The Gujarat government is planning to appoint a special purpose vehicle (SPV) for implementing bulk drugs park in the state based on in-principle approval from the Centre.
An amount of Rs. 200 crore has been sanctioned under the cluster development scheme (CDS) of the Department of Pharmaceuticals (DoP).
Informs Gujarat Food and Drug Control Administration (FDCA) Commissioner Dr HG Koshia, “The scheme envisages to develop a common facility centre (CFC) as part of the bulk drugs park. It is a big boost to the pharmaceutical industry as it will offer a common treatment effluent plant (CETP) facility which is an expensive proposition for bulk drug manufacturers.”
The scheme termed as Development of Common Facility Centre for Bulk Drug (DCFC-BD) is proposed as a central sector scheme.
The scheme would be implemented through a one-time grant-in-aid to be released for creation of identified infrastructure and common facilities to a State Implementing Agency (SIA) set up for the purpose.
The purpose of the grant is to render the financial assistance for establishment of common facilities in any upcoming bulk drug park promoted by state governments/state corporations.
Common facilities under the sub-scheme will consist of creation of tangible assets as CFCs. Some of the indicative activities under the common facilities are effluent treatment plants, captive power plants, steam and cooling systems, incubation facilities, common logistic facilities, advance common testing centre, regulatory awareness facilitation centre and emergency response centre.
DoP will provide overall policy, coordination and management support to the Scheme. The proposals under the scheme will be considered for approval by the Scheme Steering Committee (SSC) of DCFC-BD.
The central government has also recently given in-principle approval for a proposal to set up bulk drug park in Himachal Pradesh.
The proposal was approved in-principle in the first meeting of the Scheme Steering Committee (SSC) held at New Delhi last month.
The Central government plans to set up bulk drug parks at Visakhapatnam, Ahmedabad and Tamil Nadu to boost bulk drug production in the country.
This is aimed to reduce dependence of Indian pharmaceutical companies on Chinese firms for active pharmaceutical ingredients (APIs).
Around 75% to 80% of the APIs used in the formulations of National List of Essential Medicines (NLEM) are sourced from China. In 2017, India imported APIs worth US$ 2.5 billion from China.
Bulk drugs or APIs are the active raw materials used in a drug that give it the therapeutic effect.