DRUG LICENCE REGISTRATION

That Drugs Control Department regulates manufacture and sale of drugs, excluding the Ayurvedic and Unani medicines under the provisions of the Drugs and Cosmetics Act, 1940 and Rules made there under. The Department also enforces the Drugs (Price Control) Order 2013 and Drugs & Magic Remedies (Objectionable Advertisements) Act 1954. The department grants / renews licenses to sellers and manufacturers of drugs including Homoeopathic medicines, cosmetic manufacturers, Approved Testing Laboratory and Blood Bank.

Types of Drug  license

Manufacturing License– License issued to a business that manufactures drugs inclusive of allopathic/homoeopathy medicines.

Sale License – License issued for the sale of drugs. It has the following bifurcations: – Wholesale Drug License – Retail Drug License

• Wholesale License – A drug wholesaler must obtain a wholesale licence. Wholesale means the sale of the drug to a person/retailer to further sell it.
• Retail License – A retail license is required for the retail sale of drugs. A retail sale means the sale of drugs or cosmetics for the consumption of the end consumer. Retailers can sell it to a dispensary, hospital, educational, medical, or research institute. Retailers engaged in pharmaceuticals, cosmetics, stand-alone pharmacists, ayurvedic shops, etc need this license.

Details of Requirement of site for Sale license:

Under the Drugs & Cosmetics Act, 1940 and Rules there under an applicant applying for grant of licenses for sale of drugs is required to provide an independent premises of an area not less than 10sq.m.with height of 2.75 m. (in case of grant of Licenses for Retail/Whole sale of Drugs) and where the applicant intends to obtain License for retail as well as whole sale of Drugs, a premises of minimum of 15 sq.m.is required to be provided with height of 2.75 m. The said premises should be independent and easily accessible and should have adequate facilities for storage of General Drugs as well as Drugs requiring special storage conditions like cold storage and deep freezer etc. wherever applicable.

Details of Requirement of site for Manufacturing  license:

Under the Drugs & Cosmetics Act, 1940 and Rules there under an applicant applying for grant of licenses for manufacturing of drugs/cosmetics shall provide the premises in an approved industrial area and shall comply with the relevant provisions of Drugs and Cosmetics Rules, 1945 as applicable for the grant of licences for manufacture of particular type of drugs / cosmetics as per detailed given below:

Types of Manufacturing license:

• For manufacturing of drugs in licence on Form 25
• For manufacturing of drugs in licence on Form 25A
• For manufacturing of drugs in licence on Form 25B
• For manufacturing of drugs in licence on Form 25C
• For manufacturing of drugs in licence on Form 25F
• For manufacturing of drugs in licence on Form 28
• For manufacturing of drugs in licence on Form 28A
• For manufacturing of drugs in licence on Form 28B
• For manufacturing of drugs in licence on Form 28C
• For manufacturing of drugs in licence on Form 28D
• For manufacturing of drugs in licence on Form 28DA
• For manufacturing of drugs in licence on Form 28E
• For manufacturing of drugs in licence on Form 29
• For manufacturing of cosmetics in licence on Form 32
• For manufacturing of cosmetics in licence on Form 32A
• For approval of Testing Laboratories on Form 37

Application for a Drug License

The drug controlling authority, or the regulatory authority is responsible for issuing the drug license. The applicant must apply to the respective drug controlling authority based on the license he/she requires as each drug controlling authority is responsible to issue different licenses (as stated above). The following is the process for obtaining the drug license:

• Visit the respective drug controlling authority website
• Filing of application
• Upload documents
• Visit by drug inspector
• Grant of the drug license

After inspection and verification by the drug inspector, the drugs controller will issue the drug license.

Documents to be Submitted for Grant of Sales Licences:

1. Application Form
2. Fee deposit Receipt

iii. Declaration form

1. Key Plan
2. Site Plan
3. Basis of possession of the premises

vii. Proof of ownership of the premises, if rented

viii. Proof of constitution of the firm

1. Affidavit (on Rs. 10/- Stamp Paper) of non-conviction of Directors/Proprietor/Partner under Drugs & Cosmetic Act, 1940 duly attested by Notary Public.
2. Certified copy of Qualification certificates of the Competent Person/Registered Pharmacist.
3. Experience certificate of the Competent Persons.

xii. Bio-data on Proforma

xiii. Affidavit (on Rs. 10/- Stamp Paper) of Competent Person/Registered Pharmacist regarding fulltime working with the firm duly attested by Notary.

xiv. Photo identification proof of proprietor/partner/Director.

1. Certified copies of Qualification, registration with Delhi Pharmacy Council and valid photo (I.D. in respect of Registered Pharmacist.

xvi. All the photocopies of documents should be self attested.

xvii. 3 Photographs of Competent Person/Registered Pharmacist.

Document For Grant of Licences for Manufacturing of Drugs / Cosmetics or Approval of Testing Laboratories:

1. Each application should be accompanied with a cash deposit receipt as proof that the fees specified under the rules has been deposited in the proper Head of Account.
2. A Site-plan giving the layout of the manufacturing premises with dimensions in meters and detail like position of doors, windows etc.

iii. Key-plan, showing the location of the manufacturing unit giving important land marks so that officers of the Department are able to locate the premises.

1. Documentary evidence of the constitution of the firm: Memorandum and articles of association in case of company partnership deed, duly attested by Notary Public, in case of partnership firm, an affidavit of the proprietor, attested by a Notary Public, in case of a proprietorship firm.
2. Power of Attorney in the name of one or more than one partner / director/ manager /Secretary or any person who is competent to correspond with the Drugs Control Authorities with regard to grant/Renewal etc. of licence(s)
3. Detailed list of machinery and equipments installed for manufacture of drugs. The list should give full details of each machine, its make, capacity, material of which it is made, whether it is automatic or manual etc. duly signed by an authorized person of the firm.

vii. Photo copies of certificates of qualification experience latter or approval (in case where persons are already approved) Biodata, consent affidavit and joining report of the whole time technical staff employed for the manufacturing and testing of drugs/cosmetics.

viii. List of equipment, apparatus and reference books etc. with full details provided for quality control and testing of drugs signed by an authorized person of the firm.

1. List of items, with detailed formula, intended to be manufactured.
2. An affidavit / undertaking to the effect that neither the owner nor the firm had been convicted under the Drugs & Cosmetics Act 1940.
3. Proof of ownership and proof of possession in respect of the premises.

xii. All the photocopies of documents should be self attested.