Lok Sabha Question No. 278 (UNSTARRED), answered on 2020-09-15
Subject: Active Pharmaceutical Ingredients
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Dushyant Singh

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

LOK SABHA UNSTARRED QUESTION No. 278 TO BE ANSWERED ON THE 15 th  September, 2020

## Active Pharmaceutical Ingredients

## 278. SHRI DUSHYANT SINGH:

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

- (a) the list of countries exporting Active Pharmaceutical Ingredients (APIs) to India along with the quantities over the last five years;
- (b) the top 10 APIs imported the most along with the quantity and the exporting countries;
- (c) the steps taken by the Government to reduce import dependence on China;
- (d) the list of 53 APIs short-listed by the Government for incentives;
- (e) whether the industry is seeking regulatory easing to reduce import dependence on China for APIs;
- (f) if so, the list of regulatory changes sought by the pharmaceuticals industry;
- (g) whether the Government intends to undertake regulatory easing to support the incentives
- given to boost API production in the country; and
- (h) if so, the details thereof?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS

(SHRI D. V. SADANANDA GOWDA)

- (a):       Major  countries  exporting  Bulk  Drugs,  Drug  Intermediates  to  India  along  with  the quantities (in KG) over the last five years are as follows:-
- (b):       The top 10 APIs imported the most along with the quantity during the year 2019 from China,  Germany,  United  States  of  America,  Italy,  Singapore,  Japan,  Switzerland,  Spain, United Kingdom etc.is as under:-

| COUNTRY    |   2015-16 |   2016-17 |   2017-18 |   2018-19 |   2019-20 |
|------------|-----------|-----------|-----------|-----------|-----------|
| CHINA P RP | 158286479 | 169225985 | 191174327 | 202316645 | 220875185 |
| U S A      |  12942970 |  12552957 |   9445178 |  10551727 |   8432828 |
| ITALY      |   6476083 |   5042917 |   6504361 |   5298475 |   3868835 |
| SINGAPORE  |  16459493 |  18962888 |  17691122 |  28781901 |  28310604 |
| SPAIN      |   3028792 |   3479217 |   2353083 |   2390950 |   2714854 |

Source: DGCIS, Kolkata

|   S.No. | APIs                                |   Quantity (MTs) |
|---------|-------------------------------------|------------------|
|       1 | Lactulose Solution                  |           5106.8 |
|       2 | Potassium Clavulanate               |           3558.5 |
|       3 | Penicilline G Potassium 1ST Crystal |           3203.4 |
|       4 | Mannitol                            |           2524.2 |
|       5 | Lactitol Monohydrate                |           1368.2 |
|       6 | Vitamin C (Ascorbic acid)           |           1313   |

|   7 | Ibuprofen                  |   1201.1 |
|-----|----------------------------|----------|
|   8 | Ceftriaxone Sodium         |   1194.9 |
|   9 | Calcium Gluconate Granular |    876.4 |
|  10 | Paracetamol                |    843.8 |

Source: CDSCO

- (c): With a view to attain self-reliance and reduce import dependence in APIs/ Bulk drugs, the government prepared two schemes viz. (i) 'Production Linked Incentive (PLI) Scheme for promotion  of  domestic  manufacturing  of  critical  Key  Starting  Materials  (KSMs)/  Drug Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs) In India' and (ii) Promotion of Bulk Drug Parks which were approved by the Union Cabinet on 20.03.2020.

## (d): List of 53 APIs short-listed by the Government for incentives is as under:-

|   S. No. | Name of the product             | S. No.   | Name of the product   |
|----------|---------------------------------|----------|-----------------------|
|        1 | Amoxicillin                     | 28.      | Ciprofloxacin         |
|        2 | Azithromycin                    | 29.      | Losartan              |
|        3 | Erythromycin Stearate/ Estolate | 30.      | Telmisartan           |
|        4 | Ceftriaxone                     | 31.      | Artesunate            |
|        5 | Cefoperazone                    | 32.      | Norfloxacin           |
|        6 | Cefixime                        | 33.      | Ofloxacin             |
|        7 | Cephalexin                      | 34.      | Metronidazole         |
|        8 | Piperacillin Tazobactam         | 35.      | Sulfadiazine          |
|        9 | Sulbactam                       | 36.      | Levofloxacin          |
|       10 | Dexamethasone                   | 37.      | Meropenem             |
|       11 | Prednisolone                    | 38.      | Paracetamol           |
|       12 | Metformin                       | 39.      | Tinidazole            |
|       13 | Gabapentin                      | 40.      | Ornidazole            |
|       14 | Rifampicin                      | 41.      | Ritonavir             |
|       15 | Vitamin B1                      | 42.      | Diclofenac Sodium     |
|       16 | Vitamin B6                      | 43.      | Aspirin               |
|       17 | Clindamycin Phosphate           | 44.      | Levetiracetam         |
|       18 | Clindamycin HCL                 | 45.      | Carbidopa             |
|       19 | Streptomycin                    | 46.      | Levodopa              |
|       20 | Neomycin                        | 47.      | Carbamazepine         |
|       21 | Gentamycin                      | 48.      | Oxcarbazepine         |
|       22 | Doxycycline                     | 49.      | Valsartan             |
|       23 | Potassium Clavulanate           | 50.      | Olmesartan            |
|       24 | Oxytetracycline                 | 51.      | Atorvastatin          |
|       25 | Tetracycline                    | 52.      | Acyclovir             |
|       26 | Clarithromycin                  | 53.      | Lopinavir             |
|       27 | Betamethasone                   |          |                       |

- (e): No Sir. As industry has no issue in importing from China.
- (f): In view of (e) above, does not arise.
- (g) & (h):  No Sir.

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