CADILA PHARMACEUTICALS LTD Vs. STATE OF KERALA

JUDGEMENT

(1.) The question that arises for consideration in this case is as to whether EC 350 (Vitamin E and Vitamin C capsules) and Cecure (Multi - Vitamin Capsules) manufactured by the petitioner and sold in the market through medical shops as "Dietary Supplements" falls within the definition of "drug" requiring licence under the Drugs arid Cosmetics Act, 1940 (hereinafter referred to as 'the Act').

(2.) The petitioner is a limited company engaged in the business of manufacture, distribution and sale of branded formulations, generic and oncocare products, animal health and natural products, dietary supplements, biotech products, chemicals, etc. Their registered office is at Navrangpura, Ahmedabad in Gujarat State. They are having licence for the manufacture, storage, distribution and sale of 'dietary supplements' to be manufactured at its factory at Navi Kadi, District Mehsana, Gujarat under Licence No. 3071/1977 issued by the Assistant Commissioner, Food and Medicine Administration, Mehsana, Gujarat, under Edible Things Adulteration Prevention Act produced as Ext. P1. They are also having licences issued by the Commissioner, Food and Drugs Control Administration, Gujarat State for the manufacture of drugs at its factory at Village Dholka, Ahmedabad District, under the Drugs and Cosmetics Act, 1940 evidenced by Ext. P2.

(3.) The petitioner has been marketing, distributing and selling its dietary supplements 'EC - 350 and Cecure' which according to them are essentially Vitamin based in the State of Kerala from April, 1998 and April, 2001 respectively. The said dietary products are sold all over the country and were developed by the petitioner as a supplement which would induce general well being among the customers. The petitioner received letters (Ext. P3) from various medical shops in Palghat and Trichur Districts which had been selling the dietary supplements of the petitioner intimating the petitioner that they are returning their stocks of the said dietary supplements to the petitioner based on the orders of respondents 3 and 4. The petitioner had also obtained copies of the said orders issued by respondents 3 and 4 from medical shops, evidenced by Ext. P4.