Lok Sabha Question No. 50 (UNSTARRED), answered on 2024-02-02
Subject: Reduction on Import of APIs or Bulk Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Jagdambika Pal

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

LOK SABHA UNSTARRED QUESTION No. 50 TO BE ANSWERED ON THE 2 nd  FEBRUARY, 2024

## Reduction on Import of APIs or Bulk Drugs

## 50. SHRI JAGDAMBIKA PAL:

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

(a) whether the Government has taken any measures to decrease our reliance on the import of Active Pharmaceutical Ingredients (APIs) or Bulk Drugs in the country;

(b) if so, the details thereof;

(c) whether any initiatives have been undertaken by the Government to facilitate cost-effective production of bulk drugs in the country;

(d) if so, the details thereof; and

(e) the current status of the schemes or programmes implemented by the Government in pursuit of these objectives?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI BHAGWANTH KHUBA)

(a) to (e): (I)     The Government strives to minimize country's dependence on imports and to give fillip to indigenous manufacturing. In order to make the country self-reliant in APIs and drug intermediates, the Department of Pharmaceuticals is implementing the following three schemes:

- (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 -  The tenure of the scheme is from FY 2020-2021 to 2029-30 with total financial outlay of ₹6,940 crores. The scheme provides for financial incentive on sales of 41 identified products for six (06) years. 48 projects have been approved under the scheme with a total committed investment of Rs. 3938.57 Crore, against which investment worth Rs 3062.69 cr has already  been  realized.  27  Projects  have  been  commissioned  so  far.  The  envisioned production  capacity  under  the  scheme  was  82,270  MT,  out  of  which  production capacity for 41881 MT has already been installed.
- (ii) Production Linked Incentive scheme for pharmaceuticals - The total financial outlay of the scheme is Rs. 15,000 crore and the tenure of the scheme is from FY 20202021  to  2028-29.  The  scheme  also  provides  for  incentives  on  eligible  sales  of APIs/KSMs/DIs under category 2 of the scheme to  the  approved  participants  for  a period  of  6  years.  1962  APIs/KSMs/DIs  are  approved  for  manufacturing  under  the scheme.

(iii)        The scheme for Promotion of Bulk Drug Parks has been started with the objective of providing easy access to Common Infrastructure Facilities (CIF) to bulk drug units located in the park, in order to significantly bring down the manufacturing cost of bulk drugs. The scheme has a financial outlay of Rs. 3,000 crores and the tenure is from FY 2020-2021 to FY 2024-25. The scheme provides for financial assistance to three States for establishing bulk drug parks. The Department had received proposals from 13 States. After evaluation of the proposals as per prescribed criteria, the approval was accorded to the proposal of setting up bulk drug parks in the states of Andhra Pradesh,  Gujarat  and  Himachal  Pradesh.  First  instalment  was  released  to  Govt.  of Gujarat, Himachal Pradesh and Andhra Pradesh, after the receipt of corresponding state shares in the state implementing agencies' accounts. The bulk drug parks with the CIF and subsidized power, water, land etc. is expected to optimize cost of manufacturing of bulk drugs in India.

(II):    So far as regulatory measures are concerned, as informed by the Ministry of Health and Family Welfare and Central Drugs Standard Control Organisation (CDSCO), the following steps have been taken to encourage indigenous manufacturing of drugs: The Drugs Rules, 1945 was  amended  vide  G.S.R.  1337  (E), dated 27 October, 2017  providing that drugs manufacturing license, sale license and approval of drug testing laboratory shall remain valid, if licensee deposits a license retention fee as prescribed, before the expiry of a period of every succeeding five  years from the date of its issue, unless it is suspended or cancelled by the licensing authority. The Drugs Rules, 1945 were amended vide Notification No. G.S.R. 1193 (E) dated 12.12.2018 wherein application fees were increased for grant of import registration certificate as well as fees for overseas inspection.

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