India is known as the pharmacy of the world for its manufacturing capabilities, yet the country imports significant volumes of pharmaceutical products including active pharmaceutical ingredients, formulations, biologics, medical devices, and specialty drugs. The drug import procedure in India is among the most stringent regulatory processes, governed by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare.
This guide covers the complete CDSCO pharma import process, from registration and licensing to customs clearance and post-import compliance. Business professionals in the pharmaceutical distribution, hospital supply, and contract manufacturing sectors will find this essential reading.
Regulatory Framework
Pharmaceutical imports are regulated under the Drugs and Cosmetics Act, 1940, and the rules framed thereunder. CDSCO is the central authority for approving drug imports, ensuring quality standards, and granting import licenses. The Drug Controller General of India (DCGI) issues import licenses for drugs after evaluating safety, efficacy, and quality data.
Every pharmaceutical product imported into India must have a valid import license from CDSCO. This applies to finished formulations, bulk drugs, biologics, surgical devices, and diagnostic kits. Products without CDSCO approval cannot be legally imported or sold in the Indian market.
Licenses Required
An IEC from DGFT is the starting point. Apply through Patron Accounting IEC registration. The CDSCO import license is the critical pharmaceutical-specific requirement. For formulations, a Form 10 license is needed. For bulk drugs, Form 10-A applies. ICEGATE and GST registration are also mandatory.
The CDSCO license application requires submission of the drug's Certificate of Pharmaceutical Product (CoPP) from the country of origin, WHO GMP certificate, stability data, product specifications, and a letter of authorization from the manufacturer appointing the Indian importer as the authorized agent.
Step-by-Step Process
Step 1: Obtain IEC and CDSCO License
Apply for IEC from DGFT. Submit CDSCO import license application with all required documentation. CDSCO processing takes 3 to 6 months depending on the drug category and completeness of the application.
Step 2: Register Drug with State Drug Authority
After obtaining the CDSCO import license, register the drug with the state drug authority where your business operates. A wholesale drug license from the state is also required for storage and distribution.
Step 3: Place Order and Arrange Cold Chain
Many pharmaceutical products require cold chain logistics. Coordinate with specialised pharma logistics providers for temperature-controlled shipping and handling.
Step 4: Customs Clearance
Submit the CDSCO import license, drug analysis reports, and standard customs documents. CDSCO may draw samples at the port for testing before releasing the consignment.
Step 5: Quality Control
Each imported batch must undergo quality testing. Government laboratories may test samples. Maintain batch records and quality documentation for a minimum of three years after the expiry date.
Documents Required
IEC, CDSCO import license, wholesale drug license, commercial invoice, packing list, bill of lading, Certificate of Analysis from the manufacturer, Certificate of Pharmaceutical Product, WHO GMP certificate, certificate of origin, insurance, and Bill of Entry.
Duty Structure
BCD on pharmaceutical products ranges from 0% to 10%. Many essential drugs attract zero BCD to ensure affordability. IGST at 5% to 12% applies depending on the drug classification. Social Welfare Surcharge at 10% of BCD also applies.
Active pharmaceutical ingredients used as raw materials for domestic manufacturing often attract lower duties than finished formulations. Anti-dumping duties may apply on certain APIs imported from specific countries.
Compliance Requirements
Importers must maintain detailed records of each batch imported, including storage conditions, distribution chain, and adverse event reporting. The CDSCO may conduct inspections and audits. Non-compliance can result in license suspension or cancellation.
Product recall procedures must be in place. Importers are responsible for initiating recalls if quality issues are identified post-distribution. Pharmacovigilance reporting to CDSCO is mandatory for all marketed drugs.
Regulatory Pathway for Different Drug Categories
India classifies drugs into different categories with varying regulatory requirements. New drugs that have not been marketed in India require extensive clinical trial data and a longer approval timeline. Drugs already approved in regulated markets like the US FDA, European EMA, or Japan PMDA may benefit from an abbreviated review process under certain conditions. Generic drugs must demonstrate bioequivalence with the reference product.
Biologics including biosimilars have a separate regulatory pathway with additional requirements for quality characterization, preclinical studies, and clinical data. Medical devices are regulated under the Medical Device Rules, 2017, with their own classification and licensing framework. Importers must identify the correct regulatory category for their product to follow the appropriate approval pathway.
Post-Import Surveillance and Pharmacovigilance
India has a robust pharmacovigilance framework that requires importers to monitor and report adverse drug reactions. The Pharmacovigilance Programme of India, coordinated by the Indian Pharmacopoeia Commission, collects safety data from healthcare professionals and patients. Importers must establish systems for collecting, evaluating, and reporting adverse events to CDSCO.
Each imported batch must be traceable from the manufacturer through the supply chain to the end user. Recall procedures must be documented and tested regularly. If a quality defect or safety signal is identified, the importer must initiate a recall within specified timelines and notify CDSCO. Failure to comply with pharmacovigilance obligations can result in license suspension.
Clinical Trial and Import for R&D
Pharmaceutical imports for clinical trials follow a separate regulatory pathway. The CDSCO issues a Test License allowing import of investigational drugs for clinical research. The application requires approval from the Ethics Committee, the trial protocol, and investigator qualifications. These imports are exempt from commercial duties but must be used exclusively for the approved clinical trial and cannot be commercially distributed.
Pharmaceutical companies importing APIs for research and development purposes may benefit from concessional duty provisions under specific customs notifications. These provisions are designed to support India's pharmaceutical innovation ecosystem and make it cost-effective for companies to conduct drug development activities domestically.
Customs Bonded Warehouse for Pharma
Pharmaceutical importers handling high-value or temperature-sensitive drugs may benefit from establishing a customs bonded warehouse. This facility allows drugs to be stored under customs supervision without immediate payment of duties. Duties are paid only when the goods are cleared from the warehouse for domestic consumption, improving cash flow management for importers dealing with high-value pharmaceutical products.
Market Entry Strategy for Pharma Importers
Entering the Indian pharmaceutical market requires careful strategic planning. The regulatory approval timeline of 3 to 6 months means importers must commit significant time and resources before generating revenue. Building relationships with key opinion leaders in the medical community, establishing distribution partnerships with stockists and hospitals, and investing in medical representative networks are essential steps for successful market entry.
India's pharmaceutical market is the third largest by volume globally, offering immense growth potential for imported specialty drugs, biologics, and innovative formulations. However, the market is also highly competitive with strong domestic generics manufacturers. Imported pharmaceuticals typically succeed in therapeutic areas where domestic alternatives are limited or where brand trust and clinical evidence differentiate the product.
