Natco, Hetero Generic Pharma makers Get DCGI Nod to Sell Hepatitis-C (HCV) Drug

15 DECEMBER 2015

Hepatitis C virus (HCV) causes both acute and chronic infection. Acute HCV infection is usually asymptomatic, and is only very rarely associated with life-threatening disease. About 15–45% of infected persons spontaneously clear the virus within 6 months of infection without any treatment.

The remaining 55–85% of persons will develop chronic HCV infection. Of those with chronic HCV infection, the risk of cirrhosis of the liver is 15–30% within 20 years.

Daclatasvir is the first-in-class NS5A inhibitor used in combination with Sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection.

Two city-based drug makers Natco Pharma and Hetero said they received approval from the Drugs Controller General of India (DCGI) to sell generic version of Daclatasvir, used for the treatment of chronic hepatitis C.

“It is the first company in India to get approval for generic Daclatasvir Dihydrochloride (Daclatasvir) tablets, 30 mg & 60 mg, from the Drugs Controller General (India),” Natco said in a disclosure with the bourses.

“The company has received the approval from Drug Controller General of India for the generic version of Daclatasvir tablets in the strengths of 30 mg and 60 mg,” Hetero said.

Natco said it will launch immediately in India at `6,000 and `4,000 for the 60 mg and 30 mg strengths, respectively, for a bottle of 28 tablets.

“Compared with other treatment options, this combination not only increases the cure rate, but is also regarded as a valuable treatment option in some of the difficult-to-treat HCV patients subsets,” Natco said adding that it will market generic Daclatasvir under its own brand ‘NATDAC,’ and through its strategic partners in India.

This product is a generic version of Bristol-Myers Squibb's brand 'Daklinza' - approved by US FDA in July 2015. Daclatasvir is one of the direct-acting antivirals for hepatitis C treatment. A research study indicates that the drug enables the rapid decline of Hepatitis C virus. 

Daclatasvir is included the World Health Organization's List of Essential Medicines.

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