NMRA mulls recalling drugs with calcitriol metabolite from the market

After unregistered products found during raid

by Suresh Perera

The National Medicines Regulatory Authority (NMRA) is contemplating withdrawing all pharmaceutical drugs with calcitriol, an active form of Vitamin D3 prescribed largely to kidney patients, following the discovery of stocks of six unregistered imported products during a raid at Dehiwala last week.

“We will have to take a fresh look at medicines with this key metabolite to ensure that the unregistered drugs had not sneaked into the marketplace”, says Amith Perera, NMRA’s Chief Food and Drugs Inspector.

He said that a stock of a combination of six unregistered drugs with the calcitriol hormone were found during a swoop on a luxury house by officers of the regulatory body.

Calcitriol is used to treat hyperparathyroidism (overactive parathyroid glands) and metabolic bone disease in people who have chronic kidney failure and are not receiving dialysis.

The drug, which comes under different brand names, is also prescribed by some doctors to treat Covid-19 patients and those suffering from arthritis as it is an active form of Vitamin D3.

Asked whether the NMRA sealed the complex where the unregulated drugs were discovered, Perera said the medicines were placed inside a room of the house and sealed.

He said a company licensed to import six other drugs was registered under the address. As a result, the stock of ‘expired’ drugs found stored within the building was in order as an importer was authorized under the law to accept products beyond their shelf life and store them to be destroyed under NMRA supervision.

State Minister of Production, Supply and Regulation of Pharmaceuticals, Prof. Channa Jayasumana inspected the drugs in the raided complex on Wednesday and directed the NMRA to withdraw the relevant medicines from the market.

He was shown on television taking a closer look at the medicines and, at one point saying, “these are given to kidney patients”.

When the State Minister asked a company official present how the drugs were imported without authority, he replied, “we have paid taxes”.

The NMRA believes the unregistered drugs may have been imported under the ‘food supplements’ category by changing the HS code description.

The regulatory authority will be filing legal action against the company, Perera said.

When asked for comment, the company’s Chairman said he was “at a meeting” and promised to call back. However, he didn’t return the call.

Meanwhile, pharmacists complained of difficulties to secure the required approvals via the NMRA’s online portal.

The process is so complicated that we cannot even get our annual licenses renewed online, they said. “Many pharmacies are operating without renewing their licenses as a result and could face a load of trouble if there’s an issue”.

Online applications are repeatedly, “rejected”, perhaps due to a glitch in the system, and the situation is so grave that even the transport of pharmaceuticals has to be done without renewing the permit, they pointed out.

The NMRA should first put its house in order before venturing out to supervise pharmacies, they suggested.

An official of the regulatory body promised to look into the complaint.