In a significant judgment, the division bench of the high court of Jharkhand at Ranchi  pronounced that if the ingredients of a drug are within the therapeutic range as prescribed under Schedule V of the Drugs and Cosmetics Rules, 1945, it cannot be termed as a food supplement, but a drug. The court issued the order last week.

The court was considering a case on the product, A to Z Gold soft gelatin capsules, which was manufactured and marketed by a company as a food supplement (vitamin product) on a licence granted under the Prevention of Food and Adulteration Act (PF&AA).

A case was filed against it by the drug inspector of Giridih in Jharkhand, who claimed that the product was a drug and not a food supplement. His argument was that when a drug is used in its therapeutic range, in terms of the provision contained in Section 3(b) (i) of the Drugs and Cosmetics Act, it happens to be a drug and not a food supplement.

The counsel for the drug inspector argued in the court that the drug was to be sold out on a licence to be issued under the Drugs and Cosmetics Act instead of PF&AA because vitamin products in particular therapeutic range are prescribed by doctors in particular dosage to treat vitamin deficiency. On the labels of the capsules, the number of drug manufacturing licences should have been mentioned as the capsules were drugs, and not dietary supplements.

In the year 2009, the Patna high court had held that A to Z capsule was a food supplement, and not a drug. About this observation, the high court of Jharkhand, in its present order, observed that the Patna high court had arrived at such a conclusion might be on the basis of the report submitted to the court by the director general of health services (DGHS), Government of India opining therein that A to Z capsule was food supplement.

The observation of the court was that if the component of a drug falls within the definition of a drug then the intention of the manufacturer of getting it used as a food supplement will hardly matter. The definition of drug would go to show that it takes within its fold medicines as well as substances used for treatment, mitigation or prevention of disorders in human beings as well as in animals.

The counsel for the drugs control department argued that the ingredients in the A to Z Gold soft gelatin capsules are within the therapeutic range as prescribed under Schedule V of the D&C Rules, 1945. So the manufacturing company needs to have a licence under the D&C Act, 1940. The company was marketing the product on a licence granted under the prevention of food and adulteration act claiming it as a dietary supplement.

The court held that the drug in question cannot be taken as a food supplement by virtue of the definition of the drug in the D&C Act because it is well known that vitamin deficiencies in human beings may result in certain diseases. A to Z capsules were sold to contain vitamin deficiencies in human beings.