No authority to ensure sanitisers’ quality sold in Pakistan

According to the local newspaper report, in May last year, the federal cabinet had decided to transfer the authority to manufacture and sell sanitisers from the Drug Regulatory Authority of Pakistan (DRAP) to the Ministry of Science and Technology.

By law, DRAP is a government agency that ensures that medicines and medical products available in the market are manufactured following World Health Organization (WHO) guidelines.

The decision by the federal cabinet to transfer the sanitiser's license and quality authority to the Pakistan Standards and Quality Control Authority (PSQCA) created a vacuum in the system.

The PSQCA had formulated the standard for sanitisers a year ago and the companies and distributors manufacturing hand sanitisers were directed by the authority to implement the Pakistan Standard.

Rehmatullah Memon, the spokesman for the authority, said that PSQCA maintains the quality of various products across the country.

The Authority has directed all companies to indicate the quantity, date of manufacture and expiry date, batch number and company name along with the address of the items in the sanitiser on the label on each bottle or packaging.

Technically, the PSQCA was the official standards body that World Trade Organisation (WTO) listed on the Technical Barriers to Trade (TBT) agreement and was representing Pakistan in international standard agencies including International Organisation For Standardisation (ISO), International Electrotechnical Commission Geneva and International Organisation for Legal Metrology, Paris.

However, DRAP Pakistan is a legal entity that liaises with the World Health Organization for medicines and other medical products and oversees the manufacture of hand sanitisers under Section 7C of the DRAP Act 2012.

A senior official for the Ministry of Health said that under the DRAP Act 2012, the authorized body ensures the standards set by the World Health Organization for medicines and other medical products.

"The federal cabinet does not have the authority to ignore the DRAP Act, which was approved by parliament," he said.

According to this law, all kinds of drugs fall under the jurisdiction of DRAP.

But despite its expertise, DRAP does not participate in the process of ensuring the quality of a large number of imported sanitisers available in the market, while no mechanism is in place to ensure the required quality, which has raised concerns among experts.