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Citizen's Charter

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  • WHAT IS THE OBJECTIVE OF THE DRUGS CONTROL DEPARTMENT?

    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, excluding Medical Devices covered under Class C & D as described in Medical Device Rules 2017.
     

  • WHERE ARE THE FORMS FOR THE LICENCE(S) AVAILABLE?

    Application for grant / renewal of manufacturing licenses can be made on typed paper in prescribed format as well as online mode. Format can be downloaded from the website of this department https://drugs.delhi.gov.in. A check list of documents to be submitted along with application forms for licenses, the fees structure and other documents is also available on this website.

    For online applications are to be submitted on Online National Drugs Licensing System (ONDLS) having URL: https://statedrugs.gov.in and process has been described in the tab namely "How To Apply" 

    For grant / retention of sale licences applications are being received only on online mode on ONDLS portal mentioned above.

  • Documents to be submitted:
    1.  For Grant of Sales Licences:
      1. Application Form
      2. Fee deposit Receipt
      3. Declaration form
      4. Key Plan
      5. Site Plan
      6. Basis of possession of the premises
      7. Proof of ownership of the premises, if rented
      8. Proof of constitution of the firm
      9. Affidavit (on Rs. 10/- Stamp Paper) of non-conviction of Directors/Proprietor/Partner under Drugs & Cosmetic Act, 1940 duly attested by Notary Public.
      10. Certified copy of Qualification certificates of the Competent Person/Registered Pharmacist.
      11. Experience certificate of the Competent Persons.
      12. Bio-data on Proforma
      13. Affidavit (on Rs. 10/- Stamp Paper) of Competent Person/Registered Pharmacist regarding fulltime working with the firm duly attested by Notary.
      14. Photo identification proof of proprietor/partner/Director.
      15. Certified copies of Qualification, registration with Delhi Pharmacy Council and valid photo (I.D. in respect of Registered Pharmacist.
      16. All the photocopies of documents should be self attested.
      17. 3 Photographs of Competent Person/Registered Pharmacist.
    2. For Grant of Licences for Manufactruing 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.
      3.  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.
      4. 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.
      5. 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)
      6. 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.
      7. 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.
      8. 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.
      9. List of items, with detailed formula, intended to be manufactured.
      10. An affidavit / undertaking to the effect that neither the owner nor the firm had been convicted under the Drugs & Cosmetics Act 1940.
      11. Proof of ownership and proof of possession in respect of the premises.
      12. All the photocopies of documents should be self attested.
  • WHERE ARE FEES TO BE DEPOSITED?

    Fee(s) for license(s) is to be deposited by the applicant through e-payment gateway of the Drugs Control Department Govt. of NCT of Delhi on https://epayment.delhigovt.nic.in/epayentry.aspx  
     
  • WHERE CAN YOU GET MORE INFORMATION?

    A Duty Officer is available in the office during office hours. Information regarding grant of licences and other general information can be obtained from him. All relevant information regarding the department and How to Apply is also available on the website of this department https://drugs.delhi.gov.in.
     
  •  TIME FRAME FOR DISPOSAL OF APPLICATION FOR LICENCES :-
Time for disposal under eSLASale licences
For grant of licences (if the conditions are satisfied) for sale of drugs or for disposal of application.35 Days of receipt of application
Change addition/ deletion of Registered Pharmacist.07 Days of receipt of application
Change addition/ deletion of Competent Person.21 Days of receipt of application
For grant of sale licences for Homoeopathic Medicines (if the conditions are satisfied) or for disposal of application.35 Days of receipt of application
Retention of Sale license35 Days of receipt of application
For grant of sale licences for Schedule X Drugs Medicines (if the conditions are satisfied) or for disposal of application.35 Days of receipt of application

 

Time for disposal under eSLAManufacturing
Grant/ Retention of License for Medical Device45 Days ( Class –A) 140 Days ( Class- B )
Grant/ Retention of License for Manufacturing of Drugs140 Days
Grant/ Renewal of License for Blood bank140 Days
Grant/ Retention of License for Approved Testing Laboratories140 Days
Grant/ Retention of License for Manufacturing of Cosmetics45 Days

 

  • Interface with other Departments:

    This Department in general doesn’t ask for any certificate from any of the agencies for grant of Licenses for sale of Drugs. However, with respect to grant of licences for manufacturing of Drugs/Cosmetics, following certificates are required:
    1. No Objection Certificate from Delhi Pollution Control Committee in respect of all industries seeking Licenses for manufacturing of Drugs.
    2. No Objection Certificate from Delhi Fire Services in respect of :
       
      1.  Cosmetics Manufacturing Units applying for grant of Licenses for manufacturing of Nail Polish/ Alcoholic fragrances involving the use of inflammable substances.
      2. Drugs Manufacturers Units applying for grant of Licenses where the drugs involve the use of alcohol and other inflammable material in the processing.
  • Details of requirement of site :
    1.  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.
    2. 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: 
Type of LicenceRules applicable
For manufacturing of drugs in licence on Form 25Rule 71 read with Schedule ‘M’
For manufacturing of drugs in licence on Form 25ARule 71-B
For manufacturing of drugs in licence on Form 25BRule 71-A read with Schedule ‘M’
For manufacturing of drugs in licence on Form 25CRule 85E read with Schedule ‘M I’
For manufacturing of drugs in licence on Form 25FRule 71 read with Schedule ‘M’
For manufacturing of drugs in licence on Form 28Rule 76 read with Schedule ‘M/M III’
For manufacturing of drugs in licence on Form 28ARule 76A & 78A
For manufacturing of drugs in licence on Form 28BRule 76 read with Schedule ‘M’
For manufacturing of drugs in licence on Form 28CRule 122G
For manufacturing of drugs in licence on Form 28DRule 76 read with Schedule ‘M’
For manufacturing of drugs in licence on Form 28DARule 76A & 78A
For manufacturing of drugs in licence on Form 28ERule 122G
For manufacturing of drugs in licence on Form 29Rule 89
For manufacturing of cosmetics in licence on COS- 8Rule 23 of COS Rules 2020 read with Schedule ‘M II’
For manufacturing of cosmetics in licence on COS- 9Rule 25 of COS Rules 2020 read with Schedule ‘M II’
For approval of Drugs Testing Laboratories on Form 37Rule 150C read with Schedule ‘L-1’
For approval of Cosmetics Testing Laboratories on COS- 23Rule 55 of COS Rules 2020

 

  • Intimation of shortcomings to the Entrepreneurs :
    1. Issue of memorandum for shortcomings in respect of documents, if any, within fifteen days of receipt of application and time frame for submission of its compliance is seven days from the date of issue of memorandum.

    2. Issue of memorandum for shortcomings, if any observed at the time of inspection within three days and submission of its compliance within six days.

       

  • GRIEVANCE REDRESSAL
    If there is any delay, the applicants may contact the following officers: In charge of the Division.
For Sales LicencesMeeting Time
Licensing Authority of the concerned District.Any Working Day between 2.30 P.M .to 4.30 P.M.
For Manufacturing: Asstt. Drugs Controller of the concerned District.Any Working Day between 2.30 P.M .to 4.30 P.M.
If not satisfied: With the above officers. Drugs Controller, 4th Floor, F-17, Karkardooma, Delhi-32.With prior appointment.

 

  • WHERE CAN YOU MAKE COMPLAINT?

    Public can make complaint about spurious drugs, sale of habit forming drugs or about any other contravention of the Drugs & Cosmetics Act and Rules and also about over-charging by the chemists in case of sales of drugs to the Duty Officer, Drugs Control Department, F-17, Karkardooma, Shahdara, Delhi-32 in writing or in person or on telephone No. 22393705 or through email (dirdcd@nic.in) during office hours. 
    As a measure of urgent redressal of the grievances of the general public, a board is displayed in a prominent place in the department informing the public that Asstt. Drugs Controller will be available in his office on all working days between 2.30 P.M. to 4.30 P.M to attend to any grievances of the general public relating to the Drugs Control Department.

     

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