Chandigarh : Venus Medicine Research Centre (VMRC), the R&D wing of Venus Remedies Limited, a leading r
Terming it as a landmark achievement, Dr Manu Chaudhary, Joint Managing Director, Venus Remedies Limited, and Director, Research, VMRC, said, “This GLP accreditation, one of the most coveted certifications for R&D capabilities, is yet another significant milestone in our efforts to ensure product quality, safety, reliability and excellence while preserving and improving human life through innovation. It gives our research an international credibility, which will translate into more business opportunities for the company and add to the reputation of our products and personnel.”
The certification is an attestation of the consistent reliability of the company’s R&D tests and calibration as well as its documented quality management system. Besides this, the GLP certification meets the company’s strategic vision to bring to the world novel breakthroughs that cater to critical care and super-specialty segments, including anti-infective (anti-microbial resistance), anti-cancer, neurology, pain management and wound care. Led by a team of 75 highly professional, trained and passionate scientists, VMRC is dedicated to developing novel and innovative research products on a par with global quality standards. The VMRC team has brought laurels to the country by securing over 90 patents for its research products from across the world, including countries like USA, Australia, Japan, European Union constituents and many others.
The Indian pharmaceutical industry, consisting of around 20,000 units, is the world’s third largest in terms of volume and has only a few GLP accreditations. “It is a matter of great pride for us to have received GLP certification for our Venus Medicine Research Centre. We are now the eighth pharmaceutical company in India with GLP accreditation. This accreditation follows the grant of full membership to India as an OECD member country. Thus, any R&D-related data generated in VMRC will be acceptable by the registration authorities of all the OECD member countries such as USA, Japan and various European countries,” said Dheeraj Aggarwal, Chief Financial Officer (CFO), Venus Remedies Limited.
GLP evolved in the USA in the 1970s amid rising concerns about the validity of pre-clinical safety data submitted to the Food and Drug Administration (FDA) in the context of new drug applications (NDA). The Final Rule came into effect in 1979 (21 CFR 58). This was followed a few years later by the Organisation for Economic Cooperation and Development (OECD) Principles of GLP in 1992, which helped promulgate GLP in many countries. The primary objective of this accreditation is to ensure the generation of high quality and reliable research data relating to the safety of industrial chemical substances, which is acceptable throughout the world. Since then, Indian companies have been striving hard to get GLP approval, but due to extremely stringent norms and regulations, only 25 Indian laboratories have been able to clear the GLP audits till date, and most of them happen to be government organisations.
Given the cut-throat competition among pharmaceutical companies, this GLP accreditation will provide an edge to Venus Remedies Limited. The company has a robust pipeline of research products. Many of these products are out-licensed and many others have already been approved in regulated and emerging markets.
Source : Sachin Murdeshwar