Biotech firm Biocon today said its has completed the Phase-IV clinical trials for its insulin drug Insugem.In a release issued to the BSE tdoay, the company said its wholly-owned subsidiary, Clinigene International, concluded the post-marketing surveillance study (PMS) on insulin vials involving 507 doctors and 6,164 patients across the country."This is the biggest PMS for insulin conducted in India. The number of patients involved were in excess of the regulatory requirement of 500 patients as stipulated by the Drug Controller General of India (DGCI)," the release said.About 99% of the investigators (doctors) opined that safety with Insugem was at par with the leading marketed brands of insulin in the country, and clinical response to the drug was excellent in around 99% patients in terms of safety, it said.PMS or Phase-IV studies are done as part of regulatory requirement to know primarily the safety of the drug in addition to the efficacy of the drug.
