Wholesale licence, Registration Certificate, new drug permission, import licence and test licence: who applies, in which form, for how long, and under which rule.
Legal texts consulted on 10 November 2026
Scope and abbreviations
This page follows a drug for human use, made outside India and imported for sale. “Act” is the Drugs and Cosmetics Act, 1940; “Drugs Rules”, the Drugs Rules, 1945; “NDCT Rules”, the New Drugs and Clinical Trials Rules, 2019. Drugs in Schedule X, medical devices, cosmetics, and Ayurveda, Siddha, Unani and Homoeopathy drugs follow other provisions and are not covered.
The Drugs Rules are cited from the compilation published by the Central Drugs Standard Control Organization, as amended up to G.S.R. 360(E) of 1 July 2024; later amendments may change fees or periods. The content describes the general framework; it does not replace the view of the licensing authority and is not legal advice.
Who holds what
Who holds each licence, who issues it and the form of application
Rule 24A lets a foreign manufacturer apply for registration only through an Indian agent who already holds a licence to manufacture drugs for sale or to sell them by wholesale. For most importers, that is the wholesale licence.
Wholesale licence: key points
Who applies
The person who will sell, stock or distribute drugs by wholesale from named premises
Applied for in
Form 19, with a fee of ₹1,500
Granted in
Form 20B for drugs outside Schedules C, C(1) and X; Form 21B for drugs in Schedules C and C(1), other than those in Schedule X
Issued by
The licensing authority appointed by the State Government (rule 59)
Premises
A separate licence for each place where drugs are sold or stocked for sale (rule 62)
Stays valid
As long as a retention fee equal to the licence fee is paid before the end of every five years from issue (rule 63)
If missing
The Indian party cannot act as the manufacturer’s agent for registration or import (rules 24 and 24A)
A licence in Form 20B or 21B is granted for named premises, one place at a time.
“A licence issued in Forms 20, 20A, 20B, 20BB, 20F, 20G, 21, 21A, 21B or Form 21BB shall remain valid, if licencee deposits a licence retention fee referred to in sub-rule (2) before the expiry of a period of every succeeding five years from the date of its issue, unless, it is suspended or cancelled by the licensing authority.”
The wholesale licence is a State matter: each State Government appoints its own licensing authorities (rule 59). The licences for import and registration described below are granted by the licensing authority appointed by the Central Government (rule 21).
Form 41 · Registers the foreign factory and each drug
Registration Certificate
The Registration Certificate puts a manufacturing site outside India, and each drug made there, on India’s register. Without it, an import licence cannot be applied for.
Registration Certificate: key points
Who applies
The manufacturer, if it holds a wholesale licence in India, or its authorised agent in India holding a licence to manufacture drugs for sale or a wholesale licence
Applied for in
Form 40, with the information and undertakings of Schedules D(I) and D(II), signed by or on behalf of the manufacturer
The agent’s authority
A power of attorney executed in India before a First Class Magistrate, or in the country of origin before an equivalent authority whose certificate is attested by the Indian Embassy; the original goes with the application
Fees
US$10,000 for the manufacturing premises and US$5,000 for each drug, or the equivalent in rupees; testing fees are paid to the laboratory
Inspection
The applicant is liable for a fee of US$25,000 for the expenditure of inspecting or visiting the manufacturing premises
Decision
Within nine months of a complete application; in exceptional circumstances, up to three months more, for reasons recorded in writing (rule 27A)
Valid for
Three years; a fresh application made nine months before expiry keeps the certificate in force until orders are passed (rule 28A)
One factory, one certificate
Several drugs from one factory may share a certificate; each factory elsewhere needs its own (rule 25B)
If missing
No import licence application can be made, except in an emergency with the approval of the Central Government (rule 24(2))
The Registration Certificate registers the factory abroad and each drug made there.
““Registration Certificate” means a certificate issued under rule 27A by the licensing authority in Form 41 for registration of the premises and the drugs manufactured by the manufacturer meant for import into and use in India.”
For this Part of the Rules, a manufacturer abroad is one whose manufacturing facilities are approved by the national regulatory authority of its country and whose drugs have a free sale approval there or in other major countries (rule 21(d)).
“An application for issue of a Registration Certificate shall be made to the licensing authority in Form 40, either by the manufacturer himself, having a valid whole sale licence for sale or distribution of drugs under these rules, or by his authorised agent in India, either having a valid licence under the rules to manufacture for sale of a drug or having a valid whole sale licence for sale or distribution of drugs under these rules”
“A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue”
Basis Drugs Rules, 1945, rules 21(d) and (e), 24A, 25B, 27A, 28A and 29A; Schedules D(I) and D(II)
Form CT‑20 · Only for a new drug
New drug import permission
A drug not yet approved in India as safe and efficacious for its claims is a new drug, however long it has been sold elsewhere. It needs a permission of its own before the import licence.
New drug import permission: key points
When needed
The drug is a new drug as defined in rule 2(w) of the New Drugs and Clinical Trials Rules, 2019
Applied for in
Form CT‑18, with the data of the Second Schedule and the fee of the Sixth Schedule
Granted in
Form CT‑19 for an active pharmaceutical ingredient; Form CT‑20 for a pharmaceutical formulation
Issued by
The Central Licencing Authority
Decision
Within 90 working days of the application; deficiencies are notified within the same period (rule 76)
Local clinical trial
Required for an unapproved new molecule, unless waived under rule 75(7)
Afterwards
The import licence is applied for under the Drugs Rules, with the permission attached (rule 79)
If missing
A new drug cannot be imported for sale or for distribution (rule 74)
A new drug is defined by its record in India, not by its age elsewhere.
“No person shall import or manufacture for sale or for distribution any new drug in the form of active pharmaceutical ingredient or pharmaceutical formulation, as the case may be, except in accordance with the provisions of the Act and these rules.”
If the application is refused, the applicant may ask for reconsideration within 60 days of the rejection, or appeal to the Central Government within 60 days of receiving it (rule 76(2) and (3)). The definition of a new drug, and the four-year period during which an approved drug remains one, are explained in a separate note.
Basis New Drugs and Clinical Trials Rules, 2019, rules 2(w), 74 to 79 and 101
Form 10 · Held by the importer in India
Import licence
Section 10 of the Drugs and Cosmetics Act forbids importing a drug for which a licence is prescribed except under that licence. For drugs outside Schedule X, the licence is Form 10.
Import licence: key points
Who applies
The manufacturer holding a wholesale licence in India, or the manufacturer’s agent in India holding a licence to manufacture drugs for sale or a wholesale licence
Applied for in
Form 8, with an undertaking in Form 9 signed by or on behalf of the manufacturer and a copy of the Registration Certificate in Form 41
Fee
₹10,000 for one drug and ₹1,000 for each additional drug; ₹1,000 per drug for a later application by the same importer for the same manufacturer
Granted in
Form 10 (Form 10A for drugs in Schedule X)
Before granting
The authority considers the storage at the premises where the drugs will be stocked, and the applicant’s occupation, trade or business (rule 25A)
Valid for
Three years from issue; a fresh application made three months before expiry keeps the licence in force until orders are passed (rule 28)
Conditions
Inspectors may enter the stocking premises; samples and test protocols on request; a record of every sale; withdrawal and recall of a batch found not of standard quality (rule 26)
Entry
Only through the places listed in rule 43A
If missing
The import is prohibited (section 10(c) of the Act)
Drugs may be imported by air only through the nine airports listed in rule 43A.
“any drug or cosmetic for the import of which a licence is prescribed, otherwise than under, and in accordance with, such licence”
“An import licence in Form 10 shall be required for import of drugs, excluding those specified in Schedule X, and an import licence in Form 10A shall be required for the import of drugs specified in Schedule X.”
“Any application for import licence in Form 8 or Form 8A, as the case may be, shall be accompanied by a copy of Registration Certificate issued in Form 41 under rule 27A”
Where drugs may enter India
Rule 43A lists the only places through which a drug may be imported. A consignment that arrives anywhere else is not covered by the import licence.
By sea
Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva, Kandla; the inland container depots at Tuglakabad and Patparganj in Delhi; Tuticorin and Kamrajar Port in Tamil Nadu; Marmugao port in Goa; Visakhapatnam, Krishnapatnam and Gangavaram ports in Andhra Pradesh; Hazira port, the inland container depot Khodiyar, Gandhinagar and Mundra Port in Gujarat; the inland container depots at Dhannad and Tihi, Indore, in Madhya Pradesh
By air
Chennai, Kolkata, Mumbai, Delhi, Ahmedabad, Hyderabad, Goa, Bengaluru and Visakhapatnam
By rail and road
Firozepur Cantonment and Amritsar railway stations; Ranaghat, Bongaon and Mohiassan railway stations; Petrapole road in West Bengal, Sutarkandi in Assam, old Raghna Bazar and Agartala in Tripura; Raxaul, by road and rail from Birganj in Nepal
Basis Drugs and Cosmetics Act, 1940, section 10; Drugs Rules, 1945, rules 21(a), 23 to 29 and 43A
Form 11 · Small quantities, not for sale
Licence for examination, test or analysis
The Act allows small quantities of a drug to be imported for examination, test or analysis, subject to conditions. The Rules set them out in rule 33.
Licence for examination, test or analysis: key points
Who applies
The application is made or countersigned by the head of the institution, or by a proprietor or director of the firm, that will carry out the testing
Applied for in
Form 12, with a fee of ₹5,000 for one drug and ₹2,000 for each additional drug
Granted in
Form 11
Use
Exclusively for examination, test or analysis, at the place named in the licence or another place the authority allows
Records
A record of the quantities imported, the date of import and the manufacturer, reported to the licensing authority
If missing
Even small quantities for testing cannot be imported
“Small quantities of drugs the import of which is otherwise prohibited under section 10 of the Act may be imported for the purpose of examination, test or analysis subject to the following conditions”
Basis Drugs and Cosmetics Act, 1940, section 10, first proviso; Drugs Rules, 1945, rules 21(c), 33 and 34
Texts consulted
Drugs and Cosmetics Act, 1940 (23 of 1940), compilation of the Central Drugs Standard Control Organization.
Drugs Rules, 1945, compilation of the Central Drugs Standard Control Organization, as amended up to G.S.R. 360(E) dated 1 July 2024.
New Drugs and Clinical Trials Rules, 2019, G.S.R. 227(E) dated 19 March 2019, Gazette of India.
Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (21 of 1954), India Code, as on 15 April 2026.
Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024, Department of Pharmaceuticals, March 2024.
A question about one of the licences?
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