Majority of SLAs did not Submit NSQ Data in May: CDSCO

The Central Drugs Standard Control Organisation (CDSCO) reported that nearly 20 states and four Union Territories did not provide the required NSQ data for May 2024.

As per the latest Central Drugs Standard Control Organisation (CDSCO) report, a significant number of State Licensing Authorities (SLAs) have failed to submit monthly data on Not of Standard Quality (NSQ) drugs despite repeated directives from the Central Licensing Authority (CLA).

The CDSCO reported that nearly 20 states and four UTs did not provide the required NSQ data for May 2024.

"State Drugs 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, Uttarakhand, West Bengal, Andaman & Nicobar, Dadra and Nagar Haveli, Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of May, 2024 as per DCG(I) Circular dated February 9, 2024," stated the CDSCO.

Moreover, out of those who submitted, data from Jharkhand, Jammu & Kashmir, and Kerala did not adhere to the specified format.

This comes despite a circular issued by the Drugs Controller General of India (DCGI) on February 9, 2024, outlining the required format.

Other Reported Concerns

Goa's SLA reported no NSQ data for May 2024. Among the data submitted, eight out of 13 drug samples tested by state laboratories were declared NSQ, and five were classified as misbranded.

The misbranded samples included XEronac-SP tablets by Roma Pharma in Himachal Pradesh, Pedxim 200 tablets by Ticoma Pharmaciae in Punjab, DofloxOZT by Doctor's Vet-Pharma in Andhra Pradesh, Disinfectants Surgical Spirit by Transflex in Chhattisgarh, and Sif Alben suspension by Siflon Drugs and Pharmaceuticals in Telangana.

Additionally, the CDSCO released a list of 39 drug samples tested in central laboratories, which were found to be NSQ for May 2024. However, the total number of samples collected and tested was not disclosed.

Calls for Compliance

The Drugs Consultative Committee (DCC) and other advisory bodies have repeatedly urged state drug regulators to submit timely NSQ and Spurious Alerts reports.

Earlier, the 63rd DCC meeting held in January 2024 highlighted that only a few states share NSQ data monthly. It called for all states to submit data regularly for publication on the CDSCO website.

During the meeting, the DCGI raised concerns about multiple NSQ drugs from the same manufacturers, emphasizing the need to monitor repeat offenders.

The DCGI urged states to address any challenges in data submission and ensure timely reporting for transparency and stakeholder awareness.

The DCGI also stressed the need for SLAs to enhance their state drug testing laboratories using funds from the central government. Central Drugs Laboratories are overburdened with samples, including cough syrup samples from CDSCO inspectors. SLAs were informed that central laboratories would eventually stop accepting state samples.

Moreover, state drug controllers were asked to integrate the Online National Drugs Licensing System (ONDLS) for online applications and issuance of blood center licenses.