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Even as the Central Drugs Standard Control Organisation (CDSCO) has released a list of 94 Not of Standard Quality (NSQ) drug samples in August, with almost 65% of them reported by the state drug regulators, 15 states and five Union Territories (UTs) have not filed the data for the month.
For the month of August, 2025, Central Drugs Laboratories have identified 32 drug samples and State Drugs Testing Laboratories have identified 62 drugs samples as NSQ. Identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters.
According to the data shared by the CDSCO, States of Arunachal Pradesh, Assam, Chhattisgarh, Goa, Jharkhand, Karnataka, Kerala, Manipur, Meghalaya,Mizoram, Nagaland, Odisha, Sikkim, Tripura, and West Bengal did not submit any data in respect of NSQ alert for the month of August, 2025, despite the instructions from the Drugs Controller General (India) (DCGI) and the Drugs Consultative Committee (DCC).
The UTs of Andaman and Nicobar, Dadra and Nagar Haveli; Daman and Diu, Delhi, Ladakh, and Lakshadweep, also did not submit the data to the CDSCO.
The NSQs declared by the states include a batch of metronidazole tablets IP 400mg labelled as manufactured by J B Chemicals & Pharmaceuticals, five samples of iron and folic acid syrup labelled as manufactured by Baddi-based Smilax Healthcare Drug Co., three samples of tobramycin eye drops 0.3% labelled as manufactured by Uttarakhand-based Agron Remedies, a sample of paracetamol and aceclofenac tablet and a sample of rabeprazole sodium tablet labelled as manufactured by Tamil Nadu-based Firstmed Therapeutics, pantoprazole 40mg labelled as manufactured by Haridwar-based Bajaj Formulations, among others.
The 32 drug samples listed as NSQ from the CDSCO and the central laboratories during the month of August include a sample of amikacin sulphate injection IP 500mg/2ml and a sample of tobramycin ophthalmic solution USP 0.3% labelled as manufactured by Zee Laboratories, two samples of ampicillin trihydrate & bromhexine hydrochloride capsules labelled as manufactured by Baddi-based Alexa Pharmaceuticals, a sample of Iron sucrose injection USP 100 mg/5 ml and a sample of clindamycin injection IP labelled as manufactured by Hyderabad-based Sai Parenterals, ceftriaxone injection I.P. 1 g labelled as manufactured by a public sector undertaking Hindustan Antibiotics Ltd, albendazole tablets IP from Scott-Edil Pharmacia Ltd, rabeprazole gastro-resistant tablets labelled as manufactured by Morepen Laboratories, and amino acids and minerals capsules labelled as manufactured by Albert David Ltd.
As reported earlier, the NSQs reported by the states and UTs during the first seven months of 2025 has witnessed around six-fold growth, to 661 from 113 reported in the same period of 2024. The NSQs reported in the first seven months of this year is almost 95% higher than the total NSQs reported in the 12 months of 2024, and also higher than the NSQs reported every year for the previous six years.
According to data from the CDSCO, the NSQs reported by the state and UT drug regulators started to show significant growth from the last quarter of the year 2024. The last three months of 2024 witnessed reporting of 192 NSQs from the states and UTs, which was higher than the 147 NSQs reported in the first nine months of the year. The NSQs reported by the States and UTs to the CDSCO in 2019 was a meagre 125, which has grown almost three -fold to 339 in the year 2024. The NSQs reported by the States and UTs in 2020 was a total of 140, which went down to 114 in 2021, grew to 228 in 2022, and again went down to 189 in 2023 before growing to 339 in 2024.
The growth is despite the fact that several states and Union Territories fail to share the monthly NSQ report with the Central drug regulator. The CDSCO has been listing out the State and UT licensing authorities which failed to submit the routine data with the Centre every month, along with the drug alerts it releases in its website.
As reported earlier, the Drugs Controller General (India) [DCGI] had in February, 2024, issued a circular seeking the regional drug regulators to submit their data in specific format.
The CDSCO and the DCC has time and again sought the state drug regulators to share the information regarding NSQs identified during every month on a regular basis with the central authority.
The DCC meeting, held on June 17, also requested the states to make a proactive approach in taking suitable and appropriate regulatory action against manufacturers not complying with the requirements and repeatedly manufacturing the NSQ products.
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