Application for and grant of wholesalers license for notified drugs
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.
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.