Complaint to NPPA

Companies introducing 22 drugs without prior approval of the National Pharmaceutical Pricing Authority (NPPA) have been issued notices. The list of companies and the drugs are as in the list below:

1. Alembic Pharmaceuticals Ltd

Resync 75/50 mg

2. Alembic Pharmaceuticals Ltd

Trivogo tablet

3. Biocon limited

Blisto Trio 0.2/500/2 mg

4. Biocon limited

Blisto Trio 0.2/500/1 mg

5. BoehringerIngelheim India Pvt. Ltd and Kemwell Biopharma Pvt. Ltd

Buscogast plus Tablets

6. Cipla Limited

Hepcvel Tablets

7. Dr. Reddy,s Laboratories Ltd

Resof total 400/100 mg

8. Eris Life Sciences Pvt Ltd

Cyblex MV 80.3

9. Eris Life Sciences Pvt Ltd

Cyblex M 30

10. Eris Life Sciences Pvt Ltd

Cyblex M 60

11. Eris Life Sciences Pvt Ltd

Cyblex MV 80.2

12. Eris Life Sciences Pvt Ltd

Cyblex M 80

13. Eris Life Sciences Pvt Ltd

Cyblex M 40

14. Hetero Healthcare Limited

Velasof Tablets

15. Hetero Healthcare Limited / Cadila Healthcare Limited

Sovip V Tablets

16. Ipca Laboratories Limited

Pacimol Active

17. Lupin limited

Gluconorm VG pluse-1

18. Lupin limited

Gluconorm VG pluse-2

19. Sanofi India Limited

Amaryl MV 0.2 mg /500/1 mg

20. Sanofi India Limited

Amaryl MV 0.2 mg /500/1 mg pack of 15 tabs

21. Unichem Laboratories pvt.ltd

Tritelsar-80+5 similer formulation

22. Wockhardt Liited and Medibios Laboratories Limited

Alphadopa 500mg tab

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. 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.

This information was given in a written reply by the Union Minister for the Chemicals & Fertilizers, Shri D .V. Sadananda Gowda in the Lok Sabha