Maxford Healthcare & Ors. vs Union Of India & Anr.
- Court
- Delhi High Court
$~61 to 65
* IN THE HIGH COURT OF DELHI AT NEW DELHI
Date of decision: 21.04.2026.
+ W.P.(C) 6845/2025 and CM APPL. 31030/2025
MAXFORD HEALTHCARE & ORS. .....Petitioners
Through: Mr. Aman Saroha, Ms. Kushi
Sharma, Mr. Gourav Garg and
Mr.Sachin, Advocates.
versus
UNION OF INDIA & ANR. .....Respondents
Through: Mr. Nishant Gautam CGSC
Ms.Kavya Shukla, Mr. Vineet Negi,
Mr. Vibhav V. Nath and Ms. Theresa
Advocates.
62
+ W.P.(C) 6846/2025 and CM APPL. 31032/2025
AJANTA PHARMA LTD. & ORS. .....Petitioners
Through: Mr. Aman Saroha, Ms. Kushi
Sharma, Mr. Gourav Garg and
Mr.Sachin, Advocates.
versus
UNION OF INDIA & ANR. .....Respondents
Through: Mr. Nishant Gautam CGSC
Ms.Kavya Shukla, Mr. Vineet Negi,
Mr. Vibhav V. Nath and Ms. Theresa
Advocates.
63
+ W.P.(C) 7495/2025 and CM APPL. 33532/2025
Signature Not Verified
Signature Not Verified
Signed
By:PURUSHAINDRA
KUMAR KAURAV
Signed By:NEHA CHOPRA
Signing Date:30.04.2026
15:22:51
RICA ENTERPRISES & ORS. .....Petitioners
Through: Mr. Aman Saroha, Ms. Kushi
Sharma, Mr. Gourav Garg and
Mr.Sachin, Advocates.
versus
UNION OF INDIA & ANR. .....Respondents
Through: Mr. Nishant Gautam CGSC
Ms.Kavya Shukla, Mr. Vineet Negi,
Mr. Vibhav V. Nath and Ms. Theresa
Advocates.
64
+ W.P.(C) 7509/2025 and CM APPL. 33563/2025
DOLPHIN LIFE SCIENCES & ORS. .....Petitioners
Through: Mr. Aman Saroha, Ms. Kushi
Sharma, Mr. Gourav Garg and
Mr.Sachin, Advocates.
versus
UNION OF INDIA & ANR. .....Respondents
Through: Mr. Nishant Gautam CGSC
Ms.Kavya Shukla, Mr. Vineet Negi,
Mr. Vibhav V. Nath and Ms. Theresa
Advocates.
65
+ W.P.(C) 7581/2025 and CM APPL. 33807/2025
CAFOLI LIFECARE PVT. LTD. & ORS. .....Petitioners
Through: Mr. Aman Saroha, Ms. Kushi
Sharma, Mr. Gourav Garg and
Mr.Sachin, Advocates.
versus
UNION OF INDIA & ANR. .....Respondents
Signature Not Verified
Signature Not Verified
Signed
By:PURUSHAINDRA
KUMAR KAURAV
Signed By:NEHA CHOPRA
Signing Date:30.04.2026
15:22:51
Through: Mr. Nishant Gautam CGSC
Ms.Kavya Shukla, Mr. Vineet Negi,
Mr. Vibhav V. Nath and Ms. Theresa
Advocates.
CORAM:
HON'BLE MR. JUSTICE PURUSHAINDRA KUMAR KAURAV
J U D G E M E N T
PURUSHAINDRA KUMAR KAURAV, J. (ORAL)
1. The petitioners are private limited companies and firms engaged in
the business of research and development, manufacture and marketing of
drugs, cosmetics and other pharmaceutical products. The present petition
assails the order dated 11.04.2025 bearing File No.4-01/2023-DC(Misc. 3)
passed by the Directorate General of Health Services, Central Drugs
Standard Control Organisation (FDC division) [hereinafter referred to as
‘FDC division’] .
2. By way of the impugned communication, the FDC division has
requested the respective State and Union Territory Drug Controller(s) to
review the approval process for Fixed Dose Combination drugs (FDCs)
falling within the category of a “New Drug”. The record indicates that the
said communication was issued in the interest of patient safety and public
welfare; concerns were raised regarding premature approvals of new drugs
without evaluating the safety and efficacy of the same.
3. The regulatory framework governing such approvals is contained in
the New Drugs and Clinical Trials Rules, 2019 (hereinafter referred to as
Signature Not Verified
Signature Not Verified
Signed
By:PURUSHAINDRA
KUMAR KAURAV
Signed By:NEHA CHOPRA
Signing Date:30.04.2026
15:22:51
‘the NDCT Rules’), framed under Sections 12(1) and 33 of the Drugs and
Cosmetics Act, 1940 . The said framework applies to all new drugs for
human use, clinical trials, etc., and governs the approvals for the same. Rule
2(1)(w)(iii) of the NDCT Rules expressly states that a fixed dose
combination of two or more drugs which were approved separately, when
proposed to be combined for the first time, would fall within the definition
of a “new drug”.
4. A perusal of the said Rules indicates that the scheme includes a
centralised regulatory scrutiny before initiating clinical testing or market
authorisation. Rule 3 designates the respondent, Drug Controller General of
India (hereinafter referred to as the ‘ drug controller’), as the licensing
authority. No clinical trial is to be conducted without permission of the
1
respondent , along with the approval of the ethics committee. This
framework is also supplemented by additional statutes like the Good
Clinical Practise Guidelines that ensure assessment safety, scientific
validity (through pre-clinical supporting data), ethical considerations, and
the periodic reporting of adverse drug reactions.
5. The respondent submits that a practice has been developed, whereby,
licenses have been granted by State Licensing Authorities for the
manufacture and sale of FDCs without adhering to the aforementioned
statutory requirements. It is contended that such approvals granted without
evaluation of safety and efficacy in terms of the NDCT Rules have resulted
in the availability of unapproved FDCs in the market, posing a risk to patient
safety and public health at large.
Signature Not Verified
Signature Not Verified
Signed
By:PURUSHAINDRA
KUMAR KAURAV
Signed By:NEHA CHOPRA
Signing Date:30.04.2026
15:22:51
6. In view of the aforementioned reasons, the impugned order dated
11.04.2025 does not warrant any interference. The impugned
communication merely requires the concerned State and Union Territory
Drug Controllers to undertake a review of the approval process followed in
respect of FDCs falling within the category of a “new drug”. It further calls
upon the authorities to examine the licences granted for the manufacture,
sale and distribution of such FDCs, as identified in their annexure.
Concerned authorities were instructed to take appropriate action, including
revocation of licenses (to manufacture, sell, and distribute) where warranted,
in accordance with the provisions of the NDCT Rules, 2019, and to submit a
report thereon.
7. Some of the licenses were voluntarily surrendered by respective
manufacturers following the show-cause notice. The unapproved FDCs
compromise patient safety and may lead to adverse drug reactions and cause
other health hazards due to the absence of scientific validation.
8. The respondent-authority, therefore, has rightly sensitised all concern
by way of the impugned advisory.
9. The petitioners are unable to satisfy the Court as to on what ground
the impugned advisory deserves to be set aside. There does not seem to be
any valid permission being granted by the respondent authorizing the
petitioners to sell in the market the drugs in question.
10. Therefore, finding no justification to interfere into the impugned
1
Rule 19 of the New Drugs And clinical Trials Rules, 2019
Signature Not Verified
Signature Not Verified
Signed
By:PURUSHAINDRA
KUMAR KAURAV
Signed By:NEHA CHOPRA
Signing Date:30.04.2026
15:22:51
order, the instant petitions stand dismissed. Pending applications also stand
disposed of.
(PURUSHAINDRA KUMAR KAURAV)
JUDGE
APRIL 21, 2026
Nc
Signature Not Verified
Signature Not Verified
Signed
By:PURUSHAINDRA
KUMAR KAURAV
Signed By:NEHA CHOPRA
Signing Date:30.04.2026
15:22:51