The United States Pharmacopoeia (USP), a non-governmental, official public standards-setting authority for prescription and over-the-counter medicines and other healthcare products manufactured or sold in the United States, launched a free online medicines compendium (MC).
According to the USP, it initially comprises quality standards for drugs approved by the Drug Controller General of India (DCGI) for use in India. The USP has constituted a body of volunteer experts to assess and approve standards for the compendium. It is chaired by Dr Antony Raj Gomas, an industry expert and scientist, and includes 11 distinguished Indian scientists. The Indian Pharmacopoeia Commission is serving as a government liaison to the work of the expert committee. It marks the latest cooperative effort among USP and the IPC, Indian regulators, scientists and pharmaceutical manufacturers.
Announcing the launch of the medicines compendium, Roger L Williams, managing director, USP, said, “Creating MC is a logical outgrowth of USP’s public health mission and its growing international presence. As the pharmaceutical industry has become increasingly global, it is of utmost importance that patients worldwide are protected by the availability of up-to-date, scientifically vetted standards for the quality, identity, purity and strength of the medicines they take. India has emerged as a leading supplier of medicines and their ingredients worldwide.” He added that long-standing partnerships between USP and the Indian government, the IPC, industry and scientific community have fostered a climate conducive to this new initiative. It works forward to ongoing, additional collaborations with regulators and manufacturers in India as MC develops.
The USP states that standards in the compendium are intended for use by manufacturers, regulators and donor organizations in India seeking rigorous quality assurance measures where they otherwise might not exist. Documentary standards in the compendium will be offered for free online only and may be adapted or adopted by the IPC if desired. Criteria for inclusion in the MC emphasize public health impact measures such as exposure to the population.
Dr Williams further added, “We anticipate that the free availability of authoritative documentary standards will facilitate registration and regulation of medicines and further will aid legal scrutiny of these products thereby helping to combat substandard, counterfeit and spurious drugs.”