Over 5,000 pharmaceutical companies globally use the manufacturing standards set by the United States Pharmacopeia (USP). USP is an independent non-profit organisation developing quality standards that set the bar for manufacturing and distributing safe and effective medicines, supplements and food around the globe. In 2005, USP opened its first India office, United States Pharmacopeia – India (P) Ltd, in Hyderabad for research collaborations among the Indian pharmaceutical industry.
Salah D Kivlighn, senior vice-president, global strategic marketing and program operations administration, USP, tells BV Mahalakshmi that USP’s collaboration with the Indian Pharmacopoeia is focused on developing new standards, encouraging use of existing standards and exploring opportunities to make public standards available for manufacturers and regulators. While USP has no role in enforcing its standards, as enforcement is the responsibility of the Food and Drug Administration (FDA) and other government authorities in the US, it is a compendium of drug information published annually that owns the trademark and copyright. Excerpts:
What are the immediate challenges to be addressed by the Indian pharmaceutical industry, which is competitively going global for generic drugs?
According to the ministry for chemicals and fertilisers, the pharmaceuticals industry in India is now the third largest producer of pharmaceuticals in the world in terms of volume. There are over 20,000 pharmaceutical manufacturers in India and although the majority of medicines made are for local consumption, the share of production for export has tripled since 1985. Today, 50% to 60% of vaccines used globally, 40% of generics consumed in the US and 25% of all the medicines dispensed in the UK are produced in India. However, such rapidly expanding industry requires highly skilled professionals, which is why the Indian government launched the National Skill Development Mission to support growth by aligning industry demand with workforce capabilities.
To remain competitive, India’s new pharmaceutical professionals will need a good understanding of quality assurance techniques, international regulatory policies and be familiar with developments in global manufacturing technology and processes. The USP Education Hyderabad Training Institute is an effort to complement the Indian government’s vision to ensure industry-ready professionals who can support the rapid pharmaceutical growth in the country. It also aligns with USP – India’s mission, which is to work in collaboration with the Indian government as part of USP’s broader efforts to improve global public health by ensuring the quality of medicines, foods and dietary supplements through science-based quality standards and partnerships with regulators, the NGO sector and industry.
What is the perception about the concerns of Indian manufacturers on quality issues?
Quality assurance is a priority issue for Indian pharmaceutical manufacturers. They recognise that India’s position as a leading global pharmaceutical supplier rests on its ability to provide medicines that meet international standards. Likewise, Indian manufacturers recognise that exporting poor-quality medicines involves significant risks, to the local industry and to global public health, which is why strict adherence to international quality standards is essential. USP’s collaboration with the Indian Pharmacopoeia is focused on developing new standards, encouraging the use of existing standards and exploring opportunities to make public standards available for manufacturers and regulators. And it is not just manufacturers who are concerned about quality. In order to fully realise the nation’s potential as an important player in the global pharmaceutical industry, India’s regulatory infrastructure must keep pace and ensure global quality and safety demands are met.
What are the collaborative efforts of USP and the Indian Pharmacopoeia Commission (IPC)?
Since the beginning of our operations in India over a decade ago, USP and IPC have been actively partnering to advocate the use of quality standards. As the pharmaceuticals industry has become increasingly global, the long-standing partnerships between USP and the Indian government has fostered a climate conducive to new standards development and has helped India become a leading supplier of medicines and their ingredients worldwide. We look forward to continued collaborations with regulators, compendia experts and manufacturers in India.
In the wake of intense competition, what is the demand and supply of human resources and what is the current attrition rate in the pharma industry?
We continue to hear from our stakeholders in Indian industry that the pharmaceuticals industry needs more skilled workers. The attrition rate among pharmaceutical professionals in India hovers around 20%. As part of efforts to hasten development and advance the shared goal of better public health through quality medicines, USP is in talks with governments in India and around the globe to launch several USP Training Institutes. Our goal is to strengthen the employment ecosystem by offering necessary skills and knowledge for capacity building. The system of USP Training Institutes would establish a high-quality, application-oriented curriculum, aligned with compendia and regulatory guidelines; reduce downtime by ensuring that new pharmaceutical professionals are industry-ready, by providing them with rigorous and end-to-end hands-on training; and eliminate errors through multiple-case scenarios and hands-on training on real samples.
What is the investment made in India till date and going forward, what is the plan ahead?
USP is investing more than $1 million to establish the first training institute in India. This includes building a state-of-the-art laboratory and classrooms at the G Pulla Reddy College of Pharmacy in Hyderabad. We are working closely with government, policymakers, pharmaceutical and healthcare industry experts to develop training programmes that will meet their needs. The first class will be conducted in July 2018, which will benefit graduates in pharmaceutical sciences and professionals. Going forward, USP plans to expand efforts beyond Hyderabad to launch similar initiatives in other parts of India as well as in other regions of the world.