Drug regulator dysfunctional as fight against Covid-19 rages
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KARACHI: Bootleg hand sanitisers have flooded the retail market as demand skyrockets and imports are unable to keep pace.
Meanwhile, critical drugs needed for the fight against Covid-19 are running out.
Pharmaceutical executives say the Drug Regulatory Authority of Pakistan (Drap) has been dysfunctional for over a month now because 10 key posts of directors have been vacant, bringing key decisions on pricing, distribution, testing or introducing drugs to a halt.
“No new medicine can be approved for distribution in Pakistan at the moment” Pakistan Pharmaceutical Manufacturers Association (PPMA) Chairman Zaka ur Rehman says. “No price can be approved, no changes in permissions in production can be brought about, because the people required to make them are not there.”
The Drap has a cohort of 13 directors who discharge the various responsibilities that the regulator is tasked with, from pricing to product approval to vigilance. But for almost a year now, it has been hobbled by rapid turnover, of health secretaries who control key appointments, of CEOs and the directors posts have all been filled on an acting basis.
The ten directors who were performing this job thus far were appointed on three month terms that were renewed regularly. But on February 25, their tenure ended and notifications for renewal were not issued.
Asim Rauf, currently the acting CEO of Drap, told Dawn that as of Tuesday night five people had just been appointed to the posts. The notification issued by the authority said Faqeer Mohammad Shaikh has been brought in as Director Controlled Drug, Ghulam Rasool Dutani as Licensing, Dr Abdur Rashid as Pharmacy Services, Dr Mohammad Fakhruddin Aamir as Health and OTC and Dr Obaidullah as PE&R, as well as admin, human resource and logistics.
But the gap of more than one month means 30-40 companies making unregulated hand sanitisers have already entered the market, according to Rahman. Many of them are manufactured by non-pharmaceutical companies, in some cases firms that have no connection to medicines or consumer items at all.
All that is required, pharma executives tell Dawn, is ethanol, which is the most essential active ingredient in all sanitisers and is produced locally in sugar mills.
Medicines that are critical for the fight against Covid-19 have also been impacted. Kaiser Waheed, a former Chairman of the PPMA, says antiviral products are needed badly in the market to treat those infected. He points to India as an example where doctors are using a cocktail of Hydroxychloroquine and Azithromycin.
“The Drap has to approve medicines that can be developed or introduced,” he says, adding “but there has been nobody there to process these approvals” as the fight against the virus has intensified.
Khalid Mehmud of Getz Pharma is one of the only manufacturers of Hydroxychloroquine in the country. “We have no more stocks left and we cannot order new raw material because prices in the global markets have gone up by seven to eight times and are continuously increasing,” he says.
Meanwhile, the Drap has had nobody appointed in the key post where drug pricing is decided, so getting approvals for new pricing has not been possible. At this point Mehmud has no further stocks to sell and no raw materials on the way either.
“We need rapid decision-making by the regulator to be able to run this supply chain under present conditions,” he says.
Published in Dawn, April 1st, 2020
