Important short notes for Industry and Regulators

Note: 08

Supreme Court Judgment :

Case: Rakesh Kumar and 25 Other Accused.

1. Punjab and Haryana High Court have given relaxation in NDPS case against many (25) offenders who have been convicted by the lower district court.

2. The High Court ruled that if a psychotropic drug is manufactured by a licensed manufacturer, it does not constitute a violation of the NDPS Act.

3. Only a case under the Drugs and Cosmetics Act, 1940, should be filed in such instances.

4. The Punjab Government filed an appeal with the Supreme Court against the High Court's order dated January 29, 2018.

5.On December 3, 2018, the Supreme Court issued a judgment against the accused in the NDPS case.

6. The Supreme Court overturned the Punjab and Haryana High Court's orders and directed the courts to take custody of the accused.

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 07

Diphenoxylate :

1. An official drug listed in the Indian Pharmacopeia (IP).

2. Available in tablets dosage forms.

3. Notified as a "Manufactured Drug" under the NDPS Act (serial no. 58 vide notification S.O. no. 826 (E) dated 14.11.1985).

4. Only allowed with Atropine sulfate with a dose of at least one percent of the dose of Diphenoxylate.

5. This drug is included in Schedule H1 of the Drugs Act .(serial number 23).

6.A Drugs Sale License (Retail/Wholesale) under the Drugs Act is mandatory to sell this drug.

7. Licensee must maintain sale/purchase records. Failure to do so is a contravention of Rule 65A of the NDPS Act, 1985.

8. Unlicensed manufacturing, stocking, and sale of formulations are offenses under the NDPS Act, 1985, and Drugs Act.

9.Offence Severity Depends on the quantity :
Small quantity : 2 grams
Commercial quantity : 50 grams.
(vide notification S.O. no. 1055 (E) dated 19.10.2001).

10 NRx" labeling is not mandatory .

11.Dose available is 2.5 mg / 0.025 mg.

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 06

Notification NDPS : Small and commercial quantity.

1055(E) dated 19 Oct 2001 under NDPS Act 1985.

Total 239 Drugs( ND+PS)

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 05

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

Note: 04

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

Note: 03

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

Note: 02

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

Note: 01

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