Question : Active Pharmaceutical Ingredients

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?

(a): Major countries exporting Bulk Drugs, Drug Intermediates to India along with the quantities (in KG) over the last five years are as follows:-

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

(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:-

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) 1313.0
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. PiperacillinTazobactam 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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