NSF International, an independent global public health and safety organization which develops standards, and tests and certifies products for the pharmaceutical, dietary supplement, food, water, and consumer products industries, is the first to offer Secondary Reference Standards in India, helping meet the growing India pharmaceutical sectors’ need for high quality, economical alternatives to pharmacopoeia standards.
India has one of the fastest growing pharmaceutical markets in the world. Currently ranked 14th, India’s pharma market is expected to grow by $14 billion, becoming the 10th largest pharma market by 2015. NSF International has expanded Secondary Reference Standards to pharmaceutical companies in India to help them demonstrate the identity, purity, quality and strength of their pharmaceutical products and ingredients. In addition, to meet growing US Food and Drug Administration (FDA) concerns regarding the control of impurities in pharmaceutical dosage forms, NSF is releasing test kits that will include the Active Pharmaceutical Ingredient (API) as well as all pharmacopeial listed impurities.
As required by US and EU regulations, a secondary reference standard must be demonstrated to be traceable to the primary standard (USP or EP) through laboratory testing. Unlike other secondary standards, NSF Secondary Reference Standards are qualified through a unique process that requires a minimum of three collaborating laboratories and an independent expert technical review board that approves all NSF standards before their use. As this level of characterization is unsurpassed by other secondary standards providers, NSF Secondary Reference Standards are widely accepted by international regulatory authorities and traceable to both US and EU Pharmacopoeia standards (USP and EP). Purchasers also benefit from a 40-50% cost savings over purchasing USP and EP standards.
To help manage the increasing demand of NSF Secondary Reference Standards in India, NSF International has hired two new Business Development Managers based out of Mumbai and Hyderabad.
Haresh B Jeswani has more than 12 years of experience in the pharmaceutical formulation and reference standards industry in India. His experience includes working with India-based reference standards organization Kamal Udyog, as well as pharmaceutical companies such as Biological E Limited, and J.B. Chemicals & Pharmaceuticals Ltd, and the Dana Group. He earned a BSc in Chemistry from Mumbai University and Post Graduate Diplomas in Marketing Management and Import Export Management from LN Welingkar Institute of Management Development and Research in Mumbai.
Ajay K Goud has nearly 6 years of experience in the pharmaceutical and biotechnology industry. His background includes working for leading India-based biotechnology firm Performance Plastics of Saint Gobain, as well as reference standards company LGC Promochem India Pvt. Ltd. He earned a MSc in Biotechnology from Bangalore University in Bangalore, India, and a BSc in Microbiology, Genetics and Chemistry from Osmania University in Hyderabad, India.
"NSF Secondary Reference Standards set the bar for the quality and purity of pharmaceutical products while also offering companies in India favorable pricing," said Lori Bestervelt, PhD, NSF chief technical officer and senior vice president over the NSF Health Sciences Division. "Mr Jeswani and Mr Goud both have considerable expertise in Pharmaceutical quality and provide NSF customers in India and throughout southeast Asia with unsurpassed service and access to high quality NSF Reference Standards as well as other important training, testing and consulting services through NSF’s global health sciences division."
In addition to NSF Reference Standards, the NSF International’s Health Sciences Division offers training and education, consulting, GMP and GLP testing, certification, R&D, auditing and regulatory guidance for the pharmaceutical, dietary supplement and medical device industries throughout the entire product lifecycle. The NSF Health Sciences Division includes: NSF-DBA, which has more than 25 years of pharmaceutical, dietary supplement and medical devices training expertise; NSF Pharmalytica, a GLP & GMP contract laboratory; Becker & Associates Consulting, Inc., a leading clinical, regulatory and scientific consulting firm that specializes in US FDA-regulated industries; and the NSF Dietary Supplements Certification Program. NSF International developed the only American National Standard for Dietary Supplements (NSF/ANSI 173) and tests and certifies supplements against this standard.