Cadila Pharmaceuticals, Ahmedabad has formulated a polypill, a combination of five drugs for the treatment of cardiovascular disease and has completed its TIPS I study referred as 'The Indian Polycap Study' (TIPS) on humans was conducted at 50 centres across India. The Bangalore-based St John's Medical College Hospital was the main coordinator of this study. Now St John's is working towards TIPS II to assess the impact of the polypill to cure cardiovascular conditions.
St John's has sent in a proposal to the Wellcome Trust for funds to conduct the second phase of the polypill trial. The TIPS II is estimated to cost around US $12 million. While Wellcome Trust is expected to provide maximum grant of ₤7 million, the remaining will be sourced from other funding agencies including Cadila Pharmaceuticals, Dr Prem Pais, dean and professor of medicine, head clinical trials division, St John's Medical College told Pharmabiz.
Among the 50 trial centres for the TIPS I study included in Bangalore were Wockhardt and Mahaveer Jain Hospital. St John's provided the maximum number of patients for the study. Now the successful study report on humans will be submitted to the Drugs Control General of India (DCGI) for the commercial launch expected in May this year. From a scientific point of view, the polypill viewed as a five in one targeted to tackle cholesterol, blood pressure, and clot has not seen any side-effects, stated Dr Pais.
The drug will be easy on patients suffering from cardiovascular disorders. It will be marketed by Cadila not only in India but also abroad. For the European Union, company will have to undertake trials to prove that the cardiovascular diseases can be treated with the polypill, stated Dr Pais.