FSSAI issues strict warning against commercial sale of human breast milk in India

The Food Safety and Standards Authority of India (FSSAI) has clearly stated that it has not authorized the processing or selling of human milk under the FSS Act, 2006.

BySumit Jha

Published May 26, 2024 | 11:24 AMUpdatedMay 26, 2024 | 4:53 PM

FSSAI issues strict warning against commercial sale of human breast milk in India

The Food Safety and Standards Authority of India (FSSAI) issued a strict warning on Friday, 24 May, against the sale of human milk and its derivatives, emphasizing that the commercialization of mother’s milk is prohibited in the country.

“This office is in receipt of representations from various registered societies regarding commercialization of human milk and its products. In this regard, it may be noted that FSSAI has not permitted the processing and / or selling of human milk under FSS Act, 2006 and rules/regulations made thereunder,” FSSAI said in its advisory.

FSSAI advised that all such activities related to the commercialization of human milk and its products should be immediately stopped. Any violation to this may result in initiation of action against the FBO(s) in accordance with FSS Act, 2006 and rule / regulations made thereunder.

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Sale of human breast milk

The sale of human breast milk for commercial purposes is not permitted in India. FSSAI has clearly stated that it has not authorized the processing or selling of human milk under the FSS Act, 2006.

In 2021, FSSAI cancelled the licence of Bengaluru-based Neolacta Lifesciences Pvt Ltd, which was selling mother’s milk for profit, claiming it was not permitted under FSSAI regulations. However, the company later obtained an Ayush licence to sell its product “Naariksheera” (breast milk).

In August 2022, the Ministry of Ayush barred Neolacta from manufacturing products derived from human milk under the garb of Ayurveda and cancelled its licence, stating that “Nari Ksheera” or breast milk does not come under the definition of either drug or “Ayurvedic proprietary medicine”.

The ministry found that the company’s approval for production of human milk products led to ethical issues as well as women and human rights violations.

The government has made it clear that the sale of mother’s milk will not be allowed in India.

Legal action can be taken against food business operators selling breast milk, as sanctioned under the FSS Act 2006. Licensing authorities have been instructed not to grant approvals to units involved in the sale of human milk.

Donor human milk should be provided to hospitals for the benefit of newborns and infants, free of charge. The donation of human breast milk should be voluntary and not for commercial purposes.

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Donor human milk banking – benefits, challenges

FSSAI also asked licensing authorities to not give approval to such units involved in sale of human milk.

“The State and Central Licensing Authorities should ensure that no license/registration is granted to such FBOs involved in the processing or selling of ‘Mother’s milk/Human milk,” it said.

Donor human milk is a safe and effective alternative when a mother’s own milk is not available for her infant. It provides similar immune protection and can help reduce infant morbidity and mortality.

In India, there are over 90 human milk banks as of 2021, with rapid growth in recent years due to increased government support.

The first milk bank was established in 1989 in Mumbai. India has developed comprehensive lactation management centres based on the Brazilian model to prioritize universal access to human milk.

However, challenges remain in implementing and scaling up human milk banking in India.

Key issues include lack of recurring funds, dedicated lactation counselors, trained technicians, and databases for demand-supply estimates. There are also socio-cultural barriers like low acceptance due to safety concerns, religious stigmas, and beliefs about transfer of hereditary traits.

To address these challenges, social and behavior change communication interventions are needed to increase awareness and acceptance of donor human milk.

Healthcare providers play a major role in influencing infant feeding choices. Establishing milk banks in all level II and III neonatal facilities is crucial to providing safe donor milk to vulnerable infants.

Human milk banking in India shows the benefit of involving national regulatory authorities to ensure the sustainability, safety and quality of donor milk. However, clear definitions, registries, and global guidance on minimum quality, safety and ethical standards are still lacking.

(Edited by Shauqueen Mizaj)