With an aim to help Indian pharmaceutical companies to comply with pharmacovigilance (PV) programme as per Schedule Y, a group of doctors based in Coimbatore has formed a company to help the manufacturing companies to carry out the PV activities.

According to Dr Vijay Venkitaraman, CEO of Oviya Medsafe Pvt Ltd, the standalone company engaged in the study of side effects of medicines, pharmacovigilance activities would help the pharmaceutical companies manufacture and supply safer drugs on the lines of the guidelines issued by central drugs standard control organisation. He said his company has sub centres in major cities in India coordinating overseas outsourcing of business.

“Oviya MedSafe Pvt Ltd is an exclusive firm engaged in pharmacovigilance activities which supports the growth of drug safety practices across the globe. As of now we are working with a couple of clients in Europe. We are yet to get business from India, but would like to provide our services to the companies in India. We have an expert team of drug safety doctors and pharmacologists working on data outsourced from companies abroad. Recently a Chennai based global management consulting firm, Ma Foi Strategic Consultants, has acquired 17.5 per cent stake in Oviya Medsafe Pvt Ltd,” Dr Vijay Venkitaraman told Pharmabiz.

According to him global pharma industry is under pressure as regulatory bodies such as the US FDA and EMEA tighten safety regulations, forcing adoption of  pharmacovigilance by pharmaceutical companies. He said the pharma industry is increasingly turning to pharmacovigilance experts to provide them with drug safety services. The current global PV market size is about US$ 12 billion. According to a Vision Gain report, by 2015, the market size would be US$ 15 billion, and will continue to grow in double digits till 2021, he added.

When contacted a drug expert in Chennai said any drug exerting a pharmacological effect may also induce a negative or harmful effect on the body, or interact with other drugs or substances the recipient may be taking. So it is important to monitor the side effects of all medicines from the first studies in humans and throughout the product’s life cycle. This  science of collecting, monitoring, researching, assessing and evaluating information about the adverse effects of medicines is pharmacovigilance, he said. According to him, as per schedule Y, any pharmaceutical company in India holding a marketing licence should have adequate pharmacovigilance system.

Dr J Vijay Venkatraman, a diabetologist and drug safety physician, pointed out that with reports confirming India as a high-skilled country for large scale outsourcing of pharmacovigilance activities, his company wants to step in as an end-to-end provider of global pharmacovigilance support. His expert team of senior advisors, physicians and pharmacovigilance professionals will strive to provide quality drug safety services to pharmaceutical companies, contract research organisations and both governmental and non-governmental health organisations, he said.