Authority: High Court of Jammu & Kashmir and Ladakh at Jammu
Order Date: 11.08.2026
Case Overview
- Petitioners: Simran Pharmaceuticals Pvt. Ltd. (Janipur, Jammu), Affine Formulations Pvt. Ltd. (Nalagarh, Himachal Pradesh), Luv Kush Drug House (Karnal, Haryana) represented by advocates Mr. Sachin Gupta and Mr. Varut Kumar Gupta. Additional petitioners include M/s Simran Pharmaceuticals, M/s Sunil Medicates, and M/s Luv Kush Drug House as dealers.
- Respondents: State of Jammu and Kashmir represented by the Drugs Inspector, Doda and the Government Analyst, Doda, with counsel Mr. Raman Sharma, AAG and Ms. Saliqa Sheikh.
- Nature of Proceeding: Criminal proceedings under Sections 18(a)(i) read with 27(d) of the Drugs and Cosmetics Act, 1940 for alleged manufacture, distribution and sale of "Macnim Plus Tablets" (Batch No. 13329, manufactured May 2013, expiry April 2015) that failed the disintegration test.
- Key Dates & Facts:
- 04.01.2014 – Drug Inspector sampled the tablets from M/s Lucky Medical Hall, Doda (retailer) and divided the sample into four sealed portions.
- 29.01.2014 – Government Analyst reported the sample as "Not of Standard Quality" due to failure of the disintegration test (IP 2010).
- 28.02.2014 – Third portion of the sample handed to M/s Simran Pharmaceuticals (petitioner in CRMC No. 364/2016).
- 28.04.2014 – Manufacturer Affine Formulations acknowledged receipt of the analyst’s report but made no request for retesting within 28 days; instead it explained possible tablet swelling and instructed its distributor to recall the product.
- Subsequent communications traced the distribution chain: retailer → Simran Pharmaceuticals → Sunil Medicates (wholesaler) → Luv Kush Drug House (dealer) → Sian Biotech (authorized distributor) → Affine Formulations (manufacturer).
- Petitioners’ Allegations:
- The Drug Inspector and Public Analyst were not empowered to draw and analyse the sample.
- No portion of the sample was supplied to the manufacturer, depriving it of the statutory right under Section 25(3) to seek re‑analysis.
- The prosecution therefore violated procedural safeguards and should be quashed.
- Respondents’ Contentions:
- Sample division complied with Section 18‑A; a portion was given to the retailer, another to the Public Analyst, a third to Simran Pharmaceuticals, and the fourth was to be produced before the Court.
- Petitioners never exercised the statutory remedy of notifying intention to contest the analyst’s report within the prescribed 28‑day period.
- The report of the Public Analyst becomes conclusive absent such notice, per Sections 25(3) and 25(4).
- SRO 137 (dated 28.03.2013) authorises the Drug Inspector’s sampling power.
- Judicial Reasoning & Precedents Cited:
- The court examined prior judgments: August Remedies v. State of J&K (CRMC 402/2013), State of Haryana v. Brij Lal Mittal (1998), Medicamen Biotech Ltd. v. Rubina Bose (2008), GlaxoSmithKline Pharmaceutical Ltd. v. State of Madhya Pradesh (2011), among others.
- Those precedents establish that failure to invoke Section 25(3) within 28 days bars the accused from later claiming deprivation of the right to retest, even if the sample’s shelf‑life expires later.
- The present case differs because the manufacturer received the analyst’s report on 28.04.2014 and did not request retesting; it merely explained the test result and recalled stock.
- The court held that the statutory requirement of supplying a sample portion to the manufacturer applies only when the sample is drawn from the manufacturer’s premises; here it was drawn from a retailer, and the third portion was correctly supplied to the distributor per Section 18‑A.
- No evidence was presented that any petitioner stored the drug improperly.
Final Outcome
- The petitions (CRMC 364/2016, CRMC 15/2017, CRM(M) 223/2022) are dismissed.
- Any interim direction, if granted, is vacated.
- The criminal proceedings against the petitioners under the Drugs and Cosmetics Act continue.
Topics: Drug Regulation, Pharmaceutical Litigation