In the Indian pharmaceutical industry, products intended for export are marked with a “neutral code” or “special code,” while those sold domestically are identified by a “mfg. lic. no.” (manufacturing license number). The neutral code system is designed to keep the manufacturer’s identity confidential on export labels, complying with various international regulatory requirements.
To obtain a neutral code for export, manufacturers must apply to the Central Drugs Standard Control Organisation (CDSCO) with several documents, including a valid manufacturing license, export orders, and letters from foreign buyers requesting the specific code. This process ensures that products can be exported without revealing the manufacturer’s details, which can be crucial for business strategy and compliance with certain international markets.
For companies using contract manufacturers, a “loan license” can be obtained. This allows the client company to use the contract manufacturer’s site to produce their drugs under their own neutral code. The loan license enables the client to apply directly to the FDA for product permissions, facilitating streamlined regulatory compliance and maintaining control over their product’s branding and export processes. This system is crucial for maintaining confidentiality and compliance with diverse international regulations, thereby supporting India’s robust position in the global pharmaceutical market (CliniExperts) (Corpbiz) (NKG Advisory).
If three or more firms are producing products under the same neutral code, it typically indicates that these products are being manufactured at the same facility. The neutral code is associated with a specific manufacturing plant approved by the CDSCO. This code ensures that the manufacturing site complies with regulatory standards, regardless of the company marketing the product.
When multiple firms use the same neutral code, it suggests they are leveraging a common contract manufacturer’s facility. This setup is beneficial for companies without their own manufacturing infrastructure, allowing them to utilize an established, compliant plant while maintaining confidentiality about the manufacturing source on export labels. Therefore, if three different firms’ products share the same neutral code, they are indeed being produced in the same manufacturing plant. This arrangement is typically facilitated through a loan license, allowing different companies to produce their products at a contract manufacturing site while applying their own branding and regulatory approvals for export purposes (CliniExperts) (Corpbiz) (NKG Advisory).
If a product manufactured in India only has a neutral code on it, it is intended exclusively for export and cannot be sold domestically within India. The neutral code system is designed to keep the manufacturer’s identity confidential on export labels while complying with international regulatory standards. This code indicates that the product is for export purposes only and ensures that the products do not enter the domestic market. According to the guidelines set by the CDSCO, the neutral code or special code is applied to products that are manufactured for export. The regulation ensures that these products, marked for export, are not diverted to the domestic market. The use of a neutral code is part of the compliance with export regulations, and products marked with this code are subject to strict monitoring to ensure they are only sold outside India (CliniExperts) (Corpbiz) (NKG Advisory).
Citations:
- CliniExperts. “Export NOC, Special Code/Neutral Code For NOC.” CliniExperts, 2023. CliniExperts.
- Corpbiz. “Drug Export NOC: Licensing Guide | Procedure.” Corpbiz, 2023. Corpbiz.
- NKG Advisory. “SPECIAL CODE/NEUTRAL CODE FOR NOC – Drug Regulatory Services.” NKG Advisory, 2023. NKG Advisory.