Chamber of Pharmaceutical Industry meets NMRA to reiterate its stand

Thursday, 23 July 2020 01:34 - - {{hitsCtrl.values.hits}}

By Charumini de Silva

Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI) yesterday met with the National Medicines Regulatory Authority (NMRA) to resolve the dispute over the latter’s action on the import and sale of 10 drugs whilst another discussion is scheduled for next week.

NMRA last week issued notices of cancellation of registrations and import licences for 10 medicines imported by Hemas Pharmaceuticals Ltd., A. Baur & Co Ltd., Euro Asian Pharma Ltd., Pettah Pharmacy Ltd., and Robert Hall & Co Ltd. under Section 65 of the NMRA Act No. 5 of 2015, alleging that the companies had arbitrarily and unilaterally increased retail prices of the products thereby violating provisions of the NMRA Act.

However, SLCPI denied accusations by the NMRA noting that no member violated the pre-conditions set out in Section 65 of the NMRA Act, which warrants the cancellation of the certificates of registration and/or the relevant licences.

“Yesterday we had the first discussion with the NMRA officials on the matter to explain our side of the story. These 10 medications are not governed by the Maximum Retail Price (MRP) in terms of the Price Ceiling Regulation and the price adjustments were done only to cover heavy exchange losses during the COVID-19 lockdown, while incurring some losses even at present,” SLCPI spokesperson told the Daily FT.

SLCPI pointed out that it was challenging for the companies to provide quality drugs keeping in line with the foreign exchange losses due to devaluation and the shortages as a result of the COVID-19 crisis.

“All medicines fall under two categories – essential and non-essential. There is no way that we can import these 10 medications which falls on non-essential category, without a price increase. The reasonable price adjustment was made after consideration to ensure continuous supply of quality drugs,” the spokesperson stressed.

SLCPI categorically denied reports on cancellation of licences, adding that all these companies have a window of 30 days to respond with explanations before the regulator and take any action against them.

They also pointed out that NMRA had previously issued Letters of Warning to seven companies, where all seven companies and the SLCPI had responded with explanations.

Despite four years of requests by the SLCPI to introduce a pricing mechanism, NMRA had been slow to respond. “No member has violated the terms of the registration of drugs. We have always complied with the MRP imposed by Gazette,” SLCPI spokesperson added.

SLCPI members represent 25% of the importers and supply close to 80% of the medicine needs in the country.

It was noted that NMRA will study the SLCPI position communicated yesterday further, before meeting again next week.

NMRA in its website said the increase in retail prices of medicines by the aforementioned companies in violation of conditions of registration issued by the Authority will cause much hardship to patients especially in the background of the ongoing COVID-19 pandemic. Therefore, punitive action has been taken against offending companies under powers vested with the Authority to ensure affordability of medicines available to the public.