Glossary

The person in India through whom a manufacturer abroad applies for a Registration Certificate. It must hold a licence to manufacture drugs for sale or a wholesale licence, and its authority is documented by a power of attorney.

Drugs Rules, 1945, rule 24A(1) and (2)

Under the Drugs Rules, the Drugs Controller, India, a Joint Drugs Controller (India) or a Deputy Drugs Controller (India) appointed by the Central Government.

Drugs Rules, 1945, rule 2(b)

The authority that grants permissions under the New Drugs and Clinical Trials Rules, 2019, including permission to import a new drug.

New Drugs and Clinical Trials Rules, 2019, rules 75 and 76

Under the Act, among other things, all medicines for internal or external use of human beings or animals and all substances intended for the diagnosis, treatment, mitigation or prevention of any disease or disorder.

Drugs and Cosmetics Act, 1940, section 3(b)

The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, which prohibits advertisements suggesting a drug for the conditions in its Schedule and in section 3.

Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, section 3

The import licence for drugs outside Schedule X.

Drugs Rules, 1945, rules 21(a) and 23

The import licence for drugs in Schedule X.

Drugs Rules, 1945, rule 23

The licence to import small quantities of a drug, otherwise prohibited, for examination, test or analysis.

Drugs Rules, 1945, rules 21(c) and 33

The application for a licence in Form 11.

Drugs Rules, 1945, rule 34

The application for a licence to sell, stock, exhibit or offer for sale or distribute drugs other than those in Schedule X.

Drugs Rules, 1945, rule 59(2)

The wholesale licence for drugs outside Schedules C, C(1) and X.

Drugs Rules, 1945, rule 61(1)

The wholesale licence for drugs in Schedules C and C(1), other than those in Schedule X.

Drugs Rules, 1945, rule 61(2)

The application for a Registration Certificate.

Drugs Rules, 1945, rule 24A(1)

The Registration Certificate.

Drugs Rules, 1945, rules 21(e) and 27A

The application for an import licence for drugs outside Schedule X.

Drugs Rules, 1945, rule 24(1)

The undertaking, signed by or on behalf of the manufacturer, that accompanies the application in Form 8. Its observance is a condition of the import licence.

Drugs Rules, 1945, rules 24(1) and 26(i)

The application for permission to import a new drug for sale or for distribution.

New Drugs and Clinical Trials Rules, 2019, rule 75

The permission to import a new drug in the form of an active pharmaceutical ingredient.

New Drugs and Clinical Trials Rules, 2019, rule 76

The permission to import a new drug in the form of a pharmaceutical formulation.

New Drugs and Clinical Trials Rules, 2019, rule 76

A licence in Form 10, or in Form 10A for drugs in Schedule X.

Drugs Rules, 1945, rule 21(a)

For import and registration, the authority appointed by the Central Government to perform the duties of the licensing authority under Part IV of the Drugs Rules, including persons to whom its powers are delegated.

Drugs Rules, 1945, rules 21(b) and 22

For import and registration, a manufacturer in a country other than India whose drug manufacturing facilities are approved by the national regulatory authority of that country and whose drugs have a free sale approval there or in other major countries.

Drugs Rules, 1945, rule 21(d)

Among other things, a drug not used in India to any significant extent and not approved by the Central Licencing Authority as safe and efficacious for its claims. An approved drug remains a new drug for four years from its permission.

New Drugs and Clinical Trials Rules, 2019, rule 2(w)

A report on the safety of a new drug after its permission, submitted as specified in the Fifth Schedule.

New Drugs and Clinical Trials Rules, 2019, rule 77(iv)

A preparation containing one or more active pharmaceutical ingredients, with or without excipients, formulated into a specific physical form such as a tablet, capsule or solution.

New Drugs and Clinical Trials Rules, 2019, rule 2(y)

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

New Drugs and Clinical Trials Rules, 2019, rule 2(z)

One of the seaports, airports, inland container depots, railway stations and road crossings listed in rule 43A, the only places through which drugs may be imported.

Drugs Rules, 1945, rule 43A

All informational and persuasive activities by manufacturers and distributors whose effect is to induce the prescription, supply, purchase or use of medicines.

UCPMP 2024, clause 1.1

The certificate in Form 41 that registers the premises of a manufacturer abroad and the drugs made there for import into and use in India.

Drugs Rules, 1945, rule 21(e)

The fee, equal to the licence fee, that keeps a sale licence such as Form 20B or 21B valid when paid before the end of every five years from issue.

Drugs Rules, 1945, rule 63

The countries named by order of the Central Licencing Authority for considering a waiver of the local clinical trial for a new drug.

New Drugs and Clinical Trials Rules, 2019, rules 75(7) and 101

The 51 diseases and ailments that no drug may purport or claim to prevent or cure.

Drugs Rules, 1945, rule 106

The schedule of drugs whose import and sale need separate forms: 8A and 10A for import, 20F and 20G for sale.

Drugs Rules, 1945, rules 23, 24 and 61(3)

The schedules of biological and other special products. Wholesale of these drugs needs a licence in Form 21B rather than 20B.

Drugs Rules, 1945, rules 30 and 61(2)

The information and undertakings submitted with Form 40: D(I) for the manufacturer and its premises, D(II) for each bulk drug, formulation or special product to be registered.

Drugs Rules, 1945, rule 24A(1)

The authority appointed by a State Government to grant licences to sell, stock, exhibit or offer for sale or distribute drugs.

Drugs Rules, 1945, rule 59(1)

The common name for a licence in Form 11.

Drugs Rules, 1945, rule 33

The Uniform Code for Pharmaceutical Marketing Practices issued by the Department of Pharmaceuticals in March 2024.

UCPMP 2024