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Friday, January 29, 1999

Experts on call of "duty" over Novartis drugs classification 

Anju Ghangurde  
MUMBAI, Jan 28: Swiss multinational Novartis' launch of two international nutritional brands, Resource and Impact, in India has generated tremendous interest both on and off the market.

While the two brands, Resource and Impact, may possibly serve as a boon for diabetics and the critically ill in the country, experts have raised doubts over what they claim are inconsistencies in the labelling and their classification as "other foods" for the levy of duties.

Both products are imported by Novartis Nutrition India, which is held 51 per cent by Novartis Enterprises Pvt Ltd and 49 per cent by Novartis Nutrition, Berne.

Resource Diabetic, which incorporates "use under medical supervision" on the pack, is a "delicious liquid food providing balanced nutrition for individuals with impaired glucose tolerance". Resource is also available in powder form (manufactured locally) as a nutritionally balanced lactose-free supplement.

The powder form has been categorised as "other foods", while the liquid variant isclassified as a "diabetic food" for the levy of import duties. The entire labelling, experts say, seems to suggest that Resource Diabetic falls under the ambit of the Drugs and Cosmetics Act. "Such labelling would also violate the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954," they claim.

Under this act, the term drug includes "all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or preventing any disease or disorder in human beings or animals including preparations applied on the human body for the purpose of repelling insects like mosquitoes".

It also includes "such substances (other than food) intended to affect the structure or any function of the human body or intended for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time," it says.

Impact, the outer packing states, "is a high protein, nutritionallycomplete liquid medical food enriched beyond standard enteral formulas with arginine, fish oil and RNA to meet specialised nutritional and medical needs of critically ill patients who are hypermetabolic due to illness or injury". Novartis, however, refutes all these claims. "Resource and Impact are nutritional food supplements and are not covered by the Magic Remedies Act and the Drugs and Cosmetics Act.

Novartis mentions, to be used under medical supervision, as a precautionary measure in the case of products which can be tube fed. The general public is not expected to know the intricacies of tube feeding, hence the advice," a faxed response on the subject states. The Swiss healthcare giant also apparently does not require specific clearances from the local FDA, again a questionable policy, according to industry experts.

Copyright © 1999 Indian Express Newspapers (Bombay) Ltd.


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