Reply to Drug Inspector Show Cause Notice — Draft

[Name of Licensee / Firm]
[Full Address of Premises]
Drug Licence No.: [Form 20/21/25/28 No.]
Date: [DD/MM/YYYY]

To,
The Drugs Inspector / Licensing Authority,
[Office of the Drugs Control Administration],
[State / District], [Address].

Ref: Reply to Show Cause Notice No. [___] dated [DD/MM/YYYY]

Subject: Reply to Show Cause Notice issued under Rule 66 / Section 22
         of the Drugs and Cosmetics Act, 1940 read with the Drugs and
         Cosmetics Rules, 1945, proposing [suspension / cancellation of
         Drug Licence No. [___] / action for the alleged contravention].

Respected Sir / Madam,

1. We are in receipt of the Show Cause Notice bearing No. [___] dated
   [DD/MM/YYYY] ("the Notice"), issued in respect of our licensed
   premises "[Name]" operating under Drug Licence No. [___].

2. We respectfully deny each allegation in the Notice except as
   specifically admitted, and submit our reply as under.

3. BACKGROUND: We hold a valid drug licence and have been carrying on
   the business of [manufacture / wholesale / retail] of drugs since
   [year] under the supervision of our Competent/Registered Pharmacist
   Shri/Smt. [Name], Registration No. [___].

4. REPLY TO THE ALLEGATIONS:

   (a) Allegation: [e.g. sample declared "Not of Standard Quality"
       vide Government Analyst report No. [___]].
       Reply: [We received the said report only on [Date]; we hereby
       exercise our right under Section 25(3)/(4) of the Act to have
       the sample tested by the Central Drugs Laboratory. We further
       state that the batch was stored/handled as per label conditions
       and the NSQ, if any, is not attributable to us as a
       dealer/manufacturer for the reasons stated in [___].]

   (b) Allegation: [e.g. absence of qualified pharmacist / sale without
       prescription / cold-chain lapse].
       Reply: [The alleged lapse is denied / has been rectified vide
       [action] on [Date]; the pharmacist was present as per attendance
       record enclosed.]

   (c) Allegation: [e.g. record / storage deficiency under Schedule N /
       Schedule H].
       Reply: [Corrective action taken; records now maintained as
       required; supporting documents enclosed.]

5. That the alleged contravention, even if presumed without admission,
   is technical and inadvertent, involves no risk to public health, and
   has since been remedied. There is thus no ground for
   suspension/cancellation of the licence or for prosecution.

6. That any adverse order would gravely prejudice our lawful business
   and the livelihood of our staff, and would be disproportionate.

7. PRAYER: We most respectfully request your good office to:
     (i)  drop the Show Cause Notice and proceedings thereunder;
     (ii) grant us an opportunity of personal hearing before passing
          any order, in accordance with natural justice; and
     (iii) take our reply and compliance on record.

Enclosures:
   1. Copy of the Show Cause Notice dated [DD/MM/YYYY].
   2. Copy of valid Drug Licence and Pharmacist registration.
   3. Government Analyst report / correspondence (if any).
   4. Purchase / sale records / cold-chain logs, as applicable.
   5. Corrective-action documents / photographs.

Thanking you,

Yours faithfully,
For [Name of Licensee / Firm],

____________________________
([Name])
[Proprietor / Partner / Director / Authorised Signatory]
Mobile: [___]   Email: [___]