New Delhi: A large number of State Licensing Authorities (SLAs) seems to continue ignoring the Central Licensing Authority’s (CLA) direction to submit the monthly data on Not of Standard Quality (NSQ) despite repeated requests from the Centre. Almost 20 states and four Union Territories did not submit any data in respect of the NSQ alert for the month of May, 2024, says the Central Drugs Standard Control Organisation (CDSCO).
Out of those who submitted the data, details from Jharkhand, Jammu & Kashmir and Kerala were not as per the format and file format, even though the Drugs Controller General (India) (DCGI) has issued a circular regarding the format and excel sheet file in February 9, 2024, it added.
The CDSCO has released a list of 13 drug samples tested by the State laboratories as NSQs or misbranded, along with another list of 39 drug samples tested in the central laboratories as NSQs for the month of May, 2024. However the CDSCO did not release the data related to the total number of samples collected and tested during the month.
“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,” said the CDSCO.
SLA of Goa has stated that NSQ data as Nil for the month of May, 2024.
Eight out of the 13 drug samples failed during the tests conducted by the State laboratories were declared as NSQ, while five were announced as misbranded.
The misbranded samples include XEronac-SP tablets comprising aceclofenac, paracetamol and serratiopeptidase tablets labelled as manufactured by Himachal Pradesh-based Roma Pharma; Pedxim 200 tablets comprising cefpodoximeproxetil tablet labelled as manufactured by Punjab-based Ticoma Pharmaciae; DofloxOZT comprising ofloxacin and ornidazole tablets labelled as manufactured by Doctor’s Vet-Pharma in Andhra-Pradesh; Disinfectants Surgical Spirit labelled as manufactured by Transflex in Chhattisgarh, and Sif Alben suspension, albendazole oral suspension 2.5% w/v labelled as manufactured by Siflon Drugs and Pharmaceuticals, Telangana.
The drug samples declared as NSQ by the CDSCO and Central Laboratories include glipizide and metformin tablets labelled as manufactured by USV Pvt Ltd in Bengaluru; Vildagliptin and metformin hydrochloride tablets IP 50mg/1000mg labelled as manufactured by Bajaj Healthcare in Gujarat; Gentamicin sulphate injection I.P. 2ml, ceftriaxone injection I.P, and dexamethasone sodium phosphate injection I.P. (8mg/2ml) labelled as manufactured by Zee Laboratories in Himachal Pradesh; ofloxacin ornidazole tablets IP and lactulose solution USP labelled as manufactured by Skymap Pharmaceuticals; Cefuroxime axetil tablets IP, and 8. Cefixime & ofloxacin tablets labelled as manufactured by Daxin Pharmaceuticals in Himachal Pradesh, among others.
It may be noted that the Drugs Consultative Committee (DCC) and other advisory boards have repeatedly asked in the past to the State drug regulators to submit the reports on NSQs and Spurious Alerts in a timely manner with the Central drug regulator, in order to ensure better reporting standards and curbing the menace of spurious and NSQ drugs in the market.
The 63rd DCC meeting held at the end of January, this year, 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.
The 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. The 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 State Licensing Authorities (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 send 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, said the central drugs regulator during the meeting.
