Drug License for Manufacturing Drugs Other Than Schedule C & X

Deepti Mudgal

Deepti Mudgal

Published on: Feb 9, 2026

Akshit Rai

Updated on: Feb 9, 2026

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INTRODUCTION

Drugs are essential to ensure quality, safety, and proper traceability in India, as mandated by the Drugs & Cosmetics Act,1940. Drugs are different from the other commodities and due to this the government has laid down quite stringent rules and regulations. Control is exercised over drugs at every stage be it manufacture, sale, distribution, repackaging and up to the time it is passed-on to a patient or consumer by a pharmacist in retail Pharmacy, Hospital, or dispensary.

Applicable Provisions

Rules 68, 69(1)(a), 69(2)(a), 69(4),69(5), 69(6), 70, 72(1), 72(2) of Drug Rules, 1945

DOCUMENTS REQUIRED

A signed Form 24-B.
A covering Letter by the applicant.
A list of drugs to be repacked.
A proof of premises (ownership/rent, layout plan).
An affidavit.
Details of Directors/Partners/Proprietors.
No Objection Certificate (NOC) from the original manufacturer.
Copy of the manufacturer’s license.
Details of competent staff (supervisors).
Prescribed fee payment challan.

PROCESS FOR LICENSE

Applicant shall submit Form 24-B along with the prescribed fee and required documents through the State Drug Control Authority’s online portal or via physical submission to obtain License in any case other than Repacking, Manufacture Drugs other than Specified in Schedules C And C (1) and X.

Upon satisfactory inspection, the licensing authority will grant the license in Form 25-B.

RENEWAL OF LICENSE

Applicant shall fill Form 24-B for renewal of a licence to Repacking of Drugs Other Than Specified in Schedules C, C(I) and X.

VALIDITY OF LICENSE

An original licence or a renewed licence in Form 25-B unless sooner suspended or cancelled shall be valid for a period of 5 years on and from the date on which it is granted or renewed.

Procedure for Drug License in case of Repacking of Drugs Other Than Specified in Schedules C, C(I) and X								
INTRODUCTION
Drugs are essential to ensure quality, safety, and proper traceability in India, as mandated by the Drugs & Cosmetics Act,1940. Drugs are different from the other commodities and due to this the government has laid down quite stringent rules and regulations. Control is exercised over drugs at every stage be it manufacture, sale, distribution, repackaging and up to the time it is passed-on to a patient or consumer by a pharmacist in retail Pharmacy, Hospital, or dispensary.
Applicable Provisions
Rules 68, 69(1)(a), 69(2)(a), 69(4),69(5), 69(6), 70, 72(1), 72(2) of Drug Rules, 1945
DOCUMENTS REQUIRED

A signed Form 24-B.
    A covering Letter by the applicant.
    A list of drugs to be repacked.
    A proof of premises (ownership/rent, layout plan).
    An affidavit.
    Details of Directors/Partners/Proprietors.
    No Objection Certificate (NOC) from the original manufacturer.
    Copy of the manufacturer's license.
    Details of competent staff (supervisors).
    Prescribed fee payment challan.

PROCESS FOR LICENSE
Applicant shall submit Form 24-B along with the prescribed fee and required documents through the State Drug Control Authority's online portal or via physical submission to obtain License in any case other than Repacking, Manufacture Drugs other than Specified in Schedules C And C (1) and X.
Upon satisfactory inspection, the licensing authority will grant the license in Form 25-B.
RENEWAL OF LICENSE
Applicant shall fill Form 24-B for renewal of a licence to Repacking of Drugs Other Than Specified in Schedules C, C(I) and X.
VALIDITY OF LICENSE
An original licence or a renewed licence in Form 25-B unless sooner suspended or cancelled shall be valid for a period of 5 years on and from the date on which it is granted or renewed.

Industry Specific

Procedure for Drug License in case of Repacking of Drugs Other Than Specified in Schedules C, C(I) and X