Health and Me

Ishita Roy

Indian Drug Regulator Flagged 90 Combination Medicines Sold Without Approval

Indian drug regulator - Central Drugs Standard Control Organisation (CDSCO) found 90 combination medicines that are sold without mandatory central approval. This has raised concerns on regulatory compliance in the country's pharmaceutical supply chain. 

CDSCO is the apex drug regulatory body in the country. The authority wrote a letter to all states and union territory drug controllers and asked them to investigate manufacturers and marketers of these fixed-dose combinations (FDCs). 

What are FDCS? These are drugs that contain two or more active ingredients in a single formulation. The CDSCO asked them to investigate and submit reports on the action taken at the earliest.

<h2>What Made To The Unapproved List Of FDCs?</h2>

The annexure attached to the letter showed 90 combination medicines had made it to the market. These contain cough syrups, vitamins, and anti-diabetic pills. 

Cough and cold combination medicines have formed the single largest group. At least 14 to 16 entries show combination 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. Budesonide-levosalbutamol inhalation suspension that is used for asthma and chronic obstructive pulmonary disease, too features in the list.

The next group is of the vitamins, minerals and other nutritional supplement which has roughly 18 to 20 entries. They include:

<ul><li>Multivitamin capsules</li><li>Iron-folic acid syrups</li><li>Calcium-vitamin D3-K2 combinations</li><li>Abapentin-methylcobalamin preparation</li></ul>

<h3>Antifungal and Dermatological Combinations</h3>

This group has accounted for at least 10 entries, which include antifungal creams that could lead to potential misuse and skin damage when sold without prescriptions.

This has accounted for six entries, and the combination includes:

<ul><li>Glimepiride paired with metformin or pioglitazone </li></ul>

<h2>What Did CDSCO Write To Drug Controllers?</h2>

The letter dated 18 March was signed with Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi. He described the matter as being "top priority in the interest of public health". The unapproved drugs were detected during a scrutiny of laboratory testing data submitted through SUGAM, which is 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. No new drug shall be manufactured for sale unless it is approved by the licensing authority."

Under India's New Drugs and Clinical Trial Rules of 2019, any FDC is treated as a new drug and must have the central government's approval before it could be manufactured and sold. The regulator's letter noted that there were presence of unapproved drugs in the supply chain that could pose risks to public health. This also 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 urged states and UTs "to examine the unapproved FDCs in generic name as mentioned in the attached annexure". This is done to check whether any approval has been granted by the 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," the letter noted.

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Indian drug regulator - Central Drugs Standard Control Organisation (CDSCO) found 90 combination medicines that are sold without mandatory central approval. This has raised concerns on regulatory compliance in the country's pharmaceutical supply chain. CDSCO is the apex drug regulatory body in the country. The authority wrote a letter to all states and union territory drug controllers and asked them to investigate manufacturers and marketers of these fixed-dose combinations (FDCs). What are FDCS? These are drugs that contain two or more active ingredients in a single formulation. The CDSCO asked them to investigate and submit reports on the action taken at the earliest. What Made To The Unapproved List Of FDCs?The annexure attached to the letter showed 90 combination medicines had made it to the market. These contain cough syrups, vitamins, and anti-diabetic pills. Cough And Cold MedicinesCough and cold combination medicines have formed the single largest group. At least 14 to 16 entries show combination 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. Budesonide-levosalbutamol inhalation suspension that is used for asthma and chronic obstructive pulmonary disease, too features in the list.Nutritional SupplementsThe next group is of the vitamins, minerals and other nutritional supplement which has roughly 18 to 20 entries. They include:Multivitamin capsulesIron-folic acid syrupsCalcium-vitamin D3-K2 combinationsAbapentin-methylcobalamin preparationAntifungal and Dermatological CombinationsThis group has accounted for at least 10 entries, which include antifungal creams that could lead to potential misuse and skin damage when sold without prescriptions. Anti-diabetic MedicinesThis has accounted for six entries, and the combination includes:Glimepiride paired with metformin or pioglitazone What Did CDSCO Write To Drug Controllers?The letter dated 18 March was signed with Drugs Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi. He described the matter as being "top priority in the interest of public health". The unapproved drugs were detected during a scrutiny of laboratory testing data submitted through SUGAM, which is 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. No new drug shall be manufactured for sale unless it is approved by the licensing authority."What Is India's Rule For FDCs?Under India's New Drugs and Clinical Trial Rules of 2019, any FDC is treated as a new drug and must have the central government's approval before it could be manufactured and sold. The regulator's letter noted that there were presence of unapproved drugs in the supply chain that could pose risks to public health. This also 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 urged states and UTs "to examine the unapproved FDCs in generic name as mentioned in the attached annexure". This is done to check whether any approval has been granted by the 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," the letter noted.