Participation of states in NSQ reporting improves, says Centre

The Union ministry of health has said that the participation of states in reporting Not of Standard Quality (NSQ) to the central database has seen an increase in November, as compared to the previous months.

The list of NSQs declared by the Central drug regulator include a batch of compound sodium lactate injection (Ringer’s lactate 500 ml) manufactured by Paschim Banga Pharmaceuticals. It may be recalled that the Karnataka government has earlier alleged that the Ringer’s lactate intravenous (IV) fluid from the company has resulted in the death of four women in Karnataka.

The central drug regulator has released a list of 111 drug samples tested as NSQs tested in State and Central drug laboratories across the State. Two drug samples tested during the month were identified as spurious drugs.

The Ministry announced that as per the routine regulatory surveillance activity for the month of November, 2024, Central Drugs Laboratories have identified 41 drug samples as NSQs, while State Drugs Testing Laboratories have identified 70 drugs samples as NSQs.

“Salient feature of this month’s NSQ reporting has been the increased participation of states in reporting NSQs to the Central database. Increased reporting of NSQs/spurious identifications from states to Central databases will further help in improving availability of quality medicines in the country and beyond. This action of identifying NSQ and Spurious medicines is taken on a regular basis in collaboration with state regulators to ensure that these drugs are identified and removed from the market,” stated the Ministry.

According to the data released by the Central Drugs Standard Control Organisation (CDSCO), NSQ data was received as per the format from State drug licensing authorities of Himachal Pradesh, Jammu Kashmir, Puducherry, Telangana, Kerala, Tripura, and Tamil Nadu.

Data was not received, though not as per format, from Jharkhand, Karnataka, Maharashtra, Assam, Rajasthan, and Delhi.

However, State Drugs Licensing Authorities of Ladakh, Goa, Andhra Pradesh, Arunachal Pradesh, Bihar, Chhattisgarh, Gujarat, Haryana, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Sikkim, Uttarakhand, West Bengal, 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 of November, 2024, it added.

The sample of Ringer’s lactate manufactured by Paschim Banga Pharmaceuticals in March, 2024, failed the sterility test conducted by the Central Drugs Laboratory, Kolkata, according to the CDSCO.

Some of the other samples which failed the quality test by Central and regional drug testing laboratories include disease-modifying anti-rheumatoid drug Tofajak tablets (tofacitinib tablets 5 mg) labelled as manufactured by Cipla Ltd in Puducherry; and Monit 30 SR (isosorbidemono mononitrate sustained release tablets 30 mg) for treating angina, labelled as manufactured by Intas Pharmaceuticals in Sikkim, among others.

A batch of calcium and vitamin D3 tablets labelled as manufactured by public sector undertaking Bengal Chemicals and Pharmaceuticals and a batch of paracetamol 500 mg from Karnataka Antibiotics and Pharmaceuticals Ltd were also declared as NSQs by the CDSCO.

Commenting on the spurious drugs identified during November, the Ministry said that out of 2 samples, one drug sample was picked by Bihar Drugs Control Authority and the other sample was picked by CDSCO (NZ), Ghaziabad.

“They have been made by unauthorized and unknown manufacturers, using brand names owned by other companies. Investigation has been initiated in the matter,” said the Ministry.

The samples declared as spurious include a batch labelled as Pan-40, a pantoprazole gastro-resistant tablets brand from Alkem Laboratories and a sample of antibacterial drug brand Augmentin 625 Duo, containing amoxycillin and potassium clavulanate tablet brand owned by GSK Pharma.

The actual manufacturers (as per the label claim) have informed that these batches of products were not manufactured by them and that they are spurious drugs.

“The product is purported to be spurious, however, the same is subject to the outcome of investigation,” said the CDSCO in its drug alerts.

The drug samples reported as NSQ by the state laboratories include a batch of antacid drugs Zylpan and Dirab 20, labelled as manufactured by Hetero Healthcare, Assam; Xykaa 500 paracetamol 500 mg tablet labelled as manufactured by Troikaa Pharmaceuticals in Gujarat; various batches of hair colour shampoos manufactured by Vimac, in Chennai; two batches of Beaute Blanc Fruit Vinegar Gel Hair Colour from Chinese manufacturer Guangdong Rongsheng BioTechnlogy Co Ltd, among others.

Identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters. The failure is specific to the drug products of the batch tested by the government laboratory and it does not warrant any concerns on the other drug products available in the market, said the Ministry.