The Drug Regulatory Authority of Pakistan (Drap) is considering issuing licenses to one or more importers to ensure the procurement of quality raw materials, after a number of incidents in which impurities were found in raw materials for medicines and edible items.

The authority has also decided to take strict action against the illegal sale purchase of raw materials for medicines within the country.

A few weeks ago, Drap had directed nine pharmaceutical companies to recall high blood pressure medicines prepared from valsartan raw material, manufactured and supplied by Zhejiang Huahai Pharmaceuticals, China.

The direction for the recall was made after an alert was issued by the European Medicine Agency (EMA) which detected N-nitrosodimethylamine in the raw material, which could cause cancer.

The incident caused panic in patients and many decided to switch to medicines of multinational companies which cost 10 times more.

However, Drap has claimed that the issue regarding the manufacturing of high blood pressure medicines has been addressed as companies have started using active pharmaceutical ingredient from alternate sources.

In April this year, on Drap directions, a commonly used cough syrup was recalled from the market as its stability data was out of specification and the product contained a controlled drug.

A few months ago, the owner of a pharmaceutical company was arrested on the directions of the chief justice over allegations of manufacturing drugs without licenses.

In December last year, Drap had issued a statement claiming that it had stopped marketing a harmful baby formula milk which contained highly sensitive bacteria that could cause prolonged diarrhea and abdomen related diseases in infants.

University of Health Sciences Vice Chancellor Dr Javed Akram toldDawnthat though there was a Drap requirement for companies to submit a certificate of analysis of raw material, it hardly looks at the source of raw materials.

“A number of multinational companies also import raw materials from China, but there are good and bad companies in China. There is no arrangement of pharmacovigilance in Pakistan. Companies are not asked from where they will import raw materials. On the other hand, companies change the source of raw materials for small financial benefits,” he said.

Dr Akram said that companies have to purchase a drum of 50kg of raw materials even if they need five or 10kg and that they sell the leftover material on the market, which is illegal. Other companies buy this material rather than importing it through the proper channel.

“Because the requirements of companies change from time to time, I suggest five to eight companies be clubbed together and allowed to import raw material collectively, which will ensure the quality of raw material,” he said.

Dr Akram suggested that at the time of registering medicines, pharmaceutical companies should be made to undertake that they will start the production of raw materialswithin five yearswhich will decrease the burden on foreign reserves.

A Drap official said issuing licenses to one or many importers was the only option to ensure the quality of raw materials.

“The license should be given to an importer which has the facilities for testing raw materials and a warehouse. Local companies can get the raw material from the importer rather than importing it themselves.

The requirements of most pharmaceutical companies change every year as they import more if they get contracts for the supply of medicines to government hospitals and they do not require as much if they do not win tenders,” he explained.

The official said that when their requirement is low, companies either purchase raw materials on the black market or import it in excessive amounts and sell what it does not need in the black.

“If an importer is granted a license, it will be possible to keep check on companies and ensure they do not use unreliable raw materials,” he added.

Drap Director Dr Ghazanfar Khan toldDawnthe authority is considering options for ensuring the quality of raw material for the manufacturing of drugs.

“However, the license can only be given to an experienced company or importer to ensure quality raw materials are used and to ensure the importer knows which foreign companies to procure the materials from,” he said.

Asked if it was viable to push pharmaceutical companies to start manufacturing raw materials, he said it was not practical as most companies need 10 or 20kg of raw materials.

“Raw material from China and India costs very little as they are very big markets. Pakistani pharmaceutical companies cannot compete with them and the cost of the finished product will be less than that of the raw material manufactured in Pakistan,” he explained.

Dr Khan added that Drap will encourage companies to start manufacturing raw materials and can impose an import duty on raw materials to facilitate local manufacturers but it will not be wise to force companies to manufacture raw materials in the country.

Published in Dawn, July 29th, 2018