Interview

Priority to create awareness of international standards

It has been three years since United States Pharmacopeia (USP) came to India. Kumud Sampath, Vice President International, USP India charts USP India's current projects and future plans with Viveka Roychowdhury

Why did USP choose to set up its first overseas laboratory and office in India?

USP decided to increase our physical presence in India because the country has achieved significant growth in pharmaceutical industry, with Indian pharma companies now exporting to many other parts of the world. Beyond exported products, it is also the mission of USP to work with Indian companies and regulatory bodies to promote high quality, safe and effective medicines for use within India.

What have been your priorities for USP-India since 2006, when the site opened?

Our priorities has been creating awareness of international standards by offering pharmacopeial education courses, collaborating with Indian National Laboratories, establishing a collaborative lab for reference standards, holding Annual Scientific Meetings and contributing to USP monograph development.

What is the extent of your interaction with the Indian Pharmacopoeia?

USP entered into a Memorandum of Understanding (MoU) in August 2006 with the Indian Pharmacopoeia Commission. The initial MoU was for a period of one year, and this was subsequently renewed for two more years. Under this MoU, four joint working groups were formed to address monograph and reference standards, pharmacopeial education, biologics and biotechnology, herbals (including nutraceuticals). As a part of this MoU, we have also been conducting Annual Science Meetings that give both IPC and USP the opportunity to interact closely with the pharmaceutical industry. This year we had about 300 participants from 70 industries.

What do USP and others mean when they talk about working together to set common global standards?

Common global standards refer to setting up universal, worldwide standards for identity, purity, and quality of medicines. USP's standards have been helping to ensure good pharmaceutical care for people throughout the world for more than 185 years. Many countries, including India, have their own pharmacopeias, and as the pharmaceutical industry is increasingly global it will be desirable to work toward a common set of standards.

What is the USP's purpose and how does it function?

USP is the official public standards-setting authority for all prescription and over-the-counter medicines sold in the United States. We also set widely recognised standards for food ingredients and dietary supplements. USP sets standards for the quality of these products and works with manufacturers to help them reach these standards, but we have no role in enforcement. USP's standards are recognised and used in more than 130 countries.

How does it go about setting standards in the pharmaceutical, food and allied industries?

USP promotes the public health by developing and disseminating quality standards and information for medicines, dietary supplements and foods. Our standards and information help patients and practitioners maintain and improve health. The standards are set through an open, collaborative process involving the pharmaceutical industry, regulators and other stakeholders.

Will these standards take into consideration the unique features of each nation's pharmaceutical industry? For instance, India has many small- and medium-sized players who may not be able to use the same tests as the bigger players. How does the USP operate in such cases?

With regards to the Indian pharma industry, which has many small- and medium-sized players, USP, along with industry stakeholders, is working on a proposal to request some tariff benefits to enable the industry (including small and medium enterprises) to reduce cost of the reference standards.

Does USP prescribe any procedure for ayurvedic, traditional medicines?

USP does publish standards for dietary supplements such as ginger, ginseng, clover and many other products.

Could you tell us about the training courses at USP-India?

USP is working with some colleges of pharmacy, National Institute of Pharmaceutical Education and Research (NIPER) and equipment manufacturers to train local faculty who can teach USP's pharmacopeial educational courses. Courses will be offered in a variety of formats, including in- person courses and online Webinars. USP-India is holding about 12 courses in 2008. Initially, we will use teaching resources from the US along with Indian faculty.

How many Indian companies have approached USP for verification?

At this time, we have about 10 to 12 companies who we are in discussions about verification. Dr Reddy's Lab-oratories has already gone through USP's verification program and four of their ingredients have already earned verification. A few more of their ingredients are in the pipeline.

What are the advantages of such verification?

Such verification demonstrates the quality of the product and differentiates it from others. The USP Verified mark also establishes that the product meets rigorous quality requirements for purity, quality, identity, and manufacturing standards. Certification can help earn preferred supplier status with brokers, distributors and manufacturers.

What revenue model does USP/USP-India follow?

USP is an independent, science-based public health organisation. As a self-sustaining not-for-profit organisation, USP achieves its revenues from the sale of products and services that help to ensure good pharmaceutical care and quality food ingredients. USP-India is 100 percent owned subsidiary of USP, USA and works on a cost-plus-mark-up model.

Could you take us through the certification, inspection, validation procedures, etc. of USP verification?

Verification programs are designed to assist participants in assuring their customers-drug product manufacturers-that the manufactured ingredient is produced in accordance with Good Manufacturing Practices. Some of the USP's important programs include:

Drug Substance Verification Program:

• The program includes an audit of each the participating company's manufacturing sites for compliance with Good Manufacturing Practices (GMPs).
• Review of manufacturing and quality control documents for each drug substance submitted for verification, including review of characterisation, stability, and release data for compliance with labeling and certificate of analysis claims, as well as compliance with USP-NF monographs as applicable.
• Laboratory testing of drug substance samples from selected lots for compliance with labeling or certificate of analysis claims and program requirements
• Grant of the USP Verified mark upon full satisfaction of program requirements, which indicates the verification of the drug substance's quality by a trusted and established authority
• Post-verification surveillance testing of drug substances with the USP Verified mark
• Post-verification audits
• Periodic re-verification
• Reporting by participants of changes to the manufacturing or testing of drug substances bearing the USP Verified mark

Dietary Supplement Ingredient Verification Program:

• Evaluation of manufacturers' quality systems through an audit for compliance with GMPs.
• Review of manufacturing and quality control documents for products submitted for certification
• Laboratory evaluation of ingredient samples from selected lots for compliance with label claim and program requirements
• Permission to use USP Verified mark, which is granted for ingredients that successfully meet all program requirements
• Post-certification surveillance testing of ingredients bearing the USP Verified mark

Looking ahead, what are USP's future plans?

USP's vision is to be a leader in promoting the public health by creating a unique knowledge base-consisting of quality standards and information on proper use-for medicines, food ingredients, dietary supplements, and related products and practices. USP will work to assure that people throughout the world have access to this knowledge base.

USP resolves to assure good pharmaceutical care and quality food ingredients for all through four major areas of activity:

National product quality: USP will continue to remain an independent, unbiased source of information and materials to serve pharmaceutical manufacturers, government agencies, compounding professionals, patients, and consumers. The information and materials include a growing range of public monographs in the USP-NF and Food Chemicals Codex (FCC), official USP Reference Standards, verification programs, and education courses. All these products will enable independent and third-party testing of drugs, biologics, food ingredients, dietary supplements, and other products used to maintain health and prevent disease, to assure their quality and integrity at all stages before use-during manufacture, at the time of release, and throughout the shelf-life of the products.

International product quality: USP will work with various stakeholders and constituencies to assure quality therapeutic products and food ingredients, and their proper use worldwide. USP will especially focus on helping to eliminate substandard and poor quality drugs which can increase antimicrobial resistance and damage health in areas of the world where regulatory resources are restrained.

Healthcare delivery and patient safety: USP will use data from its national Internet-based reporting program, MEDMARX, to provide the healthcare community with reports, alerts, and information for research into health-system errors and interventions to advance patient safety.

Drug information: USP will investigate and evaluate approaches to provide accurate, unbiased, and timely drug information at the point of use to enhance practitioner and patient understanding about the value and proper use of a drug or related product.

USP's volunteer Convention members meet once every five years to discuss, vote upon, and adopt a set of resolutions that further USP's mission by defining specific focus areas for the next five-year period. The USP Convention adopted thirteen resolutions for 2005-2010 in March 2005. Please give more details on the kind of work you will be doing out of your Hyderabad office? How will it work on a hub-and-spoke model for South Asian countries? Having established its presence in India, the US Pharmacopeia is planning to make the Indian site the hub for surrounding regions of Asia. USP-India will soon be expanding its facility, increasing the headcount in Hyderabad and promoting collaborative work in the region.

viveka.r@expressindia.com