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India – Government Debates “Drugs Vs. Food” Status Of Health Supplement.

14 June, 2012

 

The Department of Pharmaceuticals and the National Pharmaceutical Pricing Authority (“NPPA”) have approached the Drug Controller of India (“DCI”) and the Food Safety and Standards Authority of India (“FSSAI”) for clarity on the parameters for classification of health/nutritional supplements as food products or as drugs. Various products, claiming to contain higher amounts of vitamins and minerals, are being sold in the Indian market as health/nutritional supplements. At the same time, multivitamin tablets and products containing other nutrients are being sold as drugs, with requisite licensing from the Drug authorities. 
 
It, therefore, largely remains the choice of the manufacturer to sell its multivitamin/mineral products as a “food product” or as a “drug”. Food supplements are sold at considerably higher prices as compared to their drug counterparts, and are also subjected to lesser regulatory monitoring and restrictions. Regulators believe that various pharmaceutical companies accordingly sell drugs and medicines camouflaged as food/health supplements.
 
Globally, different countries have adopted varied approaches to check similar challenges. We understand that in the European Union (“EU”), a Directive prescribes specific standards and rules for advertising, presentation, purity criteria, labeling of content and dosage of food supplements as well as enlists permitted minerals and vitamins that can only be used in food supplements. This Directive has been adopted widely across countries of the EU, including the UK where the health/nutritional supplements are otherwise broadly qualified as foods. In view of the fact that products with higher quantity of vitamins and minerals than in some prescription medicines were available for sale in the UK as food products, the authorities have also published safe levels of intake of multivitamins and minerals by humans. 
 
The USA has implemented “The Dietary Supplement Health and Education Act, 1994” regulating food supplements as food products and to provide for safety principles, guidelines for third party literature provided at the point of sale as well as the standards for good manufacturing practices and labeling.
 
The Indian Government is yet to spell its line of thinking. To start with, we can expect specific guidelines governing manufacture, license and sale of health/nutritional supplements. 
 
Blood Relatives “Can” form a Society
 
The Delhi High Court (“DHC) has recently held that the right to register a society, as a legal entity, is available to any seven or more persons coming together, whether they are related to each other by blood or not.
 
The Registrar of Societies, Government of NCT of Delhi (“Registrar”) has been, based on the guidelines issued by the Government of NCT of Delhi, requiring all persons desirous of registering a society with its offices, to submit an affidavit confirming that the members of the society are not related by way of blood or otherwise.  
 
The requirement for such a confirmation on affidavit came up for consideration by the DHC recently in the matter of Brij Mohan Gupta Vs. Registrar of Societies. In this case, the Registrar had cancelled registration of a society on the ground that an incorrect affidavit, confirming absence of any blood relationship amongst its members, was submitted with the Registrar at the time of registration inspite of two of the society’s promoter members being father and son. The order of the Registrar cancelling registration of the said society was challenged before the DHC. 
 
In terms of the DHC judgment in the said case, there is no embargo under the Societies Registration Act, 1860 that the persons desirous of forming a charitable or any other society cannot be related to each other by blood or otherwise. The DHC also observed that such a requirement had no statutory or rational basis and was patently illegal in addition to being in contravention to Article 14 (Right to Equality) and Article 19(1)(c) (Freedom of Every Citizen of India to Form an Association or Union) of the Constitution of India. 
 
Resultantly, the DHC set aside the order of the Registrar cancelling registration of the said society. Following the judgment, the persons related by blood can get together to form a society in the NCT of Delhi. 
 
 

For further information, please contact:

 

Alishan Naqvee, Partner, LexCounsel
anaqvee@lexcounsel.in
 
Swagateeka Patel, LexCounsel
spatel@lexcounsel.in

 

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