The Himalaya Drug Company which came under the scanner of the Maharashtra Food and Drug Administration for alleged presence of liquid paraffin as base in Himalaya Baby Oil created a flutter among many pediatricians and gynecologists who have been recommending the product to new born babies in Bangalore.
The medical practitioners stated that it could be a false alarm as there were no reports of allergies reported from patients. According to a section of chemists and cosmetic outlets, the products- Moisturizing Baby Soap, Baby Powder, Baby Lotion, Gentle Baby Shampoo, Nourishing Baby Oil, Baby Cream are popular among consumers who are not only new mothers but also teenagers because of the natural herbal contents.
During the product launch in November 2004, the company had stated that all the baby products had gone through dermal safety studies conducted on 500 babies in the age group from six months to four years.
Pharmabiz.com, on November 15, 2004, has reported that the company stated to have abided by the World Medical Association's Declaration of Helsinki, a charter which provides guidance to physicians and other participants in medical research involving humans.
The first round of the trial was conducted at the Kolkatta Medical College, Kolkatta, Post Graduate Institute of Medical Education and Research, Chandigarh and Apollo Hospital, Chennai which had two investigators (a dermatologist and paediatrician) modulating the trails at each facility.
Himalaya had also initiated a second round of trials at the Institute of Medical Sciences, Bananas Hindu University, Varanasi, Mahatma Gandhi Medical College Ahmedabad and CMC Vellore.
In the wake of the controversy which rocked several manufacturers of baby oil in the country including Himalaya, the company in a press statement has clarified, "Himalaya is the only company that conducted controlled clinical trials in children before the products are launched in the market. Himalaya Baby Oil was launched only after it passed extensive dermal toxicity and safety trials in infants and children, and the product was proved to be absolutely safe on babies' skin."
In Himalaya Baby Oil, we use pure herbal extracts, olive oil and mineral oil. Mineral oil used in our Baby Oil is highly refined, IP grade (grade-5), and is approved by the Indian Pharmacopoeia for its purity. Medicinal grade mineral oil is one of the safest and most non-irritating moisturizing ingredients (Source: 1.Cosmetics & Toiletries, Jan. 2001. Page-79. 2.Cosmetic Dermatology, Sept. 2000, Page-44-46). Olive oil used in our Baby Oil has been used worldwide as a natural emollient and skin nourishing agent. Along with this, we use other herbs, which have been extracted in olive oil and have proven therapeutic efficacy on babies' skin.
Further, esteemed scientific organizations such as the International Agency for Research on Cancer (IARC) have certified medicinal grade mineral oil as being highly safe and devoid of carcinogenic profile, the statement added.
The company reiterated that its commitment to quality and safety are paramount, and has given the assurance that its products are of the highest quality and absolutely safe.
Himalaya is engaged in the research, manufacture and marketing of safe healthcare and personal care products from natural sources, since 1930. Each product undergoes extensive research for safety and efficacy and has to meet stringent regulatory requirements before being made available to the consumer, according to the statement.