Most licence suspensions start with a routine visit by a Drugs Inspector. The findings are usually about records: a register not kept, bills not preserved, the licence not on display, or medicines sold without a prescription. The shop then gets a show cause notice, and if the reply does not satisfy the licensing authority, an order suspending or cancelling the licence follows.
This guide explains what happens at each stage, what an appeal should contain, and what to carry to Mantralaya. It covers drug sale licences held by retail and wholesale chemists. Food business licences are governed by a different law and follow a different route.
From inspection to appeal: the stages
| Stage | What happens | What to do |
|---|---|---|
| Inspection | A Drugs Inspector visits the shop and records the deficiencies found. | Keep a copy of anything you sign, and start correcting the lapses the same day. |
| Show cause notice | The licensing authority asks why the licence should not be suspended or cancelled. Rule 66(1) requires this opportunity before any order. | Reply within the time given, attach proof of what has been corrected, and ask for a personal hearing if the notice offers one. |
| Order | The licence is suspended for a fixed period, or cancelled, wholly or for some drugs. | Note the date of the order: the three months for appeal run from it. Stop sales while the suspension is in force unless a stay is granted. |
| Appeal | An appeal lies to the State Government under Rule 66(2). | File the memorandum of appeal and a stay application together. |
| Hearing and decision | The appellate authority hears the licensee and decides the appeal. | Attend with the original documents and the compliance proof. |
What Rule 66 says
Under Rule 66(1) of the Drugs Rules, 1945, the licensing authority may suspend a licence for such period as it thinks fit, or cancel it, either wholly or for some of the drugs it covers, if the licensee has failed to comply with a condition of the licence or with the Drugs and Cosmetics Act or the rules. It must first give the licensee an opportunity to show cause.
Under Rule 66(2), a licensee whose licence has been suspended or cancelled may, within three months of the date of the order, appeal against it to the State Government, which decides the appeal. The same appeal applies whether the licence was suspended or cancelled.
Why the stay application matters
A suspension of a few weeks can run out long before an appeal is heard. An appeal that succeeds after the suspension is over gives the shop nothing back. That is why the appeal should be filed with a separate application asking that the suspension be stayed until the appeal is decided.
The Bombay High Court dealt with exactly this problem in Apna Chemist v. Assistant Commissioner (Zone-3), decided on 10 January 2024. Chemists had filed appeals and stay applications, but the appellate authority had neither listed the appeals nor passed interim orders while the suspensions were running. The Court directed that the stay applications be decided within one week and the appeals listed for final hearing within four weeks, and kept the suspensions stayed until the stay applications were decided.
Common inspection findings, and the proof that answers them
When an authority rejects a reply, the usual reason is that the reply admits the lapse and only promises to correct it later. The appeal should show the correction already made, with documents.
| Finding | Proof to attach |
|---|---|
| Licence not displayed | Photograph of the licences displayed in the shop |
| Inspection book not maintained | Copy of the inspection book now kept at the shop |
| Purchase or sale bills not preserved | Sample bills with office copies, and the file where they are now kept |
| Schedule H1 register not maintained | Copy of the current register with recent entries |
| Medicines sold without a prescription or bill | Purchase invoices from the wholesaler for those medicines, and sale bills |
| Sales without a registered pharmacist | The pharmacist’s registration certificate, appointment letter and attendance or salary record |
| Untidy premises or storage | Photographs of the shop after cleaning and reorganising |
Put a fact in the appeal only if it is true and you can prove it. If, for example, the purchase invoices for a medicine cannot be found, the appeal should not say that the medicine was bought on proper bills.
What the memorandum of appeal should contain
- Heading: the authority it is addressed to (the Minister for Food and Drug Administration, Government of Maharashtra, Mantralaya, Mumbai 400 032) and the provision: appeal under Rule 66(2) of the Drugs Rules, 1945.
- Parties: the appellant (the licensee, with the name of the proprietor or partners, the shop address and the licence numbers) and the respondent (the licensing authority that passed the order).
- Order challenged: its number and date, the date it was received, and the period of suspension or the fact of cancellation.
- Facts: the date of inspection, the show cause notice, the reply and the order, in date order.
- Grounds: numbered, each one short. For example, that the lapses were procedural and have been corrected (with the annexure that proves it), that the reply was not properly considered, and that the penalty is out of proportion to the lapses. Add that no action was taken before only if that is true.
- Limitation: a statement that the appeal is filed within three months of the order.
- Prayer: what is asked for: that the order be set aside or the period reduced, that it be stayed until the appeal is decided, and that the appellant be given a personal hearing.
- Verification: signed by the licensee, stating that the facts are true.
- Index and annexures: numbered, so each ground can point to its proof.
The stay application is a separate, shorter document. It explains why the matter is urgent: the suspension period is already running, the shop cannot trade, and patients in the area who depend on it are affected. It asks that the order be stayed until the appeal is decided.
Documents to carry to Mantralaya
- The memorandum of appeal and the stay application, signed, with extra copies: one set for filing, one for the licensing authority, and one for your own record to be stamped at the inward section
- Copies of the order and its covering letter, the show cause notice, your reply with proof that it was received, and the licences
- The compliance proof listed above
- The pharmacist’s registration and appointment documents
- An affidavit or undertaking of compliance by the licensee, if it will help
- A vakalatnama, if an advocate will appear
- Identity proof of the person signing
Ask at the inward section whether court-fee stamps need to be affixed to the appeal.
Mistakes that weaken an appeal
- Letting the three months from the date of the order pass
- Filing the appeal without a stay application while a short suspension is running
- Repeating the reply’s promises instead of showing what has been done
- Stating facts that cannot be proved
- Continuing to sell medicines during the suspension without a stay. Suspension orders often warn that this will be treated as a further violation.
- Leaving the verification unsigned, or signed by someone without authority
Two 2026 developments
Jan Vishwas Act, 2026. The Jan Vishwas (Amendment of Provisions) Act, 2026 has turned violations under Section 28A of the Drugs and Cosmetics Act, which mostly relate to keeping records and giving information, into administrative penalties. That change concerns penalties under the Act. Suspension or cancellation of a licence under Rule 66 is a separate power of the licensing authority, and the Rule 66 appeal remains the route against it.
Bombay High Court on suspensions after compliance. In Siddharth Agro v. State of Maharashtra (Writ Petition 9946 of 2026, order dated 28 August 2026), the Court said that once an establishment has corrected the deficiencies and the FDA is satisfied of compliance, the suspension or cancellation must be revoked at once, without forcing the establishment to go to court. That case concerned a food business licence, not a drug licence.
If you need the appeal and stay application drafted, see FDA drug licence appeals.
Common questions
Who hears the appeal in Maharashtra?
The State Government. Appeals are filed at Mantralaya and addressed to the Minister in charge of the Food and Drug Administration.
Can the shop keep selling while the appeal is pending?
Not on the strength of the appeal alone. Filing an appeal does not suspend the order. The shop may trade again only if a stay is granted or the suspension period ends.
What if three months have already passed?
Rule 66(2) sets three months from the date of the order. If that time has passed, take advice promptly on what remains open.
Does the same appeal apply to a cancelled licence?
Yes. Rule 66(2) covers both suspension and cancellation.
Do I need an advocate to file the appeal?
The rule does not require one. An advocate can draft the appeal and the stay application and appear at the hearing.
Sources
- Drugs Rules, 1945, Rule 66 (text on Indian Kanoon)
- Apna Chemist v. Assistant Commissioner (Zone-3), Bombay High Court, Writ Petition 305 of 2024 and connected petitions, decided 10 January 2024 (case note on Lawtext)
- Siddharth Agro v. State of Maharashtra, Bombay High Court, Writ Petition 9946 of 2026, order dated 28 August 2026 (report on LiveLaw)
- Government operationalises Jan Vishwas Act reforms in the health sector, June 2026 (BioSpectrum India)
This guide is general information. What applies to a particular licence depends on the order, the findings and the documents in that case.