The Department of Pharmaceuticals has conveyed ‘in-principle’ approval to the proposals of the three States Viz, Himachal Pradesh, Gujarat and Andhra Pradesh under the Scheme for “Promotion of Bulk Drug Parks”, a key initiative to support the Bulk Drugs manufacturing in the country. The Scheme, with a financial outlay of Rs. 3,000 crores notified in 2020, provides for financial assistance to three States for establishing Bulk Drug Parks and aims to bring down the cost of manufacturing of bulk drugs by creation of world class common infrastructure facilities supported by the Central Governmentand thereby increase the competitiveness of the domestic bulk drug industry.

The Indian Pharmaceutical industry is the 3rd largest in the world by volume. India exported pharmaceuticals worth Rs. 1,75,040 crore in the financial year 2021-22, including Bulk Drugs/ Drug Intermediates. Also, India is one of the major producers of Active Pharma Ingredients (API) or bulk drugs in the world. India exported Bulk Drugs/ Drug Intermediates worth Rs. 33,320 crore in financial year 2021-22.

However, the country also imports various Bulk Drugs/ APIs for producing medicines from various countries. Most of the imports of the Bulk Drug/APIs being done in the country are because of economic considerations.

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 various schemes and one of the key interventions is the Scheme for Bulk Drug Parks.

The Bulk Drug Parks to be developed under the scheme will provide common infrastructure facilities at one place thereby creating a robust ecosystem for the Bulk Drug manufacturing in the country and also reducing the manufacturing cost significantly.This scheme is expected to encourage domestic manufacturing of bulk drugs to reduce import dependence and to establish a dominant position in the global market by providing easy access to standard testing & infrastructure facilities. This scheme will also help industry meet the standards of environment at a reduced cost through innovative methods of common waste management system and also to exploit the benefits arising due to optimization of resources and economies of scale.

Under the scheme, proposals were received from 13 States. The Department was guided by an Advisory Committee under CEO, NITI Aayog in the appraisal of the proposals, based on the quantitative as well as qualitative methodology.

The financial assistance to the proposed Bulk Drug Park in Gujarat and Andhra Pradesh would be 70% of the project cost of common infrastructure facilities. In case of Himachal Pradesh, being Hilly States, financial assistance would be 90% of the project cost.Maximum assistance under the scheme for one Bulk Drug Park would be limited to Rs. 1000 crores.

As per the proposals submitted by these States, the Bulk Drugs will be established in 1402.44 acres of land at Tehsil Haroli, District Una, Himachal Pradesh, 2015.02 acres of land at Tehsil Jambusar, District Bharuch, Gujarat and 2000.45 acres of land at K.P. Puram &Kodhada of Thondagi Mandal of East Godavari District, Andhra Pradesh. These three States were instructed to submit their Detailed Project Reports in next 90 days, to appraise the same and to process for issuance of final approval under the scheme.

The scheme reflects the spirit of co-operative federalism where the Central Government and State Governments will partner to develop the Bulk Drug parks for better performance of the sector.

Other interventions of the Department, in ensuring domestic manufacturing of the Bulk Drugs, include,

Production Linked Incentive (PLI) Scheme for domestic manufacturing of KSMs/ Drug Intermediates (DIs) and APIs. Under this scheme, a total of 51 projects have been approved, out of which, 14 projects have already commissioned and started manufacturing of the drugs.

PLI for Pharmaceuticals, provides for financial incentive to 55 selected applicants for manufacturing of identified products under three categories and eligible drugs under this scheme include APIs.