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Cough syrups, diabetes medications, and vitamin supplements are among the unapproved prescribed dietary supplements detected in government laboratory tests.
The drug was detected during the inspection of laboratory test data submitted through CDSCO’s online portal SUGAM for drug sample testing for the year 2025. (Image for display: X)
India’s drug regulator has found that 90 compounded drugs are being sold in the market without the necessary central approval, raising fresh concerns about regulatory compliance in the country’s drug supply chain, News18 has learnt.
The apex drug regulatory body, the Central Drug Standard Control Authority, in a letter reached by News18, has written to the drug controllers of all states and Union Territories, asking them to investigate the manufacturers and marketers of these fixed dose combinations (FDCs) – drugs that contain two or more active ingredients in one formulation – and submit a report on the actions as soon as possible.
A letter dated March 18 signed by the Drug Controller General of India (DCGI), Dr. Rajeev Singh Ragwanshi, described the issue as a “top priority in the interest of public health”. The drug was discovered during an audit of laboratory test data submitted through CDSCO’s online portal SUGAM for drug sample testing for the year 2025.
“This informs you that in the study of SUGAM laboratory test data for the year 2025, a large number of drug samples (FDCs) are unapproved and fall under the ‘new drug’ category,” the letter said.
Under India’s New Drugs and Clinical Trials Rules, 2019, a prescribed dose combination is treated as a new drug and requires approval from the central government before it is manufactured or sold. The regulator’s letter said the presence of unapproved drugs in the supply chain poses risks to public health and is in 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 Drugs and Cosmetics Act, 1940, and the regulations made thereunder.”
The DCGI has asked the states and UTs to “inspect the unapproved FDCs in the generic name as mentioned in the Annexure” to see if the approval has been given by their local office. “Accordingly, please initiate appropriate investigation and regulatory action against the relevant manufacturers, marketers, and other stakeholders, as deemed appropriate. Please ensure strict monitoring and enforcement to prevent the manufacture, sale, and distribution of such unapproved drugs.”
Cough syrups, vitamins, anti-diabetic pills are part of the unacceptable list
The analysis attached to the letter shows 90 compounds, which reveals a pattern: unapproved drugs are largely concentrated in mass-market therapeutic categories that are either over-the-counter or the most commonly prescribed drugs in Indian clinical practice.
Coughs and colds form the single largest group. At least 14 to 16 entries are combinations of ingredients found on everyday pharmacy shelves—dextromethorphan, ambroxol, guaiphenesin, chlorpheniramine, phenylephrine, terbutaline, and menthol in various orders. Many of these are sold as flavored syrups for children. Even budesonide-levosalbutamol inhalation suspension, used for asthma and chronic obstructive pulmonary disease, is on the list.
Vitamins, minerals, and nutritional supplements make up the second largest cluster, accounting for about 18 to 20 entries. These range from standard multivitamin capsules and iron-folic acid syrups to calcium-vitamin D3-K2 combinations and gabapentin-methylcobalamin preparations—the latter widely prescribed for diabetic neuropathy.
Antifungal and dermatologic preparations account for at least ten entries, including several that combine steroids with antifungals in topical creams — combinations that have previously drawn regulatory scrutiny for their potential for abuse and skin damage when sold over the counter. Also, anti-diabetic combinations—mainly glimepiride combined with metformin or pioglitazone—accounted for about six admissions, a significant finding given that diabetes management drugs are among the highest volume prescription drugs in the country.
Published in India Pharma Belt
The manufacturers whose products appear on the list are based in the main drug manufacturing centers across the country – Badi and Solan in Himachal Pradesh, Roorkee and Haridwar in Uttarakhand, Vadodara and Ahmedabad in Gujarat, Mumbai and Nagpur in Maharashtra, and Bangalore in Karnataka. The geographical spread suggests that the problem is endemic in the Indian pharmaceutical industry and not confined to any particular region or manufacturer level.
March 23, 2026, 07:28 IST
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