NEW DELHI: Five pharma giants are under the scanner of NPPA for allegedly overcharging for a new Hepatitis C combination which they launched without waiting for price approval.

Economic Times has recently reported that National Pharmaceutical Pricing Authority has sent show-cause notices to Hetero Labs, Cipla, Natco Pharma, Mylan Pharmaceuticals and Dr Reddy’s for overcharging the combination of sofosbuvir (400 mg) and velpatasvir (100 mg) used to treat the potentially fatal Hepatitis C virus.

Natco, Mylan and Hetero have responded to the notices last week and the replies are under examination NPPA, reports ET

In November 2017 NPPA had set the retail price of this drug sofosbuvir-velpatasvir combination at Rs 15,625 excluding GST with MRP set at Rs 17,500

However, according to the minutes of the NPPA meeting, most brands of this combination were sold at Rs 18,500 while Hetero, Dr Reddy’s and Natco were among the first to launch the product in India in May 2017.

Company	Brand	Launch	Price for 28 tablets (Rs)
Hetero Labs	Velasof	17 May	17,619
Cipla Ltd.	Hepcvel	17 May	18,500
Mylan Pharma	MyHepAll	17 July	18,500
Dr Reddy’s Ltd.	Resof Total	17 May	18,500
Natco Pharma	Velpanat	17 May	18,500
Abbott India Ltd.	Velpaclear	17 October	17,500
Zydus Cadila	SoviHep V	17 May	18,500

Source: ET

Read also: Dr Reddys Laboratories launches generic hepatitis C drug in India

Read also: Hetero gets DCGI nod for generic chronic hepatitis C drug

NPPA is reported to have shown the desire to know how the companies arrived at the prices of their drug brands without due regulatory submissions and approvals. The notices specify recovery of overcharged amounts, penalties, a charge of 15% interest and prosecution measures as per the Essential Commodities Act.

NPPA told ET, “Quantification of overcharging liability with interest and penalty to be calculated after examination of companies’ replies… a penalty not less than 100% of the principal amount shall be imposed in such cases.”

Some companies who have received the notices said NPPA had delayed in setting the retail prices, although they had sought pricing price approval before launching the drug.

Read also: Natco Pharma launches generic hepatitis C drug in India

Speaking with ET, a Cipla spokesperson said, “We have received a preliminary notice from NPPA routinely asking for certain information on the product in question. We are in the process of collating such information to respond to NPPA.” He also added that no penalty has been imposed on the company.

Seven brands of sofosbuvir-velpatasvir are available in India which is the generic versions of Gilead Sciences Inc’s Epclusa.

Read also: Mylan launches tablets for treatment of Hepatitis C in India