New Delhi — India’s top drug regulator has issued a nationwide alert over 90 fixed-dose combination (FDC) drugs being manufactured and sold without mandatory central approval, directing all state and Union Territory drug controllers to launch immediate investigations and enforce strict regulatory action.
The Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, wrote to state regulators on March 18 following scrutiny of laboratory testing data submitted through the CDSCO’s online SUGAM portal for the year 2025. The letter describes the presence of these unapproved FDCs in the supply chain as “a matter of serious concern” that poses “potential risks to public health and safety” and signals “non-compliance with the provisions of the Drugs and Cosmetics Act, 1940, and Rules made thereunder.”
Under the New Drugs and Clinical Trials (NDCT) Rules, 2019, any FDC containing two or more active pharmaceutical ingredients is classified as a “New Drug” and requires prior approval from the Central Drugs Standard Control Organisation (CDSCO) before it can be manufactured or sold. The DCGI reminded states that “No new drug shall be manufactured for sale unless it is approved by the licensing authority.”
Detailed Categories and Examples of Flagged FDCs
The 90 FDCs span several widely used therapeutic categories. While the full annexure attached to the letter has not been made public, reports citing the communication list the following:
Cough and cold preparations (14–16 entries): Combinations involving dextromethorphan, ambroxol, guaiphenesin, chlorpheniramine, phenylephrine, terbutaline, and menthol in various permutations. Several are flavoured syrups marketed for children. Also included: budesonide-levosalbutamol inhalation suspension used for asthma and chronic obstructive pulmonary disease.
Vitamins, minerals, and nutritional supplements (18–20 entries): Multivitamin capsules, iron-folic acid syrups, calcium-vitamin D3-K2 combinations, and gabapentin-methylcobalamin preparations (commonly prescribed for diabetic neuropathy).
Antifungal and dermatological preparations (at least 10 entries): Topical creams combining steroids with antifungals, which regulators have flagged for potential misuse leading to skin damage when sold without prescription.
Anti-diabetic combinations (around 6 entries): Mainly glimepiride paired with metformin or pioglitazone — critical because anti-diabetic drugs are among India’s highest-volume prescription medicines.
Other flagged products include additional multi-vitamin/mineral formulations and iron-magnesium tablets.
Actions Directed to States
The DCGI letter instructs state licensing authorities to:
Investigate manufacturers and marketers of the listed FDCs.
Examine whether any of the unapproved FDCs were granted approval by local (state) offices and, if so, submit copies of such permissions.
Initiate “appropriate investigation and regulatory action” against manufacturers, marketers, and other stakeholders.
Ensure strict monitoring to prevent further manufacture, sale, or distribution.
Submit an Action Taken Report (ATR) to the DCGI office “at the earliest.”
The communication emphasises “zero tolerance” and states that the matter should be accorded “top priority in the interest of public health.”
Why This Crackdown Matters
A 2012 parliamentary standing committee report had highlighted that several state licensing authorities had issued manufacturing licences for FDCs without prior clearance from the central drug authority, allowing untested combinations to reach the market. The current exercise, based on actual 2025 lab samples processed through SUGAM, indicates the problem persists despite repeated central warnings.
Manufacturers of the flagged products are spread across major pharmaceutical clusters, including Baddi and Solan (Himachal Pradesh), Roorkee and Haridwar (Uttarakhand), Vadodara and Ahmedabad (Gujarat), Mumbai and Nagpur (Maharashtra), and Bengaluru (Karnataka).
Letter Not Publicly Available on CDSCO Website
As of March 23, 2026, the DCGI letter and its annexure listing the 90 FDCs have not been uploaded on the official CDSCO website. The communication appears to be an internal directive to state regulators, consistent with standard practice for enforcement actions.
Both News18 and The Economic Times have independently reported the development with overlapping details, confirming the authenticity of the directive. No official denial or clarification has been issued by CDSCO or DCGI so far.
Public Health and Industry Implications
Health experts view the move as a significant step toward rationalising India’s drug market, where irrational or unapproved FDCs have long raised concerns over safety, efficacy, and antibiotic resistance. Patients are advised to consult doctors before using combination products and to verify approvals via the CDSCO’s online portals or pharmacist guidance.
The pharmaceutical industry has not yet issued a collective response, but individual manufacturers may face inspections, product recalls, or legal proceedings in the coming weeks depending on state-level enforcement.
States have been given no fixed deadline beyond “earliest” submission of action reports, but the DCGI’s tone signals urgent follow-up.
This nationwide directive underscores the regulator’s renewed focus on ensuring every FDC on the market meets central safety and efficacy standards — a move likely to tighten compliance across India’s multi-billion-dollar pharmaceutical sector.
