Main Subject - Business

For most people, the process of buying property requires great attention. It is often a huge investment – possibly the largest that an individual is likely to make; and they would want true value for the money invested. Coupled with the

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

decision to liberalise the FDI norms in the construction sector, it comes as a surprise that the real estate sector continues to function unregulated without a consumer friendly legal framework, especially when mutual funds, insurance po

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

Examples of combination products may in

licies, fixed bank deposits and securities are all subject to the guidelines of a market regulator. Until now, only Non-Resident Indians (NRIs) and Persons of Indian Origin (PIOs) were permitted to invest in the housing and the real est

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

te sectors. Foreign investors other than NRIs were allowed to invest only in development of integrated townships and settlements either through a wholly owned subsidiary or through a joint venture company in India along with a local part

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

ner.

Though the real estate sector in India is proclaimed to be the most promising sector today, it is still hugely plagued by market uncertainties and inhibitions. The real estate market in India predominantly continues to remain unorg

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

Combination pro

nized, fairly fragmented, mostly characterized by small players with a local presence. Thus, a Rs 500 transaction has a regulatory structure in place, while a Rs 50,00,000 contract runs on trust or might. What makes the purchase process

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

even more harrowing is the complete lack of professionalism. The sector is replete with builders and brokers who are not only ignorant of the law, but also about the ways of civil engineering. The Finance Ministry has also expressed conc

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

erns about the exponential growth in the highly unorganised sector, which is also supposed to be one of the most corrupt sectors of the economy.

In a bid to protect consumers, the urban development ministry plans to create a regulator f

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

r the real estate sector. A real estate commission will be set up to frame guidelines and a code of conduct for property dealers. This would mean that property dealers and architects would have to get themselves registered before doing b

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

usiness. These moves are all likely to be part of the proposed Real Estate Management Bill. However, keeping in view the strong opposition of a section of lobby of builders and property agents, it remains to be seen whether the governmen

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

would be able to push forward the proposed Bill. There are proposals for self-regulation by the industry.

However, a section of builders have also supported the government’s move, as it would bring transparency in the industry and an a

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

Following aspects would a

ssurance to the customers. Once confidence level improves, the quantum of foreign investment coming into the sector could rise substantially leading to growth in the sector. As per an estimate, the real estate sector is expected to get a

dd to the challenges in developing combination products:

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

n investment of over $50 billion in next 5 years. Under the proposed Bill, neighbourhood property dealers will have to compulsorily seek licence from the proposed commission for practising in specific catchment areas. To further protect

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

he interest of consumers, the commission will also entertain complaints against dealers and will be empowered to take punitive action. There are also plans for setting up an assistance window at the proposed commission, where prospective

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

buyers will be able to thoroughly check the antecedents and other details of the property.

The same act is also expected to ban pre-launch offers – a method to take consumers for a ride in the housing sector. Realtors would take huge a

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

vances for proposed flats immediately after acquiring land even without the necessary clearances. In some cases, developers have even received advance money before the land was even transferred. More often than not, the developers have s

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

Professional from academic institutions, pharmaceutical industries, health care indust

unk the money in alternate projects. Once a project has been approved, builders will be barred from accepting any advances or deposits from buyers unless a sale agreement has been executed. The moves are expected to put an end to pre-lau

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

nch bookings and publicity which jacks up property prices beyond prevailing market rates. This speculation severely disadvantages genuine buyers while aiding those out to make a quick buck. Apart from the ban on making these offers, the

.

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

ill is also likely to mandate that the developer sign an agreement with the buyers, assuring them of delivery of the property within a stipulated period.

However, the draft of the proposed enactment reveals a few serious flaws. These ma

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

Companies that provide selfless information through particip

inly stem from India’s federal constitution which places property as a subject for state legislation. The fear is that the new statute will face the fate of the National Building Code, which is being ignored by states as much as possible

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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Main Subject - Need for a Statutory Regulator for Property Transactions

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