LABELLING, PACKING AND LIMIT OF
ALCOHOL IN AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS
161. Labelling, packing and limit of alcohol:
(1) There shall be conspicuously displayed on the label of the
container or package of an Ayurvedic (including Siddha) or Unani drug,
the true list of all the ingredients used in the manufacture of the
preparation together with the quantity of each of the ingredients
incorporated therein and a reference to the method of preparation
thereof as detailed in the standard text and Adikarana, as are
prescribed in the authoritative books specified in the First Schedule
of the Act.
Provided that if the list of ingredients contained in the medicine is
large and cannot be accommodated on the label, the same may be printed
separately and enclosed with the packing and reference be made to this
effect on the label.
(2) The container of a medicine for internal use made up ready for
the treatment of human ailments shall, if it is made up from a
substance specified in Schedule E(I), be labelled conspicuously with
the words 'Caution: to be taken under medical supervision' both in
English and Hindi languages.
(3) Subject to the other provisions of these rules, the following
particulars shall be either printed or written in indelible ink and
shall appear in a conspicuous manner on the label of the innermost
container of any Ayurvedic (including Siddha) or Unani drug and on any
other covering in which the container is packed, namely:
- The name of the drug. For this purpose the name shall be the same
as mentioned in the authoritative books included in the First
Schedule of the Act.
- A correct statement of the net content in terms of weight-measure
or number as the case may be. The weight and volume shall be
expressed in metric system.
- The name and address of the manufacturer.
- The number of the license under which the drug is manufactured,
the figure representing the manufacturing license number being
preceded by the words 'Manufacturing License Number' or 'Mfg. Lic.
No.' or 'M.L.'
- A distinctive batch number, that is to say, the number by
reference to which details of manufacture of the particular batch
from which the substance in the container is taken are recorded and
are available for inspection, the figure representing the batch
number being preceded by the words 'Batch No.' or 'Bath' or 'Lot
Number' or
- The date of manufacture. For this purpose the date of manufacture
shall be the date of completion of the final products, or the date
of bottling or packing for issue.
- The works "Ayurvedic medicine" or "Siddha medicine"
or "Unani medicine" as the case may be.
- The words "FOR EXTERNAL USE ONLY" if the medicine is
for external application.
- Every drug intended for distribution to the medical profession as
a free sample shall, while complying with the labeling provisions
under clauses (i) to (viii), further bear on the label of the
container the words "Physician's sample. Not to be sold"
which shall be overprinted.
(4) Nothing in these rules shall be deemed to require the labeling
or any transparent cover or of any wrapper-case or other covering used
solely for the purpose of packing, transport or delivery.
GOVERNMENT ANALYSTS AND INSPECTORS FOR AYURVEDIC (INCLUDING
SIDDHA) OR UNANI DRUGS.
162. Duties of Inspectors specially authorised to inspect to
manufacture of Ayurvedic (including Siddha) or Unani drugs:
Subject to the instruction of the controlling authority, it shall be
the duty of an Inspector authorised to inspect the manufacture of
Ayurvedic (including Siddha) or Unani drugs:-
- to inspect not less than twice a year, all premises licensed for
manufacture of Ayurvedic (including Siddha) or Unani drugs within
the area allotted to him and to satisfy himself that the conditions
of the license and the provisions of the Act and the rules made
thereunder are being observed:
- to sent forthwith to the controlling authority after each
inspection a detailed report indicating whether or not the
conditions of the license and the provisions of the Act and the
rules made thereunder are being observed;
- to take samples of the drugs manufactured on the premises and
send them for test or analysis in accordance with these rules;
- to institute prosecutions in respect of violation of the Act and
the rules made thereunder.
163. Procedure for dispatch of sample to Government Analyst and
its receipt by the Government Analyst:
(1) Sample for test or analysis shall be sent to the Govt. Analyst by
registered post or by hand in a sealed package, enclosed together with
a memorandum in Form 18-A in an outer cover addressed to the Govt.
Analyst.
- The package as well as the outer cover shall be marked with a
distinguishing number.
- A copy of the memorandum and specimen impression of the seal used
to seal the package shall be sent by registered post or by hand to
the Govt. Analyst.
(2) On receipt of the package from an Inspector, the Govt. Analyst
or an Officer authorised by him in writing in this behalf shall open
the package and shall also record the conditions of the seals on the
package.
(3) After the test or analysis has been completed, one copy of the
results of the test or analysis shall be supplied forthwith to the
sender in Form 13-A. A copy of the result in Form 13-A shall be sent
simultaneously to the controlling authority and to the Drugs
Controller, India.
164. Method of test or analysis to be employed in relation to
Ayurvedic (including Siddha) or Unani drugs:
The method of test or analysis to be employed in relation to an
Ayurvedic (including Siddha) or Unani Pharmacopoeia, or if no such
pharmacopoeias are available or if no tests are specified in such
pharmacopoeias, such tests as the Govt. Analyst may employ, such test
being scientifically established to determine whether the drug
contains the ingredients as stated on the label.
165. Qualification of Government Analyst:
A person who is appointed a Government Analyst under Section 33-Fof
the Act shall be a person possessing the qualifications prescribed in
Rule 44 or a degree in Ayurveda, Siddha or Unani system, as the case
may be, conferred by a University, a State Govt. or Statutory
Faculties, Councils and Boards of Indian Systems of Medicine
recognized by the less than three years post-graduate experience in
the analysis of drugs in a laboratory under the control of (i) a Govt.
Analyst appointed under the Act, or (ii) a Chemical Examiner to Govt.,
or (iii) the head of an institution specially approved for the purpose
by the appointing authority.
166. Duties of Government Analyst:
(1) The Govt. Analyst shall analys or test or cause to be analysed or
tested such samples of Ayurvedic (including Siddha) or Unani drugs as
may be sent to him by Inspectors or any other persons or authority
authorised by the Central Govt. or a State Govt. under the provisions
of Chapter IV-A of the Act and shall furnish reports of the results of
test or analysis in accordance with these rules.
(2) A Govt. Analyst appointed under Section 34-F shall from time to
time forward to the Govt. reports giving the results of analytical
work and research with a view to their publication at the discretion
of the Government.
167. Qualification of Inspector:
A person who is appointed an Inspector under Section 33-G shall be a
person who--
- has the qualifications laid down under Rule 49 and shall have
undergone practical training in the manufacture of Ayurvedic
(including Siddha) or Unani drug, as the case may be; or
- has a degree in Ayurvedic or Siddha or Unani System or a degree
in Ayurveda Pharmacy, as the case may be, conferred by a University
or a State Govt. or a Statutory Faculty, Council or Board of Indian
Systems of Medicine recognized by the Central Govt. or the State
Govt. for this purpose; or
- has a diploma in Ayurveda, Siddha or Unani Systems, as the case
may be, granted by a State Govt. or an Institution recognized by the
Central Govt. or a State Govt. for this purpose.
GOOD MANUFACTURING PRACTICES FOR AYURVEDIC, SIDDHA AND UNANI
MEDICINES NOTIFIED UNDER DRUGS & COSMETIC ACT 1940 ON 23rd
JUNE 2000
The Good Manufacturing Practices are prescribed to ensure that:
- (i) Raw materials used in the manufacture of drugs are
authentic, of prescribed quality and are free from contamination.
- (ii) The manufacturing process is as has been prescribed to
maintain the standards.
- (iii) Adequate quality control measures are adopted and
- (iv) The manufactured drug which is released for sale is of
acceptable quality.
(v) To achieve the objectives listed above, each licencee shall
evolve methodology and procedures for following the prescribed process
of manufacture of drugs which should be documented as a manual and
kept for reference and inspection. However, teaching institutions and
registered qualified Vaidyas, Siddhas and Hakeems who prepare
medicines on their own to dispense to their patients and not selling
such drugs in the market are exempted from the purview of G.M.P
