LAHORE: Cumbersome and expensive regulatory requirements of the Drug Regulatory Authority of Pakistan (DRAP) are severely hampering new investments in the development of local manufacturing of Personal Protective Equipment (PPE) in the country, according to local manufacturers of PPE and other medical devices.

The PPE is equipment worn to minimize hazards that can cause serious workplace injury and illness, and comprises surgical and respiratory mask (for face protection), face shields and goggles (for eye protection), and gowns, aprons, head covering, gloves and shoe covers (for body protection).

Under the DRAP Medical Device Rules 2017, the PPE falls in the category of least invasive medical devices, and the manufacturers and importers of these items are required to fulfill several cumbersome and expensive conditions before they are legally allowed to manufacture for domestic sales.

For example, the manufacturers say, the rules require registration and enlistment of their establishments and products (each product/model even with slight variations has to be registered separately) through a process, which is ambiguous, tedious and, in most cases, prohibitively expensive, especially for manufacturers. The manufacturers – as well as importers – may take months and years before they can get an establishment registration license because of a number of factors as DRAP neither has the capacity nor manpower to process the establishment or device registration applications in a reasonable timeframe.

DRAP has only three staffers to look after its medical devices department compared to 500 in Malaysia, which has similar rules regulating the trade of medical devices, for the same job.

“Moreover, the rules require local manufacturers of medical devices to hire at least two qualified pharmacists as production manager and as head of their quality control operations just like any drug manufacturer. There is no such condition imposed by the US Food and Drug Authority or European Union. All they want is qualified persons who have studied sciences. This rule is becoming an impediment. Why would a textile garment manufacturer hire a pharmacist instead of a textile engineer to manufacture gowns?” asked a manufacturer.

This rule misses out on the needs of a manufacturer to hire engineers for these jobs, said another businessman who had recently developed disposable face masks for health workers to treat Covid-19 patients. He got orders from the USA and the EU but had to suspend production operations for local manufacture and sales when he realised the law treats the manufacturing of PPE and any other Category A medical device similar to pharmaceuticals drugs and need full compliance.

Manufacturing any kind of PPE without registering with the DRAP regulations is an offence even if the Ministry of Commerce allows its export, he added.

“The interesting thing is that the manufacturing of PPE without registering the establishment and device registration condition and/or not hiring two full time pharmacists turns the management of the establishment into criminals who may be fined and/or imprisoned for up to 10 years,” he said.

An importer of electro-medical devices said the main issue is that regulator does not realize that these rules were creating problems, seriously impacting on availability of PPE and other medical devices in the country. “It is interesting to note that the implementation of these rules from Jan 2018 turned the entire export-oriented surgical instruments industry of Sialkot illegal, jeopardizing $400mn exports. The exporters were forced to challenge these rules in the courts and obtain stay orders to carry on with their operations,” he said.

Similarly, other local manufacturers and importing companies working for the domestic market had either obtained court orders or had been operating illegally.

According to the industry sources, the enforcement of existing rules discourages local manufacturing and results in the shortages of quality and economical equipment in the market. Additionally, the rules have syntax, technical and logical errors and anomalies that can have detrimental implications on the medical devices business and make deployment of innovative technologies difficult and expensive. “Even foreign manufacturers are facing difficulty in complying with the DRAP requirements,” the importer claimed.

The government has been trying to regulate the medical device industry through DRAP and its relevant division on Medical Devices and Medicated Cosmetics since 2012. The first attempt to implement the regulations framed in 2015 failed because of DRAP’s failure to register Conformity Assessment Bodies (CABs) under them. Then the 2017 Rules were enforced in January 2018 and are still in the process of implementation. Only 15 companies have registered under the rules so far.

“The rules 2017 are not only cumbersome but also flawed, confusing and ambiguous, hampering their smooth implementation,” the electro-medical device importer argued. “This is because they are developed from the point of view of regulations of the pharmaceutical industry, and, therefore, often do not apply to medical devices manufacturing or import.”

In spite of these difficulties, the country had created PPE production capacity enough to not only meet domestic needs but also to export to the western nations. “The closure of factories in America and Europe owing to the Covid-19 restrictions, and souring US-China relations have opened up a huge PPE market for countries like us. If we don’t take advantage of this opportunity to fill this gap, others will. India and Turkey have already allowed their manufacturers to freely produce and export items like gloves, gowns, surgical masks, caps, shoe covers, etc.”

According to him, the DRAP rules were a major hindrance in PPE exports from Pakistan. “You cannot export unless you manufacture these products and you cannot manufacture them unless you meet the requirements of DRAP. The only way for us to take advantage of the opportunity created by the health crisis is to at least suspend the operation of these rules till this Covid-19 emergency is over. The US FDA has already suspended several conditions governing PPE imports into America till the emergency is over in order to cover the shortages to fight the pandemic.”

He further said the government had allowed companies to import PPE without registration for next three months due to Covid-19 health crisis. “Why can’t local manufacturers given the same waiver for next 18-24 months? This will eliminate the need to import and create export surplus to establish ourselves as a supplier of medical equipment,” the anonymous manufacturer concluded.

Published in Dawn, May 9th, 2020

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