Unit-V Herbal Drug Technology: Table: List of ASU Drug Regulation Different Section

Unit-V Herbal Drug Technology
(Compiled by: Mr. Shmmon Ahmad, Faculty of Pharmacy, Glocal University Saharanpur, email:
[email protected])
Topic : Regulatory Issues - in India (ASU DTAB, ASU DCC),
Table : List of ASU Drug Regulation different section

Sections Title
33C. Ayurvedic, Siddha and Unani Drugs Technical Advisory
Board. (ASU DTAB)
33D. The Ayurvedic, Siddha and Unani Drugs Consultative
Committee. (ASU DCC)
33E. Misbranded drugs.
33EE. Adulterated drugs.
33EE Spurious drugs.
A.
33EEB Regulation of manufacture for sale of Ayurvedic, Siddha
. and Unani drugs.
33EEC Prohibition of manufacture and sale of certain Ayurvedic,
. Siddha and Unani drugs.
33EE Power of Central Government to prohibit manufacture, etc,
D. of Ayurvedic, Siddha or Unani drugs in public interest.
33F. Government Analysts.
33G. Inspectors.
33H. Application of provisions of sections 22, 23, 24 and 25.
33-I. Penalty for manufacture, sale, etc., of Ayurvedic, Siddha
or Unani drugs in contravention of this Chapter.
33J. Penalty for subsequent offences.
Needs for Drugs Regulation

• To prescribe and enforce standards for manufacturing, distribution, sale,
marketing and information of drugs.
• To ensure availability of quality drugs to the people.
• To promote public protection from hazards/harmful effects of drugs.
Drug regulatory system in India
1
Drugs and Health is in concurrent list of Indian Constitution It is governed by
both Centre and State Governments under the Drugs &Cosmetics Act, 1940.
Main Bodies are….
Central Drug Standard Control Organization (CDSCO)
Ministry Of Health & Family Welfare (MHFW)
Indian Council Of Medical Research (ICMR)
Indian Pharmaceutical Association (IPA)
Drug Technical Advisory Board (DTAB)
Central Drug Testing Laboratory (CDTL)
Indian Pharmacopoeia Commission (IPC)
National Pharmaceutical Pricing Authority (NPPA)
CONDITIONS FOR COMMERCIAL MANUFACTURING OF ASU

DRUGS
1. License of the manufacturing unit and intended formulations
2. GMP Compliance
3. Adequate infrastructural facility, staff, equipment, reference books, record
keeping etc.
4. Compliance to Standards given in the pharmacopoeia.
Requirements for Licensing of ASU Medicines

Manufacturing unit compliant with the GMP requirements as prescribed in
Schedule ‘T’ of the Drugs & Cosmetics Rules, 1945 and Schedule M1 for
Homoeopathic medicines.
Safety, Efficacy, Quality: Standards of ASU medicines
• Standards of identity, purity and strength as given in the respective

Pharmacopeias.
• Standardized classical formulations prescribed in National Formularies
• Standard of self generated alcohol (not more than 12% v/v) for Asavas &
Arishtas prescribed in Rule 158.
2
• In-house standards and testing protocols for proprietary medicines.
Limit of Heavy Metals for exports (effective from 14th October, 2006)
• Lead – 10.0 ppm
• Arsenic – 3.0 ppm
• Cadmium – 0.3 ppm
• Mercury – 1.0 ppm
LABELING & PACKING OF ASU MEDICINES (Rule 161)

1. Name of the drug has given in API / UPI or mentioned in the authoritative
books included in the First Schedule.
2. Quantity of the drugs in Metric system (g, ml etc).
3. Name and address of manufacturer.
4. Manufacturing License No. or “M.L.”.
5. Batch No. or Lot Number.
6. Date of Manufacture.
7. Date of Expiry (if applicable).
8. The word “Ayurvedic medicine or Siddha medicine or Unani medicine.
9. The words “for external uses only” if the medicine is for external application.
10. “Physicians sample not to be sold” if it is for distribution to the medical
profession as a free sample.
Labeling & Packing of Export products of ASU Medicines (Rule 161-A)

1) Labeling and packing to meet the requirement of the law of the country to
which exported.
a) Name of the ASU drugs (Single or compound formulation).
b) Name and address of Manufacturer with Mfg. No.
c) Batch No. or Lot No.
d) Date of Mfg. along with date for “Best for uses before”.
3
e) Main ingredients with quantity, if required by the importing country.
Schedule Z: Proposed: Requirement and guideline for permission to

manufacture of ASU Drugs for sale or to undertake clinical trials.
Update shelf life
ASSIGNMENT (UNIT 5TH)
Q.1 Give the list of ASU Drug Regulation different section
Q.2 Explain about Safety, Efficacy, Quality Standards of ASU medicines
Q.3 Give the full form of ASU DTAB, ASU DCC.
Q.4 Give the LABELING & PACKING Requirement of ASU Medicines
(Highlight Text have important points. Take a Print out of all the Document and Submit 15-25 page
Hand written Assignment of Unit 4th & 5th by mail at [email protected])
…………………… (Shmmon Ahmad)

Assistant Professor (Deptt. of Pharmacy)

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Unit-V Herbal Drug Technology

Topic : Regulatory Issues - in India (ASU DTAB, ASU DCC),

Table : List of ASU Drug Regulation different section

Needs for Drugs Regulation

Drug regulatory system in India

CONDITIONS FOR COMMERCIAL MANUFACTURING OF ASU

Requirements for Licensing of ASU Medicines

• Standards of identity, purity and strength as given in the respective

LABELING & PACKING OF ASU MEDICINES (Rule 161)

Labeling & Packing of Export products of ASU Medicines (Rule 161-A)

Schedule Z: Proposed: Requirement and guideline for permission to

ASSIGNMENT (UNIT 5TH)

Q.1 Give the list of ASU Drug Regulation different section

Q.2 Explain about Safety, Efficacy, Quality Standards of ASU medicines

Q.3 Give the full form of ASU DTAB, ASU DCC.

Q.4 Give the LABELING & PACKING Requirement of ASU Medicines

…………………… (Shmmon Ahmad)

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