Covid-19 drug trials begin — but no one qualified to approve treatment

Experts point out DRAP is merely a registration authority

KARACHI:

As the world scrambles to put the pandemic behind us, clinical trials for a coronavirus vaccine have been initiated in Pakistan as well. However, no institution in Pakistan is qualified to approve or assess a new drug. The trials are reportedly being carried out in collaboration with international partners.

The Drug Regulatory Authority of Pakistan (DRAP) focuses mostly on fixing rates and registration of drugs. Any new treatment or drug can only be adopted in Pakistan after it has been approved and used by an institution from a country such as the United States of America, Japan, Canada, Australia or any of the European countries.

DRAP only approves a drug after it has been successfully used in a developed country, explained the authority's former senior officer Dr Ubaid Ali while speaking to The Express Tribune. "Research and analysis by DRAP has not yet acquired the status to approve a new drug to use within Pakistan or elsewhere."

According to Dr Ali, the Pakistani government is responsible for analysing and testing any new type of medical treatment. The government has passed on this responsibility to DRAP under the Constitution.

Similarly, National Institute of Blood Diseases chairperson Dr Tahir Shamsi also confirmed that DRAP did not have the authority to approve a new treatment. He specified that DRAP approves medicinal drugs after the US Food and Drug Administration has approved their use. DRAP's role is limited to registration of drugs, according to Dr Shamsi.

"This is why many unauthentic and unapproved treatments are being used in Pakistan's hospitals without patients being told about the benefits or side effects of the treatment," he said.

Dr Shamsi was of the view that a framework for the approval of new medical treatments should be developed and given to DRAP so patients aren't left to be experimental subjects.

Any new drug in the world that reaches the market makes its way after going through several stressful stages, and the entire process costs at least Rs160 billion, he told. But Pakistan does not yet have a notable role in drug invention or in taking such drugs to the market, he added.

Therefore, all new drugs introduced in Pakistan are done so after being successful globally, after which DRAP permits its use, stated Dr Ali, adding that Pakistan currently lags behind other countries when it comes to the use and approval of new drugs.

Published in The Express Tribune, October 5^th, 2020.