Imagine a 15 ml bottle, the size of an eye drop medicine, or those shampoo sachets commonly found in neighbourhood shops. Now imagine these bottles and sachets carrying breast milk for newborns without the need to put them in freezers.

The childcare industry in India has new entrants. And this time, they claim they are not selling formula for the infants. Their ‘magic product’ is mother’s milk. Sales are picking up even as there is no legal clarity over how to categorise and regulate it, and how to overcome the multiple ethical questions that arise.

Two private for-profit companies, with patented technology, are processing and selling human milk – a product, sector and industry currently unregulated by the government.

Bengaluru-based NeoLacta Lifesciences Private Limited started operations in 2016. It claims to collect milk from lactating mothers willing to donate it voluntarily. It then pasteurises and sells this milk to parents of infants for a steep price. The company is also offering human milk fortifiers in powder form – the first in the world – to be added to mother’s milk.

Mohali-based Neslak Biosciences Private Limited, launched in 2021, converts mothers’ milk into powder form before selling it back to them for an exorbitant price. It claims it has the technology to test the quality of milk and says it helps hospitals set up donor milk banks.

Both companies claim to retain the milk’s nutritional value and are positioning themselves as critical service providers of human milk for preterm babies.

But their innovative business model has come under the scanner of academics, public health activists and, lately, the central government.

Activists have raised concerns, questioning the ethics behind the exploitation of the poor, lactating rural women and selling their milk to affluent urban families. A group of doctors say the companies claim to be promoting human milk when as per the Infant Milk Substitutes Act, the products they are selling would clearly fall under a formula.

Within the government departments, however, there is no consensus on how to classify human milk and who should regulate it. Despite the confusion, both NeoLacta and Neslak were able to obtain the licence from the Food Safety and Standards Authority of India (FSSAI), which was cancelled in April and September this year, respectively. NeoLacta also obtained a license from the department of Ayush, Karnataka to sell its products as “ayurvedic drugs,” which was later cancelled in September after the Ministry of Ayush intervened following a report in The Times of India.

Talking to ThePrint, NeoLacta, says that it is running its business legitimately by following the highest ethical standards adapted globally. All attempts by ThePrint to reach out to Neslak failed.

Meanwhile, a long battle lies ahead on the contentious issue of the collection, processing and sale of human milk. In September, NeoLacta moved the Karnataka High Court against the cancellation of its Ayush license.

The civil society groups that are against commercialisation of human milk are also planning to intervene in the matter and the FSSAI is now contemplating taking a legal course against NeoLacta.

NeoLacta has obtained a stay order for now and its milk bottles and sachets are back in the market. Neslak’s website is up and running and the company’s status is active with the Ministry of Corporate Affairs.

Creating a demand

In 2016, when NeoLacta entered the Indian infant feeding market with their “100% human milk derived products,” it was a ripe, untapped territory.

Besides the high number of births globally, India also leads in preterm births— that is, babies born before 37 weeks of gestation (a pregnancy lasts about 40 weeks). Out of 27 million babies born every year in the country, 3.5 million are preterm.

Doctors serving preterm infants explain that most mothers produce enough milk for their infants. And inexpensive methods such as kangaroo mother care, where the baby is carried by the mother with skin-to-skin contact and frequent breastfeeding, has proven to be effective. But when a mother’s milk is not available or what she produces isn’t enough, then donor milk becomes the next best option.

“It is marginally better than formula or other milk substitutes,” said Dr Sushma Nangia, director, professor and head of neonatology department at the Lady Hardinge Medical College.

In India, around 90 out of 110 milk banks are in government hospitals or medical colleges and the remaining are in private hospitals. Women donating the milk to these banks are not incentivised in any form and the parents of receiving infants may pay a nominal fee for the processing of milk or investigations.

But these donor milk banks are few and far between, creating a demand-supply deficit. A 2019 paper published in Indian Paediatrics surveyed 22 donor milk banks and found 10 facing a demand and supply gap.

When donor human milk is unavailable, hospitals have to sometimes give animal milk or formula to infants, said Dr Satish Tiwari,national convenor,Human Milk Banking Association of India (HMBAI).

NeoLacta places itself as a service provider in this deficit.

“About 30 to 50 per cent of babies who are in the NICU [neonatal intensive care unit] require donor human milk. Studies show that 51 per cent of mothers of preterm infants had delayed lactogenesis. The current 90 milk banks are not sufficient for the entire ecosystem,” says Sunil Kumar, country general manager, NeoLacta Lifesciences.

According to NeoLacta’s conservative estimate, India needs 1,300 donor milk banks. “NeoLacta bridges this gap,” Kumar said.

Though the company collects breast milk from women as donation, it doesn’t classify itself as a donor milk bank because it offers a 17-step value addition to its products. It has different forms of pasteurised human milk with “minimum guaranteed energy of 70 cals/100 ml” and mothers’ milk fortifier in powder form. These standards, says Kumar, also justify the high cost of its products. The company charges Rs 450 for 15 ml milk and Rs 550 for 5 ml of fortifier. Following international guidelines for donor milk, the company claims to be a part of a mission to save babies in India.

But NeoLacta is no good Samaritan, say doctors working on infant care.

Their aggressive marketing approach, such as sponsoring events around infants and pushing promotional content through media, is similar to companies that sell milk substitute, doctors say. According to them, NeoLacta is replicating the formula industry model targeting the rich, young couples.

“They created an unnecessary demand and started operating in a vacuum. They are planting a doubt in the mother’s mind that her milk is not enough for her baby (in terms of quality and quantity). Oxytocin release is reduced in the bodies the moment the mother is in doubt about herself. It means the milk is there but it is not flowing from the breast to the baby. So that creates a need for donor milk for the baby,” said Dr Arun Gupta, paediatrician and central coordinator of the non-profit Breastfeeding Promotion Network of India.” said Dr Arun Gupta, paediatrician and central coordinator of the non-profit Breastfeeding Promotion Network of India.

The parents are then swayed into believing that the child needs wholesome nutrition, which NeoLacta’s “value added” products can provide, added Dr Gupta.

Dr Satish Tiwari agrees. Around 90 to 95 per cent mothers, he says, produce more milk than is required by her child in the first month after delivery, even if it is preterm. “This is the natural physiology of women. That is why we can get mothers who are willing to donate milk,” he says.

He accused companies selling breast milk of spreading biased and false information to women. “Even the educated mothers are getting misguided easily. The companies are able to convince them that they are not producing enough milk,” says Dr Tiwari.

Justifying NeoLacta’s role in the infant feeding space, Sunil Kumar claims his company has tested and profiled the milk donors to find that “Indian women’s milk has only 55 kilocalories,”whereas apreterm baby requires milk with 70 kilocalories (kcals).

He claims that NeoLacta adds a minimum of 70 kcals, again using mother’s milk, during pasteurisation through a “unique process”.

“We are the only company after the [one in] US to have mothers’ milk fortifiers. And the US [company] also doesn’t have it in powder form. It is added on top of mother’s milk for catch-up growth and for babies who have complications,” says Kumar.

Calling these claims baseless, Dr Nangia argues that pasteurisation, in fact, kills the live cells in the milk, making it inferior to natural breastmilk.

“Milk should be as fresh as possible and from the mother if possible. These companies are pooling milk from different women and pasteurising it, which makes it like any other milk,” she explains.

Unless the mother has diseases like AIDS, HIV, Hepatitis B or is severely malnourished, the quality of her milk isn’t compromised, adds Dr Tiwari.

Stirring a controversy

NeoLacta Lifesciences first received a licence to operate in India in November 2017 by the FSSAI for a year. Four out of its eight listed products on the FSSAI’s database are named ‘mother milk’. But the licence was given under the category of dairy, which was renewed in 2018 for five years.

Similarly, Neslak was also classified as a dairy producing company, but none of its 12 products listed with the FSSAI mention ‘mother’s milk’.

With the Ministry of Corporate Affairs, NeoLacta is registered as a dairy products’ company and Neslak as a chemical product manufacturer. They caught the FSSAI’s attention only earlier this year.

The health ministry said in Lok Sabha that as per the national guidelines on lactation management centres in public health facilities, donor human milk cannot be used for commercial purposes. The Food Safety and Standards Act 2006 also does not cover the commercial processing or selling of human milk.

In 2020, an article titled, ‘Nurture commodified? An investigation into commercial human milk supply chains’, published in Review of International Political Economy by academics Susan Newman and Michal Nahman, studied NeoLacta’s model of collecting human milk. They interviewed the company’s owners and employees and found that although  NeoLacta projects that its products are only meant for preterm babies, these were also being sold to parents of full-term babies and outside the hospital context.

“NeoLacta thus operates within and develops a wider market for human-milk products with a range of end-users and demands,” the paper noted.

The paper also questions the methods in which NeoLacta stratifies and portrays its milk donors. First set of milk providers are urban, educated, professional women working in large multinationals or in the medical field. They are portrayed on NeoLacta’s social media promotions.

The second set of women donors are the ones who can barely afford to feed themselves, let alone supply sufficient milk for their infants, the authors note. These women are offered incentives in the form of cash and food packets and their remuneration depends upon the volume of milk they provide. The price “paid to poor women [is] very low, intensifying their exploitation”.

NeoLacta reaches out to these women through NGOs, which must convince them that their milk is in excess of what their babies require, notes the paper. The NGOs also project milk donation as a way of gift (or daan) and a “responsibility of women as mothers beyond their own birthed children”.

“‘Excess’ milk is a creation of the company NeoLacta, borrowed, extended and deepened into an ‘issue’ in order to produce the milk itself into a thing of waste that then becomes a commodifiable substance for the company,” note the authors.

High pricing by these companies also creates an imbalance. Milk is collected from the poor mothers and given to those parents who can afford it, say doctors.

But despite these glaring findings, in November 2021, the department of Ayush, Karnataka, gave the licence to NeoLacta to produce 10 “ayurvedic drugs” under its category of Naariksheera (breast milk).

Calling Newman and Nahman’s report incomplete, Kumar says that all women donors in their network join voluntarily after signing a consent form, which is presented to them in a language they understand.

“We monitor the babies’ (of the donors) weights on a regular basis. If the babies’ weight drops, we don’t take milk from those women,” he says.

He claims that NeoLacta’s products are only available on prescription at in-patient hospital settings. There have been instances, reported by the media, where NeoLacta’s products were available online without prescription. But Kumar alleges they were “put up for sale by some distributor,” and have now been taken down.

“You might still see some distributors selling them and it is beyond our control,” he says.

Who regulates human milk?

India doesn’t have a law to regulate the collection, sale, processing or distribution of breast milk. In 2017, the health ministry formed guidelines for lactation management in public health facilities, which prohibit the sale of human milk, but these are not legally binding.

The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act 1992 is also silent on regulation of processed human milk. Dr Gupta, however, argues that the products sold by these companies fit into the definition of milk substitutes.

When the FSSAI cancelled the licences, it warned all regional directors and food safety commissioners not to allow licensing and registration of companies processing human milk or products derived from it.

“It has been further reported that such FBOs (food business operators) obtained FSSAI licenses under either standardised food product categories viz ‘milk’ or ‘dairy products’ or ‘infant milk substitutes’ or ‘infant foods’ and thus without disclosing the details of such human milk-based products being manufactured by them,” the letter from FSSAI noted.

The letter added that any foods related to infants shall comply with the standards specified under FSS (Foods and Infant Nutrition) Regulations 2020, which does not cover either mother’s milk or any products derived from mother’s milk.

“We categorically applied for mother’s milk as a category. They (FSSAI) categorised us as dairy,” claims Kumar.

If a particular item does not have a category under FSSAI, it does not fall under its regulatory ambit, says FSSAI CEO, S Gopalakrishnan..

“FSSAI has standards for all the products on its websites. There are no such standards for human milk. If we don’t have a standard for it, that means no one can sell, market, or store it,” Gopalakrishnan said.

Karnataka’s Ayush department, Kumar claims, took 11 months to give a licence to NeoLacta and the staff visited the company’s facility twice. Yet, the ministry cancelled the licence on frivolous grounds, he alleged.

“Collection and selling of ‘nariksheera’ has involved several ethical issues including human rights, women rights, which are very sensitive,” the letter from the department of Ayush said, adding that NeoLacta’s products did not qualify as “ayurvedic drugs” and the company also violated new drugs and clinical trial rules 2019.

The regulatory vacuum around human milk is also to do with the ambiguity.

Medical journal The Lancet states that global policies and standards to guide human milk donor programmes are absent. There is no consensus on the classification of human milk as a food, tissue, medicine, or possible classification for regulatory purposes, it notes. This, as a result, has hampered the scale-up of human milk banks.

NeoLacta operates in this vacuum.

“NeoLacta exploits the fluidity with which donor milk is viewed as a food, drug or human tissue in their business operation, for the marketing and sourcing of donor milk as the exploitation of regulatory gaps,” Newman and Nahman note.

In 2017, NeoLacta obtained an export licence for Australia. It has also opened another company, NeoKare, in the UK.

Why is commercialisation problematic?

There are only two companies operating in the US, UK and Germany that sell human milk and products derived from it.

In 2015, a Utah-based company called Ambrosia Labs, now shut down, sold human milk collected from Cambodian women in the US. After it was exposed, the Cambodian government suspended its operation citing nutritional needs of local children and laws on trafficking in body parts.

Human milk has also emerged as a craze among adults, notes a paper by researcher Sarah Steele and others, in the Journal of Royal Society of Medicine. Breast milk ice-creams are for sale in the UK and a lollipop company sells breast milk-flavoured sweets in the US. Breast milk is considered a ‘clean’ superfood by fitness enthusiasts and is projected to help with erectile dysfunction, among other contested ‘benefits’.

The regulatory gaps in the human milk industry then bring the discussion back full circle – donor human milk and its distribution must remain with the non-profit donor human milk banks where the milk meets the demands of preterm infants, say doctors.

“Even if donor milk banks are not able to meet the demand-supply gap, commercialisation is not the answer,” says Dr Nangia. “The government needs to open more donor milk banks. The private entities are not helping people. They are just entering areas where they see a growth potential.”

And as the global players debate the matter, Steele leaves them with a thought in her 2021 article, “This will involve difficult questions. Is employing women to pump for profit really where we wish to head in the future? Are we comfortable paying women to produce milk, much like we do with dairy cows? Should milk continue to flow from areas of poverty to areas of affluence?”

Source : The Print Dec 23rd 2022 by Sonali Matharu