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India's Infant Milk Substitutes Act, Monitoring, and Enforcement

May 30, 2018

Suboptimal breastfeeding practices, including non-exclusive breastfeeding, contribute to approximately 12% of deaths among children under five years of age; in India, this contribution is significant as exclusive breastfeeding rates are as low as 35.8% in some Indian states. In 1992, India adopted the Infant Milk Substitutes, Feeding Bottles, and Infant Foods (IMS) Act which was strengthened in 2003. The IMS Act comprehensively bans all forms of promotion of foods marketed to children up to two years of age and sponsorship to health care professionals and health organizations by infant formula companies. Violation of the IMS act is a criminal offense and may result in fines and imprisonment. Monitoring of the IMS Act is undertaken by four NGOs, food safety officials, and other government officials authorized by the government as specified in section 21. The NGO, the Breastfeeding Promotion Network of India (BPNI), has been widely involved and successful in monitoring and raising awareness of the IMS Act. From 36.8% in 2000, exclusive breastfeeding rates have jumped to 58.3% in and while infant formula sales in large markets such as China have risen drastically from USD $1 billion in 2002 to USD $3.5 billion in 2008, India has held steady at under USD $500 million, indicating a commitment to keeping the infant formula companies at bay in lieu of promoting breastfeeding and its inherent benefits.

Description & Context

In 1992, India adopted the Infant Milk Substitutes, Feeding Bottles, and Infant Foods (IMS) Act. It was further amended in 2003 to strengthen certain provisions and close any loopholes infant formula companies had found. The IMS Act comprehensively bans all forms of promotion of foods marketed to children up to two years of age. It also bans sponsorship to health care professionals and health organizations by these infant formula companies. Violation of the IMS act is a criminal offense and may result in fines and imprisonment (2).

Monitoring of the IMS Act is undertaken by four NGOs, food safety officials, and other government officials authorized by the government as specified in section 21(1). A particular NGO, the Breastfeeding Promotion Network of India (BPNI), has been widely involved and successful in monitoring the IMS Act. BPNI holds events to raise awareness of infant formula risks, develops monitoring tools, regularly monitors product labeling and promotional activities of the infant formula companies, periodically reports to the Ministry of Women and Child Development, and files cases before law, if necessary.

A 2016 study on the prevalence of formula marketing found almost full compliance with Code. A key finding from the study stated “This is a credit to the strength of the IMS Act, and to diligent application by healthcare workers and vigilant monitoring by local stakeholders such as BPNI.” (14)

Exclusive breastfeeding rates have jumped from 36.8% (2000) to 58.3% (2005) to 64.9% (2014) due to promotional, educational, and training activities regarding infant and young child feeding (IYCF) but also due to enforcement of legislation such as the IMS Act (9, 15). Moreover, while infant formula sales in large markets such as China have risen drastically from US $1 billion in 2002 to US $3.5 billion in 2008 in sales, India has held steady at under US $500 million (8).

Main Components

The IMS Act extends to all of India and stipulates that no person shall:

  • Advertise for the distribution, sale or supply of infant milk substitutes feeding bottles or infant foods
  • Give an impression or create a belief in any manner that feeding of infant milk substitutes and infant foods are equivalent to, or better than, mother's milk
  • Promote infant milk substitutes, feeding bottles or infant foods.
  • Supply or distribute samples of infant milk substitutes or feeding bottles or infant foods gifts of utensils or other articles
  • Contact any pregnant woman or the mother of an infant to offer inducement of any of the above

In addition, infant milk substitute or infant food containers must indicate in a clear, conspicuous and in an easily readable and understandable manner, the words “important notice” in capital letters with the following: “mother’s milk is best for your baby,” a warning that formula is not the sole source of nourishment for infants, instructions for safe and clean preparation, and the composition, among other particulars (11). The containers and labels are not allowed to have pictures of women and infants (11). Likewise, advertisements and promotional material for formula must include the benefits and superiority of breastfeeding, the health hazards of improper preparation and use of formula, among other stipulations (11).

The IMS Act strictly bans promotion or distribution of formula materials in any health care system. Formula producers, suppliers, and distributors are prohibited from giving any financial inducements, directly or indirectly, to a health worker.

Finally, the IMS Act reiterates strict standards of the formula nutritional composition established by previous laws, establishes the right to confiscation of inappropriate formula, establishes monitoring rights of government-approved NGOs, food safety officials, and other government officials. The violation of this Act is stipulated as up to a three-year prison sentence and may be combined with up to a five-thousand rupee fine.

BPNI was established in 1991 and now has 3,704 members and 57 organizational members including national and international organizations such as WABA, the WHO, and Doctors for You (5,6). In 2003, BPNI published a Monitoring Manual detailing the methods for monitoring the IMS Act in simple language and made available to all electronically. Through dissemination of this manual, letters to government agencies, press releases, legal action, and workshops focused on awareness, they have monitored the IMS Act and contributed to the stagnation of formula sales in India (10).

Evidence of Implementation Strategy

An international study on the implementation of the worldwide International Code of Marketing of Breast Milk Substitutes states that India has one of the most stringent legislations protecting breastfeeding. While legislation in words is a first step, documented monitoring and enforcement of the national code is more telling of situation on the ground, as evidenced below.

BNPI has a plethora of reports and letters regarding the success of monitoring the IMS Act (10):

  • In February 2016, the Indian Journal of Pediatrics blocked further circulation of their February issue, which contained infant formula advertising, when they received legal notice from BNPI regarding violation of the IMS Act.
  • In 2010, an annual conference for parental and enteral nutrition sponsored by Nestle Nutrition Institute was cancelled by the organizers when they received letters from BNPI and the India Ministry of Health and Family Welfare
  • In 2012, upon receiving a tip-off from BNPI, the regional Food and Drug Administration raided a Nestle factory, which was using inappropriate graphics targeting children under two years of age on their formula, specifically against the IMS Act. Nestle was fined after the event.
  • BNPI’s 2003-2007 Report states that BNPI has developed and shared an “Action Folder” which comprises of violations of the IMS Act and is disseminated to government organizations concerned (12).
  • BNPI’s High Court lawyer works to analyze any reported complaints. Between 2003 and 2007, labels of infant foods and infant milk substitutes like Cerelac, Nestum, Farex, Lactogen -1 and Lactogen -3 and baby care booklet “Hello Baby” from infant formula manufacturing companies were analyzed and found to violate the IMS Act. Legal action was brought against them.

A 2016 IMS compliance assessment by the Access to Nutrition Foundation found that advertising of breast-milk substitutes was “virtually non-existent” in Greater Mumbai where the survey was carried out. There were no point-of-sale promotions in stores, very low incidences of non-compliance on labels and formula company representatives had little direct contact with mothers or healthcare workers. The main formula companies had high levels of compliance with the legislation. According to the Indian Rapid Survey 2013-2014, exclusive breastfeeding rates were 64.9% compared with the global average of 38% (15). The Access to Nutrition study states that, “…in the seven northern states of India – where over half of infants are born and almost three-quarters of infant deaths occur – rates of early initiation of breastfeeding within one hour of birth increased from 12.4% in 2006 to 42.1% in 2011.” (14).

Finally, while infant formula sales in large markets such as China have risen drastically from US $1 billion in 2002 to US $3.5 billion in 2008, India has held steady at under US $500 million, indicating a commitment to keeping the infant formula companies at bay in lieu of promoting breastfeeding and its inherent benefits (8).

Cost and Cost-Effectiveness

The most recent BPNI financial reports from 2015-2016 fiscal year reports BPNI had a surplus of 578,483 (USD ~$9,000) rupees of income over expenses (13). This is due to the numerous grants BPNI has applied for and received from companies such as IBFAN and national organizations, totaling approximately 40 million rupees (USD $615,000). Most of this money goes into training workshops held by BPNI. BPNI administrative costs, meeting expenses, office repairs and maintenance, office utilities, postage and carriage, and more daily costs totaled less than 1 million rupees (USD $15,000). Printing and publications cost 293,408 rupees (USD $4,500) for the year 2015-2016.

Perceptions and Experiences of Interested People

In the 2003-2007 BPNI Report, BPNI’s coordinator Arun Gupta cited exciting new collaborations between BPNI and UNICEF that allowed for an increase in monitoring, and stressed the importance of the enforcement of the IMS Act.(12).

Benefits and Potential Damages and Risks

  • Many countries have enacted a national Code of breast milk substitutes into law, but monitoring and enforcement of these have challenges due to issues with financial, technical, and personnel capacity, and the might of the formula companies.
  • There is a risk that a monitoring body may be bought off by the formula companies, and instead serve to perpetuate or increase their sales.

Scaling Up Considerations

  • A 2015 study reports that light sentences to companies violating the IMS Act minimize the effectiveness of the strict Indian legislation. Countries need to seriously consider and review the legal repercussions for breaking the law when establishing a national code of marketing on breast milk substitutes to ensure they are appropriately powerful to enforce the law (4).
  • Political will at the highest level is crucial for both effective legislation and enforcement of the legislation. In addition, political agreement on the national code must be adapted to a country’s specific conditions and supported by local actors in order to enforce on the ground.
  • The law must designate a monitoring body or, as in India’s case, organizations or officials in charge of monitoring. There also must be evaluation of these monitoring bodies, as they are responsible for action against illegal advertising and activity by the formula companies.
  • Monitoring bodies, specifically whistleblowers such as BPNI and people resisting formula industry pressures, must be protected under the law in order to encourage monitoring.

Barriers to Implement

The 2003-2007 BPNI Report states shortage of staff are major difficulties in ensuring quality work is done (12). In addition, while a country may pass legislation regarding breast milk substitutes and their monitoring, countries with limited financial resources may find it difficult to pay its employees for the monitoring and enforcement. It is quite feasible a powerful infant formula company may be able to pay off any parties assigned to monitoring.

Government infrastructure and awareness is another possible barrier; if government leaders and officials are not sensitized or informed on the issue of breastfeeding in competition with infant formula, they may not be convinced to not only promote and issue monitoring/evaluation, but promote an act banning and regulating infant formula at all.

A 2015 study reports that light sentences to companies violating the IMS Act minimize the effectiveness of the strict Indian legislation (4). However, WHO states that the adoption of legislation has led to a noticeable decline in the promotion of formula for infants and young children (2).

Equity Considerations

Infant formula companies can have a powerful sway within the government and public sphere; they are often able to pay for mass advertisement and sponsor politicians that support them and their efforts. Without a law that first bans these actions and, if such a law is in place, without strict monitoring of this law, infant formula companies may continue to dominate this sphere and decrease breastfeeding rates.

Additionally, formula has significant and disproportional cost and health implications for poorer families leading to parents watering down the formula to make it last longer, often resulting in malnutrition and disease.

There is a segment of the population who cannot breastfeed, such as mothers with HIV and without access to antiretroviral drugs. In this case, infant formula must be respected as the only viable option for their babies, and instead safe preparation and delivery of the infant formula must be emphasized. These mothers must be considered equally.

References:

  1. Exclusive Breastfeeding in India: Trends and Gaps (2017). POSHAN. Retrieved from http://poshan.ifpri.info/2017/08/04/exclusive-breastfeeding-in-india-trends-and-data-gaps/
  2. Marketing of Breast-Milk Substitutes: National Implementation of the International Code Status Report 2016 (2016). WHO. Retrieved from http://apps.who.int/iris/bitstream/10665/206008/1/9789241565325_eng.pdf?ua=1&ua=1
  3. Breastfeeding (2017). UNICEF. Retrieved from https://www.unicef.org/nutrition/index_24824.html
  4. Barenes, H. et al. “Enforcing the International Code of Marketing of Breast-milk Substitutes for Better Promotion of Exclusive Breastfeeding,” (2015). Journal of Human Lactation. Retrieved from http://journals.sagepub.com/doi/full/10.1177/0890334415607816
  5. About BPNI (2017). BPNI. Retrieved from https://www.bpni.org/about-bpni
  6. Membership (2017). BPNI. Retrieved from https://www.bpni.org/membership
  7. Superfood for Babies: How Overcoming Barriers to Breastfeeding will Save Children’s Lives (2013). Save the Children. Retrieved from http://www.savethechildren.org/atf/cf/%7B9def2ebe-10ae-432c-9bd0-df91d2eba74a%7D/SUPERFOOD%20FOR%20BABIES%20ASIA%20LOW%20RES%282%29.PDF
  8. BMS Code (2013). UNICEF; Alive & Thrive. Retrieved from http://aliveandthrive.org/wp-content/uploads/2014/11/Code-of-Marketing-Brief-Breastmilk-Substitute-BMS-Code.pdf
  9. WHO Global Data Bank on IYCF (2009). WHO. Retrieved from http://www.who.int/nutrition/databases/infantfeeding/countries/ind.pdf
  10. Protecting Breastfeeding (2017). BPNI. Retrieved from https://www.bpni.org/protecting-breastfeeding
  11. The Infant Milk Substitutes, Feeding Bottles, and Infant Foods (Reduction of Production, Supply, and Distribution) Act, 1992, as Amended in 2003 (IMS Act), 2003. Retrieved from http://www.bpni.org/docments/IMS-act.pdf
  12. Strengthening Infant and Young Child Feeding in India: 2003-2007 (2007). UNICEF and BPNI. Retrieved from https://www.bpni.org/report/Strengthening-IYCF-in-India-report.pdf
  13. BPNI Balance Sheet: 2015-2016 (2015). BPNI. Retrieved from https://www.bpni.org/financial-reports
  14. Access to Nutrition Index, India, BMS 2016. Retrieved from: https://www.accesstonutrition.org/sites/in16.atnindex.org/files/resources/india_bms_chapter.pdf
  15. Rapid Survey On Children (RSOC) 2013-14, Ministry of Women and Child Development, Government of India. Retrieved from: http://wcd.nic.in/acts/rapid-survey-children-rsoc-2013-14

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Strong Evidence of Effectiveness

Could it work?

The case of India demonstrates that, while complex in nature, implementation of the International Code of Marketing of Breastmilk Substitutes (the Code) at the local, subnational, and national level – such as the IMS Act– could be effective in promoting, protecting, and supporting women to breastfeed. When India enforced the Act along with promotional, educational, and training activities regarding IYCF, breastfeeding rates jumped from 36.8% in 2000 to 64.9% in 2014. The implementation of the Code is replicable within any country or health care system, however it needs political will and funding.

Will it work?

There are significant considerations to enacting Code legislation and then monitoring and enforcing this legislation. While a country may pass legislation regarding breast milk substitutes and their monitoring, there may be challenges with the human and financial capacity to monitor and enforce, which can be further undermined by incentives and marketing from infant formula companies. The success of the Code is dependent on a country’s political desire to enact strong legislation and to designate and protect a monitoring body or, as in India’s case, organizations or officials in charge of monitoring. Evaluation of these monitoring bodies is critical as they are responsible for action against illegal infant formula advertising and activity by the formula companies.

Is it worth it?

Leaders and government officials must be educated and made aware of issues related to breastfeeding and the harmful effects of infant formula companies in order to garner the political will to establish satisfactory enforcement, monitoring and evaluation of such an intervention. The IMS Act represents an important and responsible effort to promote, protect, and support breastfeeding. While potential constraints in the IMS Act’s monitoring and evaluation due to financial, technical, and personnel-related reasons exist – in addition to the risk of corruption from the formula companies – regulatory efforts that address these potential damages could minimize such trade-offs. With the resources in place, monitoring and evaluation of this intervention is both conceivable and worth the risks. In spite of important cost considerations when applying this intervention and especially when monitoring and evaluating it, the case of India demonstrates that most funds go toward training workshops, with minimal resources applying to overhead.