Procedure for Drug License in any case other than Repacking, Manufacture Drugs other than Specified in Schedules C And C(1) and X

Deepti Mudgal

Deepti Mudgal

Published on: Feb 9, 2026

Akshit Rai

Updated on: Feb 9, 2026

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26

INTRODUCTION

Drugs are essential for ensuring the good health of a nation. 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

Rule 69(1)(c), 69(2)(c), 69(4), 69(5), 69(6), 70, 71, 72(1), 72(2) of Drug Rules, 1945

WHO CAN APPLY?

1. A Pharmacy or Engineering graduate from a university recognised by the central government and must have 18 months of experience in the field the license applies after their graduation.
2. A Science graduate from a university recognised by the central government and must have atleast 3 years of experience in the field the license applies after their graduation.
3. A Chemical Engineering or Chemical Technology or Medicine from a University established in India by law or has an equivalent qualification recognised and notified by the Central Government, and must have not less than 3 years of experience in the manufacture of drugs, after their graduation.
4. Having a foreign qualification, and if it has the quality and content of training which are comparable with those mentioned above, and is competent enough to work as a technical staff.

DOCUMENTS REQUIRED

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

PROCESS FOR LICENSE

Applicant shall submit Form 24 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.

PROCESS OF RENEWAL

Applicant shall submit Form 24 for renewal of a licence to repack for sale or distribution of drugs, being drugs other than those specified in Schedules C and C (1).

VALIDITY OF LICENSE

An original licence or a renewed licence in Form 25 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.