Monitoring the fast developing European drug regulatory scenario including the revision in Pharmacopoeia would help the Indian companies to grab the business opportunities in the bigger European Union (EU) market, say regulatory experts.
The common drug regulatory and standards system in the member countries of European Union can help the companies to capture the market by complying one regulatory standard set by the European Directorate of Quality of Medicines (EDQM), added the industry representatives in the IPA EDQM IDMA Symposium 2007 - Gateway to EU markets, held at Mumbai on Wednesday. The symposium was jointly organised by Indian Pharmaceutical Association (IPA), Indian Drug Manufacturers Association (IDMA) by hosting EDQM officials to explain the changing scenario of drug market and regulation in EU.
The Indian companies, which are already ahead in document filings and submission for certificate of suitability (CoS), can win the market by knowing the strategies of regulatory compliance, said Dr Milind Joshi, president - global regulatory management after his inaugural address. He added that the increased strength of Indian Rupees, with the Rupee appreciation would give the Indian companies an extra edge in export market.
The delegates from EDQM explained the latest developments and regulatory guidelines adopted by the directorate in the region for drug approvals. The companies should prepare themselves to upgrade with the standards using various strategies including awareness on the regulatory filing methods. The ongoing efforts to harmonise the standards for approval through upgrading the compliance standards with the International Conference on Harmonisation (ICH) guidelines is on the way, said Dr Claude Coune, Head of Publications and Multimedia department, EDQM. He explained the European authority's policy on monograph development and evaluation processes.
The harmonisation process has changed the EU the regulatory standards to equal or more stringent than the US standards, commented Dr Saranjit Singh, professor and head, Dept. of Pharmaceutical Analysis, NIPER in his presentation on Indian Pharmacopoeia.
The IDMA awards, for the best performance in pharmaceutical technology sector in 2007, have been distributed in the inaugural session. The Eminent Research Award for the year was presented to Dr Geena Malhotra from Cipla Ltd, The Pharmaceutical Technologist Award to Dr Shyam Khande from Dabur Pharma Ltd, Excellence in IP Development Award to Dr Raman Singh from Central Indian Pharmacopoeia Laboratory, Outstanding Pharma Analyst Award to Dr Jyothi Ganti from Matrix Laboratories Ltd and Quality Management Award was delivered to Dr Pramod Dalvi from Watson Pharmaceuticals.
Dr Parthasaradhi Reddy, chairman and managing director of Hyderabad based Hetero Drugs Ltd delivered the key note address while Dr G N Singh, director of Central Indian Pharmacopoeia Laboratory (CIPL) explained the current activities and vision of Indian Pharmacopoeia Committee (IPC). Dr Andrea Lodi, deputy head of laboratory department, EDQM explained the importance of controlling impurities by setting impurity standards for APIs and dosage forms. The welcome speech for the inaugural function was delivered by S D Joag, General Secretary, IPA and S R Vaidya, member of organising committee marked the vote of thanks.