The below article updates with few outcome of 70th DTAB (Drugs Technical Advisory Board) meeting held on August 2015.
Since 2006, medical devices entering India must be in compliance with the Indian Medical Device Regulations set forth by the Central Drug Standards Control Organization (CDSCO). The Drug Regulatory System in the country is now being monitored by the Prime Minister’s Office (PMO) as it relates to patient safety. The Government has allocated a fund of Rs. 2000 crore for strengthening of the State Drug Regulatory Infrastructure. The schemes involve 25% of the cost of each project to be borne by the concerned State. The amount is required to be utilized in the next three years. For latest updates you could keep an eye on our News section.
4 DTAB Meetings have been held at Joint Secretary Level for reviewing so far. In these DTAB meetings various topics/issues relating to New Drug, Clinical Trials, Medical Devices, IVDs and Cosmetics sector are discussed.
Updates on Drugs Technical Advisory Board (DTAB)
Update 1: Inclusion of Endometrial Ablation Devices as Notified Medical Device
In the 70th meeting of Drugs Technical Advisory Board (DTAB) held on 18th august, 2015 at CDSCO, HQ, New Delhi, the proposal to regulate endometrial ablation devices as medical devices under Section 3(b) of the Drugs & Cosmetics Act, 1940 was considered. Currently the CDSCO have officially identified 21 notified devices which must be regulated. In this meeting the Subject Expert Committee (Reproductive & Urology), after evaluating the matter on 16.01.2015 & 29-04-2015 had recommended to DTAB that the device is of critical nature, it need to be regulated to ensure its quality and safety. The DTAB after deliberations endorsed that ablation devices may be notified under Section 3(b) (iv) of the Drugs and Cosmetics Act, 1940.
The Endometrial Ablation Devices which are intended for treating heavy menstrual Bleeding (HMB) in woman in an outpatients setting. The Endometrial ablation device comprises of disposable single use device which is connected to counter-top size generator. The device is temporarily and non-invasively inserted into the uterus through the vagina without any surgical incision. No anesthesia is required. Once inside the uterus, it delivers controlled electromagnetic heat for 60-90 seconds or less to the lining of the uterus. The dielectric heat raises the temperature to over 50°C and creates thermal necrosis of the endometrium. After the heating is complete, the device is removed from the uterus and is discarded. This heating of the lining alters its nature thereby reducing or eliminating menstrual bleeding. The entire procedure is performed in the gynecologist’s office without anesthesia. The device is not an implant (such as the copper – T). The device does not deliver any pharmaceutical or chemical agents to the uterus.
The device which was considered during this meeting is manufactured in Germany and it has CE certification. The product is at present being imported into the country as unregulated devices.
Update 2: Extension of Validity of Test Licenses in Form 11 and Form 29
In the 70th meeting of drugs technical advisory board (DTAB) held on 18th august, 2015 at CDSCO, HQ, New Delhi, the proposal to extend the validity of the license to import drugs for test and analysis under form 11 and license to manufacture drugs for test and analysis under form 29 from one year to three years was considered. Representations were received from the Drug Manufacturer Associations and Department of Commerce that for the purpose of clinical trials and drug development, the licensees have to approach the licensing authorities for grant of fresh license every year. The DTAB agreed to the proposed recommendations that the validity of the licenses in Form 11 and in Form 29 to be increased from one year to three years. READ ALSO: Documents required for Clinical Trials in India.
Under the rule 33 of the Drugs and Cosmetics Rules, 1945 small quantities of drugs, the import of which is otherwise prohibited under the Act, are permitted to be imported for the purpose of examination, test and analysis in Form 11. The Form under serial number 3 provides the validity period of one year from the date of issue stated in the Form. Similarly license to manufactured drugs for the purpose of examination, test or analysis is granted in Form 29 under rule 89 of the said rules. Here also the validity of the license is for one year from the date of issue as specified in the Form.