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:-
B)
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:-
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:-
158-A. Conditions of loan license: A license in Form 25-E shall be subject to the following further conditions, namely:-
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.