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IPC - USP plans joint working group for reference standard, monograph development
Joe C Mathew, New Delhi | Wednesday, August 2, 2006, 08:00 Hrs  [IST]

Indian Pharmacopoeia Commission (IPC) and United States Pharmacopeial Convention (USP) will form a joint working group for better collaboration in the area of developing monographs and reference standards for drugs and pharmaceuticals. The working group, to be set up within two months, is to develop annual plans for time bound communication and activities between IP and USP. The IPC and USP signed a formal MoU in this regard at Delhi on August 1, 2006.

Informing this to Pharmabiz, Roger L Williams, CEO, USP, said that the tie-up is primarily aimed at mutual co-operation in the area of monographs and reference standards development for biologicals, herbal drugs and also conventional pharmaceuticals. "We have similar scientific co-operations with Japanese Pharmacopoeia and European Pharmacopoeia agencies. While the major thrust of relationships in those countries are on developing excipient standards, its monographs and reference standards in India," Williams explained.

The MoU has built-in safeguards to ensure confidentiality of the data shared between the two scientific bodies. The confidentiality clause states that both the agencies shall use the confidential information only to fulfil its obligation under the MoU and prevent unauthorized dissemination or disclose of confidential information. The confidential information include all non-public financial information concerning either party, either party's product line, research, development and marketing plans and any information designated as confidential in writing at or prior to disclosure. The Working Group, consisting equal number of representatives from each agency, will have the responsibility to monitor the activities.

The objectives of the MoU include the promotion of cooperation between the parties, improve transfer and exchange of information between the parties, increase awareness of the importance of the quality, safety, and efficacy of medicine and establish the basis for a long term relationship.

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