The High Court of Jammu & Kashmir and Ladakh has dismissed petitions seeking quashing of criminal proceedings under the Drugs and Cosmetics Act, 1940, holding that the manufacturer and other petitioners failed to exercise their statutory right under Section 25(3) of the Act within the prescribed period of 28 days.
The Court observed that once the accused fails to express an intention to controvert the Government Analyst’s report within the statutory period, the report attains finality and becomes conclusive evidence.
The Court was hearing three petitions filed by manufacturers, stockists, distributors and wholesalers of the drug “Macnim Plus Tablets”, which was declared “Not of Standard Quality” for having failed the disintegration test. The petitioners sought quashing of proceedings under Section 18(a)(i) read with Section 27(d) of the Drugs and Cosmetics Act, 1940, on the grounds that they were deprived of the statutory right to have the sample retested.
A Bench of Justice Sanjay Parihar, while dismissing the petitions, observed,
“Section 25(3) provides that the report of the Government Analyst shall be conclusive evidence of the facts stated therein unless the person concerned, within the prescribed period of 28 days, notifies the concerned authority of his intention to adduce evidence in controversion of the report. Thus, where no such intention is expressed within the statutory period by the manufacturer, distributor or any other person concerned, the report acquires the character of conclusive evidence.”
The Court further observed,
“Failure to notify the intention to controvert the report of the Government Analyst, coupled with merely raising technical objections regarding the methodology adopted for testing, does not fulfil the mandatory statutory requirement of expressing an intention to adduce evidence in controversion of the report.”
It was in 2014, the complainant-Drug Inspector lifted samples of various drugs from the premises of M/s Lucky Medical Hall, Doda (retailer), including “Macnim Plus Tablets”, Batch No. 13329, manufactured in 05/2013 with expiry date of 04/2015. The sample was subsequently reported to be not of standard quality on the ground that it had failed the disintegration test.
Four portions of the sample were prepared. One portion was handed over to the retailer, another forwarded to the Government Analyst, and the third was personally handed over to M/s Simran Pharmaceuticals (stockist/distributor). The fourth portion was to be produced before the Court. The Government Analyst’s report declared the drug “Not of Standard Quality.”
Upon receipt of the report, the complainant conveyed the result to the retailer and called for particulars of the dealer/manufacturer. The manufacturer responded contending that the disintegration test may not be applicable and requested that the test be treated as complied with.
None of the accused approached the Drug Inspector for reanalysis or retesting within the prescribed period. The complaint was thereafter instituted, leading to the present petitions.
Court’s Observation
The Court examined the statutory scheme under Sections 18-A, 23, and 25 of the Drugs and Cosmetics Act, 1940, and the legal precedents on the right to reanalysis.
The Court noted that the sample was lifted from the retailer, and the statutory requirement under Section 18-A was complied with when the third portion of the sample was delivered to M/s Simran Pharmaceuticals (accused No. 2). The Court observed,
“Merely because the manufacturer was not directly supplied with a portion of the sample would not, in the facts of the present case, render the procedure adopted by the Drug Inspector illegal or contrary to the statutory scheme.”
The Court examined the manufacturer’s response and found that it did not express any intention to have the sample retested. The Court observed,
“There is not even a whisper in the said communication that the manufacturer intended to have the sample retested or proposed to exercise its statutory right under Section 25(3) of the Act. Rather, the manufacturer sought to contend that the disintegration test may not be applicable to it, suggesting that there could have been some lapse on the part of the retailer or any other licensee in whose possession the drug had remained.”
The Court relied upon State of Haryana v. Brij Lal Mittal (1998) 5 SCC 343, where the Supreme Court held that the report of the Government Analyst attains the status of conclusive evidence if the accused fails to communicate his intention to controvert within 28 days. The Court observed, “The report of the Government Analyst had attained the status of conclusive evidence in terms of Section 25(3) of the Act.”
The Court also relied upon GlaxoSmithKline Pharmaceutical Ltd. v. State of Madhya Pradesh, Criminal Appeal No. 1489 of 2011, where the Supreme Court held that mere technical objections regarding the methodology adopted for testing do not satisfy the mandatory statutory requirement of expressing an intention to adduce evidence in controversion.
On the competence of the Drug Inspector and Public Analyst, the Court held that these were matters of evidence to be determined during trial. The Court remarked,
“Whether the Public Analyst possessed the requisite authority to conduct such analysis and whether the test was carried out in accordance with the applicable standards are matters which would require factual determination. Such questions can appropriately be examined after the Public Analyst is produced and examined by the complainant during trial.”
On a cumulative consideration of all the aspects of the matter the court dismissed all three petitions.
Case Title: M/S Simran Pharmaceuticals and Others v. State of J&K and Others
Citation: 2026 LiveLaw (JKL) 326
Appearances
Petitioners: Mr. Sachin Gupta, Advocate; Mr. Varut Kumar Gupta, Advocate
Respondents: Mr. Raman Sharma, AAG; Ms. Saliqa Sheikh, Advocate