P L D 2021 Lahore 314
(a) Drugs Act (XXXI of 1976)---
----S. 3(g)(ii), (vi)---"Drugs" and "medical devices"---Scope---Definition of 'drug' is not limited to medicine or substances which are ingested, applied or administered but includes devices---Federal Government is allowed under S.3(g)(vi) of Drugs Act, 1976 to notify any substance or device as "drug".
(b) Drugs Act (XXXI of 1976)---
----S.3(g)(ii), (vi)---Medical devices---Scope---Medical devices include health care equipment as well as devices used in cosmetic surgery and processes as well as in-vitro diagnosis medical devices (IVD)---As per definition given by the World Health Organization, it is the purpose of medical devices which is relevant and which renders medical devices to regulations similar to drugs and medicines---Such is fundamental to health and safety of user of medical devices---'Drugs and medicines' cannot be restrictively construed particularly when records shows that drugs include medical devices.
(c) Drug Regulatory Authority of Pakistan Act (XXI of 2012)---
----Ss.7 & 32---Drugs Act (XXXI of 1976), S.3 (g) (ii), (vi)---Medical Devices Rules, 2017, Rr.24, 25 & 29---Constitution of Pakistan, Art. 199---Constitutional petition---Drugs and medical devices---Drug Regulatory Authority of Pakistan (DRAP)---Role and jurisdiction---Medical Devices Board---Petitioners were importers, exporters and manufacturers of medical devices---Plea raised by petitioner was that medical devices did not fall within the ambit of 'drugs and medicines'---Petitioner further contended that under Drug Regulatory Authority of Pakistan Act, 2012, medical devices were included under 'therapeutic goods' therefore, Medical Devices Board constituted by DRAP was a result of excess delegation of power---Validity---Purpose of the Authority was to regulate manufacture, import, export, storage, distribution and sale of therapeutic goods---Therapeutic goods have a health related purpose and are to be regulated for safety efficiency and efficacy---Medical devices are specifically and purposefully included in range of therapeutic goods for the purposes of regulation---It is for DRAP to decide whether a medical device fell within their regulatory domain, as underlying principle is the purpose for which the device is used---Medical devices play a significant role in health care delivery and also carry some element of risk associated with the purpose and usage---Medical devices are regulated by DRAP to ensure safety, effectiveness and quality and are assessed on the basis of their classification---Medical devices are classified in for categories based on intended use with class A as the lowest in risk and class D as the highest in risk---Mere fact that a product was registered with a regulatory authority of foreign jurisdiction did not mean that medical device should not be scrutinized at the time of manufacture, import or export by DRAP to ensure compliance with its regulatory requirements---For the purposes of medical devices manufactured, imported or exported into Pakistan or from Pakistan it must be ensured that standards set out by DRAP were complied with
0 Comments