Under May 2013 advisory, manufacturers had to disclose any ingredient or formulation change to regulator
In what could cheer domestic drug companies and packaged food and beverage firms, the Supreme Court on Wednesday upheld the Bombay High Court judgment that quashed a product advisory issued by the Food Safety and Standards Authority of India (FSSAI) to enforce food safety norms on imported food items.
The product approval advisory issued on May 11, 2013 made it mandatory for packaged food, beverage, health drink and supplement makers to disclose any ingredient or formulation change to FSSAI. The HC had last year held that the advisory to manufacturers had no force of law and the authority had no power to issue the impugned communication without it being ratified by the two houses of the Parliament.
The SC order gives big relief to drug and health product makers in India including Ranbaxy, Cadila and Jubilant Organosys, among others, and top food and beverage companies such as Coca-Cola, PepsiCo, Nestle, Britannia and Hindustan Unilever.
This comes close on the heels of the Bombay HC last week striking down the central food safety regulator’s ban on manufacture and sale of Maggi noodles, made by Nestle India, on the grounds of violation of principles of natural justice.
A bench headed by justice J S Khehar refused to interfere with the HC last year’s decision that The advisory was challenged in the HC as the health product manufacturers and importers felt that the country’s apex food safety regulator would mire them in unnecessary red tape.
A division bench of the HC had given a split verdict on a petition by Vital Nutraceutical and the Indian drug Manufacturers’ Association, which had challenged the May 11, 2013, notification. However, the third judge, to whom the petitions were referred to after the split verdict, had quashed the advisory.
Senior counsel L Nageswara Rao, Kapil Sibal and counsel Dheeraj Nair, appearing for Vital, argued that the FSSAI does not have the power to issue advisories without resorting to the procedure of framing regulations as prescribed under the Food Safety ad Standards Act 2006.
To ensure safe food and eliminate danger to human life, the mandate of the FSSA Act was to lay down the scientific standards for the grant of product approval to food products for which standards are not in existence. At present, there are 377 existing standards for various food products described under the Food and Standard (Food Products Standards and Food Additives) Regulation 2011 which cover approximately 90% of food consumed in the country.
Section 22 of Food Safety and Standards Act, 2006, enacts an absolute prohibition against the manufacture, sale or import of novel food, genetically modified articles of food, irradiated foods, nutraceuticals, health supplements, proprietary foods etc except as provided under the law. The FSSA used to grant ‘product approval’ on a case-to-case basis for food items falling under Section 22, which included products which were not naturally occurring foods but foods produced in a novel method.
Stating that it had laid down the procedure for grant of ‘product approval’ for the imported food products for which standards were not in place in India, FSSAI said that the omnibus nature of the impugned was such that it prevented it from granting product approval to those imported food items which met the safety standards.
“The order has also had the effect of virtually paralysing almost entirely the discharge of regulatory functions by the food authority in relation to all the food products that are specified under Section 22 of the Act,” it stated, adding that “the advisory strikes a clear and adequate balance between the interest of the consumer, industry and the public at large”.
According to the authority, “The HC order had bought to a complete standstill the continuance of trade activities by those food business operators whose products possibly measure up to the safety standards and are desirous of having the products examined for safety assessment on the anvil of safety through the process of product approval.”
* A Bombay High Court judgment had quashed a product advisory issued by the Food Safety and Standards Authority of India (FSSAI) to enforce food safety norms on imported food items
* The HC had last year held that the advisory to manufacturers had no force of law and the authority had no power to issue the impugned communication without it being ratified by the two houses of Parliament