Drug prices: NMRA and pharma firms trade charges

The pharmaceutical industry yesterday accused the drug regulator of arbitrary decision-making after the latter issued notices of cancellation of licences of some products of five importers over pricing issues.

The importers who have been issued notices of licence cancellations for 10 medications and supplements by the National Medicines Regulatory Authority (NMRA) are: Hemas Pharmaceuticals (Pvt) Ltd.; A Baur & Co (Pvt) Ltd.; Euro Asian Pharma (Pvt) Ltd.; Pettah Pharmacy (Pvt) Ltd.; and Robert Hall & Co (Pvt) Ltd.

The 10 medications and supplements embroiled in the pricing controversy include an anti-histamine (Zeos 10mg); a high blood pressure drug (HerbesserSR100mg); anti-convulsants (Rivotril 0.5mg & Levitoz 5mg); a dementia medication (Dozil 5mg & 10mg); an anti-fungal

cream (Daktacort cream); a drug against worm infestations (Vermox 100mg & 500mg); an antiseptic (Betadine cream); and a vitamin C supplement (XonCe) and a calcium supplement (Calcivita).

The NMRA issued the notices of cancellation of registrations and import licences for these products under Section 65 of the NMRA Act No 5 of 2015 on Friday, charging that the pharmaceutical companies had “arbitrarily and unilaterally” increased the retail prices of these products, thereby violating provisions of the NMRA Act.

Denying allegations by the NMRA, however, a spokesperson for the Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI) told the Sunday Times that none of the members of SLCPI had violated any of 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.

Earlier the NMRA had issued Letters of Warning to seven companies -- and all seven and the SLCPI had responded with explanations that these adjustments were done only to cover exchange losses due to sharp devaluations, while still incurring some losses, the Sunday Times learns.

Explaining that medications fall under the two categories of ‘essential’ and ‘non-essential’, the spokesperson said the 10 medications and supplements fall under the ‘non-essential’ category and thus are not governed by the Maximum Retail Price (MRP) in terms of the Price Ceiling Regulation.

“We have taken losses on the medicines on which there is a price ceiling but to fulfil the needs of patients and provide quality drugs in view of the fluctuation of the dollar and the shortages as a result of the COVID-19 crisis, we cannot import these drugs and supplements categorised as ‘non-essential’ without a price increase,” the spokesperson said, stressing that this reasonable adjustment in price was done to ensure that patients have access to a continuous supply of drugs.

The spokesperson emphasised that the SLCPI members (who form 25% of the importers and supply 75-80% of the patients’ needs) had been urging for a pricing mechanism in the past four years. Their membership has always complied with the MRP imposed by Gazette and no member has violated the terms of the registration of drugs.

Alleging that some pharmaceutical importers have continued to indulge in the unethical practice of increasing prices of medicines from time to time with scant disregard to pricing regulations and laws in the country, the NMRA pointed out that these increases without any rational basis had put patients in great difficulty.

It cited the example of the price of a brand of donepezil 5mg tablet manufactured by a leading Indian company (used for the treatment of dementia) priced at SL Rs 25.70 in India being sold in Sri Lanka at SL Rs 63.00.

NMRA Chairperson Prof. Asita de Silva said the NMRA received numerous complaints regarding significant increases of prices of medicines by the People's Movement for the Rights of Patients and some pharmacies. After conducting investigations, the NMRA issued ‘showcause’ letters to the responsible companies on May 29, but the letters were disregarded by them.

“This compelled the NMRA to take strict action against these pharmaceutical companies by issuing notices of cancellations. The increase in retail prices of medicines by these companies in violation of conditions of registration issued by the Authority will cause much hardship to patients especially in the background of the 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,” he said.

Prof. de Silva added that the NMRA would continue to investigate all complaints received to ensure conditions of registration were not violated with impunity by anyone involved in the supply of medicines.

“We have taken losses on the medicines on which there is a price ceiling but to fulfil the needs of patients and provide quality drugs in view of the fluctuation of the dollar and the shortages as a result of the COVID-19 crisis, we cannot import these drugs and supplements categorised as ‘non-essential’ without a price increase