Case Note & Summary
The petitioners, Parenteral Drugs (India) Ltd and others, filed writ petitions challenging the order dated 24 September 2014 passed by the Chief Judicial Magistrate, Sindhudurg-Oros, issuing process against them in C.C. No. 42 of 2014, and the order dated 4 April 2015 passed by the Sessions Judge, Sindhudurg-Oros, dismissing Criminal Revision Application No. 18 of 2015. The petitioners are facing prosecution under sections 18(a)(i), 16, 18-B and 34 of the Drugs and Cosmetics Act, 1940. The Drug Inspector received a complaint from the Civil Surgeon regarding white fibrous substances in compound sodium lactate injection IP manufactured by the petitioner company. Samples were drawn and sent to the Government Analyst, who reported that the sample was infested with fungus growth. A notice under Section 18A was issued to the petitioners, but the complaint was filed on 10 September 2014 without giving the petitioners an opportunity to explain the report. The issuance of process was challenged solely on the ground of non-compliance with Section 18A procedure. The court considered whether the notice under Section 18A must be served before filing the complaint and whether an opportunity to explain must be given. The court held that Section 18A is mandatory and requires that the person from whom the sample was taken be given an opportunity to explain the report. Since the complaint was filed without such opportunity, the issuance of process was illegal. The court allowed the petitions, quashed the order issuing process, and set aside the order of the Sessions Judge.
Headnote
A) Criminal Procedure - Issuance of Process - Section 18A Drugs and Cosmetics Act, 1940 - Mandatory Notice - The court held that the notice under Section 18A of the Drugs and Cosmetics Act, 1940 must be served on the accused before filing the complaint, and the accused must be given an opportunity to explain the report of the Government Analyst. Failure to do so renders the issuance of process illegal. (Paras 5-10)
B) Drugs and Cosmetics Act - Section 18A - Opportunity of Explanation - The court held that the requirement of giving an opportunity to explain under Section 18A is mandatory and not directory. The complaint was filed without giving the petitioners an opportunity to explain the Government Analyst's report, and thus the process issued is invalid. (Paras 8-10)
Issue of Consideration
Whether the issuance of process against the petitioners is illegal for non-compliance of the procedure laid down under the Drugs and Cosmetics Act, 1940, particularly Section 18A.
Final Decision
The court allowed the petitions, quashed the order dated 24 September 2014 issuing process, and set aside the order dated 4 April 2015 passed by the Sessions Judge. The criminal applications are disposed of accordingly.
Law Points
- Section 18A notice must be served before filing complaint
- opportunity to explain must be given
- non-compliance vitiates process
Case Details
2019 LawText (BOM) (04) 68
Writ Petition No.2950 of 2015 with Criminal Application No. 335 of 2015; Writ Petition No. 2951 of 2015 with Criminal Application No. 334 of 2015
Mr. Nikhil Sakardande a/w. Mr. Ibrahim Merchant and Mr. Vijayesh Atre for the Petitioners; Mr. A.R. Patil, APP for the Respondent-State
Parenteral Drugs (India) Ltd and Ors.; Manoharlal Umashankar Gupta and Ors.
The State of Maharashtra, through the Drug Inspector, Sindhudurg
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Nature of Litigation
Criminal writ petitions challenging the issuance of process and dismissal of revision application under the Drugs and Cosmetics Act, 1940.
Remedy Sought
Quashing of the order dated 24 September 2014 issuing process and the order dated 4 April 2015 dismissing the revision application.
Filing Reason
The petitioners challenged the issuance of process on the ground of non-compliance with Section 18A of the Drugs and Cosmetics Act, 1940, as they were not given an opportunity to explain the Government Analyst's report before the complaint was filed.
Previous Decisions
The Chief Judicial Magistrate issued process on 24 September 2014. The Sessions Judge dismissed Criminal Revision Application No. 18 of 2015 on 4 April 2015.
Issues
Whether the issuance of process is illegal for non-compliance of the procedure laid down under the Drugs and Cosmetics Act, 1940, particularly Section 18A.
Submissions/Arguments
The petitioners argued that the notice under Section 18A was not served before filing the complaint and they were not given an opportunity to explain the report, making the process illegal.
The respondent-State argued that the notice was issued and the procedure was followed.
Ratio Decidendi
The requirement of giving an opportunity to explain under Section 18A of the Drugs and Cosmetics Act, 1940 is mandatory. Non-compliance with this provision before filing the complaint renders the issuance of process illegal and liable to be quashed.
Judgment Excerpts
The issuance of process was challenged only on the law point that the order of issuance of process is defective for non-compliance of the procedure laid down under the said Act.
Thus, a short issue is involved in this case whether the order of issuance of process is illegal for want of compliance of Section 18A of the said Act.
Procedural History
On 3 August 2012, a complaint was received from the Civil Surgeon. Samples were drawn and sent to the Government Analyst on 6 August 2012. The analytical report was received on 30 August 2012. Notice under Section 18A was issued. The complaint was filed on 10 September 2014. Process was issued on 24 September 2014. The petitioners received notice on 18 October 2014. The petitioners filed Criminal Revision Application No. 18 of 2015, which was dismissed on 4 April 2015. The petitioners then filed the present writ petitions.
Acts & Sections
- Drugs and Cosmetics Act, 1940: 18(a)(i), 16, 18-B, 34, 18A
