DRAP dragging on

Delay in legislation hampering import of crucial medical devices

Karachi: The federal government’s failure to effect necessary amendments in Medical Devices Rules 2017, as proposed by the DRAP, has blocked the clearance of thousands of medical devices of dozens of national and multinational pharmaceutical firms from the customs department, putting the lives of patients across the country at danger.

Various lawsuits were recently filed in the Sindh High Court by multinational pharmaceutical firms, claiming that despite meeting all the conditions of the Drug Regulatory Authority of Pakistan (DRAP), Pakistan Customs has not been clearing the life-saving medical devices including Covid-19 test kits.

Explaining the role of various functionaries in the manufacturing and import before a single bench of the SHC; comprising Justice Adnan Iqbal Chaudhary, the counsel for different plaintiffs stated that the DRAP established under the Drug Regulatory Authority Pakistan Act, 2012, which operates under the Ministry of National Health Services, to regulate the production/manufacture, sale and import of therapeutic goods in Pakistan.

The Medical Devices Board, a statutory body formulated under the DRAP Act, and the Medical Devices Rules 2017, has been conferred with the powers to evaluate, register, and renew the registrations by the said laws. Customs and the Federal Board of Revenue are authorised to release the shipments under section 25 of the Medical Devices Rules, 2017.

The plaintiffs have been in the business of import, supply and distribution of critical medical devices, including reagents and instruments for diagnostic laboratory testing like liver function, cardiac markers, Covid-19 testing kits, PCR tests and ICU monitoring for many years.

The counsel explained that in Pakistan, medical devices are regulated as per rules, under the DRAP Act 2012. This act was approved in 2018. The rules require the importer of a medical device, to first obtain approval from the division of medical devices of DRAP through a license to import medical devices. It further requires the importer to register the medical devices to be imported. The device classification system comprises four classes where Class A represents the lowest hazard and Class D the highest.

The counsel informed that duly enlisted, the plaintiffs made various applications for the registration of medical devices, with their accessories. They were imported from their principal manufacturers and provided all relevant documents along with the product dossiers to the board of medical devices for their approval.

They claimed that the rules have been a serious cause of concern for the manufacturers and importers since their promulgation. The same imposes vague requirements of registration and licensing, without any regard for the interests of the concerned stakeholders.  The evolving population needs better health care and improved quality of life. Consequently, the Medical Devices Rules, 2017 have been under constant deliberation for necessary amendments to facilitate the manufacture import and sale of essential medical devices in the country. For the same reason, the federal government had previously extended exemption from the operation of rules. According to which medical devices of Class A, B, C, & D were allowed exemption from registration for different periods, the latest of which is for class A, which is expiring on December 31, 2022. The exemption period for Classes B, C, & D has already expired.

The counsel explained that imported medical devices are largely supplied to hospitals and institutions across Pakistan, and the plaintiffs’ inability to freely supply their products to the hospitals will create a huge disparity in the market demand-supply.

The grievance of the plaintiffs, according to the counsel, is that Customs Authorities are not accepting the Establishment Certificate already issued for the import of medical devices, and not clearing goods from various ports. The counsel submitted that the Customs Act does not require the presence of the provisional enlistment and registration for the import of the devices, which the customs authorities are demanding.

The federal counsel claimed that this situation has developed as the Federal Government has miserably failed to discharge its regulatory duties to approve the stated amendments which have already been moved by DRAP. Therefore plaintiffs cannot be held accountable for the delay in the approval of the amendments to rules.

The government lawyers and the DRAP authorities have been trying to solve the problem on case to case basis by giving different sorts of undertakings to the court. However, multiple issues keep propping up, which the counsel for various firms pointed out during the hearing could be solved by passing the amendments moved by the DRAP in the rules.