Domestic production of APIs

Chemicals and Fertilizers

GOVERNMENT OF INDIA
MINISTRY OF CHEMICALS AND FERTILIZERS
DEPARTMENT OF PHARMACEUTICALS

RAJYA SABHA
UNSTARRED QUESTION No. 2276
TO BE ANSWERED ON THE 13th March, 2020

Domestic production of APIs

2276. DR. AMAR PATNAIK:

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

(a) whether it is a fact that there is a shortage of Active Pharmaceutical Ingredients (APIs) in the country, the details thereof;
(b) whether the domestic capacity for manufacturing of APIs in India is inadequate and if so, the details thereof;
(c) whether the manufacturing capacity of APIs in the country is being fully utilised;
(d) the details of domestic dependence on APIs imported from China; and
(e) the details of measures taken by the Government to increase API production in the country?

ANSWER

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

(a): National Pharmaceutical Pricing Authority (NPPA) has informed that they have not received any reference regarding shortage of Active Pharmaceutical Ingredients. The Indian Drugs Manufactures Association (IDMA) has assured that its members have enough stocks of APIs and formulations.
(b) to (d): The Indian Pharmaceutical industry is 3rd largest in the world in terms of volume and 14th largest in terms of value. India exported medicines worth US $14389 mn in Financial Year 2018-19. India also exported Bulk Drug/Drug Intermediates worth US $ 3911mn in Financial Year 2018-19. However, the country also imports various Bulk Drugs/Active Pharmaceutical Ingredients (APIs) for producing medicines. Two-thirds of the total imports of Bulk Drugs/Drug Intermediates is from China. The imports from China are mainly due to economic considerations. The details of India’s imports of Bulk Drugs/Drug Intermediates (including from China) are as under:
Year Total Imports
(US $ mn) Imports from China
(US$ mn) Percent of Imports from China
2018-19 3560.35 2405.42 67.56%

(e): The policies formulated by Government from time to time are designed to minimize country’s dependence on imports and to give fillip to indigenous manufacturing. In this direction, the Department of Pharmaceuticals has formulated a Scheme namely ‘Assistance to Bulk Drug Industry for Common Facility Centre’ for providing assistance to Bulk Drug Industry for Common Facility Centre in any upcoming bulk drug park promoted by State Governments/State Corporations.

Button