The Maharashtra FDA has issued a directive on compliance rules for infant products. This order applies to baby formulas, infant milk products, follow-on formulas, complementary foods, specialized medical products, and feeding bottles intended for children under two years of age.
Strict adherence to packaging, labeling, advertising, promotion, and sale regulations for these goods is required. The scope of the order covers not only the companies themselves but also the entire supply chain, including manufacturers, brand owners, importers, packagers, distributors, medical stores, hospitals, and e-commerce platforms.
The directive clearly states that no formula or infant food can be advertised as equivalent to or superior to mother's milk. Packaging must display notices such as 'Breast milk is best for your baby,' along with other warnings. The use of free samples, gifts, coupons, cashback, and other inducements is prohibited. Prohibited advertising must also not be disseminated through television, print media, websites, e-commerce, social media, messengers, and influencers.
Doctors, healthcare workers, hospitals, and medical organizations are not permitted to promote products by providing gifts, financial benefits, sponsorships, hospitality, or payment for appearances. Similar prohibitions apply to activities conducted under the guise of conferences, CME, CPD, seminars, workshops, or research.
Packaging must clearly state the age, method of use, ingredients, nutritional information, and warnings. Creating confusion using terms such as 'complete,' 'healthy product,' 'energy product,' or 'humanized' falls under the purview of these rules. There is also a ban on using images of infants or women. Complementary feeding should only be introduced after six months. The use of added colors, flavorings, preservatives, and other prohibited substances must comply with established standards. The total amount of sucrose and fructose must not exceed 20 percent of the total carbohydrates.
The FDA may conduct inspections, searches, and confiscations in case of violations, and may pursue legal action and fines depending on the nature of the violation. Measures may also be taken against licenses. This order is implemented in accordance with the Food Safety Act of 2006 and the Infant Food Regulations of 2020. These rules require compliance with the IMS Act and its 2003 amendments. Hospitals and pediatricians are obligated to report suspicious adverse events to the relevant authority. The FDA has announced meetings with hospitals, IAPs, IMAs, and other organizations.
In Maharashtra, the exclusive breastfeeding rate among children under six months is approximately 55.8 percent. In urban areas, this rate reaches about 52.8 percent, while in rural areas, it is around 75.2 percent. Despite approximately 96 percent of births occurring in healthcare facilities, there is an emphasis on improving counseling in hospitals to initiate breastfeeding within the first hour of life. After six months, combining breastfeeding with adequate complementary feeding is recommended. The sale of infant food is not banned, but its marketing is subject to strict regulations.
Another news item concerns allegations against FDA officials. Shiv Sena UBT MP Sanjay Raut sent a letter to Commissioner Tukaram Mundhe, alleging threats of license suspension in exchange for money from hotel, restaurant, and quick delivery service owners. According to him, the initial extortion amount for withdrawing a closure notice was 10–12 thousand rupees, which has now risen to 75–200 thousand rupees. He demanded an independent investigation. Mundhe stated that action cannot be taken solely on allegations, requiring solid evidence. The complainant must specify which official demanded money, from whom, and for what service. Evidence or testimony can be provided to the ACB, the department secretary, or another competent authority. He also contacted the ACB Director and reiterated the principle of zero tolerance for corruption. He assured that necessary action would be taken upon receiving evidence.
Regarding license suspensions, Mundhe noted that there is an option to appeal and a judicial path is open. Around 600 suspensions were made by August 6th, of which 100–125 appeals were received by him and decisions were rendered. Those who did not appeal likely accepted the suspension, and it can be reinstated after fulfilling the necessary requirements. Even after fulfilling the requirements, if the suspension is not revoked, an appeal or complaint can be filed. According to Mundhe, the confidentiality system in the FDA complaints portal allows the applicant to remain anonymous, and relevant officials do not receive their name or phone number. The goal is to protect the applicant from pressure or blackmail.
New details have emerged regarding surrogate advertising through FDA Commissioner Tukaram Mundhe. It was reported that actors Shah Rukh Khan, Ajay Devgn, and Tiger Shroff have also responded to a notice issued by the agency. In this case, all three actors were served a notice concerning one advertisement that allegedly indirectly promoted a prohibited tobacco/nicotine product. According to Mundhe, two out of the three actors requested a hearing, and hearings for both have already taken place. However, the commissioner did not specify whether the hearing for all three has been concluded.