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Guidelines and Procedures for Grant of Approved Laboratory


Licencing Authority

  The Director of Drugs Control, Chennai-600006                                                                       


	1.	Covering letter addressed to the Director of Drugs Control, Chennai-600006, along with
		 Rs.2/- court fee stamp for each licence.
	2.	Application in Form-36 duly filled and signed by the applicant. 
	3.	Fees of Rs. 7500/- for each form of licence in the form of Demand draft in Favour of 
		the Director of Drugs Control, Chennai-6.
	4.	Authorization of the signatory of the application form
	5.	Applicant details:
		•Document relating to constitution of concerned firm/ Company/ LLP and others.
		•List of Directors/partners and their Bio-data with their residential addresses 
		and Photo, in case of proprietorship, bio-data with their residential addresses and 
		Photo of proprietor. 
		•Address/ ID proof of the applicant
	6.	Technical Personnel Details:
		•List of Analytical Chemist along with their Bio-data, Passport size photo and 
		photocopies of Qualification Certificate and experience certificate 
		•Declaration of the Analytical Chemist.
		•Address proof and ID proof of the Analytical Chemist
	7.	Premises details:
		•Ownership document of the premises.
		•Plan of the premises- with details of partitions, measurements 
		•Rental agreement of the premises, if applicable
	8.	Details of Machineries/Equipments/Reference books: 
		•List of analytical instruments and equipments for analysis, AHU's, and water 
		system provided. 
		•The photocopies of purchase invoices with the details like, make etc. wherever 
			applicable
		•List of Reference Books provided.
	9.	In case of change of premises & change in constitution
		•Enclose original licence / Renewal Certificate if any
		•Documents related to change in constitution like sale deed, Dissolution/
		Reconstitution deed, Amalgamation court order if it is Private Limited Company 
		with board resolution & registration certificate from Ministry of Corporate Affairs 
		and any other document pertaining to change in constitution.
	10.	Any other document/ particulars which is related to the above mentioned documents 
	to verify the correctness of the particulars submitted by the applicant, if necessary.

	All the application to be sent in: 

	Original to 
		oThe Director of Drugs Control, Tamil Nadu, 359, Anna Salai, Chennai. 600 006.
	Copy to
		•The Drugs Controller General (India), Central Licence Approving Authority 
		Directorate General of Health Services, Food & Drugs Administration Bhawan, 
		Kotla Road I.T.O, New Delhi-110 002.
		•The Deputy Drugs Controller (India)South Zone, Central Drugs Standard
		 Control Organization, No. 26, Haddows Road, Shastri Bhavan Annexe Chennai -600 006.