Last Updated:March 23, 2026, 07:28 IST
Cough syrups, diabetes medicines, and vitamin combinations are among unapproved fixed-dose drugs detected in government lab testing.
The drugs were detected during scrutiny of laboratory testing data submitted through SUGAM, CDSCO’s online portal for drug sample testing, for the year 2025. (Image for representation: X)
India’s drug regulator has found 90 combination medicines being sold in the market without mandatory central approval, raising fresh concerns about regulatory compliance in the country’s pharmaceutical supply chain, News18 learnt.
The apex drug regulatory authority, Central Drugs Standard Control Organisation, in a letter accessed by News18, wrote to all state and union territory drug controllers, asking them to investigate manufacturers and marketers of these fixed-dose combinations (FDCs) — drugs that contain two or more active ingredients in a single formulation — and submit action taken reports at the earliest.
The letter, dated 18 March, signed by Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, described the matter as being of “top priority in the interest of public health.” The drugs were detected during scrutiny of laboratory testing data submitted through SUGAM, CDSCO’s online portal for drug sample testing, for the year 2025.
“This is to inform you that upon scrutiny of the SUGAM lab testing data for the year 2025, a large no. of drug samples (FDCs) are detected as unapproved and fall under the category of ‘New Drug’,” said the letter while adding “No new drug shall be manufactured for sale unless it is approved by the licensing authority…”
Under India’s New Drugs and Clinical Trials Rules of 2019, any fixed-dose combination is treated as a new drug and requires central government approval before it can be manufactured or sold. The regulator’s letter said that the presence of unapproved drugs in the supply chain poses risks to public health and amounts to a violation of the Drugs and Cosmetics Act, 1940.
“The presence of unapproved drugs in the supply chain is a matter of serious concern, posing potential risks to public health and safety. It also indicates non- compliance with the provisions of the Drugs and Cosmetics Act, 1940, and Rules made thereunder,” it said.
DCGI has urged states and UTs “to examine the unapproved FDCs in generic name as mentioned in the attached annexure” to check if the approval is granted by their local office. “Accordingly, please initiate appropriate investigation and regulatory action against the concerned manufacturers, marketers, and other stakeholders, as deemed fit. Kindly ensure strict monitoring and enforcement to prevent the manufacture, sale, and distribution of such unapproved drugs.”
Cough Syrups, Vitamins, Antidiabetic Pills Part Of Unapproved List
An analysis of the annexure attached to the letter shows 90 combinations, which points to a pattern: the unapproved drugs are heavily concentrated in a handful of mass-market therapeutic categories that are either over-the-counter staples or among the most commonly prescribed drugs in Indian clinical practice.
Cough and cold preparations form the single largest group. At least 14 to 16 entries are combinations of ingredients found in everyday pharmacy shelves — dextromethorphan, ambroxol, guaiphenesin, chlorpheniramine, phenylephrine, terbutaline, and menthol in various permutations. Several of these are sold as flavoured syrups for children. Even a budesonide-levosalbutamol inhalation suspension, used for asthma and chronic obstructive pulmonary disease, figures in the list.
Vitamins, minerals, and nutritional supplements make up the second-largest cluster, with roughly 18 to 20 entries. These range from standard multivitamin capsules and iron-folic acid syrups to calcium-vitamin D3-K2 combinations and a gabapentin-methylcobalamin preparation — the latter widely prescribed for diabetic neuropathy.
Antifungal and dermatological preparations account for at least ten entries, including several that combine steroids with antifungals in topical creams — combinations that have previously attracted regulatory scrutiny for their potential for misuse and skin damage when sold without prescription. Also, anti diabetic combinations — mainly glimepiride paired with metformin or pioglitazone — account for around six entries, a significant finding given that diabetes management drugs are among the highest-volume prescription medicines in the country.
Spread Across India’s Pharma Belt
The manufacturers whose products appear on the list are based across the country’s main pharmaceutical manufacturing hubs — Baddi and Solan in Himachal Pradesh, Roorkee and Haridwar in Uttarakhand, Vadodara and Ahmedabad in Gujarat, Mumbai and Nagpur in Maharashtra, and Bengaluru in Karnataka, among others. The geographic spread suggests the problem cuts across India’s pharmaceutical industry rather than being confined to any particular region or tier of manufacturer.
First Published:
March 23, 2026, 07:28 IST
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