Health ministry revokes suspension of manufacture, sale of dextropropoxyphene & formulations
The Union ministry of health revoked the suspension of the manufacture, sale and distribution of dextropropoxyphene and formulations subject to the conditions that the package insert, promotional literature and labeling of the drug shall clearly mention the use of the drug for cancer pain only. The direction says that the dose of the drug should not be more than 300 mg per day and the manufacturer shall advise doctors for use of the drug in cancer pain only.
The health ministry suspended the manufacture sale and distribution of dextropropoxyphene and formulationsin view of the likely risk involved to human beings in May 2013. Now the decision to revoke the suspension comes in the wake of recommendations of an expert group constituted by the ministry of health under the Chairmanship of Director General of Health Services, consisting of a group of cancer experts after detailed deliberations.
Drugs Technical Advisory Board (DTAB) agreed to these recommendations of the expert group to revoke the suspension of manufacture and marketing of the drug in the country.
Dextropropoxyphene is an analgesic in the opioid category, patented in 1955 and originally manufactured by Eli Lilly and Company. It is an optical isomer of levopropoxyphene. It is intended to treat mild pain and also has antitussive and local anaesthetic effects. The drug has been taken off the market in Europe and the US due to concerns of fatal overdoses and heart arrhythmias.