- 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.
- WHERE ARE THE FORMS FOR THE LICENCE(S) AVAILABLE?
Application for grant of licenses can be made on typed paper in prescribed format. Format can be downloaded from the website of this department http://drugscontrol.delhigovt.nic.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.
- Documents to be submitted:
- For Grant of Sales Licences:
- Application Form
- Fee deposit Receipt
- Declaration form
- Key Plan
- Site Plan
- Basis of possession of the premises
- Proof of ownership of the premises, if rented
- Proof of constitution of the firm
- Affidavit (on Rs. 10/- Stamp Paper) of non-conviction of Directors/Proprietor/Partner under Drugs & Cosmetic Act, 1940 duly attested by Notary Public.
- Certified copy of Qualification certificates of the Competent Person/Registered Pharmacist.
- Experience certificate of the Competent Persons.
- Bio-data on Proforma
- Affidavit (on Rs. 10/- Stamp Paper) of Competent Person/Registered Pharmacist regarding fulltime working with the firm duly attested by Notary.
- Photo identification proof of proprietor/partner/Director.
- Certified copies of Qualification, registration with Delhi Pharmacy Council and valid photo (I.D. in respect of Registered Pharmacist.
- All the photocopies of documents should be self attested.
- 3 Photographs of Competent Person/Registered Pharmacist.
- For Grant of Licences for Manufactruing of Drugs / Cosmetics or Approval of Testing Laboratories:
- 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.
- A Site-plan giving the layout of the manufacturing premises with dimensions in meters and detail like position of doors, windows etc.
- 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.
- 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.
- 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)
- 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.
- 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.
- 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.
- List of items, with detailed formula, intended to be manufactured.
- An affidavit / undertaking to the effect that neither the owner nor the firm had been convicted under the Drugs & Cosmetics Act 1940.
- Proof of ownership and proof of possession in respect of the premises.
- All the photocopies of documents should be self attested.
- For Grant of Sales Licences:
- WHERE ARE FEES TO BE DEPOSITED?
Fee(s) for license(s) is to be deposited by the applicant in the form of Online Payment through https://epayment.delhigovt.nic.in/epayentry.aspx Drugs Control Department Govt. of NCT of Delhi.
- 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 is also available on the website of this department.
- TIME FRAME FOR DISPOSAL OF APPLICATION FOR LICENCES :-
|Time for disposal under eSLA||Sale 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 license||35 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 eSLA||Manufacturing|
|Grant/ Retention of License for Medical Device||45 Days ( Class –A) 140 Days ( Class- B )|
|Grant/ Retention of License for Manufacturing of Drugs||140 Days|
|Grant/ Renewal of License for Blood bank||140 Days|
|Grant/ Retention of License for Approved Testing Laboratories||140 Days|
|Grant/ Retention of License for Manufacturing of Cosmetics||45 Days|
- The time frame for grant of licenses for manufacturing of Drugs / Cosmetics is 75 days from the date of receipt of application, if conditions are satisfied.
- 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:
- No Objection Certificate from Delhi Pollution Control Committee in respect of all industries seeking Licenses for manufacturing of Drugs.
- No Objection Certificate from Delhi Fire Services in respect of :
- Cosmetics Manufacturing Units applying for grant of Licenses for manufacturing of Nail Polish/ Alcoholic fragrances involving the use of inflammable substances.
- 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 inspection:
- 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.
- 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 Licence||Rules applicable|
|For manufacturing of drugs in licence on Form 25||Rule 71 read with Schedule ‘M’|
|For manufacturing of drugs in licence on Form 25A||Rule 71-B|
|For manufacturing of drugs in licence on Form 25B||Rule 71-A read with Schedule ‘M’|
|For manufacturing of drugs in licence on Form 25C||Rule 85E read with Schedule ‘M I’|
|For manufacturing of drugs in licence on Form 25F||Rule 71 read with Schedule ‘M’|
|For manufacturing of drugs in licence on Form 28||Rule 76 read with Schedule ‘M/M III’|
|For manufacturing of drugs in licence on Form 28A||Rule 76A & 78A|
|For manufacturing of drugs in licence on Form 28B||Rule 76 read with Schedule ‘M’|
|For manufacturing of drugs in licence on Form 28C||Rule 122G|
|For manufacturing of drugs in licence on Form 28D||Rule 76 read with Schedule ‘M’|
|For manufacturing of drugs in licence on Form 28DA||Rule 76A & 78A|
|For manufacturing of drugs in licence on Form 28E||Rule 122G|
|For manufacturing of drugs in licence on Form 29||Rule 89|
|For manufacturing of cosmetics in licence on Form 32||Rule 139 read with Schedule ‘M II’|
|For manufacturing of cosmetics in licence on Form 32A||Rule 139B|
|For approval of Testing Laboratories on Form 37||Rule 150C read with Schedule ‘L-1’|
- Details of intimation of shortcomings to the Entrepreneurs :
- 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.
- Issue of memorandum for shortcomings, if any observed at the time of inspection within three days and submission of its compliance within six days.
- Final disposal with regard to grant of Licenses shall be made within 35 days for grant of sale licences / 75 days for grant of manufacturing licences (except for cases under the joint jurisdiction of Central Licensing Approving Authority i.e. Drugs Controller General (India), Govt. of India.
- GRIEVANCE REDRESSAL
If there is any delay, the applicants may contact the following officers: In charge of the Division.
|For Sales Licences||Meeting Time|
|Licensing Authority of the concerned Zone.||Tuesday, Wednesday and Friday between 2.30 P.M .to 4.30 P.M.|
|For Manufacturing: Asstt. Drugs Controller of the concerned Zone.||--do--|
|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 during office hours. Any urgent information after office hours can be given to Divisional In-Charge/Head of Office at his residential telephone: 011-22241753.
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.
- WHAT IS RIGHT TO INFORMATION?
A person who wants to get any additional information may apply under RTI Act, 2005 on prescribed Proforma with prescribed fees.