The alertness of the employee of an Indian drug company has helped British Pharmacopoeia Commission rectify a mistake in the potency determination description of Ketamine injection, an anaesthetic drug in the BP. The new edition of BP, published last month, made the revision possible after the expert committee of the Commission found the mistakes pointed out to them to be true.

It was about three years ago, J P Mall, manager, quality assurance of Lifecare Innovations Pvt. Ltd, Gurgoan started his correspondence with the BP authorities on the problems associated with the potency determination methods prescribed for Ketamine injection.

"There was a discrepancy in the assay method for Ketamine injection mentioned in BP as well as Indian Pharmacopoeia (IP). It was observed that the potency of the product was erroneously coming as very high i.e., about 120% and material was declared sub standard whereas the same product gave 100% by using standard method of reference standard. Thus it became clear that the value of E1% mentioned in BP was not the correct value," Mall said.

Mall pointed out the matter to both BP and IP authorities. While IP was quick to sense the mistake and rectify it, BP went through an elaborate process of verification. The BP authorities had informed the complainant that BP Committee was in the process of investigating the matter with a view to either revise it or replace it with a reference standard as per United States Pharmacopoeia (USP). The change was finally made in the December 2005 edition of BP.

As Ketamine injection, an anaesthetic, exact potency determination is very important for the patients as well as the drug regulators.