Labelling,Packing and Limit of Alcohol in Ayurvedic and Siddha Drugs,Unani Drugs,Alcohol in Ayurvedic Herbal Drugs

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 23^rd 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

Ayurveda

Labelling, Packing And Limit Of Alcohol