 "Mumbai HC judgement to give fillip to nutraceutical industry")
The Mumbai High Court’s judgement on June 30, 2014 terming the Product Approval (PA) advisories issued by the Food Safety & Standards Authority of India as illegal is likely to give a boost to nutraceutical industry, according to Indian Drug Manufacturers' Association (IDMA), which recently organised a press meet to discuss the implications of the judgement.
As per the judgement, the advisory seeking PA dated May 11, 2013 (which supersedes all previous advisories) has no force of law and is not within the ambit and scope of the power conferred on FSSAI under the provisions of the Food Safety Standards (FSS) Act, the Rules and the Regulations framed thereunder. The judgement was issued in a case filed by Vital Neutraceutical, a Mumbai-based food business operator (FBO), and IDMA.
The FSSAI introduced PA advisory in January 2012 and thereafter amended the system more than 8 times and last such Advisory was issued in May, 2013. These Advisories required mandatory product approval for all proprietary products (for which standards were not specified) as a precondition for issuing food license, although there was no such requirement in the law. Many FBOs manufacturing and selling products for decades were suddenly asked to file product approval applications to continue their established businesses.
The order passed by the Mumbai High Court now paves the way for issuance of food licenses as per the existing licensing regulations and allows the units to continue selling their well-established products. The discontinuing of the PA system will allow unhindered manufacturing of nutraceuticals, market for which is expected to grow at a CAGR of 18%. Also, product-wise approval for proprietary food (nutraceuticals) will not be required and now cannot be demanded or enforced. The judgment is applicable for not only the existing ones but all FBOs.
“The consumers will have safe and natural options for their healthcare similar to the Over-The-Counter (OTC) products in most countries,” said IDMA.
IDMA added, “The FSSAI claimed that for safety of consumers the PA was imposed; however, there is no such requirement for the same category of products in most regulated markets such as US. Any new ingredient for the first time included in a product in the country, and not mentioned in Codex needs to undergo ‘ingredient approval’. Hence, the FSS Act has already provided a mechanism to ensure safe consumption of products.”
As per the judgement, the advisory seeking PA dated May 11, 2013 (which supersedes all previous advisories) has no force of law and is not within the ambit and scope of the power conferred on FSSAI under the provisions of the Food Safety Standards (FSS) Act, the Rules and the Regulations framed thereunder. The judgement was issued in a case filed by Vital Neutraceutical, a Mumbai-based food business operator (FBO), and IDMA.
The FSSAI introduced PA advisory in January 2012 and thereafter amended the system more than 8 times and last such Advisory was issued in May, 2013. These Advisories required mandatory product approval for all proprietary products (for which standards were not specified) as a precondition for issuing food license, although there was no such requirement in the law. Many FBOs manufacturing and selling products for decades were suddenly asked to file product approval applications to continue their established businesses.
The order passed by the Mumbai High Court now paves the way for issuance of food licenses as per the existing licensing regulations and allows the units to continue selling their well-established products. The discontinuing of the PA system will allow unhindered manufacturing of nutraceuticals, market for which is expected to grow at a CAGR of 18%. Also, product-wise approval for proprietary food (nutraceuticals) will not be required and now cannot be demanded or enforced. The judgment is applicable for not only the existing ones but all FBOs.
“The consumers will have safe and natural options for their healthcare similar to the Over-The-Counter (OTC) products in most countries,” said IDMA.
IDMA added, “The FSSAI claimed that for safety of consumers the PA was imposed; however, there is no such requirement for the same category of products in most regulated markets such as US. Any new ingredient for the first time included in a product in the country, and not mentioned in Codex needs to undergo ‘ingredient approval’. Hence, the FSS Act has already provided a mechanism to ensure safe consumption of products.”