New Delhi: 

 Raising a major concern in India’s healthcare sector, as many as 575 drugs ranging from eye drops to paracetamol tablets have been identified as substandard by India’s premier drug regulator, Central Drugs Standard Control Organisation (CDSCO), in the last four months.

The Drugs Controller General of India (DCGI) is constantly monitoring the quality of medicines and taking action against manufacturing companies, which are selling drugs which are of NSQ (Not of Standard Quality). Such a list is released every month," a Health Ministry official said.

Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), and approval of certain licences as the Central Licence Approving Authority is exercised by the CDSCO.

The data was disclosed by the Central Drugs Standard Control Organisation, which monitors the manufacturing and quality of drugs and medical products.

In April, the central drug regulator identified 60 drugs, and the state drug regulator has identified 136 drugs that have been spurious, adulterated, misbranded and not of s

tandard quality (NSQ), the CDSCO data revealed.

The data further said that in March, as many as 131 drugs were identified as substandard, whereas 103 drugs in February and 145 drugs were identified as substandard in January.

The data was disclosed by the Central Drugs Standard Control Organisation, which monitors the manufacturing and quality of drugs and medical products.

In April, the central drug regulator identified 60 drugs, and the state drug regulator has identified 136 drugs that have been spurious, adulterated, misbranded and not of standard quality (NSQ), the CDSCO data revealed.

The data further said that in March, as many as 131 drugs were identified as substandard, whereas 103 drugs in February and 145 drugs were identified as substandard in January.

The drugs that were identified as substandard and spurious from January to April 2025 are from different drug manufacturing companies, having different batch numbers.

“The Drugs Controller General of India (DCGI) is constantly monitoring the quality of medicines and taking action against manufacturing companies, which are selling drugs which are of NSQ (Not of Standard Quality). Such a list is released every month," a Health Ministry official said.

The Drugs Controller General of India is the head of the department of the Central Drugs Standard Control Organisation, responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.

Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), and approval of certain licences as the Central Licence Approving Authority is exercised by the CDSCO.

Popular drugs like Norfloxacin Tablets IP 400 mg (used to treat certain bacterial infections in different parts of the body) and manufactured by Andhra Pradesh based Revat Laboratories Private Limited; paracetamol IP Paediatric syrup 125mg/5ml (a common painkiller used to treat aches and pains) manufactured by Telangana-based Karuppharma Private Limited have also been found as sustandard.

Painkillers and drugs used for bacterial infections are common over-the-counter drugs in India. Hence, this is a serious finding and should be dealt with very strictly,” said Dr Tamorish Kole, immediate past president of the Clinical Practice Committee of the International Federation for Emergency Medicine.

The general public also needs to be cautious and should refrain from the rampant use of these medications. “People should consult a medical practitioner to save themself from any untoward effects of such drugs," suggested Dr Kole.

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