Govt okays clinical trial of plasma therapy, locally made ventilators

Published April 10, 2020
Export of anti-malarial drug allowed; Sindh CM hints at extending lockdown for another week. — AFP/File
Export of anti-malarial drug allowed; Sindh CM hints at extending lockdown for another week. — AFP/File

ISLAMABAD: While the number of the novel coronavirus (Covid-19) cases in the country has risen to 4,500, the government has taken some major decisions, including approval of clinical trials of plasma therapy and locally made ventilators for treatment of critically ill patients and permission for manufacturing of sanitisers and production of Chloroquine, the medicine for malaria.

On the other hand, the government has come under criticism over its decision to allow export of Chloroquine as Pakistan is located in the ‘malaria belt’ and the medicine is being experimented as a possible treatment for Covid-19.

Meanwhile, Sindh Chief Minister Syed Murad Ali Shah hinted at extending the lockdown, which is going to end on April 14, for one more week as seven members of a family belonging to Karachi’s District Central have been infected with the virus.

According to a statement issued by the Drug Regulatory Authority of Pakistan (Drap), the authority has held back-to-back expert committee meetings to evaluate the applications for manufacturing of various items, inc­l­uding mechanical ventilators and hand sanitisers, and production of drugs.

“The Central Licensing Board of Drap has approved local manufacturing of Chloroquine phosphate active pharmaceutical ingredient (API), a drug used in management of Covid-19 patients. Now Chloroquine API can be manufactured indigenously to meet the requirement of those pharmaceutical companies that prepare Chloroquine phosphate tablets, injections and syrups,” it states.

Export of anti-malarial drug allowed; Sindh CM hints at extending lockdown for another week

“In another meeting, the Clinical Study Committee (CSC) of Drap allowed clinical trials of convalescent plasma for the purpose of passive immunisation during the Covid-19 pandemic in Pakistan. The application was submitted by Professor Dr Tahir Shamsi, principal investigator and chairman of the National Institute of Blood Diseases and Bone Marrow Transplantation, Karachi. In this study, convalescent plasma from recovered Covid-19 patients would be injected into the bodies of moderate and serve patients for the purpose of passive immunity for the treatment and to prevent these patients from going on ventilators,” the statement said.

“The CSC also approved clinical trial/ test of basic ventilators developed by the Pakistan Engineering Council. This will facilitate manufacturing of mechanical ventilator to meet the national requirements. To ensure free availability of quality hand sanitizers, Drap has enlisted more than 50 manufacturers to prepare sanitizers for three months,” the statement said.

Special Assistant to the Prime Minister (SAPM) on Health Dr Zafar Mirza told a press conference that a decision had been made to provide personal protective equipment (PPE) to 152 hospitals, sufficient for one week, across the country and later the number of hospitals would be increased to 400.

“PPE will be provided to 74 hospitals of Punjab, 42 of Sindh, 21 of Khyber Pakhtunkhwa, seven of Islamabad and four each of Balochistan and Azad Jammu and Kashmir. The PPE includes N-95 masks, gloves, goggles, gowns, etc,” Dr Mirza said. “Moreover we will establish a database to get the intimation which hospital needs more PPE.”

“The media has been claiming that less number of cases, as compared to estimates, has been reported in Pakistan. It is true but people should continue taking precautionary measures as a sudden surge in cases can be observed anytime,” he said.

Meanwhile an eight-member team of Chinese doctors and medical experts called on President Dr Arif Alvi. The team was led by Dr Ma Minghui, an expert in infectious diseases.

President Alvi thanked the Chinese team for visiting Pakistan when it was relentlessly engaged in containing the spread of coronavirus.

Export of Chloroquine allowed

According to a notification issued by the Ministry of Commerce and available with Dawn, the ban on the export of anti-malarial drugs has been withdrawn forthwith.

Reacting to the move, Pakistan Medical Association leader Prof Dr Shahid Malik said that Pakistan needed the medicine due to its location in ‘Malaria Belt’ and it was unfortunate that its export had been allowed which could lead to its shortage in the local market.

Last month US President Donald Trump had claimed that the Food and Drug Administration (FDA) had approved the use of “very powerful” drug Chloroquine to treat Covid-19. He said the medicine had shown very encouraging results and would be available in the market almost immediately.

However, the FDA issued a statement saying it had not approved the medicine for use against Covid-19 and was studying its use for this purpose. However, due to the statement of Mr Trump, irrational use of the drug started across the globe as a prophylactic treatment.

An official of Drap said after the statement of Mr Trump, medical stores in Pakistan were directed that, just like controlled drugs, medical stores would have to keep a copy of the prescription before selling Chloroquine.

“As its export has already been banned, we also did stocktaking of the medicine and as per our record there are around 25 million tablets and around 9,000kg of raw material in the market. In general circumstances the medicine is sufficient for one year but we have learnt that people had started using the drug as prophylactic treatment so we banned the sale without prescription. However it is unfortunate that the export of the medicine has been allowed,” he said.

A prophylactic treatment is used to prevent a disease from occurring.

On March 22, SAPM Mirza had also said that the sale of Chloroquine without prescription had been banned.

“It is an old medicine which is being used for treatment of malaria but it has suddenly disappeared from market,” he said.

Published in Dawn, April 10th, 2020

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