Chapter IV A of the Act applies to Ayurvedic, Siddha and Unani Drugs. The related Rules governing activities are from Rules 151 to 167.
Ayurvedic, Siddha and Unani
Drugs (DTAB)
Chapter
IV A of the Act applies to Ayurvedic, Siddha and Unani Drugs. The related Rules
governing activities are from Rules 151 to 167.
On
lines with DTAB for Allopathic System of Medicines, the Central Government
constitutes the Advisory Committee called as Ayurveda, Siddha and Unani Drugs Technical Advisory Board. The
Board is required to advise Central and State Governments on all technical
matters pertaining to DCA in relation to Ayurvedic, Siddha and unani Tibbi
medicines. Major differences as compared to that ofDTAB (Allopathy) are as
follows:
1. It consists of
only ex-officio and nominated members whereas, in DTAB (allopathy) there are
ex-officio, nominated and elected members.
2. There are 20
members as compared to 18 in DTAB (allopathy). This is because 00 systems
involved namely Ayurveda, Siddha and Unani.
3. Chariman of this DTAB need not be always Director General
of Medical and Health Services, Government ofIndia.
4. The term of this DTAB is for 3 years.
The Central Government
constitutes the Board with 18 members representing different disciplines of
Indigenous System of Medicine (Table 8.2). The Central Government nominates one
of these members as the Chairman of DTAB. The term is for 3 years. The
Headquarters is at Nirman Bhavan, Ministry of Health and Family Welfare,
Government of India. The Board meets usually twice a year to discuss on
technical matters pertaining to Ayurveda, Siddha and Unani Medicines in
relation to DCA. The Central Government appoints Secretary, Assistant-Secretary
and other required staff.
On
lines with Drugs Consultative Committee for allopathic drugs, there is a
separate Drugs Consultative Committee for Ayurvedic, Siddha and
It is a Statutory Committee charged with the responsibility of advising
Central Government and State Government, as well as, Drugs Technical Advisory
Board for Ayurveda, Siddha and Unani Drugs on all matters pertaining to uniform
implementation of provisions of the Act and Rules in relation to Ayurvedic,
Siddha and Unani drug formulations. The Committee comprises of nominated
members, two from Central Government and one each from State Government. Drugs
Consultative Committee meets as and when required. The Director General of
Medical and Health Services is usually the Chairman of Drugs Consultative
Committee.
·
No person shall manufacture (i) misbranded, adulterated or spurious
Ayurvedic, Siddha or Unani drug and (ii) patent or proprietary medicine unless
displayed in prescribed manner with list of ingredients and sell, stock or
exhibit any such drug manufactured in contravention with provisions of the Act
and Rules. However, Vaidyas and Hakims may manufacture drugs for their own
patients.
·
The Central Government reserves power to prohibit,
manufacture etc., of Ayurvedic, Siddha or Unani drugs in public interest.
The State Government
appoints Licensing Authority for these drugs. Separate application for separate
licence for each premises is required to be made.
Form 24-D - Application for
grant or renewal oflicence
Form 24-E - Application for
Loan Licence
Form 25-D - Issue of licence to
manufacture
Form 25-E - Loan Licence for
manufacture
Form 35 - Inspection Book to
be maintained
Form 48 - Approval for carrying out tests on
behalfoflicensee for manufacture
The Good
Manufacturing Practices (GMP) for Ayurvedic Drugs have been introduced in 2000.
GMP covers requirements of factory premises, equipment for manufacture and
analysis, storage, etc.
The licence for
manufacture is issued within three months from date of receipt of application.
The licence is granted after consulting an expert identified by State
Government. The licence for manufacture and Loan licence are valid upto 31st,
December of the year following the year in which it is granted or renewed.
The licensee or loan
licensee shall maintain proper records of manufacture and analysis, allows
Inspector to inspect premises and maintain an Inspection Book in Form 35.
The
Licensing Authority, after giving an opportunity to show cause, after 15 days
may cancel a licence or suspend it for a specific period, if the licensee fails
to comply with conditions of licence. The aggrieved person may appeal to the
State Government within 3 months which shall take final decision.
The
Label should contain:
(i)
Mention ofAyurvedic / Siddha /Unani medicine
(ii) List of ingredients
(iii) Weight, measure or number, as the case may be
(iv) Name and address of manufacturer
(v) Licence number
being preceded by the words "Manufacturing Licence Number' or 'MFg. Lic.
No.' or 'M.L'.
(vi) For internal
use of schedule E (1) drugs on container-, 'Caution-to be taken under medical
supervision' both in English and Hindi
(vii) A distinctive batch number
(viii) Date of manufacture
Label and packages
or containers of Ayurvedic, Siddha and Unani drugs for export may be adapted to
meet specific requirements of the law of the country importing such drugs
State Drug Licensing Authority shall have
Ayurvedic I Siddha I Unani
qualifications as per schedule II of CCIM Act 1970/B. Pharm. (Ayurveda)
of a recognized university with minimum five years experience in manufacture or
testing of such drugs.
The Government
Analyst is
one appointed under section 33-F of the Act and shall be a person possessing
qualifications prescribed in Rule 44 or a degree in Ayurveda, Siddha and Unani
system with minimum of three years of post-graduate experience in analysis of
drugs in a laboratory under control of Government Analyst or a Chemical
Examiner or Head of approved institution.
The Qualification of
Inspector is
(i) a degree or diploma in Ayurvedic or Siddha or Unani system or a degree in
Ayurvedic Pharmacy or (ii) a qualification laid down under Rule 49 and shall
have undergone practical training in manufacture ofAyurvedic, Siddha or Unani
drugs.
The drugs included
in Ayurvedic Pharmacopoea have to comply with standards for identify, purify
and strength given in it.
Asavas and Aristas have to comply with upper limit of
alcohol (self-generated alcohol should not exceed 12 % v/v).
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