Unichem Labs under regulator scanner for launching blood pressure medicines without price approval

Indian drug maker Unichem Laboratories has come under the National Pharmaceutical Pricing Authority’s scanner for allegedly launching six medicines for the treatment of high blood pressure years before it asked the pricing regulator to fix their retail prices. The regulator has also decided to ask India’s apex drug regulator to decide whether these medicines have any therapeutic rationale.

Considering the “extraordinary circumstances”, the regulator has decided to fix the new retail prices of these brands on the basis of prices for these drugs from 2013–a decision that may see their prices drop 20-30%, based on data from pharmaceutical market research firm AIOCD PharmaTrac.

According to NPPA, Unichem launched these medicines over four years before it applied to the regulator for price fixation—a process in which the pricing regulator sets the retail prices for new drugs before they are launched in the Indian market.

The drugs, used to treat hypertension, were launched under brand names ‘Tritelsar 80 HS’, ‘Triolsar 20 HS’, ‘Triolsar 40 HS’, ‘Tritelsar 40’, ‘Tritelsar 40 HS’ and ‘Tritelsar 80’ in 2013, according to minutes of NPPA’s latest meeting on February 26. Yet, the applications to fix their retail prices were only made in December 2017, according to the minutes.

“This is in gross violation of the provisions of DPCO 2013,” stated the minutes.

ET is still awaiting a response from Unichem.
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Compared to 2017, the retail prices of these drugs were 20-33% lower in 2013, according to PharmaTrac. For instance, the maximum retail price (MRP) of Tritelsar 40 when Unichem launched it in August 2013 was Rs 90 for a pack of 10 tablets, whereas its MRP as of February 2018 is 32.73% higher at Rs 119.46, it showed.

Unichem may be liable to deposit a penalty for overcharging patients for these drugs over the years, according to NPPA. The regulator is expected to calculate this overcharging amount as well as the new retail prices of these brands by its next authority meeting, suggested the minutes.

“In this case, considering the long-time gap between the launch of the drug and the date of application, retail price fixed on the basis of 2017 prices will not be a true indicator of the retail price in 2013,” the minutes stated.

“The Authority also noted that there are only marginal variations in the composition of these “new drugs”, as shown in the tables below, and, after detailed deliberations, decided to refer the matter to DCGI (Drug Controller General of India) to give its view on the therapeutic rationale of these new drugs,” it added.

Last year, Ahmedabad-based Torrent Pharmaceuticals Ltd acquired Unichem’s India business for Rs 3,600 crore, according to a filing on the Bombay Stock Exchange dated November 3, 2017. Torrent has not received any notice from NPPA in this regard as of now, said a spokesperson for the company.

The combined value of the market for these six drugs was Rs13.20 crore as of February 2018, according to PharmaTrac.economictimes