There is a new plan to make standards of Indian medicines more stringent, as has been done earlier, and News18 got to know this.
IPC is modernizing its rules to align with global quality and intentions to prevent risky elements in them, which is a drastic change from the present perfunctory vigilance of medicines that are being locally marketed.
The IPC, the body for bringing out quality standards for medicines and ingredients as the final custodian of patients’ safety, has conveyed this in a communication to all stake holders, including the drug manufacturers through their mandated lobbies and to all the state drug controllers, the directors of the drug testing laboratories, and the officers of zonal and port offices.
“The IPC is in process of adopting elemental impurity requirements in line with other global pharmacopoeia,” said the latest notice issued by the IPC, shared with News18.
The impurity levels permissible for India’s drug manufacturers based on IP are not as stringent as provided in the European and US pharmaceutical standards.
Pharmacopoeia is a book that declares the simplest requirements for quality of all medicines to be sold in the given country. It is a book of all the detailing of the quality, safety, and efficacy requirements for the medicines and their ingredients, as well as a standard procedural reference book in the manufacturing of drugs.
European and US guidelines are based on the International Council for Harmonization (ICH), which Guide most nations follow. To date, the Indian overbearer has not embraced ICH standards for various reasons, among them being the ability of S and M firms to finance compliance.
But now it is in India that change is needed. We are doing everything that can be done to ensure that a positive message goes out on the international market that India is a place of drug manufacturing and exportation. And so they admonishe that, hence, we need to follow ICH standards,” disclosed a government official who is in the know of the development.
