Commercial sale of mother’s milk under Ayush licence has thrown up ethical questions. You can buy literally anything these days, even human breast milk. India is home to the only company in Asia that sells mother’s milk for profit, Bengaluru-based Neolacta Lifesciences Pvt Ltd. After activists objected to the commercialization of mother’s milk, the Food Safety and Standards Authority of India (FSSAI) cancelled the company’s licence stating that sale of mother’s milk was not permitted under its regulations. However, an FSSAI inspection revealed that the company continues to sell mother’s milk by obtaining an Ayush licence in November 2021 for its product dubbed ‘Naariksheera’ (breast milk). Neolacta, which was established in 2016, had originally obtained a licence from the Karnataka office of the FSSAI in the category of dairy products. “It is absolutely shocking that a company is being allowed to collect breast milk from young mothers and sell it like a dairy product with a huge price tag claiming to have added value to it,” said Nupur Bidla of the Breastfeeding Promotion Network of India (BPNI), which had alerted the government to this in 2020.
Saurabh Aggarwal, MD of Neolacta, told TOI that the company has significant experience in the human milk space supplying technology to set up the first milk bank in Australia. He said that NeoLacta had, over the past five years, “benefited over 51,000 plus premature babies across 450 hospitals.” Donated breast milk is mainly used to feed premature or sick babies when mothers are unable to nurse them for a variety of reasons. Usually, the milk is sourced through milk banks set up as non-profits. Milk collected from donors (healthy lactating mothers) is pasteurised, analysed for nutrient content and checked for contamination of any kind and is then frozen and stored. In most milk banks, especially those attached to government hospitals, the donated milk is given free of cost. However, in many others it might be free for a few poor patients but those who can afford it are usually charged a few hundred rupees for 50 ml of donated breast milk. There are over 80 non-profit human milk banks in India. Neolacta charges Rs 4,500 for 300 ml of frozen breast milk. A pre-term baby could require about 30 ml per day while a baby on full feed could need as much as 150 ml per day. It also sells human milk-derived powder that is readily available on ecommerce sites as well as its own. President of the National Neonatology Forum (NNF).
Dr Siddarth Ramji told TOI that “as a principle we do not support commercialisation of breast milk” but pointed out that NNF was not a regulatory body. Dr Satish Tiwari, national convenor of the Human Milk Banking Association of India, described it as a shame. “Does the company pay the mothers who are donors? Do they take it free and sell it at such a high cost? No one knows. The government should look into this.” In a research article published in December 2020 titled, ‘Nurture commodified? An investigation into commercial human milk supply chains’, social scientist Dr Michal Nahman and economist Prof Susan Newman from the UK examined the way Neolacta functioned. Speaking to TOI, Prof Newman said their research consultants had found evidence that women, mainly in rural areas, were actively being pursued by NGOs and associated ‘health workers’ and paid either with cash or with food packets. She pointed out that in the initial news reports on Neolacta, they freely admitted to collecting milk from women across four states but have since become more cagey about how they source the milk. The article adding that in 2016, an attempt by NeoLacta to collect breast milk from the largest government hospital for women and children in Bengaluru, Vani Vilas, was abandoned after serious concerns over the “commercial exploitation of breast milk”. “It was evident from our interviews with NeoLacta donors, intermediaries such as NGOs and community health workers and NeoLacta employees, donor milk is not framed as a commodity in spite of the marketisation of NeoLacta product. Rather, the way in which donor milk is operationalised as a ‘gift’ (or ‘daan’ in the Indian context) is built in to how it is commodified,” stated the article. Remuneration would depend upon the volume that women provide and 80% of the revenue would be paid to the mother with the NGO worker taking a 20% cut, it added.
At the time of going to press, the Ayush ministry had not responded to this reporter’s queries. BPNI wrote to the health ministry in February 2020 that “Neolacta has been involved in commercializing human milk” even though the guiding principles for using donor human milk in India in the health ministry’s ‘National Guidelines on Lactation Management Centers in Public Health Facilities’ clearly states, “DHM (donated human milk) cannot be used for any commercial purpose”. With the ministry not responding, BPNI wrote to FSSAI asking how the licence was issued. Neolacta was established in 2016, a year after Cambodia banned selling of breastmilk after a public outcry about an American for-profit company Ambrosia sourcing breast milk from poor women in Cambodia and selling it in the US. A letter from the Cambodian government was quoted as stating: “Although Cambodia is poor and (life is) difficult, it is not at the level that it will sell breast milk from mothers.” In the context of Cambodia, UNICEF had said in a statement that the trade in breastmilk was “exploiting vulnerable and poor women for profit and commercial purposes”. Most countries do not allow the commercial sale of breastmilk.
Dr Arun Gupta of BPNI alleges that Neolacta aggressively markets its products on social media. “It is using the tactics of the infant formula industry in the way it is targeting healthcare providers to gain legitimacy. Infant formula companies harp on mothers not having enough milk and Neolacta goes on about mothers producing ‘excess breastmilk’ which they can donate. It claims that its products do not come under the IMS Act, which regulates the marketing of infant milk substitutes, but it does,” said. BPNI complained to the National Neonatology Forum (NNF) in February 2021. The NNF responded in April 2021 to state that the NNF had already taken a decision in its executive board meeting to abstain from providing any form of encouragement to Neolacta Lifesciences and that a letter communicating this decision had been sent to all the members of the forum. Officials from the Bengaluru branch of FSSAI inspected the Neolacta unit on April 22 and found stocks of packing materials bearing the suspended FSSAI License, which they seized. The local FSSAI office has also asked the company to recall from the market all its products which have used the FSSAI licence and to disable online selling of such products. The company was also issued a notice for carrying out food business without a valid FSSAI license. A commercial company selling breast milk would court healthcare providers including doctors and hospitals to become their suppliers, which would increase the cost to the healthcare system and create ethical dilemmas, warned public health researcher Sarah Steele of the University of Cambridge in a piece she wrote about commercial human milk banks in October 2021. She added that if mothers moved from donating to non-profit milk banks to such companies, healthcare providers would be forced to enter into contracts with such companies and this could result in the privatization of a previously public service. Dr Sushma Nangia, professor and head of the neonatology department in Lady Hardinge Medical college who established a human milk bank, explained that donated breast milk might be better than infant formula but was inferior to mother’s own milk. “Even for pre-term babies their own mother’s milk is best for them to thrive. Donated human milk is inferior to mother’s milk as milk from different sources is pooled and vital nutrients are lost when it is pasteurized. Obviously, there are cases where donated breast milk is needed and that is why we started a bank but we do not prescribe it for all pre-term or sick babies. Neonatologists and the increase in the business of neonatal ICUs in the private sector are behind the push for donated breastmilk. It has become a lucrative business. This menace (push for commercial donor milk) can be curbed if neonatologists invest time and resources in ensuring mother’s own milk for her baby rather than going for commercial donor milk and also providing unambiguous information to families that donor milk is not the same as their own mother’s milk. The government needs to step in and enquire where the milk is being sourced from,” said Dr Nangia.