Application for and grant of wholesalers license for notified drugs

  • Act/Rule/Legislation

  • Online Link to Act/Rule/Legislation

  • Initial Setup or Ongoing Maintenance

    Initial Setup only

  • Filing and Maintenance Requirements

    Company to apply for and obtain a wholesaler’s license before starting the business of wholesale of notified drugs.

  • Penalty

    Punishable for the first offence with imprisonment for a term which may extend to one year and with fine which may extend to one thousand rupees; For the second offence, with imprisonment for a term which may extend to two years and with fine which may extend to two thousand rupees; For the third and subsequent offence, with imprisonment for a term which may extend to three years and with fine which may extend to five thousand rupees.

  • Application Guidelines / Responsible Persons / Comments

    Application for the grant of licence for manufacture of Medical Devices in India shall be
    made in Form 27 to:-
    i. The concerned State Drugs Licensing Authority, Address of all SLA are
    placed at Annexure-I.
    ii. The concerned CDSCO Zonal/Sub-Zonal Office. Address of CDSCO offices
    are placed at Annexure-II and
    iii. The Drugs Controller General of India CDSCO (HQ), FDA Bhawan, Near Bal
    Bhawan, ITO, Kotla Road, New Delhi-110002.
    accompanied by the requisite fee in the form and manner as prescribed in the Drugs
    & Cosmetics Rules.