Maharashtra - License for Drug Testing Laboratory

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Procedure

Apply In-Person:

1. Applicant shall apply for drug testing laboratory license to the Director of Drugs Control office of their respective area as applicable.
2. Link for contact details: link please use the contact details on the given page.
3. Go to the office.
4. Applicant should write a covering letter addressed to the respective authority.
5. Submit application, covering letter along with required documents and original copy of fees paid challan to the respective Assistant Drug Controller (ADC) / designated authority for your area.
6. Application form link: link Refer page 236 please refer form “FORM 36”.
7. Authorities will check the submitted application form and other documents. If all are in place the application will be accepted.
8. A receipt of acknowledgement will be provided for the acceptance of application. Keep it safe for future reference.
9. This application will be processed further.
10. Application is scrutinized and forwarded to the Inspecting Officer / designated authority of the area for inspection of the layout plan and facilities provided in the firm premises.
11. After inspection, the Inspecting Officer/designated authority shall send the inspection report along with his recommendation to State Drugs Controller / Licensing Authority of the State.
12. If all conditions are full filled licenses shall be granted by the State Drugs Controller / Licensing Authority of the State.
13. Applicant gets notification about the process updates through sms.
14. Applicant will receive information about the issue of license and shall receive it on hand or through mail as appropriate.

Note:

• It is advised to submit additional set of copy of the documents and get counter signed for your safety while applying with government department.
• No individual can start a drug testing laboratory in India, unless an appropriate license is obtained from the designated authority.
• As different state has different parameters and regulations, as a first step applicant shall consult their local drug license authority to get advice on
  • Any updated rules and regulations in issuance of license.
  • Update on drugs that were included in the list for which lab testing is not permitted.
  • Fee payment for the license is accepted in different formats like challan/cheque as applicable. Applicants are advised to take the consultation with the respective drug license authority for your area to prepare fees requirement.

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Required Documents

• Application form
• Required license fee along with additional items fee.
• Blue print with site plan of the premises, duly signed by firm’s Prop / Partners / Directors.
• Ownership proof or Rent receipt and lease deed of the premises.
• Copy of partnership deed (in case of partnership firm)
• Memorandum and Article of Association duly signed by Directors of the firm (In case of Limited or Pvt. Ltd. Firm)
• List of present directors of the firm showing their complete name and residential address.
• Copy of Form-DIR-12, in case of change in Directors (registration, addition, replacement)
• Non-conviction affidavit (under Drugs & Cosmetics Act, 1940 & Rules, 1945) of Prop / Partners / Directors. (also mention the status of partners / directors whether sleeping or active and name of responsible partner / director)
• Resolution of Board of Directors regarding appointment of authorized signatory.
• Non-conviction affidavit of authorized signatory, if appointed any by the firm.
• List of competent technical staff along with copies of their educational qualification, experience and approval letter.
• Non-conviction affidavit (under Drugs & Cosmetics Act, 1940 & Rules, 1945) of approved technical staffs (also mention the details of their educational qualification, date of joining and details of previous working).
• Copies of academic qualification & approval of technical staff.
• List of laboratory equipment’s installed along with purchase invoices.
• Qualification certificates of machineries and equipment’s.
• NOC from Fire department.
• NOC from pollution control department (if applicable).
• Proof of electricity load sanction.
• Copy of allotment /occupation certificate form HSIDC / HUDA etc. (Whichever is applicable)
• List of categories of drugs in triplicate.
• Pan card
• Aadhar card
• Age proof
• ID and address proof of director
• Passport size photograph

Note :

• Copies of documents should be self-attested
• Please take above mentioned documents in original and attested copies thereof (to be submitted) at the time of applying.
• Requirements of some of documents and procedure for submission of application may vary from State to State
• Authorities may require additional documents and details apart from the above listed ones. Please provide them for processing.

Office Locations & Contacts

Food and Drug Administration,
Survey No. 341, 2nd Floor,
Bandra Kurla Complex Opposite Reserve Bank Of India,
Bandra East, Mumbai, Maharashtra 400051
Phone: +1800 222 365
Link for contact details: Link

The Drugs Controller General (India),
Central Licence Approving Authority Directorate General of Health Services,
Food & Drugs Administration Bhawan,
ITO, Kotla Road, New Delhi -110002.
Phone:91-11-23216367(CDSCO)/ 23236975
Fax: 91-11-23236973
E-mail:[email protected]
Contact link: link

Eligibility

• Any person/company/partnership firm/LLP can apply for this license
• Applicant having competent technical expertise and education or having competent technical staff on roll.

Fees

• Please pay as authority’s advice. Fees structure changes from state to state.
• In general Rs. 7500/- and Rs. 1500/- per category will be charged.
• Rs.2 stamp to be affixed on application

Validity

• A license unless, it is sooner suspended or cancelled, shall be valid for a period of three years or five years from the date of its issue
• The license should be prominently displayed at the place of business during the business hours.

Documents to Use

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Sample Documents

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Processing Time

45 days or as notified by the department

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type="website">video ID|width|height<&/video&> from external websites.
Please remove the "&" inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url "http://www.youtube.com/watch?v=Y0US7oR_t3M" Video ID is "Y0US7oR_t3M".

Instructions

Please follow this link for more information: link

Required Information

• Applicant Name
• Applicant Father Name
• Address
• Mobile number
• Email ID

Need for the Document

• A drug testing laboratory license is required for testing and analysis of Drugs & Cosmetics drawn by enforcement Officers and samples sent by a purchaser.
• This license will be helpful to follow the rules and regulations set by regulatory department.

Information which might help

• Government has laid down stringent law and regulations in testing and approval of drugs and medicines in India.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

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Others

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