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2023 Supreme(Online)(Bom) 24517
BOMBAY HIGH COURT
S. G. MEHARE, J
Mr. Sandeep V. Bambolkar – Appellant
Versus
The State of Maharashtra – Respondent
CRIMINAL REVISION APPLICATION NO. 292 OF 2019
For the Appellants/Petitioners: Mr. Shailesh S. Chapalgaonkar
For the Respondents: Mr. S. P. Deshmukh, A.P.P.
Statutory rights under the Drugs and Cosmetics Act and adherence to testing timelines are critical to ensure fair prosecution in drug-related offenses.
Headnote:(A) Drugs and Cosmetics Act, 1940 - Sections 25(3) and 25(4) - Drugs and Cosmetics Rules, 1945 - Discharge application - Delay in testing and lodging of complaint result in infringement of statutory rights - Samples were not tested within sixty days as mandated by Rule 45 - Court finds applicants' rights compromised, warranting discharge. (Paras 5, 7, 10, 12)
(B) Legal Rights - Statutory rights of accused to test samples and question Government Analyst's report are critical in drug law compliance. (Paras 6, 10)
Facts of the case:
The applicants are employees of a pharmaceutical company whose drug sample was found 'Not of Standard Quality.' The complaint was filed after the drug's expiry, raising questions of rights under the Drugs and Cosmetics Act due to delays in processing.
Findings of Court:
The applicants were denied due process as their rights under the relevant legal provisions were not respected, necessitating the reversal of the lower court's decision.
Issues: Whether the delay in testing and subsequent complaint impacted the applicants' rights under the law.
Ratio Decidendi: The Court held that compliance with the testing timeline is fundamental for the protections afforded to those in the drug industry, and the failure to do so invalidates the prosecution's claims.
Result: Criminal revision application allowed; applicants discharged.
| Table of Content |
|---|
| 1. context of the tested drug and its quality findings. (Para 3 , 4) |
| 2. arguments regarding procedural rights and failures. (Para 5 , 6) |
| 3. legal obligations on testing timelines and implications. (Para 7 , 9 , 10) |
| 4. reasoning on statutory rights affecting outcomes. (Para 11) |
| 5. conclusion directing discharge of applicants. (Para 12) |
JUDGMENT
1. Rule. Rule made returnable forthwith. By consent of the parties, heard finally.
2. The applicants have impugned the order below Exhibits-27 and 28 declining discharge, in Special (Drug) Case No.2 of 2018, of the learned Additional Sessions Judge-3, Parbhani, dated 29.08.2019.
Facts:
3. Applicant No.7 is a pharmaceutical company that manufactures Viscid Gel (the tested drug). The remaining applicants are and were the employees of applicant No.7. They sell their drugs through their agents and shopkeepers throughout the State. The respondent is the authority controlling and regulating the drugs.
4. On 29.06.2015, the then Drugs Inspector visited M/s. Sunil Enterprises, Dr. Hedgewar Marg, Parbhani, and draw the drug sample in dispute. On 29 June 2015, the Drugs Inspector sent one sealed sample of the drug to the Government Analyst as per the procedure under the Cosmetics and Drugs Act and the Rules. The manufacturing date of the said drug was 10/2014, and its shelf life was to expire on 09/2016. After testing the sample vide its report dated 30 November 2015, the Analyst declared the said drug as "Not of Standard Quality" because "the sample does not comply with USP 37 requirements for Microbial Enumeration Test". On 4 December 2015, the Drugs Inspector received the original copy of the analysis report in form XIII in triplicate from the Analyst. Thereafter, some procedures were done, and vide letter dated 4th December 2015, applicant No.7 was informed that the drug was not of standard quality and asked to comply with the directions in the said letter. However, the said letter does not mention the Drugs Inspector had filed a complaint. On 30 November 2015, the Drugs Inspector filed a complaint in the Court of Chief Judicial Magistrate, Parbhani. He, accordingly, issued a process on 21 September 2016. The applicants appeared in Court and filed their respective discharge applications.
5. The learned counsel for the applicants would argue that Rule 45 of the Drugs and Cosmetic Rules, 1945 has not been strictly complied with, and the delay in testing the sample was not explained. Therefore, the right of the applicants to get the sample tested through the Court had been limpidly denied. Hence, the complaint would not stand. The complaint has been lodged belatedly, knowing well the expiry date of the shelf life of the drug in question. Therefore, the applicants have lost their right under Sections 25 (3) and 25(4) of the Drugs and Cosmetics Act 1940 due to the delay in filing the complaint. On this legal aspect, the applicants are liable to be discharged. However, the learned Additional Sessions Judge, Parbhani, did not consider these legal aspects and erroneously passed the impugned order. It has also been erroneously observed that the supplier of applicant No.7 did not convey to the Drugs Inspector within 28 days of the receipt of the copy of the report that he intends to adduce evidence in contravention of the report. Its supplier did not avail of that opportunity. For non-availing this opportunity, the Government Analyst's report before this Court needs to be treated as conclusive. To bolster his arguments, the learned counsel for the applicants relied on the case of (i) Medicamen Biotech Limited and another Versus Rubina Bose, Drug Inspector , (2008) 7 Supreme Court Cases 196 and (ii) Quixotic Healthcare and Others Versus State of Maharashtra and others , 2020 All M.R. (Cri) 1880.
6. Per contra, the learned A.P.P. for the State argued that there is no question, affecting the rights as per Sections 25 (3) and 25(4) of the Cosmetic and Drugs Act arise as Section 25 (3) has not been com
