(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:
(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:-
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.
(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--
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:
(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