India’s apex drugs regulator is planning a new rulebook for importing bulk drugs and finished medicines by migrating all approval processes online, according to a document reviewed by Mint.
The proposed changes have been outlined in the Central Drugs Standard Control Organisation's (CDSCO) “Guidance Document on Common Submission Format for Import & Registration of Drug(s) (Bulk & Finished Formulations) in India”, which will impact the country's $60 billion pharmaceutical market, according to the department of pharmaceuticals.
With bulk drug import dependence limited to around $5.2 billion, the country remains significantly reliant on foreign active pharmaceutical ingredients for critical bulk drugs and finished formulations used locally and for export.
The revised rules require both the drug and its overseas manufacturing facility to be registered before import, with new drugs also requiring prior approval under the clinical trial rules.
Also, “no drug shall be imported unless it complies with the standard of strength, quality and purity, if any”, the document said, adding that import of drugs with less than 60% shelf life remains banned.
Companies will also have to apply online through authorized local agents or manufacturers, with re-registration applications due nine months before registration certificates expire and import licence renewals required at least three months before expiry.
This follows a separate wholesale licensing regime for bulk drugs, active pharmaceutical ingredients (APIs) and key starting materials (KSMs) amid heightened scrutiny of drug safety lapses. Companies will have to submit factory details, quality test reports, stability data and QR codes on product labels, along with samples from three production batches for testing at India's central laboratories.
The companies must pay the prescribed statutory charges, which include $10,000 for site registration, $5,000 per drug, and $25,000 for factory inspections. The regulator has mandated digital filing through its SUGAM e-governance portal, requiring foreign applicants to clear all compliance milestones electronically before commercial shipments can enter Indian ports.
Clarifying the legal barrier for overseas consignments, the guidance document stated that “no drug shall be imported into India unless the importer holds an import licence granted by the licensing authority”.
Furthermore, to ensure local accountability, foreign manufacturers cannot apply directly; instead, "applications for the issue of Registration Certificate shall be made by the authorized agent in India or the subsidiary of the manufacturer", the document noted, establishing a legally responsible local representative for all overseas consignments.
The local agent must hold a valid Indian manufacturing or wholesale licence to represent the overseas entity. To complete registration, overseas firms must submit comprehensive site details, quality testing data, and production batch records. Applicants are also required to provide a Plant Master File, Good Manufacturing Practice certificates, and stability analysis matching tropical storage conditions.
Outlining the statutory financial obligations, the document stated that “a fee of ten thousand US dollars or its equivalent in Indian rupees shall be paid along with the application as registration fee for premises meant for manufacturing of drugs”, accompanied by “five thousand US dollars for a single drug and an additional fee at the rate of five thousand US dollars for each additional drug”.
“The applicant shall be liable for the payment of a fee of twenty-five thousand US dollars for expenditure as may be required for inspection or visit of the manufacturing premises,” the document said, noting physical audits are deemed necessary by regulatory authorities.
“This migration to end-to-end digital processing aims to improve regulatory oversight, accelerate import clearances, and eliminate manual paperwork for pharmaceutical businesses operating in India,” an official familiar with the matter said on condition of anonymity.
The regulator has noted that this guidance document is intended solely to raise public awareness of drug registration and imports and is not meant to be used for legal or professional purposes.
Mint's queries emailed to the health ministry remained unanswered.