Indian Pharmaceutical Alliance vs Central Drugs Standard Control Organisation
- Court
- Delhi High Court
$~117
* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Date of Decision : 21.08.2026
# CNR No. DLHC010392142026
+ W.P.(C) 12189/2026 & CM APPL. 56503/2026
INDIAN PHARMACEUTICAL ALLIANCE .....Petitioner
Through: Mr. Raj Shekhar Rao, Senior
Advocate along with Mr. Shyam
Kumar, Mr. Iqra Khan, Ms. Kumari
Ruchi and Ms. Akanksha Sinha,
Advocates.
Versus
CENTRAL DRUGS STANDARD CONTROL
ORGANISATION .....Respondent
Through:
CORAM:
HON'BLE MR. JUSTICE TEJAS KARIA
TEJAS KARIA, J. ( ORAL )
CM APPL. 56504/2026 ( Exemption )
1. Exemption is allowed, subject to all just exceptions.
2. The Application stands disposed of.
W.P.(C) 12189/2026
3. The present Writ Petition has been preferred by the Petitioner, Indian
Pharmaceutical Alliance (“ IPA ”), under Article 226 of the Constitution of
India, 1950 (“ Constitution ”), seeking to ensure the uniform, effective and
proper enforcement of the provisions pertaining to spurious drugs, as
defined under Section 17B of the Drugs and Cosmetics Act, 1940 (“ Act ”),
inter alia , with the following prayers:
Signature Not Verified
Signed By:NEELAM
SHARMA
Signing Date:31.08.2026
12:37:28
W.P.(C) 12189/2026 Page 1 of 5
“ A. Incorporate and expressly record violations of Section 17B
(Spurious Drugs) of the Drugs and Cosmetics Act, 1940, including
violations under Section 17B(e), in the Government Analyst's report
in Form-13, in addition to chemical or pharmacopeial test results;
B. Mandatorily call for, obtain, and retain authentic reference
samples and comparative verification reports from the original
genuine licensed manufacturer whose product is alleged to have
been counterfeited, for the purpose of determining identity, origin,
and spuriousness of the seized or suspected drug;
C. Mandate comparative examination of the seized or suspected
drug with the genuine product, including comparison of physical
characteristics, packaging, labelling, batch details, trade dress, and
other identifying features, in addition to chemical analysis;
D. Require that the findings of such comparative exanimation and
the verification report of the original manufacturer be incorporated
and reflected in Form-13, so as to conclusively determine whether
the seized drug is "spurious" within the meaning of Section 1 7B of
the Act;
E. Ensure time-bound and fast-track investigation and initiation of
prosecution in complaints involving spurious drugs under Section
17B of the Drugs and Cosmetics Act, 1940, within prescribed
timelines;
F. Direct the Respondent to integrate the reporting of Spurious
Drugs under Section 17B into the SUGAM /National Single Window
System (NSWS) portal to ensure real-time alerts across all State
Drug Control Authorities immediately upon a manufacturer's
verification of a counterfeit batch; ”
4. The principal grievance urged by IPA in the present Petition is that, in
the absence of a uniform and binding Standard Operating Procedure
(“ SOP ”) governing the investigation of offences relating to spurious drugs,
counterfeit drugs bearing the branding and trade dress of genuine
manufacturers are being treated as non-actionable merely on the basis that
the seized samples have passed limited or standard chemical analysis.
Signature Not Verified
Signed By:NEELAM
SHARMA
Signing Date:31.08.2026
12:37:28
W.P.(C) 12189/2026 Page 2 of 5
5. Accordingly, it was submitted by learned Senior Counsel for the IPA
that the Respondent, Central Drugs Standard Control Organisation, be
directed to issue a uniform and binding Circular / SOP requiring all State
Drug Control Authorities to:
i. incorporate violation of Section 17B (Spurious Drugs) of the
Act in Form 13 of the Act;
ii. call for, obtain, and retain authentic reference samples from the
original / genuine / licenced manufacturer whose product is
alleged to have been counterfeited;
iii. conduct a comparative examination of the seized or suspected
drug with the genuine product, including comparison of
physical characteristics, packaging, labelling, batch details, and
trade dress, and to prepare and place on record comparative test
reports in Form 13 based on both physical and chemical
parameters of seized or suspected drugs versus the original
product; and
iv. complete timebound fast track investigation / initiate action m
complaints qua violation of Section 178 of the Act.
6. Learned Senior Counsel for IPA submitted that, under Section 20 of
the Act, Government Analysts, being scientific analysts, are appointed for
the purpose of testing and analysing drugs and cosmetics to ascertain
whether the same conform to the provisions of the Act. It was further
submitted that Section 21 of the Act provides for the appointment of Drug
Inspectors, who are entrusted with the functions of inspection, seizure,
sampling and ensuring compliance with the provisions of the Act by
Signature Not Verified
Signed By:NEELAM
SHARMA
Signing Date:31.08.2026
12:37:28
W.P.(C) 12189/2026 Page 3 of 5
manufacturers, wholesalers, retailers and distributors of drugs and
cosmetics. Section 22 of the Act confers powers upon Drug Inspectors to
inspect premises, take samples and cause such samples to be tested by
Government Analysts.
7. Learned Senior Counsel for IPA further submitted that Section 23 of
the Act regulates the manner in which powers conferred upon Drug
Inspectors are to be exercised and prescribes the mandatory procedure in
that regard. It was also submitted that, in terms of Section 25 of the Act, the
test report in Form 13, as prescribed under Rule 46 of the Drugs and
Cosmetics Rules, 1945 (“ Rules ”), constitutes prima facie evidence for
determining whether enforcement action under the Act is required to be
initiated or curtailed at the threshold.
8. Learned Senior Counsel for IPA submitted that the existing Form 13
is confined solely to recording the results of laboratory analysis and testing,
and does not record, examine or advert to violations relating to spuriousness,
misbranding or allied contraventions prohibited under Section 17B of the
Act.
9. Learned Senior Counsel for IPA further submitted that, in these
circumstances, IPA seeks appropriate directions to remedy the regulatory
lacuna, ensure comprehensive enforcement, and prevent the object and
purpose of the Act from being defeated by an unduly restrictive evidentiary
framework.
10. Having considered the submissions advanced, this Court is of the
considered view that, while exercising jurisdiction under Article 226 of the
Constitution, it would not be appropriate for this Court to issue directions
Signature Not Verified
Signed By:NEELAM
SHARMA
Signing Date:31.08.2026
12:37:28
W.P.(C) 12189/2026 Page 4 of 5
mandating modification of Form 13 so as to include an examination of
spuriousness under Section 17B of the Act, including verification of the true
origin and manufacturer of the drug by the Drug Inspector. Such matters fall
within the legislative or delegated rule-making domain, either by way of
amendment to the Act by the Legislature or amendment to the Rules.
11. In view of the above, learned Senior Counsel for IPA submitted that
IPA may be granted liberty to approach the Respondent and / or any other
competent authority by submitting a detailed representation for redressal of
its grievances and for consideration of the suggestions made in the present
Writ Petition.
12. Accordingly, it is directed that, in the event that IPA submits such a
representation, the same shall be considered by the Respondent or any other
appropriate authority expeditiously, in accordance with law.
13. Accordingly, the present Writ Petition stands disposed of in the
aforesaid terms. The pending Application also stands disposed of.
TEJAS KARIA, J
AUGUST 21, 2026/sms
Signature Not Verified
Signed By:NEELAM
SHARMA
Signing Date:31.08.2026
12:37:28
W.P.(C) 12189/2026 Page 5 of 5