EDITORIAL: Drug Standardization: Its Regulations and Methodologies

Abstract

Standardization of drugs is an evolving process, aiming to ensure safety, efficacy and quality of the drugs. The amount of drug substance and its release profile in every drug product should be uniform, within specified limits so that the required dose is delivered to the human body. This uniformity must align with the standards laid down in the pharmacopoeias, drug indexes, formularies and other books defining standards and specifications. All drug products manufactured by all the drug manufacturing facilities must be uniform and the product should be free of impurities for patient’s safety and to avoid toxicity. ¹

Many countries have developed their own pharmacopoeias, like United States pharmacopeia (USP), British pharmacopeia (BP), International pharmacopeia (Ph. Int) and Japanese pharmacopeia (JP) and these are the most widely used pharmacopeias all over the word as well. Pakistan has not developed its own pharmacopeia, so the drug testing is relied upon USP and BP standards. There are approx. 11,000 prescription drugs actively marketed in Pakistan and sold through licensed pharmacies. Over the counter (OCT) products such as pain, cold, flu medicines contribute to significant market in our country as well. Collaborative efforts between the government, academia and industry stakeholders are essential to keep pace with global standards.²_{.................................................................................................................................}