Main Subject - Business

Pick up any national or international newspaper, all have one thing in common that is, Navi Mumbai – SEZ. Yes, this has become the latest focus of conversation not only in

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

India but also in majority of the Asian countries. Special Economic Zone or popularly known as SEZ is planned to be set up in India’s most advanced and populace state Mah

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

arashtra. And Navi Mumbai (or New Bombay) is the place identified for its set up. Known as the economic powerhouse of India, Maharashtra is the best place to kick start th

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

is SEZ.

Literally SEZ means “delineated duty-free enclaves that are deemed foreign territories for the purposes of trade operations, duties and tariffs”. With the setting

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

up of zones, majority units may be set-up for the manufacture of goods, provisioning of services, and other activities including processing, assembling, trading, repairin

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

g, reconditioning, making of gold/silver, platinum jewellery etc. The main USP is that the whole policy allows 100 per cent foreign direct investment ("FDI") in most manuf

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

acturing activities.

Completely backed by the Government of India, various SEZs will be set up throughout the country. Their main aim is to provide an internationally com

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

petitive and hassle-free environment for exports. Apart from that, these zones are designated duty-free enclaves, and are deemed foreign territories for the purpose of tra

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

de operations, duties and tariffs. Also the Policy offers several fiscal and regulatory incentives to developers of the SEZs as well as units within these zones.

Amazingl

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

y this project has already been kick started, and one of the largest SEZs in India has already been set-up in Navi Mumbai. City & Industrial Development Corporation of Mah

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

rashtra or "CIDCO" is the prime agency, looking after the development of the SEZ and lately significant progress has already been made. Being strategically located, the Na

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

vi Mumbai SEZ (NMSEZ) is spread over an area of around 50 square kilometers. Furthermore, it is also linked with well-developed road and rail linkages as well as one of In

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

dia's largest and most modern seaports - Jawaharlal Nehru Port Trust ("JNPT").

Equally backed with world-class infrastructure and services, units can be selected between

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

land plots, flatted factories and built-up office space. Also infrastructure is widespread in terms of convention centers, recreational facilities and social amenities. CI

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

DCO being the co-promoter to the project, it is ensured that NMSEZ will be powerfully supported with a stringent administrative setup. This will seal the smooth implementa

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

tion of the project, along with an easy access to a quasi-government body that would ultimately facilitate the interaction between NMSEZ and the Government of Maharashtra.

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

Currently, CIDCO is in the development process of chalking out the development phasing plan. They have also proposed to finalize the development phasing plan in consultat

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ion with the prospective strategic investors.

Moreover, CIDCO also proposes to transfer land development rights in a phased manner which will be directly linked to achiev

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ement of agreed upon development milestones. In short, whole NMSEZ project is proposed to be executed through a Special Purpose Vehicle or “SPV”. Thus, it won’t be wrong t

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

o say that in coming years not only Maharashtra but the whole of India will undergo an economic revolution and this will, in turn also put India on the global economic map

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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