|
Drugs & Cosmetic
Act, 1940
Provisions relating to (Ayurvedic,
Unani & Siddha Drugs)
[Ayurvedic, Unani &
Siddha Drugs Technical Advisory Board]
1) The Central Government
shall, by notification in the Official Gazette and with effect from such
date as may be specified therein, constitute a Board(to be called the {Ayurvedic,
Unani & Siddha Drugs Technical Advisory Board}) to advise the Central
Government and the State Governments on technical matters arising out of
this chapter and to carry out the other functions assigned to it by this
chapter.
A) The Board Shall consist
of the following members, namely:-
The Director-General of
Health Services, ex officio;
The Drugs Controller, India,
ex officio;
The principal officer dealing
with Indian system of medicine in the Ministry of Health, ex officio;
The Director of the Central
Drugs Laboratory, Calcutta, ex officio;
One person holding the appointment
of Govt. Analyst under section 34-F, to be nominated by the Central Govt.;
One Pharmacognocist to be
nominated by Central Govt.;
One Phyto-chemist to be
nominated the Central Govt.
Four persons to be nominated
by Central Govt., two from amongst the members of the Ayurvedic Pharmacopoeia
Committee, one from amongst the members of the Unani Pharmacopoeia Committee
and one from amongst the members of the Siddha Pharmacopoeia Committee;
One teacher in Darvyaguna,
and Bhaishajya Kalpana, to be nominated by the Central Government;
One teacher in ILM-UL-ADVIA
and TAKLIS-WA DAWASZAI, to be nominated by the Central Government;
One teacher in Gunapadam
to be nominated by Central Government;
Three persons, one each
to represent the Ayurvedic, Siddha & Unani drug industry, to be nominated
by the Central Government;
Three persons, one each
from among the practitioners of Ayurvedic, Siddha & Unani Tibb systems
of medicine to be nominated by the Central Government;
Three persons, one each
from among the practitioners of Ayurvedic, Siddha & Unani Tibb systems
of medicine to be nominated by the Central Government.
B) The Central Govt. shall
appoint a member of the Board as its Chairman.
The nominated members of
the Board shall hold office for three years but shall be eligible for renomination.
The Board may, subject to
the previous approval of Central Govt. make bye-laws fixing a quorum and
regulating its own procedure and conduct of all business to be transacted
by it.
The functions of the Board
may be exercised not withstanding any vacancy therein.
The Central Govt. shall
appoint a person to be Secretary of the Board and shall provide the Board
with such clerical and other staff as the Central Govt. considers necessary.
The Ayurvedic, Siddha &
Unani Drugs Consultative Committee.
1). The Central Govt. may
constitute an advisory committee to be called the Ayurvedic, Siddha and
Unani Drugs Consultative Committee to advise the Central Govt., the State
Govt. and the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board
on any matter for the purpose of securing uniformity throughout India in
the administration of this Act in so far as it relates to Ayurvedic, Siddha
and Unani Drugs.
2). The Ayurvedic, Siddha
and Unani Drugs Consultative Committee shall consist of two persons to
be nominated by the Central Govt. as representatives of that Govt. and
not more than one representative of each State to be nominated by the State
Govt. concerned.
3). The Ayurvedic, Siddha
and Unani Drugs Consultative Committee shall meet when required to do so
by the Central Govt. and shall regulate is own procedure.
MANUFACTURE FOR SALE OF
AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS.
151. Manufacture on more
than one set of premises:- If Ayurvedic (including Siddha) or Unani drugs
are manufactured on more than one set of premises, a separate application
shall be made and a separate license shall be obtained in respect of each
such set of premises.
152. Licensing authorities:
For the purpose of this part the State Govt. shall appoint such licensing
authorities and for such areas as may be specified in this behalf by notification
in the Official Gazette.
153. Application for license
to manufacture Ayurvedic (including Siddha) or Unani Drugs:
(i) An application for the
grant or renewal of a license to manufacture for sale any Ayurvedic (including
Siddha) or Unani drugs shall be made in Form 24-D to the licensing authority
along with a fee of rupees sixty:
Provided that in case of
renewal the applicant may apply for the renewal of the license before its
expiry or within one month of such expiry.
Provided further that the
applicant may apply for renewal after the expiry of one month but within
three months of such expiry in which case of fee payable for renewal of
such license shall be rupees sixty plus additional fee of rupees thirty.
(ii). A fee of rupees fifteen
shall be payable for a duplicate copy of a license issued under this rule,
if the original license is defaced, damaged or lost.
153-A. Loan License:
(i) An application for the
grant or renewal of loan license to manufacture for sale of any Ayurvedic
(including Siddha) or Unani drugs shall be made in Form 25-E to the licensing
authority along with a fee of rupees thirty.
Explanation - For the purpose
of this rule, a loan license means a license which a licensing authority
may issue to an applicant who does not have his own arrangements for manufacture
but intends to avail himself of the manufacturing facilities owned by a
licensee in Form 25-D:
Provided that in the case
of renewal the applicant may apply for the renewal of the license before
its expiry or within one month of such expiry:
Provided that in the case
of renewal the applicant may apply for the renewal one month, but within
three months of such expiry in which case the fee payable for renewal of
such license shall be rupees thirty plus an additional fee of rupees fifteen.
(ii) A fee of rupees seven
and paise fifty shall be payable for a duplicate copy of a license issued
under this rule, if the original license is defaced, damaged or lost.
154. Form of license to
manufacture Ayurvedic (including Siddha) or Unani drugs:
(I) Subject to the conditions
of Rule 157 being fulfilled, a license to manufacture for sale any Ayurvedic
(including Siddha)or Unani system shall be issued in Form 25-D. The license
shall be issued within a period of three months from the date of receipt
of the application.
(2) A license under this
rule shall be granted by the licensing authority after consulting such
expert in Ayurvedic (including Siddha) or Unani system of medicine, as
the case may be, which the State Govt. may approve in this behalf.
154-A. - Form of loan license
to manufacture for sale Ayurvedic(including Siddha) or Unani drugs:
(1) A loanlicense to manufacture
for sale any Ayurvedic (including Siddha) or Unani drugs shall be issued
in Form 25-E.
(2). A license under this
rule shall be granted by the licensing authority after consulting such
expert in Ayurvedic (including Siddha) or Unani system of medicine, as
the case may be, which the State Govt. may approve in this behalf.
(3) The licensing authority
shall, before the grant of a loan license. Satisfy himself that the manufacturing
unit has adequate equipment, staff, capacity for manufacture and facilities
for testing, to undertake the manufacture on behalf of the applicant for
a loan license.
155. Certificate of renewal:
The certificate of renewal of a license in Form 25-D shall be issued in
Form 26-D.
155-A. Certificate of renewal
of a loan license: The certificate of renewal of a loan license in
Form 25-E shall be issued in Form 26-E.
156. Duration of licensel:
An original license in Form 25-D or a renewal license in Form 26-D, unless
sooner suspended or cancelled shall be valid up to the 31st December, of
the year following the year in which it is granted or renewal:
Provided that if the application
for the renewal of a license is made before is expiry or within one month
of its expiry, or if the application is made within three months of its
expiry after payment of the additional fee of rupees thirty, the license
shall continue to be in force until orders are passed on the application.
The license shall be deemed to have expired, if application for its renewal
is not made within three months of its expiry.
156-A. Duration of loan
license: An original loan license in Form 25-E or a renewed loan license
in Form 26-E, unless sooner suspended or cancelled, shall be valid up to
the 31st December of all year following the year in which it is granted
or renewed:
Provided that if the application
for the renewal of a loan license is made in accordance with Rule 153-A,
the loan license shall continue to be in force until orders are passed
on the application. The license shall be deemed to have expired, if application
for its renewal is not made within three months of its expiry.
157. Conditions for the
grant or renewal of a license in Form 25-D: Before a license in Form 25-D
is granted or renewed in Form 26-D the following conditions shall be complied
with by the applicant, namely:-
The manufacture of Ayurvedic
(including Siddha) or Unani drugs shall be carried out in such premises
and under such hygienic conditions as are specified in schedule T.
The manufacture of Ayurvedic
(including Siddha) or Unani drugs shall be conducted under the direction
and supervision of competent technical staff consisting at least of one
person, who is a whole-time employee and who possesses the following qualifications,
namely:-
a degree in Ayurveda or
Ayurvedic Pharmacy, Siddha or Unani systems of medicine, as the case may
be, conferred by a University, a State Govt. or Statutory Facilities, Councils
and Boards of Indian Systems of Medicine recognized by the Central Govt.
or a State Govt. for this purpose, or
a diploma in Ayurveda, Siddha
or Unani System of medicine granted by a State Govt. or an Institution
recognized by the Central Govt. for this purpose, or
a graduate in Pharmacy or
Pharmaceutical Chemistry or Chemistry or Botany of a University recognized
by the Central Govt. with experience of at least two years in the manufacture
of drugs pertaining to the Ayurvedic or Siddha or Unani system of medicine,
or
a Vaid or Hakim registered
in a State Register of Practitioners of indigenous system of medicines
having experience of at least four years in the manufacture of Siddha or
Unani drugs, or
a qualification as Pharmacist
in Ayurvedic (including Siddha) or Unani system of medicine, possessing
experience of not less than eight years in the manufacture of Ayurvedic
or Siddha or Unani Drugs as may be recognized by the Central Govt.
The competent technical
staff to direct and supervise the manufacture of Ayurvedic drugs shall
have qualifications in Ayurveda and the competent technical staff to direct
and supervise the manufacture of Siddha drugs and Unani drugs shall have
qualifications in Siddha or Unani, as the case may be.
158. Conditions of license:
A license in Form 25-D shall be subject to the conditions stated therein
and to the following further conditions, namely:-
The license shall maintain
proper records of the details of manufacture and of the tests, if any,
carried out by him, or by any other person on his behalf, of the raw materials
and finished products.
The license shall allow
an Inspector appointed under the Act to enter any premises where the manufacture
of a substance in respect of which the license is issued is carried on,
to inspect the premises, to take samples of the raw materials as well as
the finished products, and to inspect the records maintained under these
rules.
The license shall maintain
an Inspection Book in Form 35 to enable an Inspector to record his impressions
and the defects noticed.
158-A. Conditions of loan
license: A license in Form 25-E shall be subject to the following further
conditions, namely:-
The license in Form 25-E
shall be deemed to be cancelled or suspended, if the license owned by the
licensee in Form 25-D whose manufacturing facilities have been availed
of by the license is cancelled or suspended, as the case may be, under
these rules.
The licensee shall comply
with the provisions of the Act and of the rules and with such further requirements
if any, as may be specified in any rules subsequently made under Chapter
IV-A of the Act, provided that where such further requirements are specified
in the rules, these would come into force four months after publication
in the Official Gazette.
The licensee shall maintain
proper records of the details of manufacture and of the tests, if any,
carried out by him, or any other person on his behalf, of the raw materials
and finished products.
The licensee shall allow
an Inspector appointed under the Act to inspect all registers and records
maintained under these rules and shall supply to the Inspector such information
as he may require for the purpose the ascertaining whether the provisions
of the Act and the rules have been observed.
The licensee shall maintain
an Inspection Book in Form 35 to enable an Inspector to record his impressions
and the defects noticed.
159. Cancellation and suspension
of licenses:
(1) The licensing authority
may, after giving the licensee an opportunity to show cause, within a period
which shall not be less than fifteen days from the date of receipt of such
notice, why such an order should not be passed, by an order in writing
stating the reasons therefore, cancel a license issued under this part
or suspend it for such period as he thinks fit, either wholly or in respect
of some of the drugs to which it relates, if in his opinion, the licensee
has failed to comply with any of the conditions of the license or with
any provisions of the Act or the rules made thereunder.
(2) A licensee whose license
has been suspended or cancelled may appeal to the State Government within
a period of three months from the date of receipt of the order, which shall,
after considering the appeal, decide the same.
160. Identification of raw
materials:Raw material used in the preparation of Ayurvedic(including Siddha)
or Unani drugs shall be identified and tested, wherever tests are available
for their genuineness, and records of such tests as are carried out for
the purpose and the methods thereof shall be maintained. |
|