Central testing labs under CDSCO finds 66 drugs substandard during Jan-March this year
As part of the regular exercise to alert the consumers and the public about the sale of substandard drugs, the different drug testing laboratories under the Central Drugs Standard Control Organisation (CDSCO) have reported 66 cases so far in the first three months of 2014.
As many as 32 drug samples failed the tests at the central laboratories during January while another 36 were found to be substandard during February and March, as part of the exercise that the CDSCO launched since November 2012 with a view to issue alerts to the public.
Lavori (levoetrizine tablets) manufactured Rallis Healthcare (batch no rt-4001) failed the test after it did not confirm with respect of dissolution test after West Zone of CDSCO sent it for evaluation at CDTL, Mumbai. Ranitidine hydrocholoride tablets (CELOC 150), from Sea Pharmaceutics having batch no MST-13355, was declared substandard in respect of weight and assay, after tests at RDTL, Chandigarh.
As many as nine samples of amoxycillin capsules by Hectomb Laboratories also failed in the tests, after the sample was sent by Drugs Control Department of Assam. The samples declared substandard on the grounds of misbranding, included those having batch numbers of AX 095, AX 102, AX098, AX 099, AX 097, AX099, and AX 10. The products were manufactured in August 2013.
ADP-25 tablets (batch no. MRT 301) from Caplet India Pvt Ltd of Kolkota, Stopain Tablets (batch no. TGT 1102098 ) by T & G Medicare from Baddi of Himachal Pradesh, two batches of Ofloxacin & Ordinazole Suspensions (b.no. CFTS-006 and CFTS 010) by Laborate Pharmaceuticals India of Paonta Sahib, Oflomin-OZ suspensions (b.no RAB-008) by Regent Ajanta Biotech of Roorkee, Oflogyl Suspensions (B No LIN-12087) by Pro Laboratories of Roorkee, Paracetamol tablets (b.no. APC 1062AL) by Hindustan Laboratories of Thane, Oflomac-M Suspensions (B.no. MEO-2014) by Macleods Pharmaceuticals of Thane, Ronflox- 400 (b.no. RXTF/1003C) by Alkem Laboratories, and Angizaar 50 (losartan potassium tablets) with batch no of ANBD0032 from Micro Labs of Solan in HP were also among those failed the tests.
Para-500 Tablets (b.n. CPAT-003) by Laboratate Pharma was another formulation that was declared substandard. Apart from this, six batches of Festive-OZ Suspension (B.no CFTS-004, CFTS -003, CFTS-007, CFTS-016 and CFTS- 017) also by Laborate Pharmaceuticals failed the tests on Assay report, in the examination at RDTL, Guwahati after the Drugs Department of Assam collected the samples during January.
As per the alert issued in April, 34 samples were declared substandard during March. They include Levocetirizine Dihydrochloride tablets (b.no. LVT-2001B) by Galpha Laboratories, two batches of Megarab-20 tablets (B. No S753777 and S752886) from Edil Pharmacia Ltd, Ranitidine Hydrochloride Tablets (B.No C3016) from Concept Pharmaceuticals, Ranitidine tablets (Bn. RNIT-002) from Laborate Pharmaceuticals, Metronidazole Benzoate Oral Suspensions (B.No MB 143) by Lolyds Pharmaceuticals, and Ofoxo-Oz Suspensions (B.No Oxz-1202) from Apple Formulations, among others.