee could not discuss other products as mentioned in the Writ Petition as the same were not available in the market as well as no information is available in respect of these products. However for classification of these products, above rule position as interpreted by the Committee shall be used.

Dr. G.B. Gupta, Vice-Chancellor, Ayush and Health Sciences University of Chhattisgarhand member of sub-committee stated that vitamins which have come into effect recently are indicated for prevention and treatment of many diseases related to vitamin deficiency states and these are generally prescribed by the physicians for the prevention and treatment of specific vitamin deficiency states. Schedule V of the Drugs and Cosmetics Rules, prescribes the standards for patent or proprietary medicines containing vitamins. It is provided that patent or proprietary medicines containing vitamins for prophylactic, therapeutic or paediatric use shall contain the vitamins in quantities not less than and not more than those specified therein in single or in two divided daily doses. Dr. Gupta also informd that Ayush products do not contain pure chemical vitamins.

Prof. M.D. Karvekar, member of sub-committee opined that the manufacturing and packaging of these products resemble to the dosage form of a drug and sometimes indications are also mentioned on such products as if these are intended to be used as a “drug”

Shri O. S. Sadhawani, Controlling Authority and Joint Commissioner, FDA, Maharashtra and member of sub-committee stated that ‘drug’ under section 3(b) (i) of the Drugs and Cosmetics Act is defined as ‘all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any diseases or disorder in human beings or animals’. Further, as per section 3(b) (iii) of the said Act, the ‘drug’ also includes ‘all substances intended for use as components of a drug including empty gelatin capsules’. He opined that Committee members shall discuss all the products one by one based on the composition of the product, effect of each ingredient on the body. Present in the product, requirement of Schedule ‘V’, food safety and standard requirements as well as indications claimed by the firms, if any so that it becomes easier for the Committee to decide each product as "drug” or as “food”. Dr. Sadhawani also informed that there are certain products which are used both as drug as well as food and are exempted under schedule K of Drugs and Cosmetics Act and rules thereunder.

CDSCO has invited comments from public within one month on recommendation of DTAB. The comments shall then be further examined by DTAB.


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