Locally produced drugs need quality control.

Madam, Discovery of H2 blockers was a major break through in the treatment of peptic ulcer disease with healing rates ranging from 65% to 89% and a 70% relapse wIthin a year. Delayed response and compliance was a major problem with H2 blockers. Proton pump inhibitors (PPI) were introducted for better compliance both in terms of dosage and duration and early return to work (due to rapid pain relief). Healing rates with various PPI’s arc around 100%. Studies Were conducted at our centre using different omeprazoles like Losec, SanamidoL and Sante to see the efficacy of locally produced drugs (Sanamidol and Sante) against internationally produced product. All patients had endoscopically confirmed duodenal ulcer. Patients with malignancy, chronic renal or liver disease, those on steroids or NSAID’s were excluded from the study. Each patient was given omeprazole (20 tug) to be taken as 1 cap after breakfast, Healing was assessed cndoscopicnlly at 2 and 4 weeks. (only non—healers nt 2 weeks were given a further treatment for 28 days). Non-healers at 4 weeks were catagorized as non responders. Any side effects if noted were also recorded. The healing rates at 2 and 4 weeks with Losec were 80% and l00%, with Sanamidol were 62% and 85% and with Sante were 64% and 95% respectively. There is a wide range of healing in these studies suggesting that the efficacy of these drugs is variable. As the patient population, examination centre and the endoscopist remain the same, removing the chances of observation bias, therefore it appears that the drug potency is at fault due to various reasons. As the cost of these omeprazoles is also variable therefore most patients tend to buy the cheaperdrug without knowing the response rate. Good quality control therefore is essential to make ulcer healingcost effective and a reality.