DCGI Found 195 Drugs, Medical Devices And Vaccines Substandard In Last Three Months

The Central Drugs Standard Control Organization which comes under the DCGI is responsible for the approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera.

New Delhi:Flagging a major concern, the Drug Controller General of India (DCGI) has revealed that as many as 195 drugs, medical devices, vaccines and cosmetics have been found spurious, adulterated, misbranded and not of standard quality (NSQ) in last three months. The data was disclosed by the Central Drugs Standard Control Organisation (CDSCO), which monitors the manufacturing and quality of drugs and medical products.

The central laboratories found 48 drugs of substandard quality in August including Calcium And Vitamin D3 Tablets IP Shelcal 500 (Shelcal), Vitamin B Complex with Vitamin C Softgels, Paracetamol Tablets IP 500 mg, Nimesulide, Paracetamol and Chlorzoxazone Tablets (NICIP MR) etc.

The CDSCO has asked the drug manufacturing companies to roll back drugs with particular batch numbers from the market. Interestingly, the drugs which were identified as substandard are from different drug manufacturing companies having different batch numbers. For instance, Calcium And Vitamin D3 Tablets IP Shelcal 500 (Shelcal), with batch number GDXD0581 and manufactured on 08/2023 and expiring on 07/2025, are manufactured by Uttarakhand-based M/s Pure & Cure Healthcare Pvt. Ltd. at Ranipur in Haridwar.

The Vitamin B Complex with Vitamin C Softgels tablets with batch number 1423, manufactured on 09/2023 with an expiry date of 08/2025, was made by Gujarat-based M/s Asoj Soft Caps Pvt. Ltd. Similarly, the state laboratories found 11 drugs as NSQ during August. Drugs like Paziva 40, Pantomed 40 and Cefixime Oral Suspension IP (Dry Syrup) among others have been found substandard.

The CDSCO has also found as many as five drugs Pulmosil (Sildenafil Injection), Pantocid (Pantoprazole Tablets IP), Ursocol 300 (Ursodeoxych olic Acid Tablets IP), Telma H (Telmisartan 40 mg) and Hydrochlorot (Hiazide 12.5mg Tablets IP) and Deflazacort Tablets ( Defcort 6 Tablets) as spurious, adulterated and misbranded.

“The DCGI is constantly monitoring the quality of medicines and taking action against manufacturing companies selling drugs that are not of standard quality. Such a list is released every month. The NSQ is mostly minor and not life-threatening,” a health ministry official said.

The CDSCO said 61 medical products and drugs have been found substandard in June whereas 70 such medical products and drugs have been found of poor quality in July.

The DCGI is the head of the department of the CDSCO, responsible for the approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera. Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB) and approval of certain licenses as Central License Approving Authority is done by the CDSCO.