The U.S. Food and Drug Administration today approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.
The RNS Stimulator consists of a small neurostimulator implanted within the skull under the scalp. The neurostimulator is connected to one or two wires (called electrodes) that are placed where the seizures are suspected to originate within the brain or on the surface of the brain.
“The neurostimulator detects abnormal electrical activity in the brain and responds by delivering electrical stimulation intended to normalize brain activity before the patient experiences seizure symptoms,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
Epilepsy produces seizures affecting varied mental and physical functions. Seizures happen when clusters of nerve cells in the brain signal abnormally, which may briefly alter a person’s consciousness, movements or actions. According to the Epilepsy Foundation, epilepsy affects nearly 3 million people in the United States and is the third most common neurological disorder, after Alzheimer’s disease and stroke. Approximately 40 percent of people with epilepsy are severely affected and continue to have seizures despite treatment.
The FDA’s approval is supported by a three-month randomized control trial of 191 patients with drug-resistant epilepsy.
The study showed that by three months after the implanted device was turned on (active use) patients experienced a nearly 38 percent reduction in the average number of seizures per month, compared to an approximately 17 percent reduction in the average number of seizures per month in patients who had the implanted device turned off. At the end of three months, the median reduction in seizures, which reflects a more typical patient experience, was 34 percent with active use and about 19 percent with the device turned off. During the trial, 29 percent of patients with an active device experienced at least a 50 percent reduction in the overall number of seizures, compared to 27 percent for those with the implanted device turned off.
During a two-year follow-up phase (unblinded), data demonstrated a persistent reduction in seizure frequency.
Patients with RNS Stimulators cannot undergo magnetic resonance imaging (MRI) procedures, nor can they undergo diathermy procedures, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS). The energy created from these procedures can be sent through the neurostimulator and cause permanent brain damage, even if the device is turned off.
The most frequent adverse events reported were implant site infection and premature battery depletion.
The RNS Stimulator is manufactured by Neuropace, Inc. of Mountain View, Calif.
The Union health ministry will soon amend Rule 96 of Drugs and Cosmetics (D&C) Rules for labeling of vaccines with specific reference to the origin of the vaccine.
The ministry’s decision in this regard comes after the World Health Organization (WHO) expressed its concern that the vaccines which are manufactured by using different source of antigen have been labeled with the same manufacturing license number without having any unique identification number which otherwise does not provide the correct information in respect of the origin of the vaccine.
The WHO expressed its concern on the issue during the National Regulatory Authority assessment conducted some time back at Central Drugs Standard Control Organization (CDSCO) in respect of vaccines manufactured in the country.
As per Rule 122 E, all vaccines are considered as new drugs and any change in the source of antigen, the new drug approval is required to be obtained from the Licensing Authority. However, there is no specific provision under Rule 96 for labeling of the vaccine with specific reference to its origin.
The ministry, therefore, proposed that Rule 96 should be amended to include new drug approval number on the label of the vaccine granted by the Licensing Authority as defined under Rule 21(b) of the D&C Rules.
The matter was first considered in the 44th meeting of the Drugs Consultative Committee (DCC) held on July 20, 2012 and the committee agreed to the proposed amendment of the ministry.
The matter also came up for discussion during the Drugs Technical Advisory Board (DTAB)’s meeting held on November 25 last year. The DTAB after deliberations agreed to the proposed amendment.
The government is planning to the revise the good manufacturing practices (GMP) guidelines and would also consider making Schedule M on par with the WHO-GMP certification.
The Drugs Controller Genera of India (DCGI) is learnt to have asked for inputs from the experts in the field on revising the GMP in tune with the global standards and asked them to suggest the methodologies that could be adopted.
Another persistent demand from the industry is to make Schedule M on par with the WHO-GMP, avoiding the duplication of having both the certifications. At present, WHO-GMP is the mandatory requirement for global markets entry and specifically for countries which had no dedicated regulatory authority. It is also required for supplying drugs under the global diseases control initiatives such as TB, HIV/AIDS, malaria control project funded by Word Health Organization and other international agencies. On the other hand, for domestic supply the manufacturers should be Schedule M compliant only.
The DCGI is creating an international regulatory cell at his office with a view to make Indian system on par with the developed countries through different initiatives. The revision of GMP and integration of GMP with Schedule M are also going to be among the main tasks, it is learnt.
“Why should we have this dual-certification system. When we introduced WHO-GMP, there was no Schedule M norms. If India can give guarantee that Schedule M is as good as WHO-GMP, we can do away with one certification. Indian regulators should impress upon other countries and the WHO in this regard,” suggests former DCGI Dr Prem Gupta.
According to statistics, there are over 1350 WHO-GMP certified plants in the country. But industry leaders have pointed out that this number could be nearly doubled if the dual system is dropped. There are more than 1000 another small and medium scale manufacturers who had adopted Schedule M, they claimed.
It is also pointed out that there were no uniform standards of GMP from one country to another at the global level, creating hurdles for the exporters.
With a view to speed up the analytical testing of samples collected by drug inspectors from various manufacturing companies and traders’ premises, the Drugs Control Department in Chennai has given a proposal to the state government for setting up a new drug testing laboratory in Madurai.
The proposal also wants the government to seek funds from the Centre to proceed for the project without much delay. The total cost of the new lab is estimated at Rs.30 crore.
A Abdul Khader, director of drugs control, said the new laboratory would benefit the industry and traders covering 18 districts in the southern part of Tamil Nadu. He said if the central fund is allotted on time, the new lab would happen within two years.
The department further wanted the government to upgrade the existing lab in Chennai with sophisticated machinery in order to increase the quantum of samples tested every month. However, it is learnt that the Tamil Nadu Medical Services Corporation (TNMSC) has ordered instruments worth about Rs.14 crore to strengthen and increase the capacity of the Chennai lab.
“We have no latest equipment in our laboratory. We need a set of additional modern apparatus to speed up our testing capacity. The present capacity is 5000 samples which will be increased to 12000 after modernization. The department, through TNMSC, has earlier placed orders for 10 High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Mass Spectrometry (MS) and other state of the art apparatuses required for a sophisticated lab,” said the DC.
He said the lab will be equipped with the most modern technologies and it will become one of the biggest drug testing labs in the country. The total number of analysts was increased to 51 last year by appointing 33 junior analysts. The increased manpower will help speed up the testing analysis in the laboratory and reduce the delay in releasing the result. The number of field staff has been increased to 135.