The drugs that have been approved for marketing in India without
clinical trials:Obinutuzumab injection, Pertuzumab, Afatinib
Three drugs Obinutuzumab injection, Pertuzumab and Afatinib used for
lung cancer, breast cancer and blood cancer, have been cleared by the
Union health ministry to be marketed in India without clinical trials.
medicines are required for treating stages 3 and 4 of these cancers.
The decision has come as a boon for patients who have been struggling to
get these medicines.
30, a businessman in the city, was diagnosed with blood cancer. The
first line of treatment didn’t work for him and he was prescribed this
targeted therapy drug.
importing the drug cost Rs 1.75 lakh per month. Mr Ahmed’s wife, Razia,
said, “We could get the drug only for two months.
price of the medicines and the manner in which we went around asking
for help killed him from inside. He refused to even talk about medicines
and we were forced to abandon treatment.”
He is bed-ridden now and the family members are not seeking help as they know that chances of survival are slim.
Srinivas Chilkuri, senior oncologist at Yashoda Hospitals, said, “The
government has made a good decision to introduce these drugs without
These advance therapies are needed for patients who have stopped responding to the first line of treatment like chemotherapy.”
Senior oncologist Dr Srikanth K. said, “The medicines are expensive and they must not be misused.
they will be given only on prescription and distributed through a
notified set of chemists who will have to pay a huge licence fee.
India, the drugs that are used for a year in the US are consumed in
four months. This shows the demand and consideration must be given for
feel that once marketing is allowed, the government must intervene and
ensure that these drugs are available at affordable prices.