The Hindu Business Line : <I>Yehi hai </I>right action, baby!

THE recent action of the Maharashtra Food and Drug Administration (FDA) against baby care product manufacturers has attracted worldwide attention. The legislation that got dusted in the process is the Drugs and Cosmetics Act, 1940, Section 17 of which is about `misbranded drugs'.

A drug shall be deemed to be misbranded if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or if it is not labelled in the prescribed manner; or if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular. It appears that the last segment is what comes into play in the case of `baby' products with a `statement' that's `misleading' as being suitable for a target use.

Sudden action by the "authorities in a western Indian state", as international media describe, has invited adverse reaction from many quarters. To check, I visit the site of the US FDA www.fda.gov and read the latest weekly `enforcement report' dated March 23 that speaks of regulatory action taken by the FDA's Department of Health and Human Services.

A long list of items such as true colour pigments, eyeliner corrector, lip corrector, and so on of scores of shades, from American Institute of Intradermal Cosmetics, are announced to have been recalled because "the pigments have not been approved for their intended use of tattooing and have been associated with adverse reactions that include swelling, cracking, peeling, blistering, and scarring as well as formation of granulomas (chronically inflamed tissue mass associated with an infection) in the areas of the eyes and lips."

Similarly, `Asian Taste Brand Dried Lily Flower' of West Honest International gets the stick because it "contained undeclared sulfites". Hundreds of batches of Medline Industries' products such as `Medline Baby Lotion', `Medline Hand & Body Lotion', `Soothe & Cool Cleansing Bath Oil', and `Medline Baby Oil' get the regulator's glare because the lotions and oils are "contaminated with Burkholderia cepacia, and fungus respectively."

There are big names too in the list of manufacturers coming under the FDA's focus. Such as BASF, for its Ibuprofen, that have been found to be "adulterated, foreign tablets co-mingled"; Pfizer's Dalacin T Gel with "insect contamination"; Platelets Pheresis, Leukocytes Reduced from American Red Cross recalled since these `blood products' were "collected from a donor who reported travel to an area designated as endemic for malaria"; Red Blood Cells from the Department of the Air Force, 81st Medical Group, as the blood product was "collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease"; and CryoVein, Saphenous Vein from CryoLife, Inc, reason, "Human tissues, possibly processed using an expired anti-microbial solution".

The enforcement report initiates corrective action not only against foods, cosmetics and drugs, but also biologicals as in many of the above instances, and `devices' too. For instance, Angiographic Syringes and Catheterization Kits of Hospira, Inc, running to more than 72,000 units of `volume of product in commerce' are recalled because the "syringes could possibly allow air to enter the patient's vascular system."

Assuming that A. Ramakrishnan, the FDA Commissioner in Mumbai, has done his homework, one can only wish him, "Yehi hai right action, baby!" However, after our regulators cut their teeth in baby products, it is necessary that they graduate themselves to watch for aberrations in other spheres too. More important, they should ensure that products that are recalled/ rejected elsewhere don't land in our shelves here.

E&OE@TheHindu.co.in

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Yehi hai right action, baby!