The Lahore Chamber of Commerce & Industry has appealed to the Drug Regulatory Authority (DRAP) to grant exemption to the local manufacturers of Class-A medical devices from operation of Article 52 of “Medical Devices Rules 2017” notified via SRO 32 (I)-2018.
In a letter written to the Drug Regulatory Authority of Pakistan (DRAP), chief executive officer, LCCI President Irfan Iqbal Sheikh said that in wake of current crisis related to Covid–19, there are serious concerns relating to insufficient supply availability of personal protective equipment for health care personnel in healthcare sector.
He said that Pakistan’s local manufacturers in many sectors have urgently geared up to supplement the government’s efforts by manufacturing the personal protective equipments, especially low hazarders as per DRAP categorization.
There is also an emerging opportunity to export these PPE’s (Class A/low hazard) devices and earn forex for the country. He said that to procure these Class-A devices, local manufacturers need to be registered as an establishment and enlist devices with DRAP which is a time taking process. He said that to fulfill the requirements of local needs, other countries/regulators have exempted several of their rules to help strengthen the nation’s public health protections against Covid-19 threats by ensuring the availability and use of these medical devices.
LCCI demands exemption to local makers of Class-A medical devices
