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2025 Supreme(Online)(Del) 6709
IN THE HIGH COURT OF DELHI AT NEW DELHI
Sanjeev Narula, J
M/S LUPIN LIMITED – Appellant
Versus
UNION OF INDIA THROUGH DRUGS INSPECTOR CENTRAL DRUGS STANDARD CONTROL ORGANISATION (CDSCO) NORTH ZONE – Respondent
CRL.M.C. 6010/2025
For the Appellants/Petitioners: Mr. Siddharth Aggarwal, Mr. Madhav Khurana, Mr. Shri Singh, Mr. Atul S. Mathur, Ms. Peshwan Jehangir, Mr. Amey Mirajkar, Mr. Prabal Mehrotra, Ms. Sarvapriya Makkar, Mr. Umang Katyariya, Mr. Parimal Kaushik, Mr. Karan Dhalla, Ms. Arunima Nair, Ms. Asees Kaur, Mr. Aman Tiwari
For the Respondents: Mr. Nishant Gautam CGSC, Mr. Dinesh Kumar, Mr. Prithiviraj Dey, Mr. Shaurya Mani Pandey
Procedural due process requires accurate classification of drug quality violations under the D&C Act to determine legal consequences; mere classification as 'Not of Standard Quality' does not imply adulteration.
Headnote:(A) Bharatiya Nagarik Suraksha Sanhita, 2023 - Section 528 - Quashing of criminal complaint regarding drug quality - Petition filed against Complaint Case No. 967/2024 alleging violation of D&C Act due to non-compliance of drug quality standards following enforcement actions - Exemption granted and stay on trial court proceedings during pendency of petition. (Paras 4-12)
(B) Proper Identification of Offences - It is crucial to classify the nature of an alleged violation correctly under the D&C Act for due legal consequences, with specific focus on whether the deficiency in quality can attribute to adulteration. (Paras 9-10)
Facts of the case:
The complaint arose against Lupin Ltd. pertaining to Pyrazinamide Tablets I.P. for alleged non-standard quality, leading to a drug recall post-licensing issues; complaints arising from this recall and subsequent regulatory actions.
Findings of Court:
Prima facie case established by Petitioners; proceedings are to be stayed pending further hearings.
Issues: The court examined the nature of allegations against the drug quality in light of the relevant provisions of the D&C Act.
Ratio Decidendi: The term 'Not of Standard Quality' necessitates a clear basis for an infringement under the D&C Act; disintegration tests alone do not suffice to establish adulteration allegations.
Result: Proceedings in CRL Complaint No. 967/2024 shall be stayed.
| Table of Content |
|---|
| 1. stay of proceedings granted pending petition. (Para 4 , 5) |
| 2. context and background regarding drug quality complaint. (Para 6 , 7 , 8) |
| 3. legal arguments regarding the classification of drug quality. (Para 9 , 10) |
| 4. court's accommodation of petitioners' plea based on prima facie case. (Para 11 , 12) |
O R D E R
% 27.08.2025 CRL.M.A. 25562/2025, CRL.M.A. 25563/2025 & CRL.M.A. 25564/2025 (Exemption)
CRL.M.C. 6010/2025 Page 1 of 5
1. Exemption is granted, subject to all just exceptions.
2. The Applicants shall file legible and clearer copies of exempted documents, compliant with practice rules, before the next date of hearing.
3. Accordingly, the applications stand disposed of.
CRL.M.A. 25561/2025(FOR STAY) in CRL.M.C. 6010/2025.
4. The above-captioned petition under Section 528 of the Bharatiya Nagarik Suraksha Sanhita , 2023, [“ BNSS ”] (formerly Section 482 of the Code of Criminal Procedure, 1973, [“Cr.P.C.”]) seeks quashing of Complaint Case No. 967/2024 (Earlier No. 12705/2021) filed before the Judicial Magistrate First Class, West District, Tis Hazari Court, Delhi along with the District, Tis Hazari Court, Delhi along with summoning order dated 04th July, 2022 passed therein and order issuing bailable warrants dated 2nd June, 2025 and all proceedings emanating therefrom.
5. The present application seeks grant of stay of the Trial Court proceedings during the pendency of the above-captioned petition.
6. The Petitioner No. 1 (Lupin Ltd.) is a company in the business of manufacturing, selling, distributing, exporting and dealing of medicines, drugs and pharmaceutical products in India. Petitioner No. 2, Manju Gupta (arrayed as Accused No. 3 in the impugned complaint) was the Executive Director of Petitioner No. 1 at the relevant time. In 2007, Petitioner No. 1, obtained a license from the Controller, Drugs and Food Control Organization,, [“DFCO:] for the manufacture and sale of Pyrazinamide Tablets I.P., [“Pyzina 1000”] an antibiotic that belongs to a class of medicines known as anti-tuberculosis CRL.M.C. 6010/2025 Page 2 of 5 drugs.
7. On, 30th January, 2017, Petitioner No. 1 received a Show Cause Notice from the Office of the Controller, DFCO, Jammu in respect a sample of Pyzina 1000, manufactured in June 2016, which was found to be “Not of Standard Quality”, for failing to meet the specifications of the Indian Pharmacopoeia 2014. This finding was premised on a report dated 6th December, 2016 issued by the Government Analyst, Tiswadi, Goa, in relation to a disintegration test conducted on the sample. This also led to the suspension of their license vide letter dated 14th February, 2017. Consequently, Petitioner No. 1 implemented Corrective Action and Preventive Action, [“CAPA”] measures, recalled the drug in question, following which their license was restored.
8. Petitioners are now aggrieved by the institution of criminal complaint dated 30th November, 2021 filed by the Drug Inspector, C.D.S.C.O (North Zone), Ghaziabad. This complaint alleges that a sample of Pyzina 1000 (Batch No. J602589, manufactured in August 2016 with expiration in July 2020) was found “Not of Standard Quality” as per the report dated 22nd February, 2018. Significantly, this sample formed part of the batches which were recalled pursuant to the suspension of license dated 14th February
2017.
9. Mr. Siddharth Aggarwal, Senior Counsel for the Petitioners, submits that the Petitioners had carried out the complete withdrawal of the concerned batch of drugs, and were unaware of its continued availability in the market. He argues that, nonetheless, the impugned complaint is not maintainable for CRL.M.C. 6010/2025 Page 3 of 5 alleged violation of Section 17A (f) of the Drugs and Cosmetics Act , 1940,6 which is applicable only if some substance is mixed with the drug so as to reduce its quality or strength. The report relied upon, which found the drug “Not of Standard Quality,” was based solely on the disintegration test. This test, he submits, merely det
