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Forces persuade generic drug expansion in the United States

The United States (U.S.) Food and Drug Administration, as protectors of public health, encourages generic drug development and use so that patients can access affordable medications. The FDA, however, has limited mechanisms to encourage generic drug manufacturing.

Generic drug manufacturers make decisions regarding development of products based on expected profitability, influenced by market forces, features of the reference listed drug, and manufacturing capabilities, as well as regulatory restrictions. Barriers to the development of generic drugs include the challenge of demonstrating bioequivalence of some products, particularly those that are considered to be complex generics.

A generic drug is equivalent to it's brand name counterpart, but is usually much less expensive. A generic drug must have the same active ingredients, route of administration, dosage form, strength, and indications as the original brand product. Generic drugs are approved by the U.S. Food an…

Simple steps to set your new venture in India: Make In India

Reaching to Indian Market? Who is the Customer in India



Business is going well and you have a solid foothold in your native/domestic market. You’re ready to explore new markets across borders and oceans. But the task is daunting: Cultural, geographic and language barriers seem like an insurmountable challenge.Lets explore with India.

Don’t put your nerve down. Penetrating a new market overseas (india) is actually easier than it might seem.

Just last year, Oppo,Vivo &OnePlus like mobile handset maker was able to become one of the most sought after smartphones on the global market in an incredibly short period of time. By focusing on airtight logistics and customer support and by creating campaigns targeting local consumers, the company was able to rapidly scale-up marketing and distribution around the world.


Company registration has forever been a major hassle for entrepreneurs looking to set up their businesses in India. It’s no wonder then that India has been ranked 142nd on the Ease of Doing Business Index and 158th on Ease of Starting a Business. The newly introduced INC-29, a five-in-one form introduced by the Ministry of Corporate Affairs (MCA) in May 2015, will go a long way toward improving this ranking.

The INC-29 doesn’t replace the old procedure (at least not yet), but significantly reduces interaction with the authorities through the clubbing of forms for DIN allotment, name reservation, incorporation, PAN & TAN, as well as ESIC registration. Do note, however, that while INC-29 does begin the PAN & TAN and ESIC registration process, you are still required to submit supporting documents and information on the MCA’s e-biz (ebiz.gov.in) portal (so for now it not clear why PAN, TAN and ESIC details are asked; perhaps the government plans to integrate these later).

The INC-29 form has tremendous ramifications on the registration process. If you have registered a company prior to May 2015, you will immediately recognise how much smoother this process can be. Here are the various steps involved:

Procedure 1:

  •     Obtain Digital Signature Certificate from MCA-authorised agency
  •     Time to Complete: 2 to 5 days
  •     Cost to Complete: INR 1,500

Any one of the proposed directors must obtain a Class-II Digital Signature Certificate (DSC) from an MCA-authorised agency to use the electronic filing system of the MCA 21. There are six vendors in all, including Tata Consultancy Services, e-Mudhra and n-Code. The rates of each vendor differs vastly, from INR 400 to INR 2650. Charges would include the cost of a physical USB token and the certificate itself.

It would take 2 to 5 days to complete this, mostly depending on how long it takes to courier your documents to the vendor.

The applicant would need to submit the completed Class-II form, self-attested copy of PAN card or, in case of foreign national, copy of Passport, and self-attested copy of Voter ID/Ration Card/Driver’s License/Latest Utilities Bill/AADHAR Card.


Procedure 2:


  •     Preparing INC-29
  •     Time to Complete: 1 to 3 days
  •     Cost to Complete: Company secretary fees

As soon as you get your DSC, you can file INC-29, but don’t assume that you will be ready to do so. The INC-29 is an eight-page form requiring several pieces of information and documents, some of which require a Company Secretary’s signature, to be submitted in one go. Also, in case of errors in your form, resubmission is allowed only once, after which you will have to pay form filing fees again and apply for a refund on the government fees you’ve paid. So please note the documents you need to have in order to prepare the INC-29 and the attachments.

For Director Information Number Application:


Up to three directors can apply for the Director Information Number (DIN) through INC-29; the rest, if any, may do so separately. The DIN is the number through which the MCA identifies directors of companies. Obtaining a DIN involves the submission of the following documents:

    Scanned copy of Passport-sized photograph
    Scanned copy of PAN card (passport if foreign national) and Driver’s License/Voter ID/Latest Utilities Bill. Both should be self-attested, but foreign nationals would need them notarised by the Indian embassy, too (if they belong to countries not in the commonwealth, they would also need to be apostilled).

For Name Approval


While the old process allowed you to submit six options for your company name, in order of preference, the INC-29 only allows you to give one option. Understanding the MCA’s naming guidelines, therefore, is critical to ensuring your form is approved on first attempt. Largely, you need to follow the following rules:

  •     Ensure that your company’s proposed name has not already been taken on mca.gov.in.
  •     Ensure that there is no registered trademark in the same name by checking at ipindia.nic.com. If there is one, you can get an NoC from the trademark owner authorising you to use it.
  •     Ensure that the first half of the name is unique. Avoid geographical references, adjectives, abbreviations and generic terms. Also, the words bank, exchange and stock exchange require approval from RBI and SEBI.
  •     Ensure that the second half describes the sector you’re in.

Once you’ve decided on a name, also describe the significance of the name in one or two sentences. It would need to be entered into the form.

For Memorandum and Articles of Association


The Memorandum of Association (MoA) and Articles of Association (AoA) need to be attached to the INC-29. These may or may not be drafted by a Company Secretary, but should contain the signature of one. The MoA will also contain the main objects of your business (keep in mind that the Registrar tends to disapprove of businesses that are in unrelated sectors). You would also need to attach an affidavit from all subscribers through Form INC-9 (available on mca.gov.in). The cost of these documents would vary depending on the Company Secretary you choose.
For Registered Office Verification

All companies must have a registered office address. This does not have to be a commercial space. It can even be the home of a director. But the details need to be provided, along with a copy of the Rental Agreement along with an NoC from the owner (if rented property) and sale deed (if property is owned).

For Appointment Letters and Declarations


A number of attachments need to be submitted along with the application. These need to be self-attested, but a Company Secretary must give a separate declaration toward your company verifying the authenticity of all the declarations. The required attachments are:

  •     Letters of appointment of directors, CEO, managers
  •     Declaration by first director in INC-9
  •     Declararion by appointee director and managing director in Form DIR-2.


Procedure 3


  •     Filing INC-29
  •     Time to Complete: 1 day
  •     Cost to Complete: Rs. 2000 + authorised capital fee + stamp duty

If you have all the papers in order, you can now file the INC-29. Fill in the form and attach all the required documents. Ensure that you haven’t missed anything out or it will come in for resubmission. And if the Registrar finds an error in your form on resubmission, too, the form will be rejected completely.

Once you file the form, you will be directed to pay the fees and stamp duty to a payment gateway. The fees will change according to the authorised capital fee and the stamp duty will vary according to your location. Stamp duty is similar in most states, but costlier in Punjab and Kerala.

Authorised capital fees are as follows:


a. INR 100,000: INR 5,000;
b. For every INR 100,000 of authorised capital up to INR 500,000, INR 4,000;
c. For every INR 100,000 of authorised capital up to INR 50,00,000, INR 3,000;
d. For every INR 100,000 of authorised capital up to INR 100,00,000, INR 1,000;
e. For every INR 100,000 of authorised capital over INR 100,00,000, INR 750.

Let’s take an example. For a company with a registered office in Mumbai and authorised capital of Rs. 300,000, the fees would be as follows:

  •     Memorandum of Association: Rs. 2000
  •     Articles of Association: Rs. 300
  •     Stamp Duty: Rs. 1300
  •     Authorised Capital Fee: Rs. 13,000
  •     INC-29: 2000


Procedure 4:


  •     Issue of Incorporation Certificate
  •     Time to Complete: 2 days onwards
  •     Cost to Complete: Does not apply

While the government claims that it will issue the incorporation certificate within two days, this is still to be tested. However, the filing of the single INC-29 form will grant you the incorporation certificate, which is, in itself, a huge step forward.

Once you receive this certificate, you can follow the old steps listed below from Procedure 6 (Make a Seal) onwards. Hopefully, the PAN & TAN and ESIC registrations are also soon combined in the INC-29, as seems to be the plan. This would shorten the procedure some more and move us further up the rankings on the Ease of Doing Business Index.


7 Reason To choose India for International expansion

In 2013, India stands at a point where the compass of its destiny is, once again, in its own hands. The needle of this compass could either point south towards the all-too-familiar path of unfunded welfare economics, intensifying the slowdown currently underway; or it could turn 180-degrees and allow entrepreneurship to take off. I believe the government will choose a mix of the two and there lies opportunity for smart entrepreneurs. Seven reasons why:

1. Where else? While the world output is expected to rise by 4% in 2013, the emerging economies are going to lead it, says IMF. Among them, the two fastest-growing will be China (8.1%) and India (5.9%), versus the US (2.5%) and the Euro area (0.8%). Of the two growth leaders, India will be easier for entrepreneurs from democracies to comprehend.

2. Government is back at the wheel: Bogged down by a severe “policy freeze,” the government soured its relationship with business in 2012. Since September, however, lawmakers have begun to show signs of life: Parliament passed the contentious Banking Laws Amendment law, which allows corporations to set up banks, making capital more readily available. The government has taken constructive action by, for example, allowing foreign companies to take ownership stakes in certain Indian retailers.

3. Inflation is beginning to moderate: The biggest cause of India’s inflation--apart from high and rising commodity prices over the past two years--is a supply side squeeze: too few goods in the system. India’s outlier status on high inflation rate throughout last year is now ending. Wholesale inflation is below 8%, and although consumer price inflation stands close to 10%, experts say this should fall to 6.5% by the next general elections in May of 2014. A falling inflation rate combined with a relatively high growth rate is the kind of environment that outside investors and entrepreneurs should relish.


4. The cost of money will come down: Fighting inflation, the Reserve Bank of India has kept interest rates high over the past few years. For most of that time, the RBI’s tight money policy hit investment harder than inflation. But if the inflation cycle has indeed played out, the next six months should see interest rates fall by 100-150 basis points, adding some spark to the economy.

5. Business-friendly laws could be enacted: Four important bills will be debated in Parliament this year. The Goods and Services Tax Bill would increase efficiency in the movement of products across India. The Direct Taxes Code Bill would clean up tax laws. But the most important (and most controversial) law will be the Land Acquisition Bill. If passed, it could provide the governing coalition political force for elections in 2014. The Companies Bill, which updates India corporate law for the 21st century, has already been cleared by the lower house and should pass the upper house in the budget session of Parliament that begins next month.

6. Workers are ready: The 500 million Indians under age 25 will continue to follow their aspirations to a better life in 2013. The median age in India is 25.1, compared to the US’s 36.9. In a free-enterprise economy this kind of population distribution has often led to a long-term economic boom, the kind begun Japan in the 1950s (median age 25.5) or China in the 1980s (median age 22.4). Further, the nature of those youthful aspirations has changed. This young population is looking beyond agriculture or daily wages. It wants to learn, which creates opportunity for entrepreneurs willing to invest in training.

7. Markets are waiting to explode: As a share of India’s GDP, consumer spending stands at just 57%, compared to 72% for the US. That suggests that there is some $1.2 trillion worth of opportunity in India’s emerging consumer sector. Current government mismanagement of finances and the resultant slowdown notwithstanding, prosperity in the medium term will increase not merely the base GDP but the share of consumer spending as well. This year and the next may see the first steps towards that trend. If you’re entering India this year, you could be getting in on the ground floor.

World's Next Manufacturing Destination-Make in India


India is on the threshold of major reforms and is poised to become the third-largest economy of the world by 2030. In the words of our Hon’ble Prime Minister, India offers the 3 'Ds' for business to thrive— democracy, demography and demand. Add to that a tech-savvy and educated population, skilled labour, robust legal and IPR regime, and a strong commitment to calibrated liberalization — India is a destination that German investors cannot overlook. India's manufacturing sector has evolved through several phases - from the initial industrialisation and the license raj to liberalisation and the current phase of global competitiveness. Today, Indian manufacturing companies in several sectors are targeting global markets and are becoming formidable global competitors. Many are already amongst the most competitive in their sectors.


Make in india : Maier and Vidorno


Key projects announced under Make in India

The sectors that are part of the ‘Make in India’ initiative are:

1. Automobiles

2. Automobile components

3. Aviation

4. Biotechnology

5. Chemicals

6. Construction

7. Defence manufacturing

8. Electrical Machinery

9. Electronic systems

10. Food Processing

11. Information technology and business process management

12. Leather

13. Media & Entertainment

14. Mining

15. Oil & Gas

16. Pharmaceuticals

17. Ports & Shipping

18. Railways

19. Renewable Energy

20. Roads & Highways

21. Space

22. Textiles & Garments

23. Thermal Power

24. Tourism & Hospitality

25. Wellness

Maier+Vidorno is a leading international business development and market entry consulting services in india, Get in touch with them for every solution  


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