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2004 Supreme(Pat) 973
PATNA HIGH COURT
Aftab Alam, J.
Jagdish Prasad Didwania
Versus
State Of Bihar
Criminal Miscellaneous No. 30780 of 2003 ;
Decided On : SEPTEMBER 16, 2004
The central legal point established is that a patent drug, being a drug and not an article of food, is excluded from the definition of food under the Prevention of Food Adulteration Act, 1954.
Headnote:
Food Adulteration - Misbranding of Patent Drug - Prevention of Food Adulteration Act, 1954, Rule 32
Fact of the Case:
The petitioners were summoned for trial under section 16 (1) (A) of the Prevention of Food Adulteration Act, 1954, for alleged misbranding of a patent drug named RUFAGE. The Public Analyst's report deemed the drug misbranded for violating rule 32 (i) of the Prevention of Food Adulteration Rules, 1955.
Finding of the Court:
The court found that the patent drug RUFAGE, being a drug and not an article of food, was excluded from the definition of food under the Act. The court also concluded that there was substantial compliance with the labelling provision under rule 32, rendering the prosecution misconceived and illegal.
Issues: The issues revolved around the classification of the patent drug RUFAGE as an article of food or a drug, and the compliance with labelling provisions under rule 32.
Ratio Decidendi: The court's decision was influenced by the interpretation of the Act's definition of misbranded, the exclusion of drugs from the definition of food, and the substantial compliance with labelling provisions under rule 32.
Final Decision: The court set aside the order taking cognizance, allowing the quashing application.
1. The two petitioners before this court seek to challenge the order dated 6.10.2001 passed by the Sub-divisional Judicial Magistrate, Patna in Case No. 93(M) of 2001/ Tr. No. 1981 of 2001. By the impugned order the S.D.J.M., on the basis of a complaint filed by the Food Inspector, Patna took cognizance of an offence under section 16 (1) (A) of the Prevention of Food Adulteration Act, 1954, arising from an alleged breach of the provisions of Rule 32 of the Prevention of Food Adulteration Rules, 1955, and summoned the petitioners for trial.
2. The petitioners hold a licence to stock and sell drugs. On 17.7.2001 the Complainant-Opposite party inspected their shop under the name and style of M/s New Drugs Agency and seized from there some packets of a patent named RUFAGE (Chewable fiber granules). He sent the seized packets of the Patent to the Public Analyst, Patna. The Public Analyst in his report dated 30.7.2001 expressed the opinion that the sample of RUFAGE (Chewable fiber) was misbranded within the meaning of section 2 (ix)(k) of the Act because it violated and failed to comply with rule 32 (i) of the Prevention of Food Adulteration Rules, 1955.
3. On the basis of the opinion of the Public Analyst the Food Inspector filed a complaint alleging that the sample of RUFAGE (Chewable fiber) was misbranded for violating clause (i) of rule 32 of the Rules; learned Magistrate took cognizance of the offence under section 16 of the Act and summoned the petitioners for trial.
4. Section 2 of the Prevention of Food Adulteratiion Act, 1954 contains definition clauses; sub-section (ix) defines misbranded and clause (k) of the subsection provides that an article of food shall be deemed to be misbranded if it was not labelled in accordance with the requirements of the Act or the rules made thereunder.
5. It is thus plain and clear that the provision relates to an article of food which is defined in section 2(v) as an article used as food or drink for human consumption other than drugs and water and includes-
(a) xx xx xx xx
(b) xx xx xx xx
(c) xx xx xx xx
6. Rule 32 of which breach is alleged deals with packing and labelling of food.
7. From the provisions noted above, it is manifest that in order to attract the provisions of the Act or to constitute an offence under the Act the allegation of misbranding must relate to an article of Food from the statutory definition of which drug is expressly excluded.
8. That being the legal position, Mr. R.K. Agrawal strongly argued that the whole case was completely misconceived, and it bordered on malafide because RUFAGE was not an article of food at all but it was a patent drug. He invited my attention to a photo stat copy (at Annexure-4) of the wrapper on the package of the patent. On the wrapper the patents composition is described as follows:
"Each 10 g contains: High-Fiber Carrot granules 9g Excipients q.s." (Excipients means an inactive substance that serves as the vehicle or medium for a drug or other active substance).
9. It is described on the wrapper as the only dietary fiber supplement in chewable granule form and as an ideal diet supplement to promote high fiber low fat diet.
10. Further claim is made in the wrapper that when added with water the granules swell several times their volume. Ten Grams (approximately 2 heaped teaspoonful) of Rufage granules with a glass of water 15 minutes before a meal helps reduce the meal size and therefore the calorie intake.
11. It is further claimed that soluble and insoluble fibers in Rufage are all derived from the same natural source, namely, Carrot root. These fibers help in bowel regulation and thereby correct irregular bowel movements, including constipation.
12. It is further claimed that Rufage is a useful diet supplement in those suffering from or at a risk of:
Hypercholesterolemia (excess cholesterol in the blood)
Obesity
Heart Diseases
Diabetes mellitus
Cancer
Gastrointestinal Disorders.
13. Mr. Agrawal further submitted that the patent
