Lok Sabha Question No. 1500 (UNSTARRED), answered on 2020-09-20
Subject: Increase in Drug Price
Ministry: CHEMICALS AND FERTILIZERS
Asked by: P. Velusamy

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

LOK SABHA UNSTARRED QUESTION NO. 1500 TO BE ANSWERED ON 20 th  September, 2020

## Increase in Drug Price

## 1500. SHRI VELUSAMY P.:

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

(a)  whether the Government has any proposal to increase the prices of commonly used medicines like key antibiotics, anti-allergies, anti-malaria drugs, BCG vaccine and Vitamin C which are being used by the poor people on daily basis and if so, the details thereof;

- (b) whether the National Pharmaceutical Pricing Authority (NPPA) has informed that the prices are increased by 50% in the interest of the public;
- (c) if so, the clarification of public interest which necessitated exorbitant price rise at this time of slowdown of the economy;
- (d) whether paragraph 19 of the Drug Prices Control Order 2013 has been used to reduce the drug prices but not for increasing the prices of common drugs; and

(e) if not, the reasons therefor?

## ANSWER

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

(a)  &  (b):          The National Pharmaceutical Pricing Authority (NPPA) has received applications for upward price revision under Para 19 of the Drugs (Prices Control) Order, 2013 (DPCO, 2013) citing various reasons like increase in Active Pharmaceutical Ingredient (API) cost, increase in cost of production, exchange rate variation etc. making the sustainable production and marketing of the drugs unviable. Based on the recommendation of Standing Committee on Affordable Medicines and Health Products (SCAMHP), ceiling price of shortlisted 21 scheduled formulations of 12 medicines were revised by allowing one time price increase of up to 50% from the applicable ceiling price in public interest as an exceptional measure by invoking Para 19 of  the  DPCO,  2013  on  13 th December, 2019. The detail of price revision is as below:

| S. No.   | Name of the Scheduled Formulation   | Dosage form & Strength            | Unit      | Revised Ceiling Price (Rs.)   |
|----------|-------------------------------------|-----------------------------------|-----------|-------------------------------|
| (1)      | (2)                                 | (3)                               | (4)       | (5)                           |
| 1.       | BCG vaccine                         |                                   | Each Dose | 8.75                          |
| 2.       | Benzathine benzylpenicillin         | Powder for Injection 12 lac units | Each Pack | 17.84                         |

|   3. | Benzathine benzylpenicillin                             | Powder for Injection 6 lac units   | Each Pack   |   11.81 |
|------|---------------------------------------------------------|------------------------------------|-------------|---------|
|    4 | Benzyl penicillin                                       | Powder for Injection 10 Lac Units  | Each Pack   |    7.64 |
|    5 | Chloroquine                                             | Tablet 150mg                       | 1 Tablet    |    1.16 |
|    6 | Dapsone                                                 | Tablet 100 mg                      | 1 Tablet    |    0.35 |
|    7 | Furosemide                                              | Tablet 40 mg                       | 1 Tablet    |    0.74 |
|    8 | Furosemide                                              | Injection 10mg/ml                  | 1 ml        |    2.43 |
|    9 | Metronidazole                                           | Oral Liquid 200 mg/5ml             | 1 ml        |    0.44 |
|   10 | Metronidazole                                           | Tablet 200 mg                      | 1 Tablet    |    0.68 |
|   11 | Metronidazole                                           | Tablet 400 mg                      | 1 Tablet    |    1.25 |
|   12 | Metronidazole                                           | Injection 500mg/100ml              | 1 ml        |    0.2  |
|   13 | Ascorbic Acid (Vitamin C)                               | Tablet 500 mg                      | 1 Tablet    |    1.34 |
|   14 | Co-trimoxazole (Sulphamethoxazole (A)+Trimethoprim (B)] | Tablet 400 mg(A)+80 mg(B)          | 1 Tablet    |    0.77 |
|   15 | Co-trimoxazole (Sulphamethoxazole (A)+Trimethoprim (B)] | Tablet 800 mg(A)+160 mg(B)         | 1 Tablet    |    1.98 |
|   16 | Co-trimoxazole (Sulphamethoxazole (A)+Trimethoprim (B)] | Oral Liquid 200mg(A)+40mg(B)/5ml   | 1 ml        |    0.32 |
|   17 | Pheniramine                                             | Injection 22.75 mg/ml(10ml pack)   | 1 ml        |    1.67 |
|   18 | Pheniramine                                             | Injection 22.75 mg/ml (2ml pack)   | 1 ml        |    2.24 |
|   19 | Prednisolone                                            | Drops 1%                           | 1 ml        |    4.92 |
|   20 | Clofazimine                                             | Capsule 50 mg                      | 1 Capsule   |    2.13 |
|   21 | Clofazimine                                             | Capsule 100 mg                     | 1 Capsule   |    3.63 |

The  ceiling  price  of  Heparin  Injection  5000  IU/ml  and  1000IU/ml  were  also increased  by  allowing  increase  of  50%  over  the  then  applicable  ceiling  price  vide notification dated 30 th June, 2020. The revised ceiling prices are Rs. 24.39 per ml for Heparin  1000IU/ml  and  Rs.  60.54  per  ml  for  Heparin  5000IU/ml.  The  increased prices are applicable till 31 st December, 2020.

- (c):       Regarding upward revision of ceiling price of 21 scheduled formulations of 12 medicines,  a Committee  comprising  of  Adviser  (Cost),  Adviser  DGHS  and  Deputy Drug Controller, DCGI with Director (Pricing), NPPA as the convenor examined such formulations  based  on  parameters  of  essentiality,  market  share  of  the  applicant Company and available alternatives etc. It was noted that these scheduled formulations are low priced drugs and have been under repeated price control. Most of these drugs are used as first line of treatment and are crucial to the public health program  of  the  country.  Many  companies  have  applied  for  discontinuation  of  the product  on  account  of  them  being  unviable.  Therefore,  these  formulations  were considered  for  upward  price  revision  to  enable  manufacturing  and  continued availability to the consumers.

Regarding  ceiling  price  of  scheduled  formulations  Heparin  1000IU/ml  and 5000IU/ml  injection,  it  was  noted  that  Heparin  injection  5000IU/ml  has  also  been included in list of medicine essential for patients admitted in ICU and Hospitalization due  to  COVID-19  circulated  by  Ministry  of  Health  &  Family  Welfare  (MoH&FW). Uninterrupted supply of such medicines is essential for management of COVID-19. Further, reports of shortage were also received for Heparin Injection. The Committee headed by Dr. S. Eswara Reddy, Jt Drug Controller, CDSCO reported an increase of 211% in the price of API Heparin when compared to base year of September 2018, recommending NPPA to consider to increase the ceiling price of Heparin Injection 5000IU/ ml by 50% to ensure continuous availability of the essential drugs in public interest.  Therefore,  the  Authority  approved  50%  price  increase  for  Heparin  upto 31 st December, 2020 by invoking extra ordinary powers in public interest under Para 19  of  the  DPCO,  2013  to  enable  manufacturing  and  continued  availability  to  the consumers.

(d) & (e):         The Paragraph 19 of the DPCO, 2013 has been used to reduce the drug  prices,  however,  the  provision  also  provides  that  in  case  of  extra-ordinary circumstances theGovernment may allow an increase or decrease in the ceiling price or the retail price, as the case may be, irrespective of annual wholesale price index for that year in public interest.

- *******