The number of states failing to submit the data has further gone up to 18 states and five Union Territories (UTs) during the month of February, according to the data from the Central Drugs Standard Control Organisation (CDSCO).
The number of States failing to submit the data during the month has gone up. During January, 17 states and three UTs did not submit the data, while in December, 2024, a total of 13 states and four UTs did not submit the NSQ reports to the CDSCO.
The drugs that fail to meet the quality standards or specifications are known as NSQ drugs.
According to the data released by the CDSCO for the month of February, 2025, the States of Andhra Pradesh, Arunachal Pradesh, Bihar, Chhattisgarh, Gujarat, Haryana, Manipur, Madhya Pradesh, Maharashtra, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Tamil Nadu, Uttarakhand, and Uttar Pradesh have not submitted any data in respect of NSQs for publication as per the directions of the central drug regulator.
Besides, Delhi, Chandigarh, Andaman & Nicobar, Dadar and Nagar Haveli and Daman and Diu, and Lakshadweep also failed to submit the data with the CDSCO.
The central drug regulator received data in Excel Sheet, which is as per the prescribed format, from Kerala, West Bengal, Tripura, Telangana, Puducherry and Jammu and Kashmir.
According to data from the central drug regulatory organisation, Goa, Ladakh, Jharkhand, Himachal Pradesh, Assam, Karnataka, and Rajasthan submitted data in PDF format, as against the requirement of Excel Sheet.
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.
It may be noted that in January, the CDSCO has said that the States of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Madhya Pradesh, Manipur, Meghalaya, Nagaland, Odisha, Punjab, Rajasthan, Sikkim, Uttar Pradesh, and Uttarakhand, and the UTs of Andaman & Nicobar, Dadar 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 January, 2025 as per DCG(I) Circular dated February 9, 2024.
The number of NSQs reported from the States have seen a significant jump in the last couple of months, which has reached the highest in the month of January.
While the number of NSQs reported by the state laboratories in August, 2024 was a meagre 11, and 18 in September, it jumped to 34 in October, 70 in November, 84 in December, and 93 in January, shows the data.
In February, 2025, Central Drugs Laboratories identified 47 drug samples and State Drugs Testing Laboratories another 56 drug samples as NSQ.
The NSQs reported by the States during the month include Para 500 from Laborate Pharmaceuticals, Phenytoin tablets 100 mg from Jackson Laboratories, Telfine-CT from Cosmas Pharmaceuticals, among others. Telangana drug regulator has reported five drugs as misbranded, as per section 17 of Drugs and Cosmetics Act, 1940 as it is not labelled in the prescribed Manner.
The UT of Puducherry has also reported seven drug samples it tested as misbranded, while six other samples as NSQs during the month.
Three Ayurveda drugs - Asokarishtam, Amrutharishtam, and Balarishtam - from Sakthi Ayurveda Pharmaceuticals were also identified as not of standard quality.
Samples of formulations listed by the CDSCO and the Central Laboratories as NSQ during the month include Ringers lactate 500 ml and ciprofloxacin injection (0.2%w/v) from Paschim Banga Pharmaceuticals, glimepiride tablets 1 mg from public sector undertaking Karnataka Antibiotics & Pharmaceuticals Ltd, multiple drug samples labelled as manufactured by Himachal Pradesh-based Martin & Brown Biosciences, Uttarakhand-based Apple Formulations, among others.
While the drug regulator lists these drugs labelled as manufactured by these firms, there are also chances that they might be produced by some other players and the label has been used to mislead the regulators.
Similarly, the CDSCO has declared a sample of Telma H (telmisartan 40 mg and hydrochlorothiazide 12.5 mg) manufactured in February, 2024, as spurious since the actual manufacturer as per label claim, has informed that the said batch of product has not been manufactured by them and that it is a spurious drug. Telma H is a brand marketed by Glenmark Pharmaceuticals.
"The product is purported to be spurious, however, the same is subject to the outcome of investigation," said the central drug regulator.
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