In a move that could affect sales of drug majors like Wockhardt, Lupin, Glenmark and Ranbaxy, the regulator has restricted usage of painkillers tramadol and tapentadol. Based on the recommendations of the new drug advisory committee, the usage of these two drugs — and their fixed dose combinations — has been limited to severe acute pain for a period not exceeding five days since these medicines have potential for respiratory depression and addiction.
The domestic painkiller market stands at R5,417 crore and it is growing at around 4%. While tapentadol is sold by top drugmakers such as Ranbaxy (Tydol) and Glenmark (Vorth TP), and makes for a R20-crore market, tramadol is manufactured by smaller players. Painkillers and anti-fever medications are usually available over the counter.
“The NDAC (analgesics, anaesthetics and rheumatology) at its meeting deliberated that tramadol as well as tapentadol have high potential for respiratory depressions and addictions. The committee recommended that all preparations of tramadol as well as tapentadol should be used for severe acute pain only for a period not exceeding five days,” said a recent directive from the Drug Controller General of India.
“The labels, package inserts and other promotional literature of such products should be revised,” the notice sent to all the state licensing authorities said. But no deadline has been prescribed to adhere to these restrictions, making patients prone to the risk of side-effects.
In June last year, the drug regulator had banned three drugs — Pioglitazone, Analgin and Deanxit — in the wake of a strong stand by the government on suspending marketing of all drugs prohibited for sale in other countries like the US, UK, EU and Australia. However, the government later decided to revoke the ban on anti-diabetic drug Pioglitazone and all its formulations due to inadequate reports on their possible harmful reactions in case of Indian patients.