ISLAMABAD: The Registration Board of the Drug Regulatory Authority of Pakistan (DRAP) accorded registration to over 400 medicine brands in its 327th meeting and banned all brands of hydroxyprogesterone caporate injections (progesterone) after US Food and Drug Administration (FDA) withdrew its approval for being carcinogenic (cancer-causing) and non-effective, officials said Friday.
The 327th meeting of the DRAP Registration Board, was chaired by Chairman Dr Fakhruddin Aamir, accorded approval for the registration to over 400 human and veterinary medicines and therapeutic goods. It also deferred over 200 applications for the registration of finished medical products as well as active pharmaceutical ingredients (API) for more data and documents.
Those medicines that were allowed to be produced included already available antibiotics, painkillers, anti-inflammatory drugs, medicines for the control and treatment of diabetes, gastrointestinal (GI) issues, anti-epileptic medicines, antipsychotics drugs and many others while several medicines of veterinary uses were also given registration, registration board officials said.
Following U.S Food and Drug Administration (FDA), the DRAP registration board cancelled the registration of all the brands of “Hydroxyprogesterone Caporate”, which is used to help pregnant women help lower the risk of giving birth too early (preterm birth or giving birth less than 37 weeks of pregnancy). “The registration board of DRAP cancelled the registration of all the brands of hydroxyprogesterone caporate injections after US Food and Drug Administration (FDA) withdrew its approval for being carcinogenic (cancer-causing) and non-effective”, the registration board official added. This injection is branded as Makena and its generic versions.
According to gynaecologists and pharmacists, over 8 million injections of hydroxyprogesterone caporate and its combination medicines were used in Pakistan to prevent preterm birth in women.