Panel for Writing off Clinical Trials for 2 New Cancer Drugs

Abbreviated New Drug Application (ANDA)
  • The government's top advisory panel on medicines has recommended waiving off clinical trials for two new cancer drugs, allowing them to be sold without testing on Indian patients.
  • This according to the panel, is permitted to cater to unmet medical needs.
  • The move is vital as it comes despite a recent directive from the Supreme Court asking the government to be careful while approving clinical trials as well as new medicines.
  • The two medicines -Aflibercept and Trastuzumab emtansine -are used in treatment of metastatic colorectal cancer and metastatic breast cancer respectively.
  • The Drug Technical Advisory Committee, considered that since both the drugs have been tested in various other countries and found to be effective, these can be allowed for sale in India in public interest.
  • The law allows waiver of clinical trial in Indian population, only for drugs approved outside India, if there is national emergency , extreme urgency , epidemic, orphan drug or a disease for which there is no therapy .
  • Many health experts feel the proposed clinical trial waiver to the two cancer drugs is in violation of rules and can have serious implications for patients.
  • According to CM Gulati, editor of the Monthly Index of Medical Specialities and an expert on the rational use of medicines, Aflibercept and Trastuzumab emtan sine do not even qualify for exemption as there are alternative therapies available.
  • This is a false and fabricated claim because there are other therapies available for metastatic breast cancer, notably Lapatinib plus Capecitabine.
  • Colorectal cancer, one of the lifestyle-related cancers, is still not much prevalent in India.
  • Doctors say it is on rise as people are pursuing a western lifestyle