bY SURESH PERERA

Amidst flak from the pharmaceuticals industry over the move by the regulatory watchdog to call for the cancellation of registration and import licenses of 10 drugs imported by five companies for “arbitrarily and unilaterally increasing their retail prices”, Prof. Asitha de Silva, Chairman of the National Medicines Regulatory Authority (NMRA) says there is no need for a regulator if anybody can bring medicines, sell at whatever prices they want and increase prices whenever they want.

“In terms of the regulatory provisions, we not only look at the safety, quality and efficacy of drugs, but also the key aspect of affordability”, he outlined in the backdrop of the pharmaceutical industry’s representative body slamming the regulator for displaying, what it termed, “a dangerous, discriminatory trend by selectively issuing cancellation notices”.

What the NMRA has done is illegal because the 10 imported products concerned do not fall within the ambit of “price-controlled essential drugs”, protested Ms. Kasturi Wilson, President of the Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI).

How can the NMRA claim the importers had violated price regulations by “arbitrarily and unilaterally increasing their retail prices” when the regulator has authority only over 74 essential drugs within the price control mechanism?, she queried.

Under a gazetted order, the prices of all medicines are regulated and cannot be increased willy-nilly, Prof. de Silva clarified. “To claim there’s no price regulation on all medicines is patently false”.

Can anybody assert that one medicine is more useful than the other, depending on the illness of a patient under treatment?, he asked.

In 2015, the Supreme Court made an observation that affordability was key to patient centric medicines and NMRA’s function and duty should be to make medicines affordable to the common man, he recalled.

“Under Section 3 of the NMRA Act, we have wide powers to regulate prices of all medicines with the objective of bringing them within the reach of the public”, de Silva continued.

What the importers of the drugs did was to marginally adjust prices, which was inevitable due to the challenging situation of the Rupee vs Dollar depreciation, Ms. Wilson explained. “They didn’t even take into account the manufacturing cost fluctuations”.

“If there was an adverse impact due to currency fluctuations, they should have discussed the issue with us without arbitrarily increasing prices of drugs”, the NMRA boss reasoned.

On July 17, 2020, the NMRA issued notice calling for the cancellation of registrations and import licenses in relation to 10 specific drugs imported by Hemas Pharmaceuticals (Pvt) Ltd., (trade name of medicines: Zeos 10mg, Herbesser 100mg, Xon Ce), A. Baur & Co (Pvt) Ltd., (Rivotril 0.5mg & 2mg, Calcivita), Euro Asian Pharma (Pvt) Ltd., (Levitoz 5mg, Dozil 5mg &10mg), Pettah Pharmacy (Pvt) Ltd., (Daktacort cream) and Robert Hall & Co. (Pvt) Ltd., (Betadine cream), for “violating conditions of registration”.

In issuing notice, the NMRA said the arbitrary increase in the price of drugs in violation of conditions of registration 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.

The NMRA has not canceled the registration and import licenses of the five pharmaceutical companies so far. With notice issued, they can make their submissions for consideration, the Chairman elaborated.

There is no stated condition either in the primary registration certificate, the renewal registration certificate or in any associated existing document or communication that a price increase cannot be made, the SLCPI asserted.

The SLCPI is merely trying to fall back on one line in the regulatory framework and use it to its benefit. Taken as a whole, the NMRA is legally empowered to regulate prices of all medicines, the senior Professor of Pharmacology further said.

At a time there is a global shortage of Vitamin C, one of the importers has been taken to task for adjusting the price of the product Xon Ce, Ms. Wilson noted. “The NMRA should be conscious of the plunge of the Rupee against the USD, and the serious situation of shortages globally caused by the Covid-19 pandemic”.

“Our top priority is to ensure a continuous supply of drugs to patients”, she stressed, while adding that if there is a disruption, the products will be brought down through unauthorized channels and sold for double or treble the original prices.

Under the circumstances, the industry was compelled to do some marginal price adjustments to prevent any shortages of these drugs in Sri Lanka, she elaborated.

What is the use of the NMRA Act passed by Parliament if importers can arbitrarily decide on pricing?, de Silva asked. “Only a few countries has a unique piece of legislation on these lines, which deals not only with safety, quality and efficacy but also on affordability of drugs”.

“We investigated consumer complaints on arbitrary price increases. For example, it was found that the price of a certain medicine sold at Rs. 700 in January this year was pushed up to Rs. 960 by July – within just six months”, he said.

When the unauthorized price revisions were taken up with the importers, a letter was received saying, more or less, that “it’s none of our business”, the NMRA chief added.