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1996 Supreme(Online)(MP) 5

MADHYA PRADESH HIGH COURT
Shri Datt, J
Ranbaxy Laboratories Limited (M/s.) v. State of M.P.
Criminal Case No. 2647 of 1985



Advocates:
For the Appellants/Petitioners: Shri Datt
For the Respondents: Shri D. V. Pendharkar

The court upheld the interpretation of misbranding under the Drugs and Cosmetics Act, making company directors liable for offenses under corporate conduct.

Headnote:This case pertains to an application for quashing an order taking cognizance in Criminal Case No. 2647 of 1985 originating from violations under the Drugs and Cosmetics Act, 1940. The petitioners contest allegations of misbranding based on provisions of section 17. The court found the labeling false and misleading, determining culpability under section 34 for corporate responsibility. The primary legal issues involved the definitions of misbranding and the standard of vicarious liability applicable to company directors. Ultimately, the petition was dismissed, and the court directed swift trial proceedings.

Table of Content
1. application for quashing cognizance. (Para 1 , 2 , 3)
2. misbranding allegations under the drugs act. (Para 4 , 5)
3. directors' responsibility in corporate conduct. (Para 6 , 12)
4. legal standards for vicarious liability. (Para 8 , 9 , 10 , 11)
5. conclusion and dismissal of the petition. (Para 13 , 14)

1. Petitioners have filed this application for quashing the order taking cognizance as also the entire proceeding in Criminal Case No. 2647 of 1985 pending in the Court of the Additional Chief, Judicial Magistrate, Jabalpur. It appears that on the basis of a complaint made by the Drug Inspector, the learned Magistrate, by its order dated 19-7-1985, took cognizance of the offence under S.18/27 of the Drugs and Cosmetics Act, 1940 (hereinafter referred to the Act for brevity) and directed for issuance of process against the petitioners.

2. Petitioner No. 1 is a company having its registered office in the State of Haryana and petitioner No. 2 is its Managing Director. Petitioner No. 3 has been termed as member of the Board of Directors, but Shri Datt, appearing on behalf of the petitioners, seeks permission to delete petitioner No. 3, permission to delete the name of petitioner No. 3 is - granted and the same stands deleted.

3. Shorn of unnecessary details the gist of the allegation, according to the complaint is that the petitioner - company was granted licence, bearing No. 28/15/83 dated 12-10-85 to manufacture for sale of drugs. The Drug Controller, by its order dated 16-12-1983 granted permission to manufacture Rescillin injection with following specification:

The aforesaid drug was manufactured in the strength of 250 and 500 mgs. of Ampicillin and packed along with one ampoule of water. The carton of the drug contained the following declaration :
"One ampoule containing 2 ml. water for injection is included in this pack."
The leaflet kept inside the carton contained the following information:
"Each vial contains : Ampicillin Sodium IP equivalent to anhydrous Ampicillin 250 mg Indications Dosage and Administration. According to medical prescription - one ampoule containing 2 ml. water for injection is included in this pack." (emphasis supplied)

4. The aforesaid drug was marketed for sale through the distributors, according to the complaint, without the water for injection. According to the complaint, although it did not contain water but the petitioner - company realised the price from the distributors, fixed by the Central Government under the provisions of the Drugs (Prices Control) Order, 1979 and the same was inclusive of one ampoule of 2 ml. of water for injection. In fairness, I must state that according to the complaint itself a slip containing information that - this pack does not contain water for injection was kept inside the carton.

5. Shri Datt, appearing on behalf of the petitioners, submits that selling of Roscillin injection without water would not amount to sale of mis - branded drug and as such the entire allegation made in the complaint petition does not constitute any offence, Having given my most anxious consideration to the submission made by the learned counsel, I am not impressed by that. The word "mis - branded" has been defined under S.17 of the Act which reads as follows:
"17. Mis - branded drugs - For the purpose of this Chapter, a drug shall be deemed to be mis - branded
(a) if it is so coloured, coated, powered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or
(b) if it is not labelled in the prescribed manner; or
(c) 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."
To, me, it appears to be plain from the reading of S.17(c) of the Act that a drug shall be deemed to be mis - branded, in case, its label or container or anything accompanying the drug, bears any statement which is "fa




























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