ISLAMABAD                     -                 As the Drug Regulatory Authority of Pakistan (DRAP) on Tuesday decided to approve registration of five medi­cines on emergency basis for clinical trials on critical novel coronavirus (COVID-19) patients, experts viewed that the approval based on assump­tions could be harmful.

The DRAP issued a notification to pharmaceutical companies for regis­tration of five drugs on priority basis being used worldwide on trial basis for the treatment of COVID-19 pa­tients.

The notification said that these medicines include Chloroquine Phos­phate, Hydroxycholoquine Sulphate, Lopinavir & Ritonavir, Oseltamivir and Ascorbic acid.

Dr. Obaid Ali, a pharmacist and ex­pert on medicines, told The Nation said that among the list two medi­cines (Chloroquine Phosphate and Hydroxycholoquine Sulphate) are anti-malarial, Lopinavir & Ritonavir and Oseltamivir are antiviral drugs while Ascorbic acid is used for the treatment of Ebola virus.

He said that these medicines were used for treatment of diseases like hepatitis-c, Ebola, Mars, Sars, malar­ia and arthritis.

Dr. Obaid said that manufacturing of antiviral drugs in multiple drug manufacturing facility is critical as it requires demonstration of clean­ing process that ensures cleaning of residual antiviral substance through the common manufacturing facility.

He said that all drugs are selected on the basis of assumptions and it could be harmful.

Dr. Obaid viewed that observation­al study is ‘nothing’ unless proven by double blind randomizes multi center large trial.

“It spreads false hope and assump­tions or incomplete information among public or health care provid­er,” he said.

He also argued that DRAP’s unrea­sonable attention may increase pre­scriptions for hydroxychloroquine that will lead to shortage and denied for lu­pus, arthritis patients who need it.

On the other hand compassionate use of any potential drug may be a treatment option that allows the use of an unauthorized medicine,” said Dr. Obaid Ali.

He also said that if it is required it may import it or ask for technology to develop product here but there must not be permission of consump­tion of drug manufactured during the hit and trial period.

Meanwhile, Chief Executive Officer (CEO) DRAP Asim Rauf talking to The Nation said that the medicines have been approved on trial basis for the patients in critical clinical situation.

He said that worldwide health ex­perts including Pakistan are taking trials for the treatment of COVID-19 patients.

“The medicines would be used as clinical trials for critical patients who are around 20 percent only,” said the DRAP chief.

However, he also admitted that the misuse of the medicines being reg­istered on priority could be harmful also.

“These are dangerous medicines and misuse of the medicine e.g Chlo­roquine damages heart vein and nor­mal person could become heart pa­tient,” said DRAP head Asim Rauf.

He also stressed that these medi­cines are for those who become crit­ical also saying that these medicines are worldwide being used on trail basis and not for the treatment.

He said that there is no issue of availability of these medicines and authority is giving registration to companies on an emergency basis.

The DRAP allowed the companies to submit registration applications Form 5, Form 5-a, Form 5-D or Form 5-E instead of Form 5F for formula­tions as approved by the reference regulatory authorities.

The DRAP letter said that the appli­cants can submit their applications till 02-05-2020 and the applications will be considered out of queue.

It also said that the validity of reg­istration period for above mentioned drugs registered during this time will be one year only and the registration holders will submit data of prod­uct development of 3 and 6 months within one year.

The data will be considered by the Registration Board for extension of validity period of registration for fur­ther period while the applications shall submit affidavit for compliance of point 4 & 5.