Drug to ease cancer pain legal again

Dextropropoxyphene was banned four years ago in India

More than four years after popular drug dextropropoxyphene, used for treating cancer-related pain, was suspended following safety concerns, the government’s chief advisory body on drugs — the Drugs Technical Advisory Board (DTAB) — revoked the ban on the condition that the drug be sold with the label indicating that it should be used for “cancer pain only”, and that its dosage should not exceed 300 mg per day.

“The manufacturer shall advise the registered medical practitioners to administer or prescribe the said drug and its formulations for use in patients with cancer pain only,” said the government’s notification.

Earlier, an expert group was constituted by the ministry of health and family welfare under the chairmanship of the director general of health services, consisting of a group of cancer experts, which recommended that the suspension of the manufacture and sale of the said drug may be revoked subject to the conditions that the package insert, promotional

The ban on the drug was revoked under the condition that it only be sold with a label that says it’s for ‘cancer pain only’ and that its dosage shouldn’t exceed 300mg a day

literature and labelling of the drug shall clearly mention the use of the drug for cancer pain only, and that the dose of the drug should not be more than 300 mg per day.

The DTAB agreed to the recommendations of the expert group to revoke the suspension of the manufacture for sale, sale and distribution of dextropropoxyphene and formulations containing dextropropoxyphene for human use.

Ironically, the cancer painrelieving drug has already been withdrawn from various countries including Australia, Canada, the European Union, New Zealand, the UK, and the US. The UK was probably the first to issue a notification regarding its withdrawal in January 2005, and later it was withdrawn across the EU in 2009.