Notices issued to companies for introducing drugs without prior nod from NPPA: Government

The government has issued notices to pharma firms including Cipla, Dr Reddy’s, Biocon, Lupin, Alembic Pharma and Sanofi India, among some others, for introducing drugs without prior approval from the national drug pricing regulator.

“Companies that introduced a total of 22 drugs without prior approval of the National Pharmaceutical Pricing Authority (NPPA) have been issued notices,” Minister for Chemicals and Fertilizers, DV Sadananda Gowda said in a written reply in the Lok Sabha.

The drugs include those used for treating conditions such as diabetes, inflammation and chronic hepatitis C, among others.

While Alembic Pharmaceuticals has introduced two drugs — Resync 75/50 mg and Trivogo tablet without prior nod from NPPA, Biocon has introduced Blisto Trio 0.2/500/2 mg and Blisto Trio 0.2/500/1 mg, he said.

Cipla has introduced Hepcvel tablets and Dr Reddy’s Laboratories has introduced Resof total 400/100 mg, without taking the prior permission, Gowda said. Eris Sciences has introduced Cyblex MV 80.3, Cyblex M 30, Cyblex M 60, Cyblex MV 80.2, Cyblex M 80, Cyblex M 40 without taking prior permission from the NPPA, he added.

The other companies that have launched the drugs without getting the prior nod from the national pharmaceutical pricing authority include — Hetero Healthcare, Cadila Healthcare, Ipca Laboratories, BoehringerIngelheim India, Kemwell Biopharma, Unichem Laboratories, Wockhardt and Medibios Laboratories, the minister said.

“The NPPA regularly takes action against such companies as per provisions of the Drugs (Prices Control) Order, 2013 (DPCO) which has been issued under the Essential Commodities Act, 1955,” he added.

NPPA has so far issued demand notices for an amount of Rs 101 crore against defaulting companies. Out of this, an amount of Rs 5.56 crores has been recovered and demand notices amounting to Rs 89.31 crores are under litigation, Gowda said.

“Cases of new drugs are identified from the market-based data being referred to by the NPPA. In addition, new drug cases are also identified through complaint or information received from other sources,” he added.