Drug registration: DRAP all set to digitize its systems by year-end

KARACHI: The Drug Regulatory Authority of Pakistan (DRAP) is all set to digitize its entire systems by the end of the current year to ensure hassle-free approval and registration of new medicines in the country as per the international best pharmaceutical practices.

This was stated by DRAP Chief Executive Officer Asim Rauf while meeting the Karachi-based drug producers at a meeting organized by the South Zone of the Pakistan Pharmaceutical Manufacturers’ Association (PPMA).

Rauf told the drug manufacturers that digitization of the DRAP was one step forward towards modernization of the pharmaceutical sector of the country as per international standards.

He said the automation would be adopted to such an extent that medicine producers wouldn’t be required to physically visit the DRAP offices not even once for getting necessary approvals for pharmaceutical products in the country.

He told participants of the meeting that DRAP was fully committed to the cause of modernizing entire systems of drug production as per the latest international standards for enhancing exports of medicines from the country.

He urged all the medicine manufacturers in the country to establish drug testing systems and hire qualified human resources in the requisite number to meet international drug production standards.

Rauf said that the decades-old obsolete drug inspection system was gradually being done away with and in its place, a risk-based auditing regime for drug industries was being introduced by the DRAP to uphold the honor and dignity of the medicine producers.

He urged the large producers of medicines that already have obtained the necessary international accreditations to help other drug manufacturers in the country to meet the same global standards for enhancing medicinal exports from Pakistan.

He told the audience that the DRAP had recommended to the government to deal in the Chinese currency RMB for the import of raw materials for drug production and medical devices for uninterrupted pharmaceutical production in the country that could otherwise be halted due to drastic measures by the government against imports.

The DRAP chief offered to the drug manufacturers to meet after every six months to review the process of removing bottlenecks for enhancing pharmaceutical exports from Pakistan.

He said the pharmaceutical industry of Pakistan had the ability and competence to compete with drug producers from any part of the world for capturing the global export market of medicinal products.

Also speaking at the meeting, PPMA Chairman, Syed Farooq Bukhari said that pharmaceutical exports from Pakistan stood at around US $ 280 million a year.

He said the PPMA had been making efforts to enhance it to $10 billion in the coming few years to become one percent of the global pharmaceutical export market.

He said the PPMA would fully support the policy decisions of the government to increase exports of medicines from the country so that the drug producers could play an important role in reversing the economic downturn.

Former PPMA Chairman, Kaiser Waheed suggested to DRAP end its traditional system of inspecting drug manufacturing sites as instead, it should launch an advisory service for medicine producers to overcome technical gaps in their manufacturing facilities.

He said the DRAP should simplify and speed up the approval process for drug exporters from Pakistan.

Copyright Business Recorder, 2023