Medicines have a wider play in human lives and it will be there in the future as well. And to make these life-saving items available across the globe, medicine exporters in India are playing a vital role.
Medicines – The crucial thing to cure ailments. Whenever we encounter any health-related problem, we usually consider that taking medicines will help us recover. When it’s a fever, we go for Paracetamol; when it’s any kind of pain, we search for Painkillers; when it’s cold, we take tablets like Sinarest.
The opportunities for medicine exporters in India have been continuously expanding along with the challenges in the Indian pharmaceutical industry.
In this blog, we’ll look at the current condition of the pharmaceutical industry in India, the market opportunities for medicine exporters in India, and the difficulties they deal with.
The Current Scenario of the Pharmaceutical Industry in India
The Indian pharmaceutical industry is the 3rd largest in the world in terms of volume and the 13th largest in terms of value. It caters to nearly a quarter of the world’s demand for generic drugs.
Regulations are of the utmost importance in the pharmaceutical industry.
The Indian pharmaceutical industry is highly regulated by government bodies such as the Central Drugs Standard Control Organization (CDSCO) and the Drug Controller General of India (DCGI), which ensure that quality standards are met.
The industry has become increasingly competitive, with more and more players entering the market. This is driving good investments for Indian pharmaceutical companies.
Market Potential for Medicine Exporters in India
With its competence in pharmaceutical manufacturing, India is ideally positioned to address the growing need for pharma products. As a result, pharmaceutical export companies in India have the opportunity to meet the rising demand for cost-effective, high-quality pharmaceutical products around the world
India’s Contribution to Global Exports of Drugs, Pharmaceuticals, & Fine-Chemicals (2021–2022):
India’s Drug & Pharmaceutical Export Trend (US$ Billion):
Challenges Faced by Medicine Exporters in India
The medicine exporters in India have a number of obstacles in the current environment, but the most significant ones are listed below:
Issues with the holding company’s ability to support their subsidiaries’ and branches’ operations:
- When a holding company in India allows usage of its IPR to its foreign subsidiaries or branches without consideration, it is not clear whether this would be treated as a taxable supply under GST.
- Similarly, when a foreign holding company allows usage of its brand name and logo to its Indian subsidiaries or branches without consideration, it is not clear whether this would be treated as an import of service under GST.
- These transactions could also have implications under Income Tax laws with respect to Transfer Pricing and FEMA laws with respect to payment realization in convertible foreign exchange.
- In order to ensure that the proper tax treatment is used, it is necessary to thoroughly examine these transactions. To track and manage these transactions, it could be necessary to create new processes and develop new valuation methodologies.
Issues with Regulation and Quality:
Quality and regulatory issues are major barriers facing medicine exporters in India. The market exhibits significant swings in drug and raw materials pricing due to the absence of a stable legislative environment and a defined pricing structure for pharmaceutical products, which discourage investments in third-party drug production.
Additionally, there is a need for the proper application of quality standards due to the large number of pharmaceutical third-party producers operating in India.
According to studies, India has had the greatest rate of FDA (Food and Drug Administration) inspections since 2009 because the country’s pharmaceutical sector lacks a robust quality control and insurance framework.
Competition from Chinese and other Asian Manufacturers:
Chinese and other Asian manufacturers seem to be steadily growing in the marketplace, adding to the competitiveness of pharmaceutical exporters in India. This is because China is a leading manufacturer and supplier of APIs (Active Pharmaceutical Ingredients) all over the world.
Besides all these challenges, the Indian pharmaceutical industry is facing, the medicine exporters in India are making a significant impact on the world with their unique strategies.
How can you get a medicine export license in India?
The actions below must be taken in order to obtain a medical export license in India:
- Apply to the Directorate General of Foreign Trade (DGFT) for an IEC (Import Export Code) number. Online or postal applications are both acceptable.
- Obtain a license for medication manufacture from the Drug Controller General of India (DCGI). To demonstrate that your products are secure and up to par, you must have this license.
- Obtain a certificate of registration from the state licensing body in the country where your business wishes to export its products. To demonstrate your eligibility to manufacture and export medications, you must present this certificate.
- Apply for a special or neutral code from the DGFT. This code is required for some types of medicines, such as those that are controlled substances or that are used for clinical trials.
- Submit an application for an export license to the DGFT. You will need to provide the following documents with your application:
- IEC number
- Drug manufacturing license
- Certificate of registration
- Special or neutral code (if applicable)
- Details of the medicines you are exporting, including the name, dosage, strength, and quantity
- Export order from the buyer
- Letter from the buyer stating that they are aware of the import regulations in their country
The DGFT will go over your application and may ask for a few more details. If your application is accepted, an export license will be given to you, allowing you to export pharmaceutical products from India. This license is valid for a year and is renewable.
CSP Lifesciences: Medicine Exporters in India
CSP Lifesciences is one of the top pharmaceutical exporting companies in India. We provide comprehensive solutions in multiple therapeutic areas, such as oncology, anti-diabetics, cardiology, gynecology, pain and analgesics, and many more, with an in-house team that has a collective experience of over 50 years.
With a solid chain of subsidiaries in the United States, Peru, and the Philippines, as well as associates in the United Arab Emirates, Uzbekistan, Sri Lanka, Tanzania, Ecuador, Kenya, and French West Africa, we are working to establish our presence in several other countries across the world.
Let’s build a healthier world together!
The Indian pharmaceutical industry boasts immense potential as a major global contributor, with medicine exporters playing a crucial role. Although there are challenges with regulations and competition, India is still a significant manufacturer of pharmaceutical products.
Medicine exporters in India, such as CSP Lifesciences, are expertly navigating these complexities and making use of India’s manufacturing expertise to provide high-quality, affordable healthcare solutions to foreign markets. The efforts, along with a dedication to excellence and innovation of such exporters, are crucial in establishing a more wholesome and open future for global healthcare.