Cipla?s i-pill is not an exception (see FE dated Nov 19); the office of the Drug Controller General of India (DCGI) has allowed several other drugs including Letrozole (Sun Pharma’s fertility drug) and Nimesulide for paediatric use (marketed by Panacea Biotec) without the data provided to the regulatory authority by respective companies to ensure that the drug is safe in Indian population. Both, the Canadian drug regulator and the innovator company Novartis, have warned gynaecologists all over the world not to use its brand ‘Letoval’ for female infertility.
The company had issued a warning saying, ?The drug may cause foetal harm when administered to pregnant women.?
The DCGI, however, cleared Letrozole without having safety studies conducted in the local population. An e-mail to Sun Pharma asking the safety trials conducted in India remained unanswered, while a Cipla official told FE that the company has not carried out safety trial in India.
When contacted the Drug Controller General of India M Venkateswarlu said, ?In cases where we feel there is strong public interest and there is enough international safety data available, we approve a drug without having safety trials in local population.?
According to the schedule Y of the Drugs and Cosmetics Act, safety studies of a particular drug should be carried out in local population before granting marketing approval. It could be overlooked in case of any epidemic where there is paucity of time to conduct such trials, said a senior health ministry official. ?In these specific cases, there was no emergency to actually avoid safety trials,? the official added.