Important short notes for Industry and Regulators

Important short notes for Industry and Regulators

Procedure to obtain license for Commercial Testing Laboratories

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 130 License in Form 29

Note: 130

License in Form 29

1. As per notification no. GSR 103(E) dated 02.02.2017 by the Government, the Test License in Form 29 (rule 89) under Drugs and Cosmetics Act & Rules is granted for a period of three years.

2. After three years, the license can be renewed annually.

3. A fee of Rs. 250/- is required to be deposited while submitting the application in Form 30.

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Important short notes for Industry and Regulators

Ketamine: Understanding its Classification and Regulations in India

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 129 Additional Documents Required for Issuance of Form 30 for Ketamine (API and Formulations)

Note: 129

Additional Documents Required for Issuance of Form 30 for Ketamine (API and Formulations)

For the issuance of Form 30 to the firm applying for Form 29 for Ketamine (API and formulations), a Schedule X drug under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, the following additional documents and conditions are required:

2. Record Maintenance:
The laboratory must maintain records as per NDPS Rules to prevent misuse of Ketamine.

3. Quantity Justification: Provide a detailed justification for the quantity of Ketamine requested, along with restrictions on the approved amount.

3. CBN Registration:
Submit valid registration with the Central Bureau of Narcotics (CBN).

4. Exemption under Rule 66: As per Rule 66 of the NDPS Rules, scientific or medical institutions are exempt for research and development purposes.

5. Declaration:
Submit a declaration stating that the Ketamine (API/formulations) will be used exclusively for testing, analysis, and examination, and not for commercial purposes.

6. Undertaking: Provide an undertaking confirming that there will be no commercial sale of the substance.

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Important short notes for Industry and Regulators

Procedure to obtain license for Commercial Testing Laboratories

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 128 Qualifications of technical person under form 29

Note: 128

Qualifications of technical person under form 29 :

1. The Drugs Act does not specify qualifications for a technical person under Form 29.

2. An expert is permitted to develop analytical methods and products.

3. The rules do not mandate specific qualifications or experience.

4. The State Licensing Authority (SLA) may impose qualification conditions as per law.

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Important short notes for Industry and Regulators

FAQs on Blood centres

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 127 Veterinary Blood Centers in India

Note: 127

Veterinary Blood Centers in India

1. There is no provision under the Indian Drugs Act for veterinary blood centers.

2. Currently, there are only three veterinary blood banks in India:

A. Madras Veterinary College, Chennai (Tamil Nadu)

B. Jeevashram Foundation, Rajokri, South West Delhi

C. Guru Angad Dev Veterinary and Animal Sciences University (GADVASU), Ludhiana (Punjab)

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 126 License in Form 29

Note: 126

License in Form 29

1. As per notification GSR 766(E) dated 27th October, 2021, issued by the Government, the license in Form 29 under the Drugs Act & Rules must be granted by the Licensing Authority within seven working days of receiving a duly completed application in Form 30.

2. If the applicant does not receive any communication from the Licensing Authority within the aforementioned seven-day period, the license will be deemed to have been granted by the Licensing Authority.

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Important short notes for Industry and Regulators

Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 125 Powder Formulations

Note: 125

Powder Formulations :

1. The category of powders is defined under Schedule M.

2. Separate sections are required to manufacture formulations ie :
a. Oral General
b. Oral Beta-lactum

3. These formulations should be manufactured in a separate section.

4. They should not be manufactured in capsule sections.

5. Dusting powder should be manufactured in the External Preparation Section.

6. No detailed requirements are mentioned in Schedule M regarding manufacturing of powder formulations.

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Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 124 Drug Buprenorphine

Note: 124

Drug Buprenorphine

1. Drug Buprenorphine is notified as a psychotropic substance under the NDPS Act, 1985.

2. Its definition is given in Section 2(xxiii) of the NDPS Act.

3. It is also notified as a Schedule H1 drug.

4. A valid drug sale license is required to sell Buprenorphine.

5. Buprenorphine is available in both injectable and tablet forms in the Indian market.

6. The sale of psychotropic drugs is governed by the rules 64 to 67 of the NDPS Rules.

7. The small quantity limit for Buprenorphine is one gram, and it is listed at sr. No. 169 of NDPS list.

8. Its commercial quantity limit is 20 grams.

9. 'NRx' must be printed on the top left corner of the label of the drug.

10. Stocking Buprenorphine without a valid drug sale license is a violation of Section 8 and Rules 64 & 67 of the NDPS Act and is punishable under Section 22 of the Act.

11. Registration with Narcotics Control Bureau (NCB) and online submission of reports is mandatory for manufacturers of Buprenorphine.

12. As per orders of DCGI, CDSCO, and New Delhi, the sale of FDC of Buprenorphine + Naloxone in sublingual tablets dosage form is restpsychiatric clinics, hospitals and de-addiction centres only.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 123 Ear Drops

Note: 123

Ear Drops:

1. Technically, ear drops are classified as the External Preparations which are for 'external use' only.

2. Ear drops are not to be injected directly into the bloodstream.

3. When surgical intervention is required, sterilized products should be used.

4. According to the Indian Pharmacopoeia (IP), ear drops are non-sterile products.

5. Non-sterile ear drops should not be manufactured in the area/section used for manufacturing injectables.

6. Sterile ear drops must be manufactured under the manufacturing conditions and labeling provisions specified for sterilized products.

7. However , a separate category for ear drops is not mentioned in Schedule M, but under the External Preparation category, it is specified that a separate area must be provided for manufacturing the products meant for internal use.

8. As per Rule 105 of the Drugs Rules, pack size for ear drops must be be 3ml, 5ml, and 10 ml only.

9. As some drop formulations are intended to be used as both eye drops and ear drops, they should be sterilized formulations and should be manufactured in the sterilized injectable area of the manufacturing facility.

10. As per Rule 97(xi) of the Drugs and Cosmetics Rules, ear drops are exempted from the requirement of Schedule H warning on the label, but as per Note 2 of the Schedule, the antibiotic and steroid ear drops are not exempted from the provision of Rule 97(xi).

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FAQs – on Ear Drops

Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 122 Class A Non-Sterile and Non-Measuring Medical Devices

Note: 122

Class A Non-Sterile and Non-Measuring Medical Devices:

1. As per G.S.R. 777(E), dated October 14, 2022, Class A Non-Sterile and Non-Measuring Medical Devices have been exempted from the licensing regime.

2. Only registration on 'Online System for Medical Devices' 'www.cdscomdonline.gov.in' is required for manufacturing of Class A Non-Sterile and Non-Measuring Medical Devices.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 121 Steroid hormones are mainly classified into two groups

Note: 121

Steroid hormones are mainly classified into two groups:

1. Corticosteroid - examples: Dexamethasone, Betamethasone, etc.

2. Corticosteroids are manufactured in a facility licensed under Form 25, where other drugs are also manufactured.

3. Sex Hormones - male, female hormones.

4. A dedicated manufacturing facility, licensed under Form 28, is required for the manufacturing of sex hormones.

5. The manufacturing area must be separate for male hormones and female hormones.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 120 Labeling of API with QR code

Note: 120

Labeling of API with QR code

As per the amendment in rule 96(5) of the Drugs Rules, 1945 vide notification G.S.R. 20(E) dated 18th January, 2022, a QR (Quick Response) code must be printed on the label of every Active Pharmaceutical Ingredient (API). This notification has been in effect since 01.01.2023.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 119 Hemodialysis Concentrate

Note: 119

Hemodialysis Concentrate :

Medical Devices : Class C

Use:

Intended to remove metabolic waste from the blood and help maintain physiological blood electrolyte and pH levels during hemodialysis.

2. Before MDR 2017, this product was non-sterile and was permitted under Form 25 by the SLA.

3. Now, under MDR 2017, this product is classified as a Class C medical device, and a license will be granted by the DCGI office.

4. It is possible that some manufacturers are unaware of this change and may still be producing this product under Form 25.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 118 Rule 45(1) of the Drugs Rules 1945: Test reports

Note: 118

Rule 45(1) of the Drugs Rules 1945: Test reports

According to notification number GSR 103(E) dated 02.02.2017, the Government Analyst must furnish reports of the results of tests or analysis of drug samples within sixty days of receipt of the sample by the Government Analyst from the Drugs Inspector or other person under provisions of the Act.

If it is not possible to give a test report within the specified period, the Government Analyst must seek an extension of time from the Government giving specific reasons for the delay.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 117 Stop Manufacturing Activities & Stop Testing Activities

Note: 117

Stop Manufacturing Activities & Stop Testing Activities

1. Rule 85 of the Drugs Rules vests the Licensing Authority with power to issue an order to drugs manufacturing firms to stop manufacturing activities of allopathic drug(s) for a valid reason.

2. Whereas, Rule 150K of the Drugs Rules empowers the licensing authority to withdraw the approval or suspend approval wholly or partially of an approved institution for a valid reason. There is no provision to stop testing activities in this rule.

3. It means the State Licensing Authority (SLA) cannot issue an order to stop testing activities of an approved institution or drug testing laboratory.

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Important short notes for Industry and Regulators

Notification: 223(E) dated 19 March 19, 2019

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 116 Test Reports Issued to Government Health Institutions by Private Labs :

Note: 116

Test Reports Issued to Government Health Institutions by Private Labs :

As per this notification, private labs must issue test reports for samples received from government institutions using Form 39A.

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Important short notes for Industry and Regulators

Lalit. Kr. Goel
Deputy State Drugs Controller
FDA Haryana

Note: 115 Tramadol/Tapentadol: Labeling

Note: 115

Tramadol/Tapentadol: Labeling.

1. The labels of the drugs Tramadol and Tapentadol must include a statement indicating the use of these drugs by adults in acute pain only.

2. It should also be noted that these drugs should not be used for more than five days, as it may cause respiratory depression in patients.

3. A letter regarding this matter was issued by the DCGI, New Delhi.

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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