Case Note & Summary
The petitioners, who are the Director, Managing Director, and the manufacturing company (M/s. Shree Umiya Surgical Pvt. Ltd.), challenged the order of issuance of process dated 16.01.2006 passed by the learned Chief Judicial Magistrate, Nanded in Special Case No.7 of 2015 (Old RCC No.12 of 2006). The complaint was filed by the Drug Inspector, Food and Drug Administration, Nanded, alleging that a sample of Mediplus Scalp vein set (Batch No.26, manufactured on 01.10.2004, expiry 30.09.2007) drawn from the Civil Hospital, Nanded on 03.06.2005 was found not complying with IP standards for sterility as per the analyst report dated 08.09.2005. The Drug Inspector sent a notice under Section 18-A of the Drugs and Cosmetics Act, 1940 to the supplier (distributor) on 15.09.2005, and the supplier disclosed the name of the manufacturer. However, the Drug Inspector sent the test report and a sealed counter sample to the manufacturer only on 04.10.2005, after obtaining sanction on 23.09.2005 and filing the complaint on 16.01.2006. The petitioners argued that the mandatory notice under Section 18-A was not given to them before filing the complaint, and therefore the complaint and issuance of process were invalid. The court examined Section 18-A of the Drugs and Cosmetics Act, 1940, which requires the Drug Inspector to give notice to the person from whom the drug was purchased or received, and held that the manufacturer is such a person. The court relied on the Supreme Court judgment in State of Haryana v. Unique Farmaid Pvt. Ltd. (1999) 8 SCC 190, which held that the notice under Section 18-A is mandatory and must be given before filing the complaint. The court found that the Drug Inspector gave notice only to the distributor and not to the manufacturer, and the notice to the manufacturer was sent after the complaint was filed. Therefore, the court held that the mandatory requirement was not complied with, and the issuance of process was illegal. The court quashed the complaint and the order of issuance of process, and allowed the petition.
Headnote
A) Criminal Procedure - Issuance of Process - Quashing of Complaint - Mandatory Notice under Section 18-A of Drugs and Cosmetics Act, 1940 - The court considered whether the complaint and issuance of process were valid when the Drug Inspector failed to give the mandatory 10-day notice to the manufacturer before filing the complaint. The court held that the notice under Section 18-A is mandatory and must be given to the person from whom the drug was purchased or received, and failure to do so vitiates the complaint and the issuance of process. (Paras 6-10) B) Drugs and Cosmetics Act - Section 18-A - Notice to Manufacturer - Interpretation - The court interpreted Section 18-A of the Drugs and Cosmetics Act, 1940, which requires the Drug Inspector to give notice to the person from whom the drug was purchased or received, and held that the manufacturer is entitled to such notice as the drug was received from the manufacturer. The court relied on the Supreme Court judgment in State of Haryana v. Unique Farmaid Pvt. Ltd. to hold that the notice is mandatory and non-compliance renders the complaint invalid. (Paras 6-10) C) Criminal Procedure - Quashing of Complaint - Abuse of Process - The court held that continuing the proceedings against the petitioners would be an abuse of process of law as the mandatory notice under Section 18-A was not given, and the complaint was filed without affording the manufacturer an opportunity to respond. The court quashed the complaint and the order of issuance of process. (Paras 10-11)
Issue of Consideration
Whether the issuance of process against the petitioners is sustainable when the mandatory notice under Section 18-A of the Drugs and Cosmetics Act, 1940 was not given to the manufacturer before filing the complaint?
Final Decision
The petition is allowed. The order of issuance of process dated 16.01.2006 passed by the learned Chief Judicial Magistrate, Nanded in Special Case No.7 of 2015 (Old RCC No.12 of 2006) and the complaint itself are quashed and set aside. Rule is made absolute.
Law Points
- Mandatory pre-cognizance notice under Section 18-A of Drugs and Cosmetics Act
- 1940
- Non-compliance renders complaint invalid
- Issuance of process without proper notice is illegal
- Right to fair trial and natural justice
