Raising Standards

After a few false starts and delays, India's pharmacopoeia is finally being updated and harmonised with global norms. 

- Sachin Jagdale

In a welcome move, Indian Pharmacopoeia Commission (IPC), along with the health ministry, has initiated interactions with key global pharmacopoeias. This step is expected to help strengthen and harmonise Indian pharmacopoeia standards. Harmonisation of Indian pharmacopoeia (IP) will help the Indian pharmaceutical industry achieve its dream of being a global pharma power.

Need for harmonisation Despite being third largest in volume, the Indian pharma industry has time and again found itself embroiled in quality-related issues. In recent times, overseas regulatory authorities have issued warning letters to some major Indian pharma companies for lack of adherence with regulatory norms. Standardisation of quality and tests will help resolve this problem to a considerable extent.

A US Pharmacopoeia (USP) spokesperson also stresses on the necessity for harmonisation of standards. He says, “Standards facilitate registration, market surveillance, free movement and trade of medicines among countries. Globalisation and expansion in international trade present a growing need to develop global quality standards for medicines. Public standards are an integral part of the global medicine public safety net that protects patients and helps ensures access to quality medicines. Public quality standards for medicines protect patients and consumers, increase practitioners’ confidence in the quality of medicine, provide benchmarking tools and predictability to industry, and safeguard the integrity of the supply chain, helping to ensure patients’ access to quality medicines. Harmonisation is the process through collaborative effort where by differing requirements among participating ' authorities' move towards alignment on common requirements that yield the same outcome.”