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N. S. SANJAY GOWDA
Zim Laboratories Ltd. – Appellant
Versus
Union Of India, Ministry Of Health And Family – Respondent
ORDER :
N S Sanjay Gowda, J.
1. This criminal petition is filed opposing the criminal proceedings initiated against the petitioners — for the offence punishable under Section 27D of the Drugs and Cosmetics Act, 1940 (“the Act”) — in Criminal Case No.273 of 2016, relatable to the subject samples of a drug called “Regunac Na+ SR 100 (Slow Diclofenac Tablets B.P. 100 mg)” [referred to as “Regunac” or “the drug sample” or “the subject drug”] which was termed as being – “Not of Standard Quality (NSQ)”.
2. For ease of reference, this order has been indexed as follows:
| Sl. No. | Particulars | Page Nos. |
| I. | Brief facts | 05 |
|
| A. Re: 1st sample [Batch No.F957 G220] | 05 |
|
| B. Re: 2nd sample [Batch No.F957 C404] | 11 |
| II. | Counsels’ submissions | 19 |
| III. | Overview of the Act and the Rules | 22 |
| IV. | Application of the law to the facts of this case | 43 |
| V. | Conclusion | 68 |
| VI. | Directions | 69 |
I. BRIEF FACTS:
3. The facts leading to the filing of this petition, in respect of the two samples in question, are as under:
(a) On 28.02.2013, the Drugs Inspector (India), Central Drugs Standard Control Organization (CDSCO), S
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....
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....
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....
The main legal point established in the judgment is the conclusive nature of the State Analyst Report and the requirement to exercise the statutory right to request re-analysis by the Central Drugs L....
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....
Quash of Criminal proceedings - once it is shown that the right of accused to adduce evidence in controversion of the Government Analyst’s report is defeated due to acts and omission of the Drugs Ins....
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....
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....
The expiry of a drug sample before testing negates the prosecution's case, impacting the accused's right to challenge the evidence.
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