New Delhi : The Central Drugs Standard Control Organisation (CDSCO) has declared 45 samples of drugs it has tested in the month of August as not of standard quality, almost 3.4 per cent of the total drug samples it has tested during the month. The samples tested as not of standard quality include batches from Boehringer Ingelheim India, Glenmark Pharmaceuticals, Wockhardt Ltd, and USV Pvt Ltd, among others.

The drug regulator has tested a total of 1,330 samples during the month of August and declared 45 out of them as not of standard quality. There were no spurious or misbranded drugs among the samples, according to data released by the CDSCO.

The drug regulator’s data shows that the samples of teneligliptin tablets IP 20 mg, branded as Ziten, from Glenmark Pharmaceuticals as not of standard  quality. The drug has been picked up for testing by the CDSCO Port Office in Visakhapatnam and was tested in the Central Drugs Testing Laboratory, Hyderabad.

Interestingly, the CDSCO has recently said that the blood pressure drug teneligliptin tablet from Glenmark it declared as not of standard quality in May, this year, has been identified as a spurious drug.

Sample batch of Boehringer Ingelheim‘s Ondero Met 2.5 mg/500 mg, which is the fixed dose combination of linagliptin and metformin hydrochloride tablets to manage diabetes, picked up by CDSCO sub-zone Bengaluru and tested in Central Drugs Testing Laboratory, Kolkata, failed the standard quality test in terms of
dissolution, degradation of active ingredient and Assay of Linagliptin.

Out of these samples 18 failed in assay, 15 in Dissolution, 3 in Description, 2 in related substance tests, two in identification, two samples in Sterility tests and three in Bacterial Endotoxin tests .

The failed samples include medicines for diabetes, fever, depression, infection, fungal, acidity, gallstones and gas.

Total 7 samples of injectables failed in quality tests. These include Iron Sucrose Injection U.S.P. 5 ml of Vivek Pharmachem (India) Ltd, Jaipur; RL – 500 ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) of Ives Drugs (India) Pvt Ltd, Ghatabillod, Dist. Dhar; Two samples of RL – 500 ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) of Swaroop Pharmaceuticals Pvt Ltd, Aligarh (UP); Iron Sucrose Injection U.S.P of Maan Pharmaceuticals Ltd, Mehsana; Gentamicin Injection I.P. (Vet) – 30 ml of Pushkar Pharma, Bhandariwala, Kheri, Kala-Amb; Gentamicin Injection IP (GERAGEN INJECTION) of B.M.Pharmaceuticals, Chandigarh and In this, samples of 13 medicines made in Himachal have also been found to be failed.

One sample of (PRICON) Sterile Single Use Hypodermic Needle of ISCON SURGICALS LTD, Jodhpur failed in sterility tests.

Two samples of Primaquine Phosphate Tablets I.P. 2.5 mg. of Centurion Remedies Pvt Ltd, Vadodara and Primaquine Tablets I.P. 7.5 mg of Modi Antibiotics, Odhav, Ahmedabad failed in Assay.

Two sample of Ivermectin Tablets USP of OMEGA PHARMA, Roorkee and Iverzest 12 (Ivermectin Dispersible Tablets 12 mg) of Plena Remedies, Bhatoli Kalan, Baddi failed in dissolution/ Uniformity of Dispersion.

Apart from these 5 samples of vitamins/ probiotics, 11 samples of Antibiotics, 2 samples of anti diabetic drugs, 6 Samples of Antacids/anti-emetics/ GI reflux disorders, one sample of Antifungal drugs, two samples of drugs prescribed for depression and One sample of drugs prescribed for Biliary Cirrhosis failed in quality tests.

Others include samples of Paracetamol, a fever medicine from three companies. Two samples of two companies of Solan district have failed. The medicines whose samples have failed in the state include companies from Sirmaur and Solan districts. State Drug Controller Navneet Marwah said that notices have been issued to the concerned company operators. The market has been asked to lift the stock. The department itself will also examine the samples in these companies at its level.

USV Private Ltd of Baddi in Solan District, T&G Medicare at Kunjahal, Plena Remedies, Bhatoli Kalan, baddi, Wockhardt Ltd at Kunjahal, Barotiwala, Maxtar Bio-Genics at Malku Majra, ANG Lifesciences India Ltd, Theon Pharmaceuticals Ltd at Saini majra, Nalagarh, Navkar Life Science at Lodhi Majra , Biogenetic Drugs Pvt.Ltd based in Jharmajri and Pushkar Pharma Company based in Kala-Amb, Khaeri, Sirmaur have failed.

These failed samples are tested by 23 by RDTL, Guwahati; 20 by CDL, Kolkata; 2 by CDTL, Mumbai; 4 by RDTL Chandigarh; by CDTL, One by Hyderabad and 4 by CDTL, Chennai.

The CDSCO has not categorized the reports on the basis of ‘Guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the Drugs and Cosmetics (Amendment) Act, 2008.’ Neither mentioned that the samples were original products of manufacturer or fake/ counterfeit formulations.