The United States Pharmacopoeia (USP) will, reportedly, work with Indian pharma companies and Micro, Small, and Medium Enterprises (MSMEs) in areas of upskilling manpower and quality management systems, according to a senior official. “To address the gaps in capability building and quality control, USP is in discussion with the concerned stakeholders in the value chain to upskill manpower of pharma companies and MSMEs in labs and offer them courses at a reduced rate or free of cost to help them adopt quality practices”, the official said.

USP is an independent, scientific nonprofit organisation and its standards development process is transparent and inclusive of diverse global perspectives from government, academia, civil society and industry. Its standards are public and open source and are an important resource for making sure safe and quality medicines reach patients. USP is addressing quality assurance, enhancing regulatory predictability and helping manufacturers distribute quality medicines.

“Advocacy is an important part of our organisation and USP works with all the stakeholders like the industry, academia and regulators towards offering holistic solutions which are patient-centric and industry-friendly,” the official further said.

USP-India is currently working with Indian Pharmacopoeia Commission (IPC) based on a Memorandum of Understanding (MoU) to increase awareness of the importance of quality, safety and efficacy of medicines, safeguard the integrity of the global supply chain by increasing the availability of and access to needed public standards for medicines.

It has also collaborated with the National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad on an academic exchange programme which focuses on the dissemination of knowledge in pharmacopeial education and quality standard setting, collaboration through the exchange of scientific dialogue pertaining to pharmacopeial training and quality standards development and on-site training of students deputed by NIPER-Hyderabad at USP India premises.

It is also working with the Indian Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) to promote the quality and integrity of traditional medicines and botanical dietary supplements.

USP and AYUSH are collaborating to increase the awareness and understanding of quality traditional /herbal medicines, botanical dietary supplements, increase the availability and access to needed public standards for traditional/herbal medicines, increase programmes that support the adoption and use of public standards for traditional/herbal medicines.

The standards in the USP and the National Formulary (NF) are used to help ensure the quality of medicines and their ingredients, and to protect the safety of patients. USP is an official quality standard for medicines marketed in the US. USP–NF combines two compendia, the USP and the NF. Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP, while monographs for dietary supplements and ingredients appear in a separate section.

Bhagwati Prasad