Court affirms manufacturer's right to retesting under Drugs and Cosmetics Act only upon timely expression of intent; failure to do so renders Government Analyst’s report conclusive
In a significant judgment delivered on August 11, 2026, the Jammu & Kashmir and Ladakh High Court dismissed multiple petitions filed by pharmaceutical companies and drug dealers challenging criminal proceedings initiated against them under the Drugs and Cosmetics Act, 1940. The case arose from a complaint involving the seizure of "Macnim Plus Tablets" from a retailer, which were found not to meet the prescribed quality standards due to failure in the disintegration test.
The petitioners—comprising manufacturers, stockists, distributors, and retailers—contended that the Drug Inspector lacked the statutory authority to draw samples in the manner undertaken and that the Public Analyst who tested the drugs was not competent to analyze the drug falling under Schedule C of the Act. Additionally, the petitioners argued they were denied their statutory right to have the drug samples retested or reanalyzed, as no portion of the sample was directly supplied to the manufacturer.
The Court meticulously examined the statutory framework under the Drugs and Cosmetics Act, especially the provisions under Sections 18, 18A, 23(4), 25(3), 25(4), and 27(d). The judgment clarified that when a sample is drawn from a retailer or distributor, the Drug Inspector is legally obliged to supply a portion of the sample to the person whose particulars are disclosed under Section 18A. In this case, the Inspector had handed over one portion to the retailer and another to the distributor, who were part of the distribution chain, thereby fulfilling the statutory requirements.
Critically, the Court emphasized the manufacturer’s statutory right to challenge the Government Analyst’s report under Section 25(3). This right must be exercised by notifying the relevant authorities within 28 days of receipt of the Analyst’s report, expressing the intention to adduce contrary evidence or seek reanalysis. The Court found that the manufacturer had received the report but failed to communicate any such intention within the prescribed period. The manufacturer’s response instead offered explanations for the failed test and initiated a voluntary product recall, but did not invoke the statutory mechanism for retesting. Consequently, the Court held that the Government Analyst’s report had attained conclusive status.
The Court distinguished this case from earlier precedents where manufacturers were deprived of the sample or the report in time, resulting in quashing of prosecution. Here, the petitioners had adequate opportunity to exercise their rights but did not do so, rendering their challenge unsustainable. The Court further held that any disputes regarding the competence of the Public Analyst or the testing methodology could only be resolved through evidence during trial, not at the quashing stage.
Regarding the liability of the retailer, stockist, and distributor, the Court noted there was no evidence that the drug was improperly stored or handled in their possession. Therefore, criminal proceedings against them could not be quashed on the ground of mere failure to meet storage standards without specific proof.
This ruling reaffirms the procedural safeguards built into the Drugs and Cosmetics Act to balance regulatory enforcement with the rights of manufacturers and dealers, underscoring the importance of timely exercise of statutory rights to contest adverse reports.
Bottom Line:
Drugs and Cosmetics Act - Manufacturer's statutory right to retesting under Section 25(3) - Failure to express intent within prescribed time forfeits right to challenge the Government Analyst's report.
Statutory provision(s):
Drugs and Cosmetics Act, 1940 - Sections 18(a)(i), 18A, 23(4), 25(3), 25(4), 27(d)
