Important short notes for Industry and Regulators

Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 114 Status of Gentamicin Drug

Note: 114

Status of Gentamicin Drug

1. Drug gentamicin is an antibiotic.

2. It's not a beta-lactam antibiotic.

3. Gentamicin should be manufactured in the General Section Manufacturing Facility.

4. Gentamicin is manufactured under the license granted on Form 28.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 113 Hon’ble Supreme Court: 03.12.2018 (On NDPS)

Note: 113

Hon’ble Supreme Court: 03.12.2018 (On NDPS)

1. The State of Punjab appealed to the Hon’ble Supreme Court against the order of the Punjab & Haryana High Court dated 29.01.2018 in NDPS matters.

2. Case Title: State of Punjab vs. Rakesh Kumar & 26 Others

3. Points Raised by the State of Punjab (Appellant):

i) The NDPS Act does not bar the application of the Drugs & Cosmetics Act, 1940.

ii) Inderjit Singh vs. State of Punjab (2014, HC).

iii) Union of India vs. Sanjeev Deshpande (2014, SC) – This judgment clarified that narcotic and psychotropic substances are permissible only for medical and scientific purposes.

4. Points Raised by the Accused:

i) If a person manufactures or deals in NDPS drugs in bulk without a license, the offense falls under the NDPS Act, 1985.

5. Findings of the Hon’ble Supreme Court:

i) Section 80 of the NDPS Act clearly states that the application of the Drugs & Cosmetics Act is not barred.

ii) The provisions of the NDPS Act do not override the Drugs & Cosmetics Act.

iii) The Drugs & Cosmetics Act regulates various aspects of drug manufacture, sale, and purchase, whereas the NDPS Act specifically deals with a certain class of drugs. Therefore, the NDPS Act is a special law on the subject.

iv) The NDPS Act should not be read in isolation from the Drugs & Cosmetics Act, 1940. Additionally, it is the state’s authority to prosecute offenders in accordance with the law.

v) In the present case, since the accused’s actions prima facie violated Section 8 of the NDPS Act, they were charged under Section 22 of the NDPS Act.

6. Final Decision:

The order passed by the Hon’ble High Court is hereby set aside.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 112 Color of test reports

Note: 112

Color of Test Reports:

1. Certificates of test or analysis / Test Reports of a drug sample are issued by the State Drugs Testing Laboratory / Government Analyst on Form-13 and by the Central Drugs Testing Laboratory on Form-2.

2. White paper is used to issue test reports on Form-13.

3. Pink paper is used to issue test reports on Form-2.

3. Although the Drugs & Cosmetics Act and Rules do not mandate any color for the paper used to issue test reports, pink paper is used by the department to issue test reports on Form-2 to differentiate them from Form-13 as per departmental SOPs.

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Forms: All types of Drugs

Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 111 Gelatin

Note: 111

Gelatin:

1. Gelatin is used in many industries, such as food industry, pharmaceutical industry, cosmetics industry, nutraceutical industry, etc.

2. In the pharmaceutical industry gelatin is used as an ingredient in drug formulations like tablets, capsules, and drug coatings.

3. As per Section 3(b) of the Drugs Act, an empty gelatin capsule is a component of drugs; hence, it falls under the definition of a drug.

4. Consequently, only IP (Indian Pharmacopeial) grade gelatin should be used in allopathic drugs.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 110 Excipients: Status

Note: 110

Excipients: Status

1. Excipients fall under the definition of drugs.

2. Stability data is needed for approval.

3. Category of raw material.

4. The firm should follow Schedule M to manufacture

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Important short notes for Industry and Regulators

FAQs – on Alcohol (in Pharma Industry)

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 109 Different Types of Alcohol Used in Various Products

Note: 109

Different Types of Alcohol Used in Various Products:

Cosmetics: Denatured Alcohol (DNA)

External drugs: Denatured Alcohol (DNA)

Medical devices: Denatured Alcohol (DNA)

Homeopathic medicines: Extra Neutral Alcohol (ENA)

Oral drugs: Extra Neutral Alcohol (ENA) or Absolute Alcohol

Injections: Absolute Alcohol

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The Effectiveness of 70% Alcohol as a Disinfectant

Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 108 Retention Samples: (As per the Revised Schedule-M)

Note: 108

Retention Samples: (As per the Revised Schedule-M)

1. Retention samples of finished products should be kept for at least one year after their date of expiry.

2. Samples of active starting material should be retained for at least one year beyond the expiry date of the corresponding finished product.

3. Samples of other starting materials (excluding solvents, gases and water) should be retained for a minimum of two years, provided their stability allows it.

4. Retention samples (starting material and products) should be retained in a quantity sufficient for at least two full re-examinations.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 107 Atezolizumab Drug

Note: 107

Atezolizumab Drug:

1. This drug is used for monoclonal antibody therapy.

2. It may be used in anti-cancer therapy.

3. This drug is not categorized as a 'cytotoxic drug'.

4. Atezolizumab can be manufactured in the General Section of a valid Drug Manufacturing Facility.

5. A separate manufacturing area, as required for manufacturing 'cytotoxic drugs' is not required for manufacturing Atezolizumab.

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Important short notes for Industry and Regulators

Read or download latest Notifications on NDPS

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 106 Notification of 5 Manufactured Drugs under NDPS Act

Note: 106

Notification of 5 Manufactured Drugs under NDPS Act

The Central Government by notification no. S.O. 1431 dated 21.06.2011, has declared the following 05 substances and preparations as 'Manufactured Drugs' under NDPS Act :

1. Betamethadol

2. Dihydroetorphine

3. Oripavine

4. Racemoramide

5. Remifentanil

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 105 Definition of Spurious Drug

Note: 105

Definition of Spurious Drug:

Section 17-B:

A drug shall be deemed to be spurious,—

(a) if it is manufactured under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by another drug or substance; or

(e) if it purports to be the product of a manufacturer of whom it is not truly a product.

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Important short notes for Industry and Regulators

Read or download latest Notifications on NDPS

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 104 NDPS Judgement Hon’ble Supreme Court (Codeine)

Note: 104

NDPS Judgement

Hon’ble Supreme Court (Codeine)

1. Judgment issued by the Hon’ble Supreme Court of India on 5.10.2012.

2. Mohammad Sahabuddin vs. State of Assam.

3. The appellant was held with 347 cartoons containing syrup of Codeine Phosphate of different brands.

4. The appellant went to the Supreme Court for bail.

5. The appellant said that he is only transporting Codeine Phosphate Syrup, which is less than 10 mg (per dose), and as per notification S.O. 826 (E) dated 14.11.1985 and GSR 40 (E) dated 19.01.1993. No offense was made out under the NDPS Act.

6. He also submitted that this drug was controlled by Rule 65 & 97 of the Drug Act and penalty under Section 27, and the driver has no obligation to hold a license under the Drugs & Cosmetics Act.

7. Submission of Learned Counsel:

i) A huge quantity of drugs is transported without any valid document. So, he has not fulfilled the statutory requirement under the Drugs & Cosmetics Act.

ii) He is not in a position to explain to whom the supply was meant.

iii) The firm should have certified twin conditions of NDPS Act notification:

1. The content of the drug should not be more than 2.5%.

2. It should be for therapeutic use (therapeutic practice is the cure of disease).

iv) No document in his possession for what purpose is such a huge quantity of schedule NDPS being transported.

v) It cannot be presumed that such transportation was for therapeutic practices, as mentioned in notification dated 14.11.1985.

8. The appeal is dismissed.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 103 Manufacturing of Prednisolone Tablets

Note: 103

Manufacturing of Prednisolone tablets:

1. Prednisolone tablets are manufactured in the 'Other than Beta-Lactam Section'.

2. Unlike sex hormones, a dedicated manufacturing area is not required for manufacturing Prednisolone Tablets.

3. Prednisolone Tablets can be manufactured in a facility in which Paracetamol is being manufactured, provided that necessary Standard Operating Procedures (SOPs) and Line Clearance Protocols are strictly followed.

4. Prednisolone is a corticosteroid (glucocorticoid).

5. The license to manufacture Prednisolone Tablets is granted on Form 25.

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Important short notes for Industry and Regulators

Latest notifications – NPPA / DPCO

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 102 DPCO 2013 - Key points

Note: 102

Drugs (Price Control) Order, 2013
(DPCO 2013) (Key points)

1. The DPCO 2013 was notified on May 15, 2013, vide notification no. S.O. 1221(E).

2. The DPCO 1995 has been superseded by the DPCO 2013.

3. DPCO is not applicable to Ayurvedic and Homeopathic medicines.

4. Ceiling Price is the maximum price for Scheduled Formulations fixed by the Government of India.

5. The 'National List of Essential Medicines' (NLEM) is notified by the Government of India and updated periodically. The NLEM is notified as Schedule-1 of DPCO, 2013.

6. 'New Drug' is that formulation in which the dosage or strength of a molecule listed in Schedule-1 has been changed.

7. As per Section 15 of DPCO 2013 for a drug falling under the definition of 'New Drug', the Drug Manufacturer should get price fixed/approved from the Government on the relevant form specified under DPCO

8. Non-scheduled formulations refer to the drugs that are not included in Schedule I.

9. A maximum 10% increase in MRP is allowed in the preceding 12-month period for non-scheduled formulations.

10. Maximum Retail Price (MRP) = Ceiling Price + Taxes.

11. As per Section 25 of the DPCO, every retailer/dealer should display the price list in a prominent place in their sale premises.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 101 Propylene Glycol (PG)

Note: 101

Propylene Glycol (PG):

1. Propylene Glycol is a drug.

2. It is used as a solvent.

3. It is official in IP, BP, and USP.

4. Testing of PG should be done as per Pharmacopeial guidelines.

5. Testing of PG requires Gas Chromatography (GC).

6. PG must be tested for DEG impurities.

7. Test reports should also include graphs.

8. PG should be purchased only from drug manufacturing license-holder firms along with a valid invoice/bill.

9. Only Pharmacopeia-grade PG should be purchased.

10. PG packed in sealed containers should be purchased.

11. Proper storage of PG is essential.

12. The record of PG should be maintained and kept for five years.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 100 Naproxen Tablets

Note: 100

Naproxen Tablets:

1. Naproxen (API) is official in IP 2022.

2. Naproxen tablets are official in IP 2022.

3. Naproxen Sodium (API) is official in USP.

4. Naproxen tablets are official in USP.

5. So, for Naproxen Tablets, USP firm has to use API as Naproxen Sodium only.

(The major difference between naproxen and naproxen sodium is that naproxen sodium is more rapidly absorbed).

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 99 Export NOCs : Combination of 'Tapentadol' and 'Carisoprodol'

Note: 99

Withdrawal of all export NOCs and permissions to manufacture issued for combination of 'Tapentadol' and 'Carisoprodol' and all combinations of Tapentadol' and 'all combinations of Carisoprodol'

1. A letter dated 21.02.2024 has been issued by the International Cell, CDSCO, New Delhi.

2. Vide which DCGI has requested all Licensing Authorities to immediately withdraw all export NOCs and permissions to manufacture issued for combination of 'Tapentadol' and 'Carisoprodol'.

3. Further, It has also been requested to withdraw all export NOCs and permissions to manufacture issued for 'all combinations of Tapentadol' and 'all combinations of Carisoprodol', which are not approved by the importing countries.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 98 Schedule K: Categories

Note: 98

Schedule K: Categories

A total of 39 categories of drugs have been listed under Schedule K of Drugs Act & Rules. Some categories are as under:

1. Antimalarial drugs - 1950
2. Antacid preparations- 1961
3. Inhalers for cold - 1961
4. Disinfectants - 1964
5. Aspirin tablets - 1972
6. Paracetamol tablets-1986
7. Oral rehydration salts - 1988
8. Vaginal contraceptive pessaries containing nonoxynol- 1989
9. Chemical contraceptive - 1991
10. Petroleum Jelly IP - 1999
11. First aid kit 2002
12. Nicotine gum - 2003
13. Antiseptic - 2022

No Drug Sale License is required for the above-mentioned drugs.

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Schedule-K

Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 97 Sterile Solutions

Note: 97

'Sterile Solutions intended for parenteral administration with 100 ml. in one container of the finished dosage form for single use manufactured for export only'

1. Vide Notification No. GSR.47(E) dated 25.01.2019: 'Sterile Solutions intended for parenteral administration with 100 ml. in one container of the finished dosage form for single use manufactured for export only' have been included in Schedule K of the Drugs Act and Rules.

2. Subject to the condition that such drugs have been manufactured for export purpose only under a licence granted by the State Licensing Authority.

3. Approval from CLAA is not required.

4. Though parenteral of 100 ml. pack size is Large Volume Parenteral, i.e., LVP, SLA can grant product permission, and the counter signature of CLAA is not required.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 96 'Liquid Antiseptics for Household Use'

Note: 96

'Liquid Antiseptics for Household Use'

1. Liquid Antiseptics for Household Use'
have been included in Schedule K of Drugs Act and Rules vide notification no. G.S.R.30(E) dated 20.01.2022.

2. No Drug Sale license is required for sale of Liquid Antiseptics for household use subject to the following conditions:

* The drugs should be manufactured under valid Drugs Manufacturing License.

* The drugs should not contain any substance specified in Schedule G, H, H1 or X.

* The drugs must be sold in the original unopened containers of manufacturer.

* The drugs must be purchased from a wholesaler or manufacturer having a valid license.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 95 Oseltamivir and Zanamivir - Schedule H1 drugs

Note: 95

Oseltamivir and Zanamivir - Schedule H1 drugs

1. Vide notification no. GSR 95(E) dated 05.02. 2024, Oseltamivir and Zanamivir have been notified as Schedule H1 drugs.

2. Earlier these drugs were notified as Schedule X drugs.

3. Vide notification GSR(E)144 dated 17.02.2017 conditions of Schedule X were withdrawn.

3. For export, the permission has to be obtained from the CDSCO.

4. The manufacturer should submit data to the DCGI office on monthly basis.

5. Chemists should submit sale data to Licensing Authority on monthly basis.

6. Old notification no. G.S.R 677(E) dated 15.09.2009 has been deleted.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 94 Updated list of Schedule H1 Drugs

Note: 94

Updated list of Schedule H1 Drugs

As far as 50 drugs have been notified as Schedule H1 Drugs under the Drugs and Cosmetics Act & Rules, which are as follows:

1. Alprazolam (NRx)
2. Balofloxacin
3. Buprenorphine (NRx)
4. Capreomycin
5. Cefdinir
6. Cefditoren
7. Cefepime
8. Cefetamet
9. Cefixime
10. Cefoperazone
11. Cefotaxime
12. Cefpirome
13. Cefpodoxime
14. Ceftazidime
15. Ceftibuten
16. Ceftizoxime
17. Ceftriaxone
18. Chlordiazepoxide (NRx)
19. Clofazimine
20. Codeine (NRx)
21. Cycloserine
22. Diazepam (NRx)
23. Diphenoxylate
24. Doripenem
25. Ertapenem
26. Ethambutol Hydrochloride
27. Ethionamide
28. Feropenem
29. Gemifloxacin
30. Imipenem
31. Isoniazid
32. Levofloxacin
33. Meropenem
34. Midazolam(NRx)
35. Moxifloxacin
36. Nitrazepam (NRx)
37. Pentazocine (NRx)
38. Prulifloxacin
39. Pyrazinamide
40. Rifabutin
41. Rifampicin Sodium
42. Para-aminosalicylate
43. Sparfloxacin
44. Thiacetazone
45. Tramadol (NRx)
46. Zolpidem (NRx)
47. Oxytocin
48. Tapentadol.
49. Oseltamivir
50. Zanamivir

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Schedule for Dugs

Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 93 Tapentadol: Schedule H1 Drug

Note: 93

Tapentadol: Schedule H1 Drug

Tapentadol has been notified as Schedule H1 Drug vide notification no. GSR 258(E) issued on April 7, 2021, enforced from November 1, 2021. This drug is not covered under the NDPS Act.

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Schedule for Dugs

Important short notes for Industry and Regulators