DoP invokes Emergency Clause- Directs Manufacturer to maintain HEP C medicine production

New Delhi: Department of Pharmaceuticals said it has invoked powers under the Drugs Prices Control Order, 2013 to direct Fulfords India to maintain production, distribution, and availability of Viraferonpeg 100 mcg injection in the market.

The injection is used for the treatment of chronic hepatitis C.

"In order to maintain normal production, distribution, and availability of the formulation Viraferonpeg 100 mcg injection in the market, it has been decided to invoke the powers of Section 3 (i) of DPCO, 2013," Department of Pharmaceuticals said in a letter to Fulfords India Ltd.

The company is directed to continue to maintain the same level of production and availability as during the period from November 2013 to November 2015 of the Viraferonpeg 100 mcg injection, it added.

Fulfords India has also been asked to submit a weekly report along with production plan for the next week to National Pharmaceutical Pricing Authority (NPPA) and DOP, the letter dated March 5, 2018, said.

"The order will be valid for three months from the date of issue. NPPA will recommend withdrawal or extension as the case may be, two weeks before the expiry of the period," it added.

Section 3 (i) of DPCO, 2013 deals with directions to manufacturers of active pharmaceutical ingredients (API) or bulk drugs or formulations with a view to achieve adequate availability and to regulate the distribution of drugs, in case of emergency or in circumstances of urgency or in case of non-commercial use in the public interest.