Delhi High Court - Orders
M/S Lupin Limited Through Its ... vs Union Of India Through Drusgs Inspector ... on 27 August, 2025
Author: Sanjeev Narula
Bench: Sanjeev Narula
$~64
* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ CRL.M.C. 6010/2025 & CRL.M.A. 25561-25564/2025
M/S LUPIN LIMITED THROUGH ITS AUTHORIZED
REPRESENTATIVE & ANR ......Petitioners
Through: Mr. Siddharth Aggarwal and Mr.
Madhav Khurana, Senior Advocates
along with 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 and
Mr. Aman Tiwari, Advocates.
versus
UNION OF INDIA THROUGH DRUSGS INSPECTOR CENTRAL
DRUGS STANDARD CONTROL ORGANISATION (CDSCO)
NORTH ZONE .....Respondent
Through: Mr. Nishant Gautam CGSC along
with Mr. Dinesh Kumar, Mr.
Prithiviraj Dey and Mr. Shaurya Mani
Pandey, Advocates.
CORAM:
HON'BLE MR. JUSTICE SANJEEV NARULA
ORDER
% 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 This is a digitally signed order.
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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, 20231 (formerly Section 482 of the Code of Criminal Procedure, 19732) 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 04 th July, 2022 passed therein and order issuing bailable warrants dated 2 nd 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,3 for the manufacture and sale of Pyrazinamide Tablets I.P.4, an antibiotic that belongs to a class of medicines known as anti-tuberculosis 1 "BNSS"
2"Cr.P.C." 3
"DFCO:4
"Pyzina 1000"CRL.M.C. 6010/2025 Page 2 of 5
This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/08/2025 at 22:28:49 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 Action5 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 5 "CAPA"
CRL.M.C. 6010/2025 Page 3 of 5This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/08/2025 at 22:28:49 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 determines whether a tablet or capsule disintegrates into smaller particles within a prescribed time to allow drug release, and therefore, it cannot establish the presence of any extraneous substance affecting the drug's quality or strength so as to attract Section 17A(f) of the D&C Act.
10. Mr. Aggarwal further contends that "Not of Standard Quality" is a term of art under D&C Act, and cannot by itself form the basis to categorise a drug as "adulterated." He emphasizes that the identification of the correct provision within the statutory framework is of critical importance, as the classification of the offence directly determines the consequences under Section 27 of D&C Act which prescribes the punishments and liabilities depending on the specific nature of non-compliance.
11. It is also urged that the summoning order does not disclose any cogent reasons for taking cognizance, thereby running contrary to the law laid down by the Supreme Court in M/S JM Laboratories and Ors. v. State of Andhra Pradesh and Anr.7
12. Having regard to the above, the Petitioners have made out a prima facie case and accordingly, till the next date of hearing the proceedings in CRL Complaint No. 967/2024 shall be stayed.
13. Issue Notice, Mr. Nishant Gautam, CGSC accepts notice.
6"D&C Act" 7
Judgement arising out of SLP (Crl.) No. 5067 of 2024.
CRL.M.C. 6010/2025 Page 4 of 5This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/08/2025 at 22:28:49
14. Reply/Counter Affidavit be filed within four weeks from today. Rejoinder there to be filed within 4 weeks thereafter.
15. Re-notify on 03rd November, 2025.
SANJEEV NARULA, J AUGUST 27, 2025/MK CRL.M.C. 6010/2025 Page 5 of 5 This is a digitally signed order.
The authenticity of the order can be re-verified from Delhi High Court Order Portal by scanning the QR code shown above. The Order is downloaded from the DHC Server on 28/08/2025 at 22:28:49