May 24,2024
The Central Drugs Standard Control Organisation (CDSCO) has declared that 50 drug samples tested in both Central and State drug laboratories have failed the quality standard test during the month of April, 2024. The Central drug regulator said that almost 21 states have not submitted any data in respect of the Not of Standard Quality (NSQ) alert for the month, while another two States have not submitted the data in prescribed format.
Out of the 50 NSQ samples published for the month of April, 33 were tested in CDSCO laboratory while the rest of the samples were tested in state/Union Territory laboratories including Jammu & Kashmir, Goa, Kerala, and Madhya Pradesh.
Drug Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Himachal Pradesh, Maharashtra, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Rajasthan, Sikkim, Tamil Nadu, Telangana, Uttarakhand, and West Bengal, and Union Territories of Andaman Nicobar, Dadar and Nagar Haveli, Daman and Diu, and Lakshadweep have not submitted any data in respect of the NSQ alert for the month, despite a circular from the Drugs Controller General (India) (DCGI) directing submission of the data issued on February 9, 2024, said CDSCO.
NSQ data was not received as per the format and in a prescribed file from the State Drugs Licensing Authorities of Karnataka and Uttar Pradesh for the month, said the Central regulator. State Drugs Licensing Authorities of Mizoram, Tripura and Puducherry have reported the NSQ data as nil for the month, it added.
Unlike its practice in the past years, the NSQ alert for the month does not reveal the total number of samples collected and tested during the month.
According to the alert, the samples failed the quality test include a sample of Norditropin Nordiflex 15mg/1.5 ml (human growth hormone injection) labelled as manufactured by Novo Nordisk, ofloxacin and ornidazole tablets from public sector undertaking Karnataka Antibiotics and Pharmaceuticals Ltd, Rez-Q 300 (quinine sulphate tablets 300 mg), and Thyrox-75 (thyroxine sodium tablets) labelled as manufactured by Shreya Life Sciences.
The samples failed in the test conducted by State Drug Testing Laboratories include multiple samples supplied by Kerala Medical Services Corporation, Warfarin sodium tablet 5 mg labelled as manufactured by Centurion Remedies, Sallaki tablets labelled as manufactured by Gufic Biosciences, paracetamol paediatric oral suspension 125 mg/ml from Quest Laboratories, and paracetamol paediatric oral suspension 250 mg/ml from Zenith Drugs.
It may be noted that the 63rd Drugs Consultative Committee (DCC) meeting held at the end of January sought the state drug regulators to submit data related to NSQs and spurious drugs on a monthly basis. The committee also mooted preparing a list of manufacturers who repeatedly produce Not of Standard Quality (NSQ) drugs and black list them.
The Committee also noted that only a few states are sharing the NSQ data with the Central authority on a monthly basis and called for all the States to share the data periodically and in a timed manner for publication on the website.
Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India) (DCGI) during the meeting highlighted the concerns with respect to multiple NSQ drugs manufactured by the same manufacturer, and the need to watch such repeated offenders in future.
“It was discussed about black listing of such manufacturers and preparing a list of such offenders so that the Government procurement agencies become careful before procurement of drugs from such manufacturers,” said the drug regulator.
The Committee also looked at the status of the recommendation made with regard to the sharing of information on NSQs in the previous meeting. It observed that only a few states are sending the NSQ data on a monthly basis. The Central drug regulator sensitised all the States to look into the matter regarding any difficulties and to send the NSQ data periodically and in a timely manner, so that the information can be compiled and published on the website for the attention of all the stakeholders.
The DCGI also requested all SLAs to strengthen or upgrade their State Drugs Testing Laboratories with the funds released by the Central Government as the Central Drugs Laboratories are overburdened with the cough syrup samples and others sent by the Central Drugs Standard Control Organisation (CDSCO) drugs inspectors. He also informed the SLAs that after a certain period of time, the CDLs will not accept samples from the states.
The State Drugs Controllers urgently need to onboard the SLAs on the Online National Drugs Licensing System (ONDLS) for receiving applications and issuance of blood centre licenses online, added the Committee.
Source: Pharmabiz
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