How Companies in Mexico Can Source Pharma Products & CDMO Services from India

India has risen to become one of the largest countries for pharmaceutical manufacturing in the world, acclaimed for its quality, volume, and affordability. Over the last decade, India has become one of the main partners in global markets, providing high-tech manufacturing, USFDA and WHO-GMP compliance, and low production costs, all at the same time. For companies in Mexico, India is the best choice for pharmaceutical sourcing and CDMO partnerships.

The pharmaceutical and healthcare industries in Mexico are rapidly developing to meet increasing demand for low-cost drugs, medications for the chronic treatment of diseases, and biosimilars. By sourcing medicines from India, Mexican distributors, importers, and pharmaceutical companies ensure access to a variety of Active Pharmaceutical Ingredients (APIs), finished formulations, injectables, and wellness products that fulfill international regulations and standards. Further, in order to provide efficiencies in custom manufacturing, packaging, stability testing, and regulatory submissions, Indian CDMO services are becoming a trustworthy and valuable partner in the pharmaceutical supply chain in Mexico.

The reasons why Mexico Businesses should outsource Pharma from India

Pharmaceutical industry in India is the third most popular industry in the world and a worldwide leader in the export of generic drugs. It is successful because it is based on three major pillars, quality, cost efficiency, and regulatory strength. To the importers and healthcare suppliers in Mexico, collaborating with the Indian manufacturers will present several advantages:

• Meet the requirements of USFDA, WHO-GMP and EU-GMP: The plants in India are always able to meet the international standards of regulation, which guarantees the safety and quality of the products.
• Competitive Manufacturing Costs: India has production costs that are between 40-60% cheaper than most western nations and does not affect the quality.
• Experienced formulation & API environment: India has a good scientific background with skilled chemists that facilitate invention and scale-up.
• Good compliance record/ audit preparedness: Indian exporters are used to foreign checks and paperwork including COFEPRIS filing.
• Extensive product range: India has one of the most diversified therapeutic portfolio in the world, including generic tablets to oncology injectables.
• Experience in Latin America export: Many Indian firms already have regulatory acquaintance in exporting to Mexico, Brazil, Colombia and Chile.

Meeting the Diverse Demands of the Mexican Market

India’s pharmaceutical industry is diverse and flexible, making it well-equipped to meet the varied demands of the Mexican market. Whether Mexico requires affordable generics, high-cost oncology treatments, or over-the-counter wellness products, India offers a wide range of proven manufacturers that can meet these needs. With a deep understanding of global markets and a strong export track record, India remains the go-to source for pharmaceutical products in Mexico.

Process of sourcing Pharma products in India

1) Define Product & Regulatory Requirements

• It is important to identify your product type, dosage form and packaging needs before starting with the sourcing process. In the case of Mexico, it is necessary to be in accordance with COFEPRIS (Federal Commission for the Protection against Sanitary Risk).

 Determine:

• The type of APIs, completed formulations or specialty injectables you require.
• Forms of dosage (tablet, capsule, vial, syrup, and so on)
• Type of registration and technical documents needed.

2) Indian Audited Manufacturers Shortlist

• Partners that have verifiable WHO-GMP, EU-GMP, or USFDA certification are selected. Give preference to those that already have export experience in Latin America or dossier that has been certified by COFEPRIS.

3) Request Product Files & COA

• After short listing, demand the Certificate of Analysis (COA) of the product, data on its stability and technical dossiers. Manufacturers will involve the provision of prices, MOQ and lead time.

4) Submissions of Regulatory and Dossier

• In Mexico, the regulatory filing is in the form of CTD (Common Technical Document). Make sure that the manufacturer helps in the preparation of the dossier and translating the data (Spanish versions are frequently required).

5) Perform Quality Tests and Stability tests

• Mexico is categorized in Stability Zone IVb implying high humidity and temperature levels. Indian manufactures that have their stability capabilities in tropical regions are highly suited to this provision.

6) Complete Supply Chain and Logistics

• Arrange your delivery by means of an efficient freight forwarding company that has done business in transporting pharmaceuticals. It has to be well packaged, labeled and put under cold chain (where necessary).

Different documentation needed when importing to Mexico

To import pharmaceutical products out of India, the following are the documents required to clear through customs and register COFEPRIS:

• WHO / local GMP certificate.
• Certificate of Pharmaceutical Product (COPP)
• Batch records of Certificate of Analysis (COA)
• CPD format documentation / registration dossier.
• Free Sale Certificate (where necessary)
• Material Safety Data Sheet (MSDS).
• Bill of Lading & detailed packing list.

The availability of a full documentation makes the process of clearing of the customs to go through smoothly and the process of registering it with Mexican authorities be quick.

India to Mexico Logistics & Shipping.

Shipment management is an important part of sourcing in the pharmaceuticals industry. Most pharmaceutical exports are through India major ports of Mumbai, Mundra and also Chennai.

Examples of logistics timelines are:

• Sea freight: 3-6 weeks (appropriate when shipping in large quantities and APIs)
• Air freight 4-10 days (good in a hurry or high valued consignments)

Cold-chain management: This is offered on temperature sensitive items such as vaccines and biologics.

In the case of Mexico, the receiving ports of the country are Veracruz and Manzanillo. The choice of the mode will be based on the urgency of the shipment, the cost, and the sensitivity to temperature. The Indian exporters who are reliable often liaise with the certified freight forwarders who can handle the logistics in compliance with GDP.

Import

In order to import without any hassle, the companies have to adhere to the set rules of COFEPRIS, which is the main drug regulation authority in Mexico.

Key compliance steps:

• Grant import licence and sanitary registration.
• Send CTD -format dossier to review.
• Make sure that it is labeled and packaged in Spanish, with dosage and warnings.
• Track the batches of products.
• Quality testing and issue COA to every delivery.

Indian CDMOs are quite familiar with these processes and can be helpful in assisting Mexican partners in the preparation of dossiers, language translation, and stability testing to meet Zone IVb requirements.

In order to import without any hassle, the companies have to adhere to the set rules of COFEPRIS, which is the main drug regulation authority in Mexico.

Key compliance steps:

• Grant import licence and sanitary registration.
• Send CTD -format dossier to review.
• Make sure that it is labeled and packaged in Spanish, with dosage and warnings.
• Track the batches of products.
• Quality testing and issue COA to every delivery.

Indian CDMOs are quite familiar with these processes and can be helpful in assisting Mexican partners in the preparation of dossiers, language translation, and stability testing to meet Zone IVb requirements.

Challenge                                               Solution

• Long COFEPRIS approval cycles-     Establishment of working relationship with Indian   plants that are already exporting to Mexico in accelerated documentation preparation.
• Language and labels compliance-       Indian CDMOs offer language and bilingual packages and translation.
• Lead times and production delays Build up production cycles ahead; maintain buffer inventory.
• Complexity of regulations-     Hire domestic regulatory attorneys to facilitate the coordination with COFEPRIS.
• Quality issues- Carry out third party audits and testing of stability before shipment.

The exporters in India are accustomed to dealing with the regulatory, quality and logistical issues that are inherent to the process of cross-border trade of pharma. Through ensuring that early on documentation and compliance expectations are aligned, most of the hurdles can be prevented.

The pharmaceutical sector in India is a pillar to healthcare provision in the world and has unparalleled capacity, quality and innovation. To Mexican firms, sourcing in India would result in the ability to access high quality generics, APIs, injectables, and wellness items at competitively low prices worldwide.

Through the use of the capabilities of the CDMOs in India, the Mexican companies also have access to the contract manufacturing, the customization of the packaging, and the support of the regulatory documents, i.e. the complyability to the COFEPRIS and worldwide standards. The alliance between the two countries is also on the rise, and this is evidenced by the increasing trade relations and the appreciation of the quality systems.

As an importer, distributor, or healthcare group in Mexico, this is the best opportunity to increase sourcing relations with India. The financial gains to the reliable quality are self-evident and the possibilities are numerous.