Archive for December 18th, 2007

New Pharma code – Pharmacopoeia 2007

Today, Union Health and Family Welfare Minister Anbumani Ramadoss has released Indian Pharmacopoeia 2007. Document has been published in three volumes. Fifth edition of India Pharmacopoeia, lays down the standards of drugs being produced and marketed in India. Procedures and standards are legally enforceable which further helps in inspection and licensing.

Pharmacopoeia by it's dictionary name means art of the drug compounder. & by definition from “wikipedia”, is a book containing directions for the identification of samples and the preparation of compound medicines, and published by the authority of a government or a medical or pharmaceutical society.

I think, there is no denying the fact that these standards will help drug makers compete better at international arena. These guidelines will also help the sectors where no set guidelines exists. Especially biogenerics, where international requirements are not fully met by all manufacturers as no distinct guidelines are in place. This is expected to change, with the introduction of monographs for seven rDNA products in the Indian Pharmacopoeia.