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  • Top Adding - Corporate Laws In India

    A company incorporated in India under the Companies Act, 1956, being a legal personality, has to obey all the laws enacted by the Government of India for its creation, continuation and association with the parties of the outside world.

    The main laws which will impinge upon the existence of a company in the corporate sector are:

    -The Indian Companies Act, 1956;
    -Foreign Exchange Management Act, 1999;
    -Laws
    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
    on Foreign Investment in India;
    -Laws on Financial Systems and Capital Markets;
    -Immigration Laws; and
    -Taxation laws of India.

    COMPANIES ACT

    The existence of a legal framework is perhaps the most significant aspect of the corporate environment. Not being an exception, the Indian company law, largely based on its English counterpart, streamlines the procedure for regulation of Indian companies & bra
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ches of foreign companies operating in India.

    Concept & Types

    As understood under Companies Act, 1956 a company is an incorporated association registered under the act, having an independent entity distinct from the members constituting it. Companies so incorporated can exist as public or private companies with or without limited liability.

    Incorporation

    The promoters, deciding the nature of company to be floated
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    can initiate incorporation of a company, by making application for availability of the name, prepare memorandum & article of association and file it with Registrar of Company (R.O.C.), who after scrutinizing the documents issues the certificate of incorporation.

    MoA &AoA

    Memorandum of association (MoA) comprises of the fundamental parameters upon which company is enacted which includes clauses of name, registered
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    ffice, objects, liability & subscription. Similarly, articles of association (AoA) constitute the rules & regulations that govern the management of its internal affairs & conduct of business including provisions relating to share capital of the company, rights of various shareholders, transmission of shares etc.

    Share Capital Shares may be defined as indivisible units of fixed amounts into which the capital of the
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    company is divided. Generally, a public company is entitled to issue two kinds of shares-equity & preference.

    FOREIGN EXCHANGE MANAGEMENT ACT

    The object of this Act is to help corporate India to have foreign associations in Indian companies and Indian associations in foreign companies in the form of investments, collaborations, mergers & acquisitions and joint ventures, etc.

    Foreign Investment in India:

    ► A
    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
    an Indian company
    A foreign company can commence operations in India by incorporating a company under the Companies Act, 1956 through:
    • Joint Ventures
    • Wholly Owned Subsidiaries
    Foreign equity in such Indian companies can be up to 100% depending on the requirements of the investor, subject to equity caps in respect of the area of activities under the Foreign Direct Investment policy.
    Othe
    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
    options are:
    -Joint Venture
    -Wholly Owned Subsidiary
    ► As a foreign company
    Foreign Companies can set up their operations in India through:
    • Liaison Office / Representative Office:
    • Project Office;
    Branch Office;
    • Branch Office on a ‘Stand Alone Basis’.

    ► Automatic Route
    Under the existing policy, FDI up to 100% is allowed under the automatic route in
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    all activities/sectors except the some selected sectors, which require the prior approval of the Government:

    ► Government Route
    FDI activities not covered under the automatic route require prior Government approval & are considered by the Foreign Investment Promotion Board (FIPB). An application can be made online or on a plain paper accompanied by all the relevant documents. The approvals are generally g
    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
    ranted expeditiously.

    THE FINANCIAL SYSTEM

    The financial system in India is regulated by the Government of India for raising capital for the corporate sector from the Indian capital market and by the Reserve Bank of India for regulating the foreign exchange loans in the form of external commercial borrowings. The Securities and Exchange Board of India is an important and independent legal authority created by the C
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ntral Government for regulating the raising of capital through offer of shares to the public.

    BANKING

    Foreign Direct Investment (FDI) in India is permitted in the banking sector, however, there is a limit for FDI in the banking sector in India.

    Foreign investment by way of transfer of shares of 5% and more of the paid up capital of a private sector banking company, requires prior approval of RBI. Wherever applicab
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    e, FDI in banking companies should confirm to provisions regarding shareholding and transfer etc.

    Financial Institutions:

    The financial system in India allows an Indian corporate to raise foreign currency resources abroad by issuing ADR/GDR, Foreign Currency Convertible Bonds (FCCBs). India also encourages foreign institutional investors.

    Mergers & Acquisitions:

    In case of mergers and acquisitions, the primary as
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ect is the acquisition of shares in the Indian entity. An Indian corporate through the issue of ADRs or GDRs can issue shares.

    IMMIGRATION LAWS

    A foreigner is a person born in or coming from a foreign country. The entry of foreigners’ stay, movements and departure is regulated by the Immigration Laws passed by the Indian Parliament and rules framed there under by the Central Government from time to time.

    The relev
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ant laws as applicable for various purposes to foreigners visiting India are:

    • The Passports (Entry into India) Act, 1967
    • The Foreigners Act, 1946 (as amended from time to time)
    • The Citizenship Act, 1955 (as amended from time to time)
    • The Immigration (Carriers' Liability) Act, 2000
    • The Illegal Migrants (Determination By Tribunals) Act, 1983

    Types of Visas:

    (1) Tourist Visas;
    (2)
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ollective Visas;
    (3) Transit Visas;
    (4) Business Visa;
    (5) Student Visa;
    (6) Conference Visa;
    (7) Employment Visa;
    (8) Recreation.

    The intention behind the above immigration laws is to see that genuine entrepreneurs and business enterprises come to participate in the blooming economy of this country by participating in the economic activities of this country.

    TAXATION SYSTEM IN INDIA

    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
    ndia has a well-developed tax structure with clearly demarcated authority between Central and State Governments and local bodies. Central Government levies taxes on income (except tax on agricultural income, which the State Governments can levy), customs duties, central excise and service tax.

    Value Added Tax (VAT), (Sales tax in States where VAT is not yet in force), stamp duty, State Excise, land revenue and tax o
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    professions are levied by the State Governments. Local bodies are empowered to levy tax on properties, octroi and for utilities like water supply, drainage etc.

    In last 10-15 years, Indian Taxation System has undergone tremendous reforms to come at par with International taxation Systems. The tax rates have been rationalized and tax laws have been simplified resulting in better compliance, ease of tax payment and b
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    etter enforcement. Since April 01, 2005, most of the State Governments in India have replaced sales tax with VAT.

    LAW ENFORCEMENT AGENCIES IN INDIA

    The three-tiered system of Indian judiciary comprising of Supreme Court (New Delhi) at its helm, High Courts standing at the head of State judicial system followed by District and Sessions Courts in the judicial districts, form the backbone of all laws, including Busine
    .

    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
    s Laws.

    The Supreme Court

    The apex court of the country enjoys original, appellate & advisory jurisdiction.

    The High Courts

    The High Courts are generally the last court of regular appeal. The High Courts of Mumbai, Chennai, Kolkata & Delhi enjoy original jurisdiction beyond a certain financial limit (For instance, Rs.20 lakhs & above in case of Delhi).

    The Subordinate Courts

    This segment of the Indian judicial
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ystem comprises of (a) District Courts, empowered to hear appeals from courts of original civil jurisdiction besides having original civil jurisdiction under many enactments (b) Sessions Court are courts of criminal jurisdiction, having the similar scope of powers. The courts of specific original jurisdiction are courts of Civil judges, of Judicial Magistrates; Small Causes courts & Courts of Metropolitan Magistrates


    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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