As mentioned earlier, there are several drugs that continue to be sold in the Indian market even though they have been withdrawn elsewhere. The Committee decided to look into allegations that some such drugs had been approved unlawfully, and found several cases where drugs had been approved in contravention of the existing laws.
- Buclizine, an anti-histamine, was approved for appetite stimulation in children without any expert consultation or clinical trials. As per the law, if a drug approved for one condition is proposed for the treatment of a different condition, it must be treated as a new drug, following all the required procedures and meeting all regulatory requirements. This was not done for buclizine. The Ministry also claimed that buclizine had been previously approved in other countries, when in fact it had either been discontinued or banned in those countries.
- Letrozole, an anti-cancer drug, is to be used for the treatment of breast cancer only in women of post-menopausal age. Yet, India was the only country where letrozole was approved for improving female fertility in women of reproductive age. No Phase II studies were conducted, an especially crucial requirement since this drug had not been tested for its impact on female fertility anywhere else in the world. Phase III trials were approved without any Phase II information being provided, and were conducted on a small group of women, far fewer than the number specified in Good Clinical Practice rules. No post-marketing surveillance reports were provided by the manufacturer to determine whether this novel use of letrozole had any adverse impact, either on the women taking the drug or the babies born to them. When the entire episode received negative coverage in the media, CDSCO took no action against any erring officials or the manufacturer, and instead referred the matter to experts to determine drug efficacy and safety. The drug has since been banned for use in improving female fertility, and the report sternly demands that the DGCI "...take action against those CDSCO functionaries who colluded with private interests and got the drug approved in violation of laws."