Moxifloxacin is used as supporting drug for tuberculosis patients

Marking the country’s maiden drug approval, the World Health Organisation (WHO) has approved the first-ever Pakistani drug, paving way for a major boost in the country’s pharmaceutical industry.

The country’s leading news agency, The News International, reported that tablet Moxifloxacin Hydrochloride 400mg manufactured by Karachi-based Getz Pharma Pvt Ltd has been included in the lists of pre-qualified products after a detailed inspection.

Moxifloxacin, used as supporting drug for tuberculosis patients, is the first Pakistani drug to be accredited by the WHO despite that the country has over 450 drug manufacturing companies. In comparison, over 100 Indian and six Bangladeshi products have so far been accredited by the world health body, said an official of Drug Regulatory Authority of Pakistan (Drap), read the news report.

The WHO prequalification means the drug can now be sold to world bodies like the Unicef and will lead to approval by the US, the EU and other developed countries for sale. “This is the only way Pakistan can have a quantum jump in pharma exports, otherwise we will keep on exporting low quality products to third world countries in Asia and Africa,” he added, as quoted by the news agency.

According to the WHO report issued last week, its inspection team is satisfied with the drug quality, production units, quality control, sanitation and hygiene and good manufacturing practices for pharmaceutical products at Getz Pharma’s facility.

Getz Pharma had applied to the WHO over two years ago by submitting a dossier for Moxifloxacin. After preliminary review of the plant profile and technical dossiers, a WHO team audited the facility in August 2017 and informed the company last week that it stood pre-qualified.