IN THE HIGH COURT OF RAJASTHAN JODHPUR BENCH
Pratap Krishna Lohra, J.
Lupin Limited - Appellant
Vs.
State of Rajasthan - Respondent
S.B. Criminal Misc. (Pet.) No. 2052/2012
Decided On : 14-12-2016
DRUGS AND COSMETICS ACT - SECTION 25(3) & (4) - QUASHING OF PROCEEDINGS - DENIAL OF RIGHT TO ADDUCE EVIDENCE IN CONTROVERSION OF REPORT - VITIATION OF PROCEEDINGS - ABUSE OF PROCESS OF COURT - FACTUAL BACKGROUND, LEGAL PROVISIONS, INTERPRETATIONS, AND COURT'S DECISION.
Fact of the Case:
A complaint was filed against the petitioner company under Sections 27(b)(i) and 27(d) of the Drugs and Cosmetics Act, 1940, alleging that a sample of Rifampicin capsule manufactured by the company was found to be sub-standard. The company objected to the report within the stipulated period, but the sample was sent for re-analysis after its expiry, and the Central Drugs Laboratory declined to give an opinion on the standard and quality of the sample.
Finding of the Court:
The court held that the denial of the right to the petitioner company to adduce evidence in controversion of the Central Drugs Laboratory report, despite notifying its objection in writing within the stipulated period, vitiated the entire proceedings. The court also held that allowing the proceedings to continue would result in abuse of the process of the Court and may lead to miscarriage of justice.
Issues: Whether the denial of the right to adduce evidence in controversion of the Central Drugs Laboratory report violated the provisions of Section 25(3) & (4) of the Drugs and Cosmetics Act, 1940.
Ratio Decidendi: The court relied on the provisions of Section 25(3) & (4) of the Drugs and Cosmetics Act, 1940, which provide that a manufacturer or seller of a drug can notify the Inspector or the Court in writing within 28 days of receipt of a copy of the report that they intend to adduce evidence in controversion of the report. The court also relied on the judgments of the Supreme Court in State of Haryana v. Brij Lal Mittal & Ors. and M/s. Cadila Health Care Ltd. v. The State of Rajasthan & Ors., which held that the right to controvert the report of the Central Drugs Laboratory is a valuable right that cannot be denied to the manufacturer or seller of the drug.
Final Decision: The court allowed the criminal misc. petition and quashed the entire proceedings in the criminal case against the petitioner company.
Pratap Krishna Lohra, J.
1. Petitioner-company, incorporated under the Indian Companies Act, 1956, has preferred this criminal misc. petition for seeking quashment of the entire proceedings in Criminal Case No. 102/2011, pending before Sessions Judge, Bikaner (for short, 'learned trial Court').
2. The facts, in brief, giving rise to this petition are that a complaint came to be filed against petitioner Company under Sections 27(b)(i) and 27(d) of the Drugs and Cosmetics Act, 1940 (for short, 'Act') before the learned trial Court, inter-alia, alleging therein that on 10th of September 1999 Drug Inspector inspected the premises of M/s. Bikaner Sahakari Upbhokta Wholesale Bhandar Limited at Indira Market and purchased Rifampicin capsule of brand name R-CIN-600 having Batch No. 907 with the date of manufacturing July 1999 and expiry date of June 2001. Said capsule was sampled as per the provisions of the Act and thereafter sent for analysis to the Central Drugs Laboratory, Kolkata. The Central Drugs Laboratory, Kolkata, by its report dated 28th of August 2000, found the sample to be sub-standard not conforming to Indian Pharmacopoeia (I.P.). On receipt of the report, the same was forwarded to the vendor, who is arrayed as accused No. 2 in complaint, and thereafter usual proceedings as per the Act initiated and when it was revealed that manufacturer of the drug in question is petitioner-Company, a copy of the report was endorsed to it on 21st of April 2001. The petitioner-Company, immediately after receiving the report, on 30th April 2001 informed the Drug Inspector that the report is not acceptable to it. The petitioner-Company further clarified to the Drug Inspector that it intends to adduce evidence in controversion of the report. Be that as it may, no endeavour was made by the Drug Inspector to acknowledge the communication sent by petitioner-Company for almost seven months and ultimately on its behalf an application under Section 25(4) of the Act was filed before Chief Judicial Magistrate, Bikaner on 27th of November 2001, which was almost five months after expiry of the sample. Pursuant to the said application, sample was forwarded and on re-analysis the report was received on 24th of April 2002. In the said report, the Analyst desisted from giving any opinion regarding the sample precisely by citing the reason that sample was received after the date of expiry. Therefore, no opinion was expressed by the Analyst in connection with standard and quality of the said sample. Subsequent to the receipt of report dated 24th April 2002, requisite sanction was accorded for filing prosecution against responsible persons of the Company after soliciting their names from Food & Drugs Commissioner, Maharashtra. Finally, the complaint was filed in the Court on 1st of July 2006.
3. Learned counsel for the petitioner, Mr. Vineet Jain, has strenuously urged that in the instant case denial of right to the petitioner-Company to adduce evidence in controversion of the Central Drugs Laboratory report despite notifying its objection in writing within the stipulated period, has vitiated the entire proceedings. Learned counsel, Mr. Jain, would contend that a valuable right of the Company to adduce evidence in controversion of the report envisaged under sub-sec. (3) & (4) of Section 25 of the Act is clearly abrogated inasmuch as when the sample was sent for re-analysis it had already expired. Learned counsel, therefore, submits that in view of denial of legitimate right of defence to the petitioner-Company, allowing proceedings to continue in the matter would be a sheer abuse of the process of the Court. In support of his contentions, learned counsel for the petitioner has placed reliance on following judgments:
(i) State of Haryana v. Brij Lal Mittal & Ors., 998 SCC (Cri.) 1315
(ii) M/s. Cadila Health Care Ltd. v. The State of Rajasthan & Ors., 2007 Cri. L.J. 1899.
4. Per contra, learned Public Prosecutor submits that the first report of Central Drug
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