- Guidance Documents for FDA Officers - June 25, 2026
- From Prescription to Addiction: Misuse of Drugs in India - June 23, 2026
- Objectionable Advertisements: Salient features of DMROA Act, 1954: Part-II - March 26, 2026
Last Updated on June 25, 2026 by The Health Master
Guidance Documents for Food and Drugs Administration (FDA) Officers (Drugs Control Officers)

Disclaimer: The views expressed are solely those of author, and TheHealthMaster.com does not necessarily subscribe to them. TheHealthMaster.com shall not be responsible for any damage caused to any person / organization, directly or indirectly.
Daily updates
Guidance Documents for FDA Officers
GD 4. Medical practice by a Pharmacist
GD 4. Medical practice by a Pharmacist
Based on a complaint, a premises is raided, and the owner cum Registered Pharmacist (RP) is found doing medical practice by adding another floor to the premises where Outpatient Department (OPD) is done, and even patients are admitted for the day.
There are 4-5 patient beds; a cannula, IV fluids, and syringes are found on the premises.
Action to be taken:
Immediately call for a team of Medical Officers (MO) from the O/O the Civil Surgeon, which can take appropriate action under the National Medical Commission Act, 2019 (NMC Act) for the violation of unauthorized practice.
For storing allopathic drugs and medical devices without a license on a separate floor, the Drug Authority will have to take seizure on Form 16 and proceed with violations u/s 18(c) of the Drugs and Cosmetics Act 1940.
Further, a thorough inspection of the premises in the licensed area must be done to prove other violations of the conditions of the license.
In case the Registered Pharmacist (R.P.) is found practicing, then information may also be sent to the concerned Pharmacy Council for appropriate action against the R.P.
To read more articles by the author, click the below links:
From Prescription to Addiction: Misuse of Drugs in India
Objectionable Advertisements: Salient features of DMROA Act, 1954: Part-II
Objectionable Advertisements: Salient features of DMROA Act, 1954: Part-I
Sarika Malik
SDCO cum Licensing Authority
FDA Haryana
GD 3. Inspection of the firm w.r.t. Pharmacist
GD 3. Inspection of the firm w.r.t. Pharmacist
On a particular inspection of a firm, the responsible person of some other premises is found working and making sales at the said firm in the absence of the Registered Pharmacist (R.P.) of this firm.
Action to be taken:
A complete inspection of this firm may be carried out, and violations of Rule 65(2) of the Drugs Rules 1945 may be recorded.
The Licensing Authority (LA) shall proceed with appropriate action for these violations.
However, a prompt and detailed investigation of the premises whose responsible person was found working elsewhere is necessary.
Especially for the day when the sale at the said firm was detected. Hence, action by the LA will be taken against both firms.
To read more articles by the author, click the below links:
From Prescription to Addiction: Misuse of Drugs in India
Objectionable Advertisements: Salient features of DMROA Act, 1954: Part-II
Objectionable Advertisements: Salient features of DMROA Act, 1954: Part-I
Sarika Malik
SDCO cum Licensing Authority
FDA Haryana
GD 2: Small quantity of intoxicating drugs
GD 2: Small quantity of intoxicating drugs
A suspected sale of an intoxicating drug has been made.
The drug in question has been sold loose without any strip; only one or two tablets have been recovered from the possession of the customer/decoy.
What is the legal course in this scenario?
Option 1.
Take disclosure from the owner/pharmacist of the premises itself of which drug has been sold by him to the customer/decoy.
Fill in all particulars in Form 35 and take a separate statement with witnesses.
The samples of the said drug may be taken by cutting the tablets (only if non-coated) and dividing them into four equal portions.
The Form 18 for the Drug Analyst shall declare the name of the drug as disclosed by the owner or the pharmacist on Form 35.
Option 2.
If taking samples is not possible, then based on the statement recorded and the circumstantial fact that loose tabs were sold, seizure under Form 16 may be done, and after complete investigation of records, prosecution may be launched.
To read more articles by the author, click the below links:
From Prescription to Addiction: Misuse of Drugs in India
Objectionable Advertisements: Salient features of DMROA Act, 1954: Part-II
Objectionable Advertisements: Salient features of DMROA Act, 1954: Part-I
Sarika Malik
SDCO cum Licensing Authority
FDA Haryana
GD 1. Illegal sale of intoxicants
GD 1. Illegal sale of intoxicants
Based on a suspected illegal sale of intoxicants, a premises is raided. The premises is connected from a backdoor with a house.
The owner/his relative locks the doors from the inside, and he does not allow the Food and Drugs Administration (FDA) officials to enter the premises from either entry.
Option 1.
Take immediate police assistance and persuade the owner to let in the authorities through the entry of the licensed premises.
Conduct a thorough investigation of the premises in their presence.
A separate criminal offense also arises under Sec. 22(3) of the Drugs and Cosmetics Act, 1940, which may be invoked when filing the complaint.
Option 2.
The owner/relative doesn’t respond and the premises is not opened.
In such a scenario, the police can invoke their powers under Sec 42(1)(b) of the NDPS Act or their powers u/s 44 or 185 Bharatiya Nagarik Suraksha Sanhita, 2023 (BNSS).
BNSS to break open into the house and enter the licensed premises.
To read more articles by the author, click the below links:
From Prescription to Addiction: Misuse of Drugs in India
Objectionable Advertisements: Salient features of DMROA Act, 1954: Part-II
Objectionable Advertisements: Salient features of DMROA Act, 1954: Part-I
Sarika Malik
SDCO cum Licensing Authority
FDA Haryana
Objectionable Advertisements: Salient features of DMROA Act, 1954: Part-I
Sarika MalikSDCO cum Licensing Authority FDA Haryana" } }] }








