India calls for post-marketing data on cancer drugs approved without local trials
The committee, which met Dec. 24, is calling on cancer drug developers to submit the data, along with an analysis on safety and efficacy, to the DCGI (Drugs Controller General of India). The DCGI will then have to present the data to both the Technical and Apex committees.
Cancer drugs also “shall be placed on focused pharmacovigilance and the findings/summary shall be placed before these Committees,” the Apex Committee said.
The new recommendation comes after the Apex Committee agreed with technical committees to grant marketing approval to four out of five treatments that have not undergone local clinical trials. Two of the four drugs approved, including Merck’s Zolinza (vorinostat) and Medivation and Astellas’ Xtandi (enzalutamide), are treatments for cancer.
The only drug not granted approval was Janssen’s Sirturo (bedaquiline) -- which is approved in the US, EU and other major countries – because the clinical trial used to help approve the drug only included five Indian patients. “The number of subjects from India was not considered adequate to address the safety concern,” the Technical Committee said, and the Apex Committee agreed.
The Apex Committee also further clarified that in order for a local clinical trial to be waived, sponsors must establish that a treatment has been approved elsewhere and that it’s a case 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.”
India’s Parliamentary Standing Committee previously raised concerns about the approval of drugs in India without local trials.
In addition to the recommendations on drug approvals, the Apex Committee also agreed with the Technical Committee to approve nearly all clinical trials that sought approval. Of 31 applications submitted, both the Technical and Apex Committees concluded that 28 should be recommended for approval.
Among the trials rejected was one for a Phase III trial of a potential schizophrenia treatment that has not been approved anywhere in the world. The committee said that the safety and efficacy of the tablet had not been established in Phase I or II studies.