Three cancer drugs — Obinutuzumab injection, Pertuzumab and Afatinib — have been allowed by the Union Health Ministry to be imported and marketed in the country without clinical trial on local population as these medicines are meant for the diseases for which there is no therapy at present.
In other words, said a senior official from the Ministry, “These medicines come under the category of ‘the drugs indicated for diseases for which there is no therapy’ in the country at present.” He said that these medicines are required for treating stages 3 and 4 of these cancers.
While Obinutuzumab injection in combination with chlorambucil is indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (Cll), Pertuzumab is indicated for the treatment of positive metastatic or locally recurrent unresectable breast cancer who have not received previously treatment or whose disease has relapsed after initial therapy.
Afatinib is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSClC) with epidermal growth factor receptor (EGFR) mutation, the official said.
He further said that Obinutuzumab injection has been approved in the US, Australia, Switzerland and Ecuador. Based on the fact that the drug got an orphan drug status in the US and Europe and it is a rare disease, therefore clinical trial waiver can be granted.
The new directive for approval of such drugs is as per recommendations of Ranjit Roy Chaudhury committee report. It says that, “the waiver of clinical trial on Indian population for approval of new drugs, which have already been approved outside India, can be considered only in cases of national emergency, extreme urgency, epidemic and for orphan drugs for rare diseases and drugs indicated for conditions/diseases for which there is no therapy.”