Lok Sabha Question No. 145 (STARRED), answered on 2016-03-08
Subject: Prices of Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: BIDYUT BARAN MAHATO, SUDHEER GUPTA

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

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## LOK SABHA

STARRED QUESTION NO. *145

TO BE ANSWERED ON 8 th  March, 2016

## Prices of Drugs

## * 145.   SHRI BIDYUT BARAN MAHATO:

SHRI SUDHEER GUPTA:

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

- (a) the mechanism in place to regulate the prices of medicines, both life saving and nonlife saving and the extent to which the present system has been able to moderate the prices of medicines and drugs;
- (b) whether the National Pharmaceuticals Pricing Authority (NPPA) has permitted hike in the prices of 108 cardio-vascular, anti-diabetes drugs and other medicines and if so, the details thereof and the reasons therefor;
- (c) whether  the  National  Human  Rights  Commission  (NHRC)  has  issued  notice  to  the Government and NPPA in the matter, if so, the details thereof and the corrective steps taken by the Government in this regard; and
- (d) whether NHRC has also requested the Government to put a cap on the prices of the medicines, if so, the details thereof and the corrective steps taken by the Government in this regard?

## ANSWER

MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI ANANTH KUMAR)

(a) to (d): A statement is laid on the Table of the House.

Statement  referred  to  in  reply  to  Lok  Sabha  Starred  Question  No.  145*  for  answer  on 08.03.2016 regarding Prices of Drugs.

- (a): 'Life  Saving  drugs'  are  neither  defined  in  the  Drugs  (Prices  Control)  Order,  2013 (DPCO, 2013) nor in the National Pharmaceutical Pricing Policy, 2012 (NPPP, 2012). All the medicines  specified  in  the  National  List  of  Essential  Medicines  2011  (NLEM)  have  been included in the First Schedule of DPCO, 2013. The prices of scheduled medicines are fixed on the  principle  of  market  based  pricing  as  enunciated  in  the  NPPP,  2012.  Out  of  total  680 scheduled formulations (628 net) under Schedule- I of DPCO, 2013, NPPA fixed the ceiling prices of 530 scheduled formulations on market based pricing methodology (This includes 53 formulations  for  cardiovascular  diseases,  6  for  diabetes,  20  for  HIV  /  AIDS,  24  for Tuberculosis, 47 for Cancer and 6 for kidney diseases). Consequent to the price fixation of drugs under this order, affordability of the medicines has improved. NPPA has also fixed the retail price of 283 'new drugs' (which fall within the purview of Para 2(u) of DPCO.2013).
- (b): No,  Madam.  On  the  contrary,  NPPA  capped  the  MRP  of  108  non-scheduled medicines,  out  of  which  84  are  used  for  treatment  of  cardiovascular  diseases  and  22  for diabetes under paragraph 19 of Drugs Prices Control Order, 2013 on 10.07.2014 (Subsequently  prices  of  2  formulations  were  withdrawn,  as  they  were  already  fixed  under scheduled category).  A large number of manufacturers have implemented the price reduction and the price notifications of 10.07.2014 issued by NPPA are still in operation. The reduction in  prices  effected  as  compared  to  the  highest  price  prevailed  prior  to  price  capping  are  as follows:
- (c) & (d): Law Division of National Human Right Commission (NHRC) issued notice to the  Government on 01.01.2015 calling for a  report  on  withdrawal  of  internal  guidelines  of NPPA    issued  on  29.05.2014.  The  reply  to  the  notice  of  NHRC  was  furnished  by  the Government on 19.03.2015. NHRC has asked for some further details in the matter by letter dated 23.02.2016 which will be replied within stipulated time.

| %reduction with respect to Highest prevailingMRP (No. of Drugs)   | %reduction with respect to Highest prevailingMRP (No. of Drugs)   | %reduction with respect to Highest prevailingMRP (No. of Drugs)   | %reduction with respect to Highest prevailingMRP (No. of Drugs)   |
|-------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
|                                                                   | Diabetic                                                          | Cardiovascular                                                    | Total                                                             |
| 0 <= 5%                                                           | 7                                                                 | 10                                                                | 17                                                                |
| 5 <= 10%                                                          | 2                                                                 | 10                                                                | 12                                                                |
| 10 <= 15%                                                         | 1                                                                 | 11                                                                | 12                                                                |
| 15 <= 20%                                                         | 1                                                                 | 8                                                                 | 9                                                                 |
| 20 <= 25%                                                         | 2                                                                 | 12                                                                | 14                                                                |
| 25 <= 30%                                                         | 2                                                                 | 7                                                                 | 9                                                                 |
| 30 <= 35%                                                         | 2                                                                 | 7                                                                 | 9                                                                 |
| 35 <= 40%                                                         | 1                                                                 | 4                                                                 | 5                                                                 |
| Above 40%                                                         | 4                                                                 | 15                                                                | 19                                                                |
| Total                                                             | 22                                                                | 84                                                                | 106                                                               |

The provisions of para 19 of DPCO, 2013 are still in force and the delegated power to exercise the same rests with the National Pharmaceutical Pricing Authority (NPPA).

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