The Ministry of Ayush has barred Neolacta Life Sciences, the Indian arm of a U.K.-based company, from manufacturing products derived from human milk under the garb of Ayurveda and cancelled its licence.
The company was manufacturing and selling five products, which included pasteurised human breast milk under the brand name PHBM 70, human milk powder under brand names NeoLact70 and NeoLact70 Prime. The three products were sold as alternatives when mother’s milk is not available or the baby needs extra calories.
The company also sold mother’s milk fortifier (MMF) as NeoLactMMF and NeoLactMMF Plus to help mothers fortify their milk for feeding a premature infant. Some of these items could cost as much as ₹4,500 for a 300 ml bottle.
Karnataka’s Drug Licensing Authority (KDLA) under the State government’s Department of Ayush constituted a Technical Expert Advisory Committee and reviewed the approval it had granted in November 2021 and found that “Nari Ksheera” or breast milk does not come under the definition of either drug or “Ayurvedic proprietary medicine” as per the Drugs and Cosmetics Act, 1940 as the five products contained only one ingredient, which was human milk. It found violation of the New Drug and Clinical Trial Rules 2019. The order states, “approval for production of the products by the said company using mother’s milk has led to ethical issues and women and human rights [violation]”.
The order was issued on August 29, and came into effect after two weeks.
The company sought an Ayush licence months after FSSAI in 2021 cancelled their licence obtained under “dairy” category. NeoLacta has said in a statement that it will appeal against the decision and take legal recourse.
The FSSAI Rules and Regulations do not cover commercial processing or sale of human milk. As per the guidelines of Lactation Management Centre (LMC) in Public Health Facilities, donor human milk ca not be used for commercial purposes, Minister of State for Health Ministry, Bharati P Pawar told Lok Sabha in July, 2022. Donation of human milk is to be done freely and voluntarily and is recommended only for pre-term or sick babies whose mothers are unable to breastfeed them.
In a research article published in December 2020 titled “Nurture Commodified”, authors Susan Newman and Michael Nahman have highlighted Neolacta’s donor milk sourcing practices through a web of NGOs “under a shroud of secrecy” while the company claimed it was collected through volunteers.
Responding to the report and its conclusions, Saurabh Aggarwal, MD Neolacta, told The Hindu, “There are ideological views about the ethics of human milk collection. The milk collected from mothers is in excess of her own child’s requirement. We don’t pay directly to mothers, but we pay to NGOs who run breastfeeding programmes and provide nutrition support for those who are breastfeeding.” He said that the Karnataka body’s decision followed a 10-month long review during which it made scientific presentation and explained the innumerable references to breast milk in Ayurveda as a ground for seeking a licence as an Ayush product.
The government action is based on a complaint by Arun Gupta, Central Co-ordinator of Breastfeeding Promotion Network of India who told The Hindu, “apart from the promotion of baby foods in violation of the law, we are increasingly seeing new products in the market that seek to promote convenience for mothers. What is needed instead is a focus on ensuring a supportive system. Though we have a six-month maternity leave by law, it is only for the organised sector. Workplaces also must be encouraged to provide lactation support to working women.”
