Drug License

Rajasthan drug license is a document of permission for carrying out businesses related to pharmaceutical industries that deal with drugs, medicines and cosmetics. The government of Rajasthan issues drug license to regulate the manufacture, storage, distribution and sales of drugs. Rajasthan Drug License issues under the Drug and Cosmetics Act, 1940 to the person dealing with drugs. As per this act, it is mandatory to obtain a drug license before the commencement of the drug business. In this article, look at the procedure for obtaining Rajasthan drug license in detail.

Drugs & Cosmetics Act

Rajasthan drug license is mandatory under the provisions of Drugs & Cosmetics Act; 1940. This act moderates the import, manufacture, distribution and sale of drugs and cosmetics which includes allopathic drugs, homoeopathic drugs and even the Ayurvedic, Siddha or Unani drugs.

Documents Required for Sale License

  • Memorandum of Articles / Constitution
  • Current photo of individual owners
  • Signature of individual owners
  • Declaration by owners
  • Current photo of Pharmacists
  • Signature of Pharmacists
  • Pharmacist Registration Certificate (both sided) of Pharmacists
  • Declaration of Pharmacists
  • Map of shop premise
  • Ownership Title Deed in case of shop ownership is own), Rent Agreement and Rent Receipts (in case of shop ownership is on Rent or Lease), Allotment Letter (in case of ownership is Allotted Premises)
  • Refrigerator Purchase Voucher/ Declaration

Documents Required for Manufacturing License

  • Application on prescribed format
  • Affidavit of Proprietor/ Partners/ Director/Managing Director on Rs 10/= Non-Judicial Stamp Paper duly attested by Notary Public
  • List of partners, directors names with age and residential address
  • Specific Power of attorney in favour of Authorized signatory for submitting an application on behalf of the Company on Rs.10 Non-judicial Stamp paper duly attested by Notary Public
  • Affidavit of Manufacturing Chemist & Analytical Chemist on Rs 10/= Non-judicial Stamp paper duly attested by Notary Public
  • Attested Photostat Copies of qualification, experience and approval certificates of Manufacturing Chemist and Analytical Chemist
  • Original & Attested copies of Registration issued by Pharmacy Council in the name of Manufacturing Chemist or Analytical Chemists
  • Site Master File duly signed
  • Performa for approval of products
  • Section wise list of Plant and machinery, AHU's, water system, analytical instruments, apparatus for physicochemical, microbiological, biological along with their attested photocopies of purchase invoices
  • Medical examination Certificate of technical staff & employees include the absence of contagious disease
  • Registration from District Industries Center
  • Consent to establish & consent to operate from Rajasthan State Pollution Control Board
  • List of Reference books and literature
  • Document of ownership for the proposed site of the unit & reports Attested copies of partnership deed / Memorandum & article of Association
  • Specific resolution for commencing Drug/Cosmetic- Manufacturing activities (if not already included in Memorandum of Association)
  • Section wise blueprint of the location of plant and pieces of machinery (dimensions in Metric system), & site plan
  • Consent letter from government approved laboratory for sophisticated tests
  • Consent letter from the principal manufacturing unit in case of loan license

Documents Required for Blood Bank License

  • Affidavits of Medical Officer, Blood Bank Technician, & Registered Nurse on Rs 10/= Non-judicial Stamp paper duly attested by Notary Public
  • Attested Photostat Copies of qualification, experience and approval certificates
  • No objection certificate from Rajasthan State Transfusion Council
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