Top drug maker Cipla has said it hasn?t carried out safety trials of its newly launched emergency contraceptive i-pill before marketing it in India.
When asked, Cipla?s medical services director Jaideep Gogtay said the company had not undertaken safety trials in the country. ?We had provided the safety data of a similar drug marketed in Europe.?
Drug Controller General of India M Venkateswarlu said, ?The company must have done clinical trials but I do not have the details.? When informed that there were no safety trials on Indian women, he said, ?The DCGI can approve a drug without safety data on local population if there are safety data available for similar drugs in other countries.?
?Section 122 of the Drugs and Cosmetics Rules says, if the amount of active ingredient in a fixed-dose combination of cleared medicines is altered, it has to be deemed a new drug. So, safety trials need to be done before marketing ,? CM Gulati, editor, Monthly Index of Medical Specialities, told FE.