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T. Rajasekar and Others Vs. State of Tamil Nadu, Rep by Drugs Inspector, Chennai - Court Judgment

LegalCrystal Citation
CourtChennai High Court
Decided On
Case NumberCrl.O.P.No. 523 of 2010 & M.P.No. 1 of 2010
Judge
AppellantT. Rajasekar and Others
RespondentState of Tamil Nadu, Rep by Drugs Inspector, Chennai
Excerpt:
.....for quash complaint pending on file of trial court - complainant issued show cause notice to petitioners company saying that without warning label, drug 'preventol' was misbranded and same was in contravention of provision of section 3[a] of act, 1954 and petitioners company sent a reply to show cause notice hence this criminal original petition court held - petitioners company need not display warning in label - considering facts that particular provision of law was made inapplicable in this case and condition regarding warning initially imposed was subsequently withdrawn, prima facie alleged offences are not made out as against petitioners - complaint lodged against petitioners company was liable to be quashed - to invoke inherent jurisdiction under section 482 cr.p.c. not..........stipulated in the approval is that the product as well as the packing should contain the following warning, "warning : to be sold by retail on the prescription of a registered medical practitioner only." the said condition was subsequently deleted by the directorate general of health services in its communication dated 18.08.2005, which reads thus, "please refer to this directorates permission letter of even number dated 02.04.2002 issued to you to manufacture the formulation of levonorgestrel 0.75mg tablet. the condition number 4 of the said permission that the drug is to be sold on the prescription of a r.m.p. only is hereby deleted while all other conditions of the permission remaining the same." therefore, the petitioners company need not display the warning in the label. considering.....
Judgment:

(Prayer: Criminal Original Petition filed under Section 482 Cr.P.C., to call for the records in C.C.No.7088 of 2008 on the file of the XV Metropolitan Magistrate, George Town, Chennai and to quash the same.)

1. This Criminal Original Petition has been filed under Section 482 of Code of Criminal Procedure, 1973 seeking to quash the complaint in C.C.No.7088 of 2008 pending on the file of the XV Metropolitan Magistrate, George Town, Chennai.

2. It is averred in the petition that the petitioners are employees of M/s.HLL Lifecare Limited, a Government Company incorporated as a corporate entity under the Ministry of Health and Family Welfare of the Government of India and is engaged in the manufacture and marketing of contraceptives and various health care products as per approval under the Drugs and Cosmetics Act in Form 46. The Company introduced an emergency contraceptive pill in the year 2003. Though initially, it was required that the said product be sold only under the supervision and prescription of a Medical Practitioner, the Directorate General of Health Services had subsequently permitted by a communication dated 18.08.2005, the removal of the above requirement/condition. The complainant issued a show cause notice to the petitioners Company dated 30.01.2008 saying that without a warning label, the drug 'Preventol' was misbranded and the same was in contravention of the provision of Section 3[a] of the Drugs and Magical Remedies [Objectionable Advertisement] Act, 1954 [herein after referred to as Act] and the petitioners Company sent a reply to the show cause notice.

3. It is further averred that the Government had already removed the requirement of the pill being sold under prescription and other manufacturers of the same pill under a different brand were exempted from the application of the Act and that, there is no specific plea in the complaint that the petitioners, who were in charge of the affairs of the Company and were actually involved in the conduct of the business.

4. Learned counsel for the petitioners Company contends that the provisions of Section 3[a] of the Act, shall not apply, insofar as it relates to prevention of conception and to attract the offence under Section 3[a] to [d] of the Act, the publication of the advertisement should have reference to a drug and that product should have been suggested as a cure for certain ailments as mentioned in the Section.

5. Learned counsel for the respondent per contra, contends that prima facie, offences as alleged are made out and the learned Magistrate after considering the materials, took cognizance of the offences.

6. The Petitioners Company is admittedly a Government Company incorporated as a corporate entity under Ministry of Health and Welfare, Government of India and is engaged in manufacture and marketing of contraceptives and various health care products. The petitioners here in are employees of the Company. As per Section 9 of the Drugs and Magical Remedies [Objectionable Advertisement] Act, 1954, every person who at the time of the commission of the offence was in charge, and was responsible to, the Company for the conduct of the business of the Company as well as the Company shall be deemed to be guilty. Therefore, to make out a case against the petitioners, there should be some averment that the petitioners were in charge and were responsible for the conduct of the business of the Company. Learned counsel for the respondent also fairly concedes that there is no such averment in the complaint.

7. Section 3[a] of the Drugs and Magical Remedies [Objectionable Advertisement] Act, 1954, relates to prohibition of advertisement of certain products for treatment of certain diseases and disorders. Section 17[b] of the Drugs and Cosmetics Act, 1940, relates to labelling of the product in the prescribed manner, i.e., misbranded products. As per Section 3[a] of the Drugs and Magical Remedies [Objectionable Advertisement] Act, 1954, no person shall take any part in the publication of any advertisement referring to any drug in terms which suggest or are calculated to lead to the use of that drug for the procurement of miscarriage in women or prevention of conception in women. The allegation in this case is that the petitioners Company has not labelled the warning on the pills.

8. Notification No.S.O.282 dated 24.01.1961 issued by the Ministry of Health and Public in the Gazette of India dated 04.02.1967 reads thus,

"In exercise of the powers conferred by Section 15 of the Drugs and Magical Remedies [Objectionable Advertisement] Act, 1954 [21 of 1954], the Central Government hereby directs that the provisions of clause [a] of Section 3 in so far as they relate to "prevention of conception in women" and those of Section 6 of the said Act shall not apply to or in relation to any advertisement in respect of contraceptives, provided that the advertisement shall relate only to such contraceptives as have been approved by the Government."

9. Thus, in exercise of powers conferred by Section 15 of the Act, the Government made the provision Section 3[a] and also Section 6 of the Act, inapplicable in relation to any advertisement in respect of contraceptives approved by the Government. There is no dispute that contraceptive in question namely, levonorgestrel has been approved by the Licensing Authority under Form 46. But, the condition stipulated in the approval is that the product as well as the packing should contain the following warning, "WARNING : To be sold by retail on the prescription of a registered Medical Practitioner only." The said condition was subsequently deleted by the Directorate General of Health Services in its communication dated 18.08.2005, which reads thus,

"Please refer to this Directorates permission letter of even number dated 02.04.2002 issued to you to manufacture the formulation of levonorgestrel 0.75mg tablet.

The condition number 4 of the said permission that the drug is to be sold on the prescription of a R.M.P. only is hereby deleted while all other conditions of the permission remaining the same."

Therefore, the petitioners Company need not display the warning in the label. Considering the facts that the particular provision of law is made inapplicable in this case and the condition regarding warning initially imposed was subsequently withdrawn, prima facie the alleged offences are not made out as against the petitioners. Therefore, the complaint lodged against the petitioners Company is liable to be quashed.

10. Under the said circumstances, this Court is of the considered view that this is a fit case to invoke inherent jurisdiction under Section 482 Cr.P.C. not only to avoid the ordeals of the petitioners, but also for the ends of justice.

11. In the result, the Criminal Original Petition is allowed and the complaint in C.C.No.7088 of 2008 pending on the file of the XV Metropolitan Magistrate, George Town, Chennai, is hereby quashed. No costs. Consequently, connected Miscellaneous Petition is closed.


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