Q.1 Whether Drugs are under the ambit of “Legal Metrology (Packed Commodities) Rules 2011” ?
A. No, as per the Rule 26 (c) under Chapter V of the Legal Metrology (Packed Commodities) Rules 2011, the Scheduled & non scheduled formulations are exempted from the provisions of these Rules, however Medical devices are not exempted.
Q.2 Under which Rule of Legal Metrology (Packed Commodities) Rules 2011 exemption has been given?
A. As per rule 26(C) under Chapter V of the Legal Metrology (Packed Commodities) Rules 2011, all the scheduled Drugs and non scheduled Drugs are exempted.
Q.3 By which notification such changes have been made and date of such exemption are effective?
A. Notification no. GSR 629(E) dated 23 June 2017 which is effective from 01 January 2018.
Q.4 What are the parameters to be mentioned on the labels of medical devices as per Legal Metrology (Packed Commodities) Rules 2011?
A. Quantity, MRP, Expiry Date, Customer Care Number etc. should be mentioned on the medical devices.
Q.5 What is the status of blood bags? Whether these fall under the definition of Medical Devices ?
A. Blood bags are medical device as per section 3(b)(iv) of Drugs and Cosmetics Act 1940.
Q.6 Who is the Licensing Authority to issue license to manufacture blood bag?
A. It comes under the category “C” of Medical Devices Rules 2017. Drugs Controller General (I) is the Licensing Authority to issue manufacturing license for blood bags.
Q.7 What is the status of CPD-A blood bag ? Whether it falls under the definition of Medical Devices ?
A. The government has notified CPD-A blood bag as medical devices w.e.f. 16/08/2018.
Q.8 Whether CPD-A blood bag containing Whole Human Blood IP is drug or Medical Devices ?
A. It is drug as per Section 3(b)(i) of the Drugs and Cosmetics Act 1940.
Q.9 Whether blood bag is scheduled or non scheduled formulation under DPCO 2013?
A. It is non scheduled formulation under DPCO 2013.
Q.10 Whether the blood bags are under the ambit of DPCO 2013?
A. Yes, as per notification No. 1232 (E) dated 31.3.2020 wherein all medical devices to be governed under the provisions of the DPCO 2013 w.e.f. 01/04/2020.
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