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Pharma companies received notices for introducing drugs without prior approval of the NPPA

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Pharmaceutical Companies which introduced 22 drugs without prior approval of the National Pharmaceutical Pricing Authority (NPPA) have been issued notices by Government. 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.

Pharmaceutical companies which received notices includes Alembic Pharmaceuticals, Biocon, BoehringerIngelheim India Pvt. Ltd and Kemwell Biopharma, Cipla, Dr. Reddy's Laboratories, Eris Life Sciences, Hetero Healthcare, Cadila Healthcare, Ipca Laboratories, Lupin, Sanofi India, Unichem Laboratories, Wockhardt and  Medibios Laboratories.

The 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 crore has been recovered and demand notices amounting to Rs. 89.31 crore are under litigation. 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.

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