Express Pharma

‘We will continue working to promote science-based solutions around the world’

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It has been 10 years since USP set up its office in India and has been working towards integrating global pharma standards into the industry in India. Shalini Gupta finds out more in an interview with KV Surendranath, Senior VP, International Site Operations; Senior VP, USP–India and Ashok Dang, Senior Director – Marketing & Technical Services, USP

What have been the highlights at USP India in the past year? Elaborate.

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KV Surendranath

The focus of work at USP-India has been on the development and creation of new monographs, along with the modernisation of existing standards, including those addressing impurities, which are an important factor in assuring the quality of medicines. Additionally, we continue to build on our strong working relationship with the Indian Pharmacopeial Commission, supporting joint education programmes and workshops as part of our ongoing outreach to the Indian pharma industry.

China and India are important pharma markets of the world. What do you see as the challenges when it comes to quality of products and standardisation in both these countries?

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Ashok Dang

A substantial portion of the world’s pharma ingredients and products come from China and India, which has a significant impact on the global pharma marketplace. In those countries, and around the world, USP continues to encourage cooperation and harmonisation as a mechanism to advance standards that help ensure the quality, safety and benefits of medicines.

USP has facilities and laboratories in both China and India, and we have good working relationships with both the Chinese Pharmacopoeia Commission and Indian Pharmacopeial Commission (including Memorandums of Understanding with both, supporting collaborative work on education programs and the development of standards). USP also provides education programmes to promote quality medicines to manufacturers in both India and China. We believe that the quality of medicines is a shared concern and we will continue working to promote science-based solutions around the world.

How far has USP India come in the last 10 years since it started office and how does this compare to USP’s operations in other offices in APAC regions?

The India facility is the first office opened by USP outside the US, with a modest start in 2005, including a small laboratory and only 20 employees. Over the past ten years, USP-India has grown substantially and now includes more than 100,000 sq ft of lab space and 150 scientists working on the development and modernisation of standards for chemical and biological medicines, along with dietary medicines. It is USP’s largest facility outside the US.

Herbal medicines form an integral part of Indian pharma. How do you at USP ensure that companies manufacturing herbal drugs go through proper quality standards? Are any such awareness drives or workshops conducted in India for Indian companies engaged in manufacturing of herbal products?

Herbal medicines have been an active area for USP with public standards available in several publications, including USP-NF, the Dietary Supplements Compendium (DSC) and Herbal Medicines Compendium (HMC). USP is continuously evaluating newer products to be included in these compendiums. Additionally USP offers verification programmes for dietary ingredients and supplements manufacturers. These programmes are aimed at adherence to good manufacturing practices, proper documentation and ultimately good quality products.

PharmaChk has been a revolutionary device to detect counterfeit drugs. What other initiatives are underway at USP to counter the menace of fake drugs? Especially in India? Will PharmaChk be available in India anytime soon?

PharmaChk is one of several new technologies that USP is helping to develop and evaluate, using our Center for Pharmaceutical Advancement and Training (CePAT) facility in Ghana, Africa. In the trials conducted so far, PharmaChk has shown promise in helping to detect poor quality medicines, but there is much development work that remains. In August, PharmaChk received a substantial grant in order to help bring the device closer to commercial production and availability, and we are hopeful for the future.

In addition to working with PharmaChk, USP is also involved in field testing another device, called CD-3+, which was launched in 2013 by the US Food and Drug Administration – intended to help rapidly screen for counterfeit or poor quality medicines. Also, one of this year’s USP Fellowship Award recipients is working on research into a simple paper-based technology as a test for counterfeit medicines in regions where more sophisticated equipment is not available. It is important to note that different devices will have various strengths, and no single device will be a universal solution, but we are encouraged by this work.

Additionally, USP’s Promoting the Quality of Medicines (PQM) programme works with pharma manufacturers around the world, including businesses in India, to provide technical assistance at no cost to the manufacturers to help prequalify various medicines that are used to treat multi-drug resistant tuberculosis. The prequalification programme is managed by the World Health Organization for the United Nations – to help assure the quality of essential medicines.

What activities have been underway at USP India this year? Workshops, meetings etc.? How are you working along with the Indian Pharmacopeia?

USP has strong working relations with Indian Pharmacopeial Commission (IPC) via a Memorandum of Understanding (MoU) established in 2008. This MoU allows us to work on joint education programmes, conducting workshops on topics of interest to Indian pharma industry. We are also exploring the possibility of a pilot programme on development of standards.

USP India will be focussed on the development of standards for chemical and biological medicines and will continue to reach out to industry and other concerned parties with regular educational efforts.

Is the recently released compounding compendium to be available in India too? What benefits will it offer?

The new USP Compounding Compendium is available worldwide – purchased online and delivered electronically to subscribers. The publication brings together all of USP’s quality related standards for compounded medicines, including more than 170 monographs for compounding preparations and 40 supporting general chapters, which would be a useful resource for any pharmacist or health care facility involved in this activity.

What are your goals and plans for the next few years?

This is an exciting time for USP because a very special event that is on the horizon – the 2015 US Pharmacopeial Convention meeting. This gathering, which occurs once every five years, will provide guidance on issues relating to USP’s future. The meeting, which will be held in April 2015 in Washington, DC, includes:

Election of USP’s Council of Experts – the body that oversees USP’s scientific and standard-setting decisions.

Election of USP’s Officers and Trustees – the leaders who make decisions that guide USP’s policies and strategic direction.

Adoption of resolutions that advance the mission and vision of USP.

As part of this process, USP is in the midst of a worldwide search for expert volunteers – pharmaceutical scientists, academicians, regulatory professionals, healthcare practitioners, and others who work with medicines and foods – to apply to serve as scientific decision makers on the USP Council of Experts and Expert Committees for the period from 2015 to 2020.

Currently, there are 880 volunteer experts on USP’s many Expert Committees, Expert Panels and Advisory Groups. 272 of those experts come from outside the US, including 48 different countries. India has the largest international delegation of volunteer experts at USP (42 experts).

For more information, see the Call for Candidates section of the USP website for information about applying to serve as an expert volunteer (https://callforcandidates.usp.org/)

What plans do you have for the USP India office in the next few years? Do you plan to add more labs and recruit more people?

Future plans for USP-India and USP as a whole are directly connected to the upcoming USP 2015 Convention.

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