Important short notes for Industry

Different between cream and ointments :

Example :

1. Fusidic acid cream IP.

2. Firm can't claim Fusidic acid Ointment IP.

3. SLA can't grant permission Fusidic acid Ointment IP.

4. The word "ointment" is not recognized in the case of Fusidic in IP and BP both.

5. Ointments typically have a higher oil content than creams.

6. Creams generally have a higher water content than ointments.

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

As per rule 7 of MDR-2017.

Standards for medical devices in India are as under:

BIS.
ISO.
IEC.
IP/BP/USP, etc
IH

ASTEM (draft)

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

PG : Propylene Glycol

1.All Allopathic manufacturers must conduct comprehensive testing of Propylene Glycol (PG) in their formulations as per the pharmacopeia standards (IP/BP/USP).

2. To test PG, gas chromatography (GC) is required.

3. Every batch of PG must undergo testing, and the test report should include a graphical representation.

4. Proper storage of PG is also crucial.

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Banned drug :

• Aceclofenac SR and Paracetamol are banned under section 26A of the drug act.
• Aceclofenac + Paracetamol is not banned.

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

1. Notification no. S.O. 1577 (E) dated 28th March 2024.

2.Now, Sections 27(d) and 27–A(ii) have been added to the list of compoundable offenses under the Drugs Act.

3. W.e.f 31st December 2024

4. The offenses committed prior to 31st December 2024 are not compoundable.

5.Decriminalised & only fine .

6.The provision for Compounding of offense Section 28 & Section 28A of the D&C Act was already there, which was inserted w.e.f. 2009.

7. Applicable in the cases of medical devices, cosmetics, homeopathic medicines, disinfectants, blood centers, etc.

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana