IN THE HIGH COURT OF HIMACHAL PRADESH AT SHIMLA
RAKESH KAINTHLA, J.
M/s Unital Formulation and Another - Petitioners
Versus
Union of India - Respondent
Cr. MMO No. 321 of 2023
Decided On : 21-03-2025
(A) Drugs and Cosmetics Act, 1940 - Sections 18(a)(i), 18(a)(vi), 18(b), 18(c), 21, 25(4) and 32 - Criminal complaint for substandard drug - The complaint was quashed due to the expiry of the drug sample before testing by the Central Drugs Laboratory, impacting the accused's right to challenge the evidence. (Paras 1, 26, 32)
(B) Jurisdiction - The learned Additional Sessions Judge had no jurisdiction to take cognizance of the complaint without prior commitment from a Magistrate, as mandated by Section 193 of Cr.P.C. (Paras 10, 32)
(C) Vicarious liability - A proprietorship firm lacks separate legal identity; thus, the proprietor alone is liable for the firm's actions. (Paras 12, 16)
Facts of the case:
The petitioners challenged a complaint filed by the Drugs Inspector against them for manufacturing a drug that was reported as substandard. The complaint was filed after the sample's shelf life had expired, raising issues of jurisdiction and the validity of the complaint.
Findings of Court:
The court found that the delay in testing the sample after its expiry deprived the accused of their right to challenge the evidence, leading to the quashing of the proceedings.
Issues: The main issues included the jurisdiction of the Additional Sessions Judge, the expiry of the sample affecting the prosecution, and the question of vicarious liability of the proprietorship firm.
Ratio Decidendi: The court ruled that the expiry of the sample negated the prosecution's case, and the Additional Sessions Judge could not take cognizance of the complaint without proper commitment from a Magistrate.
Result: The proceedings pending against the petitioners were quashed.
JUDGMENT :
Rakesh Kainthla, J.
The petitioners have filed the present petition for quashing the criminal complaint and the consequent proceedings pending before learned Additional Sessions Judge, Nalagarh, District Solan, H.P. for the commission of offences punishable underSections 18(a)(i), 18(a)(vi), 18(b), 18(c) read with Rules 76 and 78 of the Drugs and Cosmetics Act, 1940. (Parties shall hereinafter referred to in the same manner as they were arrayed before learned Trial Court for convenience).
2. Briefly stated, the facts giving rise to the present petition are that the complainant, Drugs Inspector, filed a complaint against the petitioners/accused before the learned Trial Court asserting that accused no.1 is a manufacturer of Tablets, Capsules, Liquid Orals, Ointments, Liquid Injections (General Section) and Dry Powder Injection (Betalactum). Accused No.2 is the proprietor of accused No.1. A Sample of Uni-Dexa Injection (Dexamethasone Injection IP) was drawn for analysis on 24.2.2020 from Sanjeev Puri, Pharmacist, Main Store (Basement), Civil Hospital, Manimajra. The sample was sent to a Government Analyst, who issued a report stating that the sample was not of standard quality and did not conform to the claim as per IP-2018 regarding sterility and free Dexamethasone. The report was sent to the person from whom the drug was acquired. He disclosed that accused No.1 was the manufacturer of the drug. The test report and one portion of the sealed sample were served upon accused No.1. Accused No.1 replied that the sample was sent to a laboratory, and the result was awaited. Hence, the Drugs Inspector prayed to the learned Additional Chief Judicial Magistrate, Nalagarh, on 22.6.2020 to get the second portion of the sample tested. The accused also submitted a report from the private laboratory mentioning that the drug was as per the standard laid down under the Act. The second portion of the sample was sent to the Central Drugs Testing Laboratory, which issued a report stating that the sample did not conform to the standards laid down under the Act. Hence, the complaint was filed against the accused for taking action as per the law in the Court of learned Additional Sessions Judge, Nalagarh, District Solan, H.P.
3. Being aggrieved from filing the complaint, the petitioners/accused have approached this Court asserting that the Union of India had no jurisdiction to appoint the Drugs Inspector. There is no averment that accused No.2 is in charge and responsible to accused No.1 for its affairs. The accused have nominated Mr Alok as a competent person for manufacturing activity. The sample is to be analyzed within 60 days. The compliance of Section 202 of Cr.P.C. was mandatory. The shelf life of the drug was to expire in June 2020. The Central Drugs Testing Laboratory tested the drug after its expiry and such a report cannot be used against the petitioner. Learned Sessions Judge had no jurisdiction to take cognizance without the case having been committed to it. Therefore, it was prayed that the present petition be allowed and the complaint and consequent proceedings pending before the learned Additional Sessions Judge be set aside.
4. The petition is opposed by filing a reply and making a preliminary submission regarding the lack of maintainability. The contents of the petition were admitted to the extent that the sample was sent for retesting. It was asserted that the sample was found to be not of requisite standards after retesting. The complainant was validly appointed under Section 21 of the Drugs and Cosmetics Act. Accused No.1 is a proprietorship concern, and provisions of Section 34 of the Drugs and Cosmetics Act do not apply to it. Accused No.2 is the proprietor of accused No.1, and he is liable by virtue of his position. Section 32 of the Drugs and Cosmetics Act provides that no Court inferior to the Court of Sessions shall take cognizance of the commission of an offence punishable under the Drugs Act, and the learned Addition
The expiry of a drug sample before testing negates the prosecution's case, impacting the accused's right to challenge the evidence.
The judgment establishes that the failure of the prosecution to adhere to statutory requirements, particularly regarding the right to contest the Government Analyst's report, can lead to the quashing....
Seizure of sub-standard quality of drug – When report of Government Analyst itself is shrouded in serious suspicion and it is not sure as to whether report of Government Analyst relates to sample lif....
Prosecution quashed for delay in sample testing beyond 60 days without extension under Rule 45 and failure to send sample to manufacturer under Section 23(4)(iii), depriving re-analysis right post sh....
Drugs and Cosmetics - Criminal Proceedings quashed - Statutory right of petitioner for retesting drugs in question under sections 25(3) and 25(4) of Act has been violated by respondent and learned tr....
The prosecution of drug quality violations is unsustainable when testing delays invalidate the accused's rights to challenge the results, highlighting the need for timely compliance under the Drugs a....
The main legal point established in the judgment is that the rights of the accused under sections 25(3) and 25(4) of the Drugs and Cosmetics Act, 1940 must be upheld, and any violation of these right....
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