A Compliance Checklist for Foreign Manufacturers Entering Indian Healthcare
A Compliance Checklist for Foreign Manufacturers Entering Indian Healthcare
Blog Article
Entering the Indian healthcare market presents tremendous opportunities for foreign manufacturers of medical devices, pharmaceuticals, and healthcare products. With one of the world’s largest populations and an increasing demand for quality healthcare, India offers a growing market with potential for significant returns. However, this opportunity also comes with a highly regulated environment. To successfully launch and distribute products in India, manufacturers must adhere to various compliance and certification standards governed by Indian authorities.
1. Import-Export Code (IEC)
Before initiating any import-related activity, you must obtain an Import Export Code (IEC) from the Directorate General of Foreign Trade (DGFT). This is a mandatory requirement for clearing shipments through Indian customs.
2. CDSCO Registration
If you're importing medical devices, pharmaceuticals, or cosmetics, registration with the Central Drugs Standard Control Organization (CDSCO) is non-negotiable. CDSCO ensures that all medical and drug-related products meet India's safety and quality standards. Depending on the product, the registration process may include submitting technical documentation, clinical evidence, free sale certificates, and compliance with India's risk-based classification of medical devices.
3. BIS Certification (if applicable)
Certain medical equipment and healthcare-related electronic devices may fall under the Bureau of Indian Standards (BIS) mandatory certification list. This ensures that the products conform to Indian safety standards before they are allowed into the market.
4. Legal Metrology Registration
If your healthcare product involves pre-packaged commodities, such as OTC medicines, personal care items, or diagnostic kits, you will also need an LMPC (Legal Metrology Packaged Commodities) certificate. This certificate ensures proper labeling as per Indian standards, including MRP, quantity, importer name, and customer care details.
5. FSSAI License (for Nutraceuticals or Health Supplements)
If your product falls under the category of nutraceuticals, dietary supplements, or functional foods, it must comply with the Food Safety and Standards Authority of India (FSSAI). You’ll need to secure a license and label approval before marketing or distribution.
6. Environmental and Waste Compliance
For medical devices and equipment that may contribute to e-waste or plastic waste, manufacturers must register under the Extended Producer Responsibility (EPR) framework and obtain appropriate clearances from pollution control authorities.
7. Appointing an Indian Authorized Agent
Foreign manufacturers must appoint a licensed Indian Authorized Agent to represent them in regulatory matters, including liaising with CDSCO, BIS, and FSSAI. This representative must be registered with the respective regulatory bodies and hold the necessary licenses to act on your behalf.
8. Labelling and Language Requirements
All products must adhere to India’s specific labeling norms. Apart from information in English, some products may require local language labeling depending on the region of sale.
Agile Regulatory: Your Trusted Partner in Indian Market Entry
At Agile Regulatory, we specialize in helping foreign healthcare manufacturers enter and thrive in the Indian market. With deep expertise in CDSCO registration, BIS certification, LMPC labeling, and FSSAI licensing, we offer complete regulatory solutions tailored to your product type and business goals. From document preparation to post-approval support, our experienced team ensures end-to-end compliance, minimizing delays and maximizing market readiness. Partner with us to navigate India's healthcare regulatory maze confidently and compliantly
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