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Affine Formulations Loses Plea as J&K High Court Holds Retest Right Expires in 28 Days
In a significant ruling under the , the has dismissed a batch of petitions filed by drug manufacturers, stockists, and distributors, holding that the failure to exercise the statutory right to seek retesting of a drug sample within 28 days renders the 's report conclusive and unassailable.
Justice Sanjay Parihar, presiding over the case, rejected arguments that the manufacturer — — had been denied its . The Court clarified that the right to challenge the analyst's report is strictly time-bound and that mere cannot substitute for a timely expression of intent to controvert the findings.
A Critical
The dispute originated from a routine inspection on , when a lifted samples of "Macnim Plus Tablets" (Batch No. 13329) from , a retailer in Doda. The samples were divided into four portions: one given to the retailer, one sent to the , one handed to the distributor , and the last reserved for the court. The 's report, received on , declared the drug "" for failing the disintegration test.
The manufacturer was eventually informed and responded on , but did not request retesting. Instead, it sought to explain away the test result, suggesting the tablet might have behaved differently over time. Importantly, the manufacturer did not communicate any intention to adduce contrary evidence within the 28-day period prescribed under Section 25(3) of the Act.
Legal Framework and Precedents Examined
The Court delved into the statutory scheme, emphasizing that Section 25(3) provides a clear mechanism: the 's report becomes conclusive unless the person concerned notifies the authority within 28 days of receipt of the report of their intention to dispute it. The accused may then apply to the court under Section 25(4) for the sample to be sent to the for reanalysis.
Justice Parihar cited the 's ruling in State of Haryana v. Brij Lal Mittal (1998), where the Apex Court held that failure to communicate such intent within the prescribed period renders the report conclusive. The Court also drew support from GlaxoSmithKline Pharmaceutical Ltd. v. State of Madhya Pradesh (2011), which clarified that raising about testing methodology does not satisfy the .
The petitioners had argued that the manufacturer was never supplied with a portion of the sample, thus depriving it of its right to retest. However, the Court noted that the sample was lifted from the retailer, and Section 18-A required the to hand a portion to the person whose particulars were disclosed — in this case, , the stockist. Merely because the manufacturer was not directly given a sample did not render the procedure illegal.
Manufacturer's Response Falls Short
A critical piece of evidence was the manufacturer's own letter of . The Court observed that the letter contained "not even a whisper" of an intention to seek retesting. Instead, the manufacturer requested that the disintegration test be treated as complied with and suggested that the drug might have been mishandled by others in the supply chain. It also directed its distributor to recall the remaining stock — conduct that, in the Court's view, indicated awareness of the adverse report.
"Failure to notify the intention to controvert the report of the
, coupled with merely raising
regarding the methodology adopted for testing, does not fulfil the mandatory
of expressing an intention to
in contravention of the report,"
the Court observed.
A Timely Warning for the Pharmaceutical Industry
The judgment underscores that the is not an automatic entitlement but must be actively invoked within the statutory timeline. Manufacturers and distributors cannot wait until prosecution is launched to complain about being denied a sample; they must act promptly upon receiving the analyst's report.
The Court also rejected arguments that the lacked competence to draw the sample or that the was not empowered to test the drug, holding that such factual disputes could only be resolved during trial, not in .
Verdict and Implications
All three petitions — CRMC No. 364/2016, CRMC No. 15/2017, and CRM(M) No. 223/2022 — were dismissed, and any interim directions were vacated. The ruling sends a clear message to the pharmaceutical industry: the under Section 25(3) is sacrosanct, and failure to act within it will result in the 's report becoming final and binding.
The decision aligns with the legislative intent to prevent and ensure that drug quality issues are addressed promptly, without being derailed by technical delays.
Key Observations from the Judgment:
-
"Section 25(3) provides that the report of the shall be of the facts stated therein unless the person concerned, within the prescribed period of 28 days, notifies the concerned authority of his intention to in contravention of the report."
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"Failure to notify the intention to controvert the report of the , coupled with merely raising regarding the methodology adopted for testing, does not fulfil the mandatory of expressing an intention to in contravention of the report."
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"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 illegal or contrary to the statutory scheme."
