On behalf of Oviya MedSafe, I am very glad to convey the season’s greetings to you through this July 2013 edition of Oviya MedSafe’s newsletter.
Oviya MedSafe made a mark in June 2013 by simultaneously starting to work with two new pharmaceutical markets – India and the Middle East. It was one of our breakthrough moments when we won the bid to write the Periodic Safety Update Reports (PSURs) meant for submission to the office of the Drug Controller General of India (DCGI), from one of India’s largest pharmaceutical companies. At this moment, I think it is worthwhile to add a small note on the regulatory requirements in India for submission of India-specific PSURs, which can be read below:
A Periodic Safety Update Report (PSUR) is a report which is submitted to the regulatory agency at set intervals in the lifetime of a product and provides an update of the safety experiences seen both nationally and globally since the product was authorized. In India, according to the requirements of Schedule “Y” of the Drugs and Cosmetics Rules, PSURs of new drugs are required to be submitted to the office of the DCGI once in six months for the first two years and annually for the subsequent two years. The PSURs due for a period must be submitted within 30 calendar days of the last day of the reporting period in order to:
• report all the relevant new information from appropriate sources;
• relate these data to patient exposure;
• summarize the market authorization status in different countries and any significant variations related to safety; and
• indicate whether changes should be made to product information in order to optimize the use of the product.
We at Oviya MedSafe are committed to take up the writing of India-specific PSURs as one of our main activities and consider it to be a part of our role in strengthening Indian pharmacovigilance by empowering generic pharmaceutical companies with pharmacovigilance support. We will be glad to extend the service to all Indian and multinational companies, including innovators, who market products in India. Please do contact us if you have a requirement.
As I mentioned earlier, our maiden venture in the Middle East market too happened in June 2013, with us being contracted to work on Corrective And Preventive Action plans (CAPAs) for one of the largest drug distributors in the region. And, as it is obvious, we are continuing and rather expanding the range of services which we have been offering to the European and the North American markets so far.
On the events’ front, I had the opportunity to speak on ‘Employment Opportunities in Pharmacovigilance for Indian Professionals’ at the National Level Seminar on ‘Widening the Horizons for Practising Pharmacists in Industries and Hospitals’, organized by the Department of Pharmacy Practice of PSG College of Pharmacy, Coimbatore on July 5th, 2013. I attended the Capacity Building Workshop on Pharmacovigilance in Clinical Trials, conducted by the All India Institute of Medical Sciences, New Delhi on July 16th, 2013.
I am happy to mention that I have been shortlisted to participate in the ‘WHO Dissemination Workshop on the Clinical Trial Registry of India’ organized by the National Institute of Medical Statistics in collaboration with the Centre for Research in Medical Entomology (both being constituents of the Indian Council of Medical Research) at Madurai in Tamil Nadu on July 24th, 2013.
Before signing off for the month, I am pleased to share with you that I have been inducted as a Special Invitee Member of the Pharma Research and Development Association, Ahmedabad, Gujarat (PRADA Global) which aspires to foster R & D activities & support companies, institutes and individuals to grow in their professional and personal domain. I hope I will be able to justify PRADA Global’s decision to add me to their board, with all your support and advice.
Looking forward to meeting you through our next newsletter edition in August 2013,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA
Managing Director & CEO,
Oviya MedSafe Pvt. Ltd.
Pharmacovigilance Consulting & Services
2nd Floor, KTVR Gardens,
220a-3, Marudha Konar Road,
Coimbatore – 641 025.
Tamil Nadu, India.
Office Mobile: +91-94422-25311
Office Phone: +91-422-2444442