‘Ayurveda, Siddha and Unani Drugs in Drugs and Cosmetic Act, 1940; Drugs and Cosmetic Rules 1945’ by Prof. Rabinarayan Acharya

Chapter IV-A

Provision relating to ASU drugs

2.    The board shall constituted of following members

I.   Director General of Health Services, ex officio;

II.    the Drugs Controller, India, ex officio;

III.   the principal officer dealing with Indian systems of medicine in the Ministry of Health, ex officio;

IV.   the Director of the Central Drugs Laboratory, Calcutta, ex officio;

V.   one person holding the appointment of Government Analyst under section 33F, to be nominated by the Central Government;

VI.   one Pharmacognocist to be nominated by the Central Government;

VII.    one Phyto-chemist to be nominated by the Central Government;

VIII.   four persons to be nominated by the Central Government, 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;

IX.   one teacher in Dravyaguna and Bhaishajya Kalpana, to be nominated by the Central Government;

X.   one teacher in ILM-UL-ADVIA and TAKLIS-WA-DAWA-SAZI, to be nominated by the Central Government;

XI.   one teacher in Gunapadam, to be nominated by the Central Government;

XII.   three persons, one each to represent the Ayurvedic, Siddha and Unani drug industry, to be nominated by the Central Government;

XIII.    three persons, one each from among the practitioners of Ayurvedic, Siddha and Unani Tibb system of medicine, to be nominated by the Central Government.

3.    The Central Government shall appoint a member of the Board as its Chairman.

4.    The nominated members of the Board shall hold office for three years but shall be eligible for re-nomination.

5.    The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and regulating its own procedure and conduct of all business to be transacted by it.

6.    The functions of the Board may be exercised notwithstanding any vacancy therein.

7.    The Central Government shall appoint a person to be Secretary of the Board and shall provide the Board with such clerical and other staff as the Central Government considers necessary.

2)   ASUDCC shall consist of two persons to be nominated by the Central Government as representatives of that Government and not more than one representative of each State to be nominated by the State Government concerned.

3)   ASUDCC shall meet when required to do so by the Central Government and shall regulate its own procedure.

a)    If colored, coated, powdered or polished to conceal the damage or made appear better  than therapeutic value than it relay is; or

b)   If it is not labeled in prescribed manner; or

c)    If label or container or anything accompanying the drug bears any statement, design or device which may makes false claim for the drug or which is false or misleading in any particular

a)    If it consists, in  whole or in part, of any filthy, putrid or decomposed material; or

b)   If prepared, packed or stored under insanitary conditions; or

c)    If its container contains any poisonous or deleterious substance colour other than one which is prescribed harmful or toxic substance; or

d)   If it bears or contains, for purpose of colouring,, a colour other than prescribed one; or.

e)   If it contains any harmful or toxic substance which may render it injurious to health; or

f)     If any substance mixed to reduce its quality or strength.

a)    If it is sold, or offered or exhibited under name of  another name; or

b)   if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive, or bears upon it or upon its label or container the name of another drug, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

c)    If the label or container bears the name of an individual or company which is fictitious or does not exist; or

d)   if it has been substituted wholly or in part by any other drug or substance; or

e)   if it purports to be the product of a manufacturer of whom it is not truly a product.

a)       shall manufacture for sale or distribution

I.    Misbranded, adulterated or spurious ASU drugs

II.    patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container there of the true list of all the ingredients contain in it.

III.    contravention to any of the provisions of the this act or any rule  there under

b)      Sell, stock or exhibit or offer for sale or distribution, any ASU drugs which has been manufactured in contravention of any of the provisions of this act, or any rule made there under.

c)       Manufacture for sale or for distribution, any ASU drug, except under, and in accordance with the conditions of, a license issued for such purpose under this chapter.

a.  Drug involve any risk to human beings or animals

b.  Drug does not have the therapeutic value claimed

a.  Adulterated(33-EE), without a valid license as required (33-EEC): one year imprisonment  or two thousand

b.  spurious(33EEA) : one / three years imprisonment  or two/five  thousand

a.  with imprisonment for a term not less than two years but which may extend to six years and with fine not less than 5000 INR.( vary as per 33-I section, sub sections and clause)

b.  No Court inferior to that of a [Metropolitan Magistrate] or of a [Judicial Magistrate] of the first class shall try an offence punishable under this Chapter.

In certain circumstances, Govt.  may formulate rules but the board should be consulted within six months.

a.  Establishment of ASU laboratories

b. Qualification  and duties of Govt. analyst

c. Prescribe method of tests to determine the ingredients of ASU drugs

d. Specify any substance as poison

e. Prescribe forms of liscences for the manufacture for sale of ASU drugs

f. Prescribe conditions to be observed in the packing of ASU drugs

g.  Prescribe the conditions for manufacture of small quantity of ASU drugs

h. Prescribe standards of ASU drugs

i.  Any other matter which is to be or may be prescribed under this chapter

Part XVI

Manufacture for sale of ASU drugs

any ASU drugs shall be issued in Form 25-D.

any ASU drugs shall be issued in Form 25-E.

Approval of institutions for carrying out tests of ASU drugs and raw materials on behalf of licensees

The withdrawal/ suspended laboratory may apply within three months of order of suspension to the state Govt.

Labeling, packing and limit of alcohol in ASU drugs

2)   If made up with substances specified in schedule E(1), be labeled conspicuously with the words “caution; to be taken under medical supervision” both in English and Hindi

3)   ASU drugs should be labeled in the innermost container, in indelible ink, in conspicuous manner

i.      Name of the drug same as in the authoritative book included in the first schedule

ii.      A correct statement net content in terms of weight and measure in metric system

iii.      Name and address of the manufacturer

iv.      Manufacturing Licence Number or Mfg. Lic. No. or M.L.

v.      A distinct Batch no. or Batch or Lot Number or Lot No. or lot or distinguishing prefix

vi.      The date of manufacture i.e. date of completion of the final product or the date of bottling or packing

vii.      To be specified  i.e. Ayurvedic medicine or Siddha medicine or Unani medicine

viii.      For external application the words ”FOR EXTERNAL APPLICATION”

ix.      To be specific if for free distribution “Physician’s sample. Not to be sold”

a)    Maximum size of packing for high content alcohol as base i.e karpur Asava, Ahiphenasava and Mrgamadasava is 15 ml.

b)   Maximum size of packing for self-generated alcohol i.e Mritsanjivani sura is 30 ml and Mahadrakshashava is 120 ml. bor both the drugs maximum content of alcohol(ethyle alcohol v/v) is 16 percent.

4)   These rules are not deemed to require for covering used for the purpose of packing, transport or delivery.

Government analyst and inspector for ASU drugs

ii.   To send a detailed report to the controlling authority after each inspection

iii.    To take samples from premises and send for test or analysis

iv.   To institute prosecutions in respect of violation of the act and the rules

ii.      At least 5 years experience in ASU drug manufacturing or testing /teaching/research on clinical practice

ii.      The analyst will open and shall record the condition of the seals on the package

iii.      After the test the report is to be supplied to the sender in Form-13 with copy to the controlling authority

i.         To develop pharmacopoeial standards and monographs of ASU drugs

ii.         To act as central Appellate Drug Laboratory for testing of ASU drugs

iii.         To test or analyse ASU drugs

iv.         To maintain reference museum and herbarium for ASU drugs

v.         To carry out such duties assigned by Government

ii.      The packet as well as the outer cover should be marked with distinguishing number.

iii.      Copy of the memorandum in Form I-A and specimen impression of the seal used to seal the packet shall be sent separately by registered post to the Director PLIM.

A got 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 dissertation of the Govt.

Has qualification under rule-49 and shall have undergone practical training in the manufacture of ASU drugs

Has a degree of ASU/Ayurveda pharmacy recognized by university/ central/state Govt.

Has diploma in ASU, as the case may be,

Asavas and Arishtas : The upper limit of alcohol as self-generated alcohol should not exceed 12 % v/v except those that are otherwise notified by the Central Govt. from time to time.

Good manufacturing practices for ASU Medicines

Manufacturing premises required for the manufacture of

Various categories of ayurvedic, siddha system of medicines

Required for the manufacture of various categories of unani

System of medicines

Section