WHO accredits first-ever Pak drug

ISLAMABAD: In a major development, the World Health Organisation (WHO) has accredited the first-ever Pakistani drug, paving way for a major boost in the country’s drug exports which currently stand at only $110 million.

According to the WHO, 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).

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 said.

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.

Pakistani pharmaceutical industry dates back to 1959. The country has about 600 manufacturing units set up by the local business community and multinational companies. However, till last week not a single manufacturing facility in Pakistan was accredited or pre-qualified by the WHO.

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.

Getz Pharma is Pakistan’s third largest pharma company and the largest exporter. It exports medicines to about 20 countries and has been receiving the FPCCI and the Prime minister’s Highest Export Trophy for the past 12 consecutive years.

The company claims it is the second largest taxpayer in the industry. Getz Pharma CEO Khalid Mahmood claimed that the WHO accreditation had put Pakistan on the map of the WHO and it will also give credibility to the country’s regulatory authorities such as Drap.

In addition, the company will be able to bid for the international medicine tenders. The company now plans to enter about 30 more international markets and expects that its exports will double within five years.

According to the WHO, this was the third inspection, with the last being in September 2015. The first WHO inspection was conducted in 2013 for quality control laboratory managed by Getz.

The site has also been inspected by the drug regulatory authorities of Ivory Coast, Tanzania, Ethiopia, Kenya, Yemen and Malaysia in the past three years. It is pertinent to mention that no other drug testing laboratory in Pakistan is accredited by the WHO including the facility run by the National Health Institute (NIH).