Delhi High Court Refuses To Interfere With CDSCO Advisory On Unapproved Fixed Dose Combination Drugs
The Delhi High Court has refused to interfere with an advisory issued by the Central Drugs Standard Control Organisation (CDSCO) directing State and Union Territory Drug Controllers to review approvals granted to certain Fixed Dose Combination (FDC) drugs categorised as “new drugs” under the New Drugs and Clinical Trials Rules, 2019, observing that unapproved FDCs pose serious risks to patient safety and public health.
A Bench of Justice Purushaindra Kumar Kaurav dismissed a batch of petitions filed by pharmaceutical companies challenging the communication dated April 11, 2025 issued by the Directorate General of Health Services through the FDC Division of the CDSCO. The Court held that the impugned communication merely directed authorities to review the approval mechanism adopted for FDCs falling within the definition of a “new drug” and did not warrant judicial interference.
The petitioners, including Maxford Healthcare, Ajanta Pharma Ltd., Rica Enterprises, Dolphin Life Sciences and Cafoli Lifecare Pvt. Ltd., contended that the impugned advisory adversely affected licenses granted for manufacture and sale of various FDC drugs. However, the Court found no infirmity in the advisory and accepted the stand of the Union Government that certain State Licensing Authorities had been granting approvals for manufacture and sale of FDCs without complying with the mandatory statutory framework prescribed under the NDCT Rules, 2019.
The Court noted that Rule 2(1)(w)(iii) of the NDCT Rules specifically classifies a fixed dose combination of two or more separately approved drugs, when proposed to be combined for the first time, as a “new drug”, thereby requiring centralised scrutiny and approval before manufacture, clinical testing or market authorisation.
Justice Kaurav observed that the statutory framework under the NDCT Rules was enacted to ensure patient safety, scientific validation, ethical compliance and assessment of safety and efficacy before drugs are introduced into the market. The Court recorded that the Drug Controller General of India functions as the designated licensing authority under the Rules and that clinical trials cannot be conducted without requisite approvals from the competent authority and ethics committees.
According to the Union Government, approvals granted by State Licensing Authorities without evaluating safety and efficacy had led to the proliferation of unapproved FDCs in the market, thereby posing serious risks to public health. The Court accepted this concern and observed that such drugs could potentially result in adverse drug reactions and other health hazards due to absence of scientific validation.
The Court further noted that the impugned communication merely required State and Union Territory Drug Controllers to review the approval process adopted in respect of FDCs classified as “new drugs”, examine licenses already granted for manufacture and sale, and take appropriate action including revocation of licenses wherever necessary in accordance with the NDCT Rules, 2019.
The judgment also records that certain manufacturers had voluntarily surrendered their licenses after issuance of show-cause notices by authorities. The Court observed that the respondent authorities had acted correctly in issuing the advisory to sensitise concerned authorities regarding compliance with the statutory regime governing approval of new drugs.
Rejecting the challenge mounted by the petitioners, the Court held that they were unable to demonstrate any valid ground for setting aside the advisory and further failed to establish that they possessed valid permissions authorising them to market the drugs in question.
Consequently, the Court dismissed all the petitions and declined to interfere with the advisory issued by CDSCO. Pending applications were also disposed of.
Case Details
Case Title: Maxford Healthcare & Ors. v Union of India & Anr. connected matters
Court: Delhi High Court
Bench: Justice Purushaindra Kumar Kaurav
Date of Judgment: April 21, 2026
Case Numbers: W.P.(C) 6845/2025, W.P.(C) 6846/2025, W.P.(C) 7495/2025, W.P.(C) 7509/2025 and W.P.(C) 7581/2025
Appearances
For Petitioners – Mr. Aman Saroha, Ms. Kushi Sharma, Mr. Gourav Garg and Mr. Sachin, Advocates.
For Respondents – Mr. Nishant Gautam, CGSC, Ms. Kavya Shukla, Mr. Vineet Negi, Mr. Vibhav V. Nath and Ms. Theresa, Advocates.