Cancer drugs get nod without trials

Hyderabad: 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.

These 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.

Imran Ahmed, 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.

However, 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.

The 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.

Dr Srinivas Chilkuri, senior oncologist at Yashoda Hospitals, said, “The government has made a good decision to introduce these drugs without clinical trials.

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.

Hence, they will be given only on prescription and distributed through a notified set of chemists who will have to pay a huge licence fee.

In 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 Indian patients.”

Other oncologists feel that once marketing is allowed, the government must intervene and ensure that these drugs are available at affordable prices.