Food and Drug Administration of Maharashtra Government grants approval for Public Testing Laboratory in Form 37 and also approves Blood Storage Centre. Process for procuring an approval for Public Testing Laboratory and Blood Storage Centre in Maharashtra is mentioned below:
Stage 1: Approval of Layout Plan
- For Approval of Lay out Plan, the Applicant has to submit 3 Blueprint copies of plan to the concerned Licensing Authority.
- The plan should be as per the requirements prescribed in the Drugs and Cosmetics Act 1940.
- The plan is scrutinized by panel of officers as per the requirements of the Drugs and Cosmetics Act 1940 and rules thereunder.
- Finally after scrutiny and compliance as per requirements of the Act, the Layout plan is approved and two copies are given to the Applicant.
Stage 2: Application for Approval of Public Testing Laboratory and Blood Storage Centre
The applicant has to make application in the Form 36 for approval for Public Testing Laboratory. For Approval of Blood Storage Centre application to be made in the form of a covering letter. The applicant has to pay necessary fees as given in Appendix A.
Fee can be paid in cash at Head Office/Division as well as any other District Office. The fee can also be paid through challan at Government Treasury, Reserve bank of India, State Bank of India and State Bank of Hyderabad for Maratha Wada Region under Head Account.
Documents to be attached along with the application:
- Receipt for the fees paid or challan, (the fees are as given in Appendix A) as the case may be or their attested copies.
- Copy of Approved layout plan.
- Documents viz. Rent receipt, purchase documents or its attested copies showing lawful possession of the premises
- List of machinery and equipments.
- Documents relating to the constitution of the firm viz. Partnership-deed, Memorandum and article of association etc.
- Full particulars of the competent technical staff employed along with copies of their educational qualifications, experience certificates and approval letter as competent staff. The competent technical staff is required to furnish consent letter for full time employment with the applicant firm.
- Full name of the proprietor or the partners, as the case may be shall be provided in the application.
- In case of private or public limited concerns, full name of the Directors who sign the application and the authorized signatory, if any, shall be provided in the application.
- List of products in duplicate along-with undertaking to be submitted for Blood Storage center(in case of Blood Storage Centre).
- Agreement between the Blood Storage Centre and the Mother Blood Bank (Appendix I ) (in case of Blood Storage Centre).
Stage 3: Inspection
The application is scrutinized and premises inspected.
Stage 4 : Grant of Approval
If all conditions prescribed by the act are complied with, then the approval is granted.
Download:
Application Form 36
Details of Fees Appendix A , Appendix I , Appendix J