22 drugs in the market without approval, govt sends notices to pharma companies

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

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New Delhi: The government has issued notices to the pharma companies which introduced 22 drugs in the market without prior approval of the National Pharmaceutical Pricing Authority (NPPA). This information was given in a written reply by the Union Minister for the Chemicals & Fertilizers, Mr D V Sadananda Gowda in the Parliament.

The companies that have been issued notices include the pharma majors such as Biocon, Cipla, Dr Reddy’s and Lupin.

“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,” explained Mr Gowda.

S. No.

Name of the Company

Name of the Drug

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

Alpha

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, said the Minister.