DoP To Create Pharma Bureau To Facilitate Ease Of Doing Business Through Single Window Clearance

DoP To Create Pharma Bureau To Facilitate Ease Of Doing Business Through Single Window Clearance

Mumbai, 21 Jan 2020:


In order to facilitate ease of doing business in the Indian pharma industry, the Department of Pharmaceuticals (DoP) is in the process of creating a Pharma Bureau to allay concerns of the investors both local and foreign who have to approach multiple agencies under the Central Government for setting up manufacturing facilities in India.


This is very much required as the industry has been struggling to get coordinated support from agencies like the Drug Controller General of India (DCGI), Directorate General of Health Services (DGHS), Departments of Health, Pharmaceuticals, Environment, Commerce, Finance, Revenue, Bio-technology, Department for Promotion of Industry and Internal Trade (DPIIT), Labour, Ministry of Micro, Small and Medium Enterprises (MSME), Chemicals and Petrochemicals.


Pharma Bureau will help remove the bottlenecks and provide policy support and mechanism to the industry for its sustainable growth.


“Setting up of a Pharma Bureau will address concerns and problems of the pharmaceutical industry under one roof. This will save valuable money, time and ensure uninterrupted production of medicines and medical devices for introduction of newer and effective therapies for the patients,” informed Secretary, DoP, P D Vaghela.


He further added that DoP is in the process of framing guidelines to help manufacturers understand the protocol and processes to get approvals through a single window mechanism under Pharma Bureau which will be again led by DoP Secretary.


A team of seven experts will be constituted from different ministries to discuss the broad contours of setting up a Pharma Bureau.


Industry has welcomed DoP for initiating the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) and releasing the ‘Guidelines for Implementation’ for the growth of pharma manufacturing sector.


DoP has extended PTUAS to small scale industry (SSI) manufacturers along with medium scale manufacturers for availing of loan amount of Rs.4 crore with interest subvention of 6 per cent.


However, industry has raised concern of restricting loan under PTUAS for mandatory export activities and asked for its exemption as many SMEs are interested in improving their manufacturing standards and quality of products for the domestic market.


Industry has also stated that the moratorium period is also required to be extended to at least 5 years for API and pharmaceutical manufacturing industries. Also the loan amount of Rs.4 crore is inadequate and needs to be raised to at least Rs.10 crore. Pharmabiz