Lok Sabha Question No. 375 (UNSTARRED), answered on 2016-04-26
Subject: Drug Prices
Ministry: CHEMICALS AND FERTILIZERS
Asked by: SAUGATA ROY, N.K. PREMACHANDRAN

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

*******

## LOK SABHA

UNSTARRED QUESTION NO. 375

TO BE ANSWERED ON 26 th  APRIL, 2016

## Drug Prices

## 375. PROF. SAUGATA ROY:

SHRI N.K. PREMACHANDRAN:

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

- (a) whether the Government is aware that the cost of life saving medicines are increasing and if  so,  the  action  taken  by  the  Government  to  ensure  the  availability  of  medicines  at reasonable prices;
- (b) whether the Government is aware that the companies are selling combination medicines at  exorbitant  prices  and  if  so,  the  action  taken  by  the  Government  to  fix  the  price  of combination medicines;
- (c) whether the Government proposes to ban combination medicines and if  so, the details thereof; and
- (d) whether  the  Government  proposes  to  introduce  scheme  for  supply  of  medicines  to citizens  through Government controlled outlets at reasonable prices and if so, the details thereof?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI HANSRAJ GANGARAM AHIR)

(a): National  Pharmaceutical  Pricing  Authority  (NPPA)    fixed  the  prices  of  530  medicines under First Schedule of DPCO, 2013 (including 53 cardiovascular, 6 diabetes, 20 HIV/AIDS, 24 Tuberculosis, 47 Cancer and 6 Kidney disease) based on market based pricing methodology as enunciated in NPPP, 2012. The details of reduction in prices  of scheduled formulations effected under  DPCO,  2013  as  compared  to  the  highest  price  prevailed  prior  to  the  announcement  of DPCO, 2013 is at Annex I.

In addition, maximum retail price (MRP) was capped under Para 19 of DPCO, 2013, in respect of 106 non scheduled medicines, out of which 84 are used for treatment of cardiovascular diseases and

22 for diabetes. Reduction in prices  effected as  compared to the highest price prevailed prior price capping is at Annex II .

NPPA  has  also  fixed  the  ceiling  prices  of  173  scheduled  medicines  of  revised  Schedule  I (including 22 anti cancer, 19 cardiovascular, 5 antidiabetic medicines, 14 anti-retroval and 13 anti-TB medicines). Statement showing reduction in price with respect to maximum price (as on 12.4.2016) is at Annex III.

(b): Fixed Dose Combination (FDC) which are included in the National List of Essential Medicines (NLEM), 2015 and hence are in revised Schedule- I, are being fixed by NPPA.

NPPA had earlier fixed the retail prices of 211 FDCs (which are qualified as new drugs under para  2  (U)  of  DPCO,  2013  as  on  22.04.2016).  Further,  companies  are  not  allowed  to  increase  the price of any non-scheduled medicine more than 10% of the price of the preceding 12 months period. As per Para 15 of DPCO, 2013, where an existing manufacturer of a drug with dosage and strengths as specified in National List of Essential Medicines launches a new drug (combination or otherwise), such existing manufacturers are to take prior-pricing approval from NPPA in Form-I specified under Schedule-II of DPCO, 2013.

(c): Central Government has recently prohibited 344 Fixed Dose Combinations for manufacture for  sale,  sale  and  distribution  in  the  country.  However, many pharmaceutical companies have filed various writ petitions in various courts in the country and the matter is sub-judice. Certain other Fixed Dose  Combinations  licensed  by  State  Licensing  Authorities  without  approval  of  Drugs  Controller General (I) are under scrutiny.

(d): To make quality drugs available at affordable prices to the needy people, a scheme namely 'Jan Aushadhi Yojana' has been launched by the Government of India. This scheme is implemented through Bureau of Pharma Public Sector Undertakings of India (BPPI). As on 31 st March, 2016, 273 Jan Aushadhi Shops are operating in different parts of the country.

*******

Statement showing reduction in price with respect maximum price

| %reduction with respect to Maximum Price   |   No. of drugs |
|--------------------------------------------|----------------|
| 0<= 5%                                     |             80 |
| 5<=10%                                     |             50 |
| 10<=15%                                    |             57 |
| 15<=20%                                    |             43 |
| 20<=25%                                    |             65 |
| 25<=30%                                    |             49 |
| 30<=35%                                    |             26 |
| 35<=40%                                    |             34 |
| Above 40%                                  |            126 |
|                                            |            530 |

## Annex- I

## Annex- II

## Statement showing % reduction with respect to Highest prevailing MRP under para 19 of DPCO, 2013

| %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                                                               |

## Annex III

Statement showing reduction in price with respect to maximum price (as on 12.4.2016)

| %reduction with respect to Maximum Price   |   No. of formulations of revised Schedule-I for which ceiling price has been fixed so far |
|--------------------------------------------|-------------------------------------------------------------------------------------------|
| 0<= 5%                                     |                                                                                        16 |
| 5<=10%                                     |                                                                                        10 |
| 10<=15%                                    |                                                                                        21 |
| 15<=20%                                    |                                                                                        26 |
| 20<=25%                                    |                                                                                        25 |
| 25<=30%                                    |                                                                                        17 |
| 30<=35%                                    |                                                                                        15 |
| 35<=40%                                    |                                                                                        12 |
| Above 40%                                  |                                                                                        31 |
| Total                                      |                                                                                       173 |