Introduction
In India, human milk banking is handled by Lactation Management Centres (CLMCs), Lactation Management Units (LMUs), and Lactation Support Units (LSUs), which are organised into tiers. In order to collect, pasteurise, test, store, and distribute donor breast milk—mainly for premature or low birth-weight infants in NICUs and special newborn care units.
In situations where a mother’s milk is unavailable, human milk banks can be a lifesaver for newborns, particularly those who are preterm or very low birth weight. Pasteurised donor human milk has been demonstrated to improve feeding tolerance, improved short and long-term health outcomes including gastrointestinal maturity and neurodevelopment, cutting the risk of necrotising enterocolitis (NEC) in half and dramatically lowering sepsis. Donor milk fed babies had 50% lower NEC and less digestive problems. Health authorities including WHO and AAP recommend donor milk as the preferred alternative when maternal milk is unavailable. The establishment of human milk banks in South India has produced amazing results. After setting up a milk bank, exclusive breastfeeding rates increased from 34% to 74%, and NEC incidence decreased from 1.26% to 1.07%, according to a tertiary care hospital research. To guarantee operations that are safe, equitable, and moral, a strong regulatory framework is necessary. Many milk banks today operate with inadequate staffing, pasteurisation, donor screening, and record-keeping systems. Nearly 24,000 babies receiving donor milk between 2022 and 2025 helped the NICU at Coimbatore Medical College reach a survival rate of 82% for extremely low birthweight infants, which was much higher than the state and national averages. These findings highlight the ways in which milk banks enhance survival, breastfeeding rates, and the standard of neonatal care in addition to providing essential nutritional support.
The Need for Guidelines in India
According to a Lancet study, India had the biggest national burden of preterm births globally in 2020, with around 3.02 million preterm births, or more than 20% of the global total. India’s rate, which is still persistently high at almost 13 percent of all births, is much higher than the global average (~10 percent), even if it has somewhat decreased from 3.49 million in 2010.
In order to guarantee safety, ethics, fair distribution, and public trust, India’s National Guidelines for Lactation Management Centres (2017) establish strong standards that require lactation counsellors, informed consent, pasteurisation, microbiological testing, cold-chain traceability, and donor screening (HIV, hepatitis, syphilis, and HTLV). However, there are still issues: distribution is still skewed towards urban areas with insufficient rural coverage and missing logistics frameworks. Ethics are threatened by the absence of enforceable regulations, which puts donors at risk of exploitation. Safety is hindered by understaffing, hygiene lapses, unmonitored pasteurisers, and poor tracking of milk supply and demand; and trust is weakened by cultural fears about contamination, milk kinship concerns, and a lack of knowledge about the safety and advantages of donor milk.
With technical assistance from WHO and other partners, the Ministry of Health and Family Welfare (MoHFW) and the Indian Academy of Paediatrics (IAP) released India’s National Guidelines for Lactation Management Centres. Donor screening, milk handling, ethics, and quality control are all based on national policy and international best practices thanks to this multi-stakeholder framework.
Here are the key components of India’s guidelines for human milk banks,
a) Donor Screening & Consent
Donors must be breastfeeding, healthy women who do not smoke, who don’t use alcohol in excess, and dont take medications that are incompatible with their health. HIV, hepatitis B and C, syphilis (VDRL), and a tuberculosis screening (such as a puncture or chest X-ray) are all included in serological testing. Prior to any donation, a thorough assessment of the donor’s health and lifestyle is conducted, and formal informed consent is acquired, highlighting the process’s voluntary nature.
b) Collection & Storage Protocols
Using breast pumps or manual expression, milk can be expressed at a lactation centre or at home with clean breasts and sanitised hands. Only sterile, food-grade containers are used, usually made of stainless steel or hard plastic that is BPA-free and has tight lids. Donor ID and the date of collection must be written on the label of the milk that has been collected; barcode systems are recommended for traceability. Cold chain management is crucial. To maintain temperature, milk must be refrigerated right away, frozen within 24 hours, and delivered in insulated containers.
c) Pasteurization & Testing
Pasteurization of milk is done by heating it to 62.5°C for 30 minutes. This effectively eliminates the majority of germs and viruses while mostly maintaining the health benefits of milk.
Microbial culture is applied to milk both prior to and following pasteurisation. No bacterial growth is permitted after pasteurisation; any batch that tests positive should be thrown out completely.
d) Milk Dispensation & Eligibility
For neonates in the NICU, especially those who are premature, low birth weight, or seriously unwell, pasteurised donor human milk (PDHM) is given priority and needs to be administered by a neonatologist. Preferential matching, such as preterm donor to preterm receiver, is encouraged and dispensation is first-in, first-out according to storage dates. Complete documentation maintains confidentiality throughout the process and guarantees complete traceability, from individual donor batches to recipient records.
e) Infrastructure & Staff Training
With a systematic arrangement that includes areas for the expression of milk, pasteurization/testing labs, cold storage zones, counselling rooms, and record-keeping stations, milk banks are frequently a part of Lactation Management Centres (LMCs/CLMCs) in India. A minimum of 250 square feet of physical space that is divided for counselling, pasteurisation, expression, and storage is advised. Support personnel, technicians, laboratory microbiologists, and qualified lactation counsellors are important positions. Aseptic technique, screening procedures, pasteurisation, microbiology, documentation, cold chain management, and safety procedures including separating raw and pasteurised milk are all included in the training.
Ethical and Legal Consideration
The human milk banking system in India maintains stringent donor-receiver anonymity, keeping anonymised records and safe paperwork all along the way. To protect privacy, donor and recipient identities are kept secret, and traceable data is handled with limited access. Donors must not get any financial gain or reward, and donations are entirely voluntary. This emphasises the selfless aspect of milk sharing.
Role of Private & NGO-led Initiatives
By setting up milk banks in urban areas—like Surya Hospitals in Mumbai (2019) and Sri Ramakrishna Hospital in Coimbatore (2021) in collaboration with Rotary—private hospitals and non-governmental organisations have greatly aided government initiatives by increasing geographic coverage and access to vulnerable infants. In order to maintain sustainability and guarantee equal access, nonprofit organisations like as Amaara in Bangalore and Breast Milk Foundation in Delhi streamline home-based collection, provide to NICUs across several hospitals, and use non-profit pricing methods.
Parents place a high value on India’s human milk banking because it guarantees safety and uniformity—each drop of donor milk is screened, pasteurised, and microbiologically tested before use. With this stringent procedure, milk is guaranteed to be devoid of dangerous infections, drugs, or adulterants that are frequently present in unofficial sharing networks. Parents can have confidence in both the donating and receiving families knowing that donor milk is being used in an ethical and proper manner, guided by clear medical guidelines and recipient prioritisation (particularly for premature or critically unwell infants).
Conclusion
The milk banking ecosystem in India is developing at a remarkable rate thanks to an expanding network of public, private, and non-profit-led projects that combine global best practices with innovative ideas. In 2015, there were just 22 banks operating countrywide; today, there are over 90, and the 2017 National Guidelines set the stage for the expansion of lactation management centres throughout the nation. Real gains in neonatal outcomes are demonstrated by models such as Sion Hospital’s innovative bank and Rajasthan’s integrated milk hubs, which have an effect of fewer infections, increased breastfeeding initiation, and improved community involvement.
These rules form the foundation of a system of donor milk that is safe, moral, and efficient; they guarantee stringent screening, uniform pasteurisation, traceability, and voluntary, non-commercial donation. By upholding strict guidelines, they foster confidence among parents, donors, and medical experts, guaranteeing that milk is given to the most vulnerable—preterm or seriously ill infants. Every kid can have the best nutritional start possible if we all work together—hospitals implementing procedures that comply with guidelines, donors coming forward, and parents fighting for equity and quality.
References
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