Pharmaceutical export from India
pharmaceutical exporters

How to Export Medicines from India to Other Countries?

The Indian pharmaceutical industry is the third-biggest in terms of volume and thirteenth-largest in terms of value. It has established itself as a worldwide research and manufacturing hub. The Indian pharmaceutical industry is anticipated to develop at a compound yearly growth rate (CAGR) of 22.4% to touch US 55 billion dollars by 2020.

The Indian Pharmaceutical market is overwhelmed by generic drugs which establish almost 70% of the market, whereas Over the Counter medicines and patented drugs makeup 21% and 9% respectively.

PHARMACEUTICAL EXPORTS AND ADVANTAGE INDIA

  • Pharmaceutical export from India stood at US$ 17.27 billion in 2017-18 and is projected to grow by 30% to reach the US $20 billion by the year 2020.
  • Exports of pharmaceutical products together remained at US$ 10.80 billion during April-October 2018.
  • During April-October 2018, the top importers of India’s pharmaceutical products were UK (US$ 383.30 million), the USA (US$ 3.21 billion), South Africa (US$ 367.35 million), Nigeria (US$ 255.89 million), and Russia (US$ 283.33 million).
  • India is projected to rank amongst the top three pharmaceutical markets regarding incremental growth by 2022.
  • India is the biggest supplier of generic medicines around the world(20 to 22 percent of worldwide export volume)
  • India has one of the least manufacturing costs on the planet. It is lower than that of the USA and practically 50% of Europe.

Fortunately, the government of India has been very supportive, and there are many facilities and concessions are being offered to those who need to start export units.

Step-by-step guide for export of pharmaceutical products and medicines from India

  • Establish a company or firm that will manufacture or advertise pharmaceutical products
  • Import Export Code Number or Get the IEC Number
  • Appoint distributors or agents, or you have to register an office in the country to export
  • Get the specifics, and terms and conditions signed off by the agent or wholesaler
  • Register your product in the nation you are exporting
  • Get the endorsement for export from DCGI
  • Formulize the shipping method, delivery terms, and payment mode
  • Get Purchase Order
  • Send a Pro-forma invoice with details such that sort of packing, freight details, rate, etc.
  • Get commercial invoice against Letter of Credit or Purchase Order
  • Sign agreement with the freight forwarding agency to dispatch the material to a particular country
  • Send products to custom clearance
  • After getting clearance, the material will be shipped
  • In the importing country, customs clearance is needed

Guide for applying for IEC to export medicines from India

Procedure to apply for IEC Number which is needed to export medicines from India.

Step 1: Go to the official website of the Directorate General of Foreign Trade

Step 2: Click on the ‘Online Application’ tab and choose the ‘IEC’ from the drop-down menu.

Step 3: Then select ‘Online IEC Application’

Step 4: Enter your PAN number to log in and click on the Next button.

Step 5: Go to File and pick new IEC Application details’

Step 6: Then a form will show up. Fill all the required details in the form and click on ‘Upload Documents’

Step 7: Once uploading the documents and filling the form, click on the ‘Branch’ button to add any branch details.

Step 8: Then click on ‘Director’ to fill in the details of the directors.

Step 9: Then click on ‘EFT’ for making an online payment.

Step 10: Fill in the number of details and select your bank to make a transaction.

Step 11: Then a draft invoice will show up. Check details you’ve entered and clicked on the ‘Pay now’ button.

Step 12: Make the payment by utilizing your internet banking details.

 

Mandatory Requirements to apply for IEC Number

  1. PAN Number
  2. Current Bank Account Details
  3. Bankers Certificate
  4. IEC Code Number Application Fee
  5. The paper copy of the application including essential documents should reach DGFT RLA concerned within 15 days of its online submission.

 

CUSTOM CLEARANCE

Customs clearance is another significant document that ought to be mandatorily obtained when you need to export medicines abroad.

.You can do it personally or enlist a customs clearance agent. Generate online shipping bills electronically. Thus, the material is moved to the shipping area where custom experts examine it.

Custom department issues ‘Let Export Order which implies the shipping bill can be printed.

These are two processes explained quickly. You need to collect complete data from reliable sources before moving further.

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generic-pharmaceutical
Pharmaceutical Manufacturing

Making the Case for Indian Generic Drug Manufacturing

American consumers are often amazed to find out about the drugs prescribed to them. For example, numerous individuals are taken aback to discover that more than 90% of the medicines prescribed by specialists in the U.S. are generics.

Considerably more surprising is the fact that in excess of 33% of these drugs were likely manufactured in India. This country’s ability to manufacture cost-effective, generic drugs has led to its reputation of being the “pharmacy of the world.” By export volume, India is presently the biggest supplier of generic medicines globally, providing 18% of global generic medicines.

It makes sense that when the media raises concerns about the safety and scope of imported and exported generic medicines, consumers question the quality of medicines fundamental to their health. Ongoing stories have depicted an industry laden with quality issues. These concerns raise fears among patients that consuming medicines made in India may bring about unpredictable effects.

Luckily, the generic medicines manufactured in India are as safe and efficacious as those produced in the United States.

In the past few years, expectations of regulatory organizations around the globe have increased. With the number of companies and manufacturing facilities supplying to the regulated market growing fast, it is natural that the agencies are increasing their efforts. Since 50% of India’s pharmaceutical exports are too highly regulated markets such as the United States, Indian manufacturers must comply with severe U.S. Food and Drug Administration (FDA) guidelines that incorporate regular and rigorous inspections to guarantee compliance.

Also, Indian manufacturers are being examined by inspectors from every market they export to — Mexico, South Korea, Germany, Japan, Brazil, to name a few — who regularly visit and assess Indian pharmaceutical factories.

In response to this growing regulatory environment, pharmaceutical companies in India keep on reinforcing their processes, while improving operating procedures, automation, and quality management systems. This incorporates vigorously proficient quality control and quality assurance systems close by workshops and training programs, building an omnipresent culture of quality. The outcome is a focus on quality that begins at a shop-floor level for machine operators, guaranteeing compliance from the ground up.

Redefining India’s reputation

So, what should be done in order to the practical steps being taken by Indian generic manufacturers to grasp a culture of high-quality? Significantly, beyond presenting a proof-based case that generics manufactured in India are efficacious and safe, we should likewise show the huge great these drugs provide to consumers.

For instance, Indian generic drug manufacturers play an important role in bringing safe, new, affordable drugs to US consumers. In 2018 alone, the FDA affirmed a record of 741 generic drugs with Indian organizations, representing almost 50% of the approvals. (Indian companies got 73 tentative approvals and a total of 415 product approvals in 2018.)

Consider that the Indian pharmaceutical industry has altogether reduced the burden on the U.S. public health system by making genuinely necessary medicines affordable and readily accessible. Every third tablet sold in the U.S. comes straight from India. Generic drug savings added up to $292.6 billion in 2018, as per the AAM Access & Savings Report (2019). Of this, expected savings adding up to $80 billion in 2017 can be credited to the contributions from Indian generic companies.

Indeed, Indian pharmaceutical companies are presently turning into a key source of medication for the rest of the developing world.

India’s global reach

The worldwide demand for medication from India will keep on going up. India’s share of the US generic market is growing quickly, and the number of organizations and manufacturing facilities supplying to the U.S. market is growing too fast. The focus on improved healthcare infrastructure, growing regulatory necessities, and surge in research and development spend bodes well for the pharma business.

This growth isn’t exclusive to India. Indian generic manufacturers are additionally producing in the U.S. and in other countries at whatever point necessary. The Indian Pharmaceutical Alliance (IPA) accounts for 23 research-based national pharmaceutical companies centered with respect to patient health and safety with a pledge to give quality drugs to patients throughout the world.

To drive forward this commitment to give high-quality and safe drugs, IPA organizations have attempted a few focused steps towards excellence in quality. Over the past 4 years, IPA has worked towards:

  • Benchmark Indian pharma drug quality with the rest of the world
  • Create targeted guidelines and best practices in areas of significant, which are vetted by regulators over the world, including the FDA
  • Expand the capabilities and skills of quality talent for Indian pharmaceutical companies

Moreover, between 2012 and 2016, IPA companies contributed $161 million to generic-drug user fees, subsequently offering more than half of the revenue under the Generic Drug User Fee Amendments, which empowers the FDA to bring more prominent predictability and timeliness to the review of generic drug applications, just as assists with funding the inspection of generic plants.

In conclusion

Indian companies will keep on expanding globally, enriching their manufacturing capabilities to fulfill the growing demand on the planet. The future will see a significant role in worldwide healthcare by Indian pharma, not only in making medicines affordable, yet in addition to reinforcing India’s position as a worldwide hub for making innovative and high-quality medicines.

By making key strategic moves in uncharted geographies, technologies, and products, Indian generic manufacturers look to recover their position as a world-class provider of affordable, excellent drugs. Guaranteeing we communicate this vision and quality-centric focus will be essential to the splendid future between manufacturers and those who depend on these medicines.

All things considered, a clear and concise understanding of our record of achievement and emphasis on quality supports the continuous efforts of Indian generic manufacturers to give quality solutions that eventually benefit consumers across the globe.

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Indian Pharma Industry
Pharmaceutical Company

The Pharmaceutical Industry in India: Invest in Pharma Sector

India is a prominent and rapidly growing nation in global pharmaceuticals. It is considered as the biggest supplier of generic medicines globally, occupying nearly 20% share in global supply by volume, and furthermore supplies 62% of global demand for vaccines. India positions 3rd worldwide for production by volume and 14th by value. India is the only nation with the biggest number of US-FDA-compliant Pharma plants which includes 262+ APIs. India has in excess of 2000 WHO-GMP approved pharma plants, 253+ European Directorate of Quality Medicines (EDQM) affirmed plants with modern cutting-edge technology.

India is the primary source of 60,000 generic brands across 60+ therapeutic categories and manufactures more than 500 various Active Pharmaceutical Ingredients (APIs). The API industry is ranked 3rd largest in the world presenting nearly 57% of APIs to the WHO prequalified list.

The nation is home to in excess of 3,000+ pharma organizations with a solid network of more than 10,500 manufacturing facilities.

  • From 2018-19, India’s pharmaceuticals exports were worth around $19.3 billion with a growth of 10.72% consistently.
  • India holds 12% of all worldwide manufacturing sites catering to the US market.
  • The expense of manufacturing in India is roughly 33% lower than.

Market Size

Indian pharmaceutical sector is extended to grow to US$ 100 billion, while the medical device market is foreseen to grow US$ 25 billion by 2025. Pharmaceuticals exports from India represent at US$ 20.70 billion in the Financial year 2020. Pharmaceutical exports incorporate intermediates, drug formulations, bulk drugs, herbal, and biologicals products.

India’s biotechnology industry involving bio-agriculture, biopharmaceuticals, bio-services, bioinformatics, and bio-industry is anticipated to grow at a normal growth rate of around 35% consistently to reach US$ 100 billion by 2025.

India’s domestic pharmaceutical market turnover reached roughly Rs 1.4 lakh crore in 2019, up 9.8% every year from Rs 129,015 crore (US$ 18.12 billion) in 2018.

Investments and Recent Developments

The Union Cabinet has given its nod for the amendment of the existing Foreign Direct Investment (FDI) strategy in the pharmaceutical sector in order to permit FDI up to 100% under the automatic route for the manufacturing of medical devices subject to particular issues.

As per the data released by the Department for Promotion of Industry and Internal Trade (DPIIT), The drugs and pharmaceuticals sector attracted cumulative FDI inflows worth US$ 16.50 billion between April 2000 and March 2020.

Some of the recent developments/investments in the Indian pharmaceutical sector are as per the following:

  • During December 2019, on a moving annual total (MAT) basis, industry growth was at 9.8%, with price growth at 5.3%, new product growth at 2.7%, while volume growth at 2% y-o-y.
  • The Healthcare sector observed private equity of a total of US$ 1.1 billion with 27+ deals in H12019.
  • Indian pharmaceutical industry’s export to the US will get a lift as branded drugs worth US$ 55 billion will become off-patent during 2017-2019.

Growth Drivers

  • Innovation and R&D
    • To develop new complex generic drugs, enhanced by the New Drugs and Clinical Trial Rules, 2019 and the Atal Innovation Mission (a Government of India initiative with the targets of entrepreneurship and innovation promotion via competition, mentorship, etc.)
  • Medical tourism
    • Quality services at marginal expenses compared to Europe, US, and South Asia.
  • Infrastructure development
    • India has the most noteworthy number of US-FDA compliant plants outside the US.
  • Strong drug manufacturing
    • Expertise in low cost generic patented drugs and a movement towards end-to-end production.
The pharmaceutical industry in India provides a couple of opportunities for investments and trade due to the following factors:
  1. Concerning India’s huge population it is an excellent center for clinical trials.
  2. India has productive and cost-effective sources for taking a few to get back generic drugs, particularly the drugs that are going off their patents in the coming years.
  3. India has abundant manpower with solid technical, scientific knowledge.
  4. The cost required for research and development is extremely low.
  5. India houses magnificent laboratories with world-class facilities. It has labs that specialize in process development and the development of cost-efficient drug manufacturing technology.
  6. India is self-sustaining in terms of the manufacturing of bulk drugs. Practically 70% of the requirements for the formulation of drugs are accessible within the nation itself.
  7. India’s fast-growing biotech industry, which offers extraordinary potential in the worldwide market, likewise has contributed to making the pharma sector in India an appealing industry to make investments.

Due to all these advantageous elements, India is recognized as one of the leading players in pharmaceuticals in the worldwide market.

Road Ahead

Medicine spending in India is anticipated to grow 9-12% over the next five years, driving India to become one of the best 10 countries in terms of medical spending.

Going ahead, better growth in domestic sales would likewise rely upon the ability of organizations to align their product portfolio towards chronic therapies for diseases such as anti-diabetes, antidepressants, cardiovascular, and anti-cancers, which are on the rise.

The Indian Government has found a way to reduce costs and cut down healthcare expenses. The rapid introduction of generic drugs into the market has stayed in focus and is needed for the growth of Indian pharmaceutical companies. Moreover, the thrust on rural wellbeing programs, life-saving medications, and preventive vaccines additionally foreshadow well for pharmaceutical companies.

With such an exceptional initiative of the Indian government, the Indian pharmaceutical industry looks incredibly positive for attracting more foreign investments.

 

Contact us for more information:
Call : +91 9979382527
Mail us at [email protected]
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