How Chilean Pharma Companies Can Source Affordable & WHO-GMP Certified Products from India

India has been positioned as a reliable pharmaceutical manufacturing centre in the world. The country is a sourcing destination of choice in the manufacturing of finished pharmaceutical products, Active Pharmaceutical Ingredients (APIs) and contract manufacturing services (CDMO) as exports have gone past over 200 countries. India is the best choice of a balance between quality, affordability, and regulatory predictability of Chile Pharma Market that depends on the imported pharmaceutical products greatly, making it a leading destination for sourcing pharma products and CDMO services.

The Indian manufacturers are regulated by the standards of USFDA, WHO-GMP, and EU-GMP, which means that the products can be discussed as globally safe and effective. The Chilean pharma importers, distributors, and healthcare corporations resort to India more and more to find medicines, cooperate in CDMO services, and to import pharmaceutical products which meet the requirements of Instituto de Salud Publica (ISP-Chile).

India has become the most trusted ally of Chile in consolidating its supply chains and constant availability of necessary healthcare products as the demand of the country in affordable and quality generics and specialty products increases. (Read: Why global pharma companies choose India for CDMO)

Why Chile Businesses are in favor of sourcing Pharma from India

The industry of pharmaceutical manufacturing in India is premised on the aspect of scale, professional expertise and adherence of regulations. The advantages of Chilean importers are the advanced facilities of India, the variety of products, and the costs.

The major factors that drive the businesses in Chile to source in India are:

• Global conformity: Indian through Indian facilities conform to the standards of USFDA, WHO-GMP and EU-GMP that are accepted in Chile.
• Favorable pricing: The production in India is 40-60 per cent cheaper when compared to western markets, which means the Chilean firms can remain price competitive.
• Large-scale supply: India possesses more than 3,000 formulation units and 1,500 API manufacturers.
• Established quality track record: Indian firms are regularly audited by top health organizations all over the world.
• Large product portfolio: It deals with generic drugs, oncology, injectables, biosimilars and APIs as well as wellness products.

Major Pharma Requests in Chile from India

The pharmaceutical needs of Chile are varied in the types of drugs required, and India is the major provider of drugs in all the significant areas of therapy.

Active Pharmaceutical Ingredients (APIs) and Intermediates

India is a world leader in producing API, which provides the molecules in the world like Paracetamol, Metformin, Amoxicillin, and Atorvastatin. These are the main elements of the local formulation and compounding industry of Chile.

Finished Formulations

The Indian manufacturers have high-quality tablet, capsule, syrup, and oral liquid manufacturing plants, which are approved by the USFDA and МHRA. These finished products are imported to Chile by importers, who retail, sell to hospitals, and government procurement.

Drugs injected and Oncolytic Drugs

Indian plants used in specialized plants do provide sterile injectables, oncology vials and antibiotics in a highly maintained containment and cleanroom environment. The oncology and hospital care sectors in Chile are on a high demand of these.

OTC and Wellness Products

Other high growth products in Chile are vitamins, dietary supplements, herbal formulations, nutraceuticals. The Indian companies provide low priced certified wellness solutions to satisfy consumer and retail market demand.

Hospital and Clinical Supplies

The Chilean healthcare facilities and distributors frequently import products such as IV sets, syringes, gloves, and diagnostic consumables, particularly when it comes to tenders and institutional supply.

Pharmaceutical products sourced in India to Chile are clearly planned and in line with the requirements of ISP-Chile in importing products.

Step 1: Product and Regulatory Requirements definition

• Determine the requirement of APIs, formulations or OTC products.
• Indicate dosage forms, areas of therapy and packaging.
• Discuss ISP-Chile regulatory rules of registration and labelling.

Step 2: Shortlist Indian Indian Manufacturers which have been audited.

• Select suppliers who have certifications of WHO-GMP, EU-GMP or the USFDA.
• Check their experience of exporting to the Latin American markets, particularly Chile.
• Order audit reports, certifications or third party inspection summaries.

Step 3: Requirement Product Files and COA

• Request full product dossiers, Certificate of Analysis (COA), and specifications of how it is made.
• Ensure that quality parameters are of pharmacopoeial standard (USP, BP or IP).

Step 4:write Regulatory and Dossier Submissions

• File CTD-format dossiers according to ISP-Chile.
• Add safety information, GMP certificates and product specifications.

Step 5: Quality Check and Stability Testing

• Sample on test products without any final approval.
• Make sure that stability studies are done in the Zone IVb (hot and humid) conditions - applicable to the geography of Chile.

Step 6: Supply Chain and Shipping Planning

• Organize production schedules, shipment schedules and Incoterms.
• Hire freight companies that are familiar with the pharmaceutical shipments.

The Importation requirements into Chile takes the form of documentation.

Chilean importers require special documents in case of importing pharmaceutical materials in India, in order to satisfy the requirements of ISP and customs.

Such necessary documents are:

• Certificate of Pharmaceutical Product (COPP)
• GMP Certificate either of the Indian authorities or WHO
• Base records Certificate of Analysis (COA) and batch records
• Registration Dossier (CTD format)
• Free Sale Certificate (as necessary)
• Bill of Lading or Airway Bill
• Product Safety DataSheet (MSDS)
• Packing List and Commercial Invoice

Successful imports are dependent on efficient logistics. Indian export network is linked flawlessly to the major ports in Chile.

Typical shipping timelines:

• Sea freighter: 3-6 weeks between Indian ports like Mumbai, Mundra or Chennai to Valparaiso or San Antonio, Chile.
• Air transport - 4-10 days between Mumbai or Delhi and Santiago

Cold Chain management: Provided with vaccines, biologic, and temperature-sensitive products.

Favorite Indian ports: Mumbai (Nhava Sheva), Mundra and Chennai - all these ports have pharma export and cold storage facilities.

The Instituto de Salud Publica (ISP) regulates the pharmaceutical imports in Chile and all the medicines must be tested regarding their standards in terms of safety and quality before entering the market.

Key regulatory highlights:

• Name of the Import licensing body: ISP-Chile.
• Registration Process: It involves CTD-format dossier, GMP certification and COPP.
• Timelines of approval: 6-12 months in a typical case of approval on the basis of the completeness of the dossiers.
• Stability Zone: Zone IVb (hot and humid) of which already the compliance data are provided by the Indian suppliers.

The involvement of Indian firms that have done ANMAT or ISP-Chile submissions is helpful in reducing registration delays and product approval is easier.

The collaboration that Chilean pharma and biotech companies have with Indian Contract Development and Manufacturing Organizations (CDMOs) can introduce the world of affordable innovation and mass production.

Rewards of cooperating with Indian CDMOs

• Product Development and Scale-Up: R&D support to validation batches.
• Packaging & Labeling Compliance: Packaging in accordance to the ISP-Chile and Spanish labeling standards.
• Flexible MOQs: This is suitable in small and middle-size companies that may be entering new treatment fields.
• Tech Transfer & IP Protection: Proprietary data is protected with the help of tech transfer and confidentiality agreements.
• Regulatory Support: Dossier preparation- Experienced teams prepare dossiers that fit the standards in Chile.

Normal Problems and Resolutions

• Regulatory Delays: Collaborate with Indian suppliers that have earlier experience with the ISP-Chile registration to eliminate protracted approval procedures.
• Long Lead Times: Produce and schedule shipments ahead of time, particularly with orders of volume.
• Labeling Compliance: The Indian partners are in a position to supply artwork and Spanish labeling in compliance with the Chilean packaging regulations.
• Quality Verification: Stability test and COA verify commercial shipments.
• Language & Coordination: Select Indian exporters who have bilingual (English-Spanish) communication to facilitate easy cooperation.

The pharmaceutical production capability of India gives the Chilean importers and the healthcare firms an upper hand in their quest to obtain quality, affordable and reliable medicines. Indian firms are the best regarding regulatory preparedness and product variety, whether they are sourcing APIs, finished formulations, injectables, or OTC products.

Chilean business focused collaboration with GMP-certified Indian manufacturers will allow their companies to grow their portfolios, maintain high supply, and lower the cost of procurements at the same time without breaching the high standards of ISP compliance.