When the Food and Drug Administration suspends or cancels a chemist’s drug licence, the licensee has three months from the date of the order to appeal to the State Government under Rule 66(2) of the Drugs Rules, 1945. In Maharashtra the appeal is filed at Mantralaya, Mumbai. Because a suspension runs for a fixed period, the appeal is usually filed together with an application to stay the order.
Situations this covers
- Reply to a show cause notice issued after an FDA inspection
- Memorandum of appeal against suspension or cancellation of a retail or wholesale drug licence
- Application for stay of the suspension until the appeal is decided
- Index, annexures and compliance affidavit for filing at Mantralaya
- Appearance at the hearing of the appeal
What to bring
- The suspension or cancellation order, with its covering letter and envelope
- The show cause notice and the reply already given, with proof of receipt
- Copies of the drug licences
- Proof of what has been corrected since the inspection: photographs, registers, sample bills, purchase invoices
- The registered pharmacist’s registration certificate and appointment letter
- Any earlier appeal format or order you have received
How the appeal works
- Time limit: three months from the date of the order, under Rule 66(2).
- Stay: filing an appeal does not by itself suspend the order. A separate stay application asks the appellate authority to hold the order until the appeal is decided. In Apna Chemist v. Assistant Commissioner (Zone-3) (2024), the Bombay High Court directed the appellate authority to decide pending stay applications within a week.
- Proof, not promises: an appeal is strongest when each finding in the order is answered by a document showing it has already been corrected.
- Until a stay is granted: the shop should not sell medicines while the suspension is in force.
Proceedings can be drafted in Marathi or English. Consultations are in English, Hindi, Marathi and Urdu.
Related guides
- Chemist Licence Suspended by FDA Maharashtra? How to Appeal Under Rule 66
- Application and letter drafting
- Legal notices
- Shop and establishment (Gumasta) and Udyam
Consultations are by appointment. To fix a time, telephone +91 99301 50560 or send a message on WhatsApp.
This page describes general procedure and does not constitute legal advice. What applies to a particular matter depends on its own facts.
This page describes general procedure and is published for information only, in keeping with Rule 36 of the Bar Council of India Rules. It is not legal advice and does not solicit work. What applies to a particular matter depends on its own facts.