Lok Sabha Question No. 4800 (UNSTARRED), answered on 2019-07-23
Subject: Complaint to NPPA
Ministry: CHEMICALS AND FERTILIZERS
Asked by: K. Shanmuga Sundaram

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS & FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION NO. 4800 TO BE ANSWERED ON 23 rd  July, 2019

## Complaint to NPPA

## 4800.  SHRI SHANMUGA SUNDARAM K.:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether the National Pharmaceutical Pricing Authority (NPPA) has received any information/complaint  regarding  introduction  of  new  drugs  by  the  Pharma companies without its approval;
- (b) if so, the details thereof;
- (c) the number of drugs introduced in the market without NPPA approval and the details of the name of the companies;
- (d) whether the Ministry will take appropriate action against these companies under the Essential Commodities Act; and
- (e) the manner in which NPPA will identify the 'New Drugs' when the components of the  new  drugs  are  having  a  drug  listed  under  the  National  List  of  Essential Medicines (NLEM)?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI D. V. SADANANDA GOWDA)

(a), (b) & (c): Yes, Sir. A list of 22 drugs introduced in the market without prior approval of  the  National  Pharmaceutical  Pricing  Authority  (NPPA)  alongwith  names  of  the companies introducing these drugs, where demand notices have been issued by the NPPA is at Annexure.

- (d): 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.
- (e): 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.

## Annexure

List  of  New  Drugs  launched  by  pharmaceutical  companies  without  prior  price approval where demand notices have been issued by the National Pharmaceutical Pricing Authority

|   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                                        | CyblexM 30                                 |
|       10 | Eris Life Sciences Pvt Ltd                                        | CyblexM 60                                 |
|       11 | Eris Life Sciences Pvt Ltd                                        | Cyblex MV 80.2                             |
|       12 | Eris Life Sciences Pvt Ltd                                        | CyblexM 80                                 |
|       13 | Eris Life Sciences Pvt Ltd                                        | CyblexM 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                        |

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