In order to meet the challenges faced by Indian companies on account of non-compliance in terms of CGMP norms, experts deliberated that Indian pharma companies need to adopt a policy of self control and as far as possible get the required expertise to resolve regulatory challenges.
Potential solutions to challenges faced by exporters to regulated markets; stumbling blocks faced while making abbreviated new drug applications and how to overcome them; quality standards and certification available to grade pharmaceutical excipients in the current regulatory scenario were some of the major topics discussed on the occasion of the second edition of EMPROVE Seminar Series held in Mumbai on November 21, 2013 organised by Merck Millipore, the Life Science division of Merck, under the theme 'Stability in Turbulent Times'.
Said Pharma Industry Analyst Tapan Ray on the sidelines of the seminar, "The country has witnessed an increasing trend of import bans and people have started generalising India with violations of CGMP norms and falsification of data."
"Therefore, there is a need for the drug regulators to be more vigilant and accountable to improve the regulatory scenario," he added.
Echoing similar views, Dr Claus-Dieter Boedecker, managing director, Merck India and head, Merck Millipore India said, “Today the pharmaceutical industry in India is grappling with challenges owing to an uncertain and ever-changing regulatory environment. It is imperative for the industry to understand, interpret and prepare to meet the challenges of tomorrow.”
“The setbacks on the regulatory front in the year 2013 have adversely impacted advancements in drug manufacturing processes and technology. In such a scenario, pharmaceutical companies will need to focus their attention on appropriate corrective measures in this area sooner,” Ray concluded.
Aimed at meeting the challenges posed by rising imports of US FDA regulated products and the regulatory complexity of pharmaceutical supply chain, US FDA had also released a document for a new strategy on June 20, 2011.
Peter Salazar, head, Pharm Chemicals Solutions, Merck Millipore India and pioneer of the EMPROVE Seminar Series remarked, “The 2013 edition of EMPROVE Seminar Series has helped gain better insights into the rapidly evolving global regulatory scenario for improving stability of the pharmaceutical industry in such turbulent times. Merck Millipore’s customer-friendly EMPROVE products and services, along with providing regulatory support, have always offered information on greater product safety, cost and time savings.”
At the seminar, Dr Najib Sehat, head, Global Regulatory Management, Merck Millipore and member, EXCiPACT Global Steering Committee spoke on the need for pharmaceutical excipient quality standards and certification in the current regulatory environment. Other leading experts who spoke at the seminar were Dhiraj Chopra, associate director, Dr Reddy’s Laboratories Limited, Amit Bansal, managing partner, Resolute IP and Legal Solutions, Meena Kashyap Shah, senior manager – Regulatory Affairs, JB Pharmaceuticals; and Dr Christian Dittrich, global marketing manager – Bioavailability Enhancement, Merck Millipore.