In 2 very unusual scenarios the Indian regulations seen not in sync. In one scenario we saw Drugs Controller of India (DCGI) taking an initiative to regulate clinical trials, CROs whereas in other case we saw lapse in Indian laws dealing with the testing and approval of drugs when a new diabetes drug was approved without trial.
There was a zeal among the clinical research community with DCGI’s announcement of “Registration of CROs in the country will become mandatory from June in view of glaring deficiencies found during the audits as the sponsors, monitors and Contract Research Organisations (CROs) do not adhere to protocols”. This decision embarked a new rising of the Indian regulations.
However, few days later there were reports of “A new drug to combat diabetes, which is administered orally and not injected, was given a marketing approval by the Drugs Controller General of India (DCGI) without being put through the mandatory human clinical trials”.
As per the Drugs and Cosmetics Rules any change in route of administration makes even an old, approved medicine, a ‘new drug’ making the clinical trials mandatory.
Anoop Misra, director and head of department of diabetes and metabolic diseases, Fortis Hospitals who reviewed the published papers said, “Most of this data are preliminary and anecdotal, and do not make a strong case for it. Its safety remains to be demonstrated, especially in view of (the) fiasco of inhaled insulin.” He has not prescribed the drug to any patient as the side effects are not clear due to inadequate data.
Once again the practitioners would be in the lime light in view of their ethics and GCP while prescribing such a drug.
