Chloroquin
- Posted by CERC India
- Posted in Pharmaceuticals
We tested 17 brands of Chloroquine Phosphate tablets (250 mg). Of these, 8 were branded products and 9 were generic (unbranded). Five of these were national brands, and the rest regional. All were tested against the specifications of the Indian Pharmacopoeia (IP).
Septmeber-October 1999
KEY FINDINGS
We tested 17 brands of Chloroquine Phosphate tablets (250 mg). Of these, 8 were branded products and 9 were generic (unbranded). Five of these were national brands, and the rest regional. All were tested against the specifications of the Indian Pharmacopoeia (IP).
Of the 17 brands tested, only 12 were considered for the final rating and ranking. Because of the difference in the type of coating, Leoquin EC (enteric-coated) and Malariaquin and Chloroquine from Sunny (both sugar-coated) could not be taken up for comparative rating and ranking.
Of the 12 rated, the costliest generic Chloroquine Phosphate (Rs 13) from Medibest Pharma ranked the first with 92 per cent. Resochin (Rs 9.31), which enjoys the highest market share,stood third with 77 per cent, along with Cloquin (Rs 9.31) and Chloroquine Phosphate (Rs 15.83 for 500 mg.) of Lark Laboratories. Welquin (Rs 9.31) and Chloroquine Phosphate (Rs 7.50) from Bhadra Pharmacare were at the bottom with 57 per cent.
There was considerable difference in prices between the branded and the generic. Of the tested brands, the generic Chloroquine Phosphate from Agam & Gem Laboratories was priced the lowest at Rs 6.50 (10 tablets). Another generic, chloroquine Phosphate from Medibest Pharma was priced the highest at Rs. 13.00 for 10 tablets. All the 5 national brands carried a uniform price of Rs 9.31 for 10 tablets.
Only two generic products did not conform to all the parameters tested. The Chloroquine Phosphate manufactured by Agam & Gem Laboratories, Daman, failed in the ‘uniformity of Weight’ parameter. It did not confirm to the + 5% variation on the average weight of 20 tablets, as per the IP.
Chloroquine Phosphate from Dee-Pharma Limited, Delhi, did not conform to the dissolution parameter. Against a minimum requirement of 70% in 45 minutes, only 66.86% of the tablet dissolved, showing it may possibly be less effective in treatment. But the test batch was manufactured before IP incorporated the dissolution parameter.
Chloroquine (Sunny) gave a wrong labelling information. While the tablets were labelled as ‘film coated’, on testing they were found to be ‘sugar coated’.
The ‘dissolution’ standard in IP (70% in 45 minutes) may be brought on a par with the US Pharmacopoeia limit of 75% in 45 minutes.
