The Centre told the Delhi HC that approval for all new drugs for human use is centralised, and governed by clinical trials. (File photo)The Delhi High Court has paved the way for the revocation of licences to manufacture, sell, market and distribute fixed-dose combination (FDC) drugs that have not been approved based on safety and efficacy studies.The court upheld an order passed by India’s central drug regulator in 2025 prohibiting the sale of unapproved FDC drugs.Such “unapproved FDCs compromise patient safety and may lead to adverse drug reactions and cause other health hazards due to the absence of scientific validation”, the court said in its order passed on April 21.An FDC drug is a medicine that contains two or more active pharmaceutical ingredients — chemical compounds in medicines that have an effect on the body — in a single pill, capsule, or shot.FDCs can reduce the number of pills a patient needs to take each day. At the same time, an FDC could mean that a patient ends up taking a drug they may not need.The government has been putting combination drugs under scrutiny from time to time. In August 2024, a batch of 156 FDCs were banned for being “irrational”, bringing no therapeutic benefit.In earlier challenges by pharma companies to the Drug Controller General of India’s (DCGI) action against the sale of unapproved FDC drugs, the court had, as an interim measure, directed that no coercive steps be taken against the companies pending final disposal of the cases.Story continues below this adThe dismissal of the petitions by the court on April 21 without granting such interim relief marks a departure from this trend.Several generic pharma companies including Maxford Healthcare, Ajanta Pharma, Rica Enterprises, and Dolphin Life Sciences had moved the HC in 2025 asking that the DCGI’s communication on the licensing of unapproved FDC drugs by state authorities be set aside.On April 11, 2025, DGCI had asked drug regulatory bodies in states and Union Territories to ensure that unapproved FDCs are not allowed to be sold, marketed and distributed.The central regulator also asked drug controllers in the states to conduct an investigation and take necessary action under the New Drugs and Clinical Trials (NDCT) Rules, 2019, and the Drugs and Cosmetics Act, 1940.Story continues below this adIn his order on April 21, Justice Purushaindra Kaurav of the Delhi HC said, “There does not seem to be any valid permission being granted by the respondent (DCGI) authorizing the petitioners (pharma companies) to sell in the market the drugs in question.”The DCGI communication had listed 35 unapproved FDC drugs, including several used for treating diabetes, such as combinations of metformin hydrochloride IP and voglibose IP, glimepiride IP and metformin HCL IP, as well as FDCs for infection control including antibiotics and antifungals, for treating female infertility, high blood pressure, multivitamins, and antacids.The Centre told the HC that approval for all new drugs for human use is centralised, and governed by clinical trials. Under NDCT Rules, a fixed-dose combination of two or more drugs that may have been approved separately earlier would, when proposed to be combined for the first time, fall within the definition of a “new drug”.‘New drugs’ are subjected to centralised regulatory scrutiny before clinical testing or market authorisation. NDCT Rules designate the DCGI as the licensing authority, without whose permission, and the approval of the ethics committee, no clinical trial may be conducted. A license for the manufacture, sale, and distribution of a drug is issued only after it has been assessed for safety and efficacy.Story continues below this adHowever, the DCGI said, “a practice has been developed” where licences are granted by state licensing authorities for the manufacture and sale of FDCs without adhering to statutory requirements.DCGI has cautioned 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.Sohini Ghosh is a Senior Correspondent at The Indian Express. Previously based in Ahmedabad covering Gujarat, she recently moved to the New Delhi bureau, where she primarily covers legal developments at the Delhi High Court Professional Profile Background: An alumna of the Asian College of Journalism (ACJ), she previously worked with ET NOW before joining The Indian Express. Core Beats: Her reporting is currently centered on the Delhi High Court, with a focus on high-profile constitutional disputes, disputes over intellectual property, criminal and civil cases, issues of human rights and regulatory law (especially in the areas of technology and healthcare). Earlier Specialty: In Gujarat, she was known for her rigorous coverage in the beats of crime, law and policy, and social justice issues, including the 2002 riot cases, 2008 serial bomb blast case, 2016 flogging of Dalits in Una, among others. She has extensively covered health in the state, including being part of the team that revealed the segregation of wards at the state’s largest government hospital on lines of faith in April 2020. With Ahmedabad being a UNESCO heritage city, she has widely covered urban development and heritage issues, including the redevelopment of the Sabarmati Ashram Recent Notable Articles (Late 2025) Her recent reporting from the Delhi High Court covers major political, constitutional, corporate, and public-interest legal battles: High-Profile Case Coverage She has extensively covered the various legal battles - including for compensation under the aegis of North East Delhi Riots Claims Commission - pertaining to the 2020 northeast Delhi riots, as well as 1984 anti-Sikh riots. She has also led coverage at the intersection of technology and governance, and its impact on the citizenry, from, and beyond courtrooms — such as the government’s stakeholder consultations for framing AI-Deepfake policy. Signature Style Sohini is recognized for her sustained reporting from courtrooms and beyond. She specialises in breaking down dense legal arguments to make legalese accessible for readers. Her transition from Gujarat to Delhi has seen her expand her coverage on regulatory, corporate and intellectual property law, while maintaining a strong commitment to human rights and lacuna in the criminal justice system. X (Twitter): @thanda_ghosh ... Read More © The Indian Express Pvt LtdTags:delhi high courtdrugs