Ayurveda, Siddha and Unani Drugs in Drugs and Cosmetic Act, 1940; Drugs and Cosmetic Rules 1945
Prof. Rabinarayan Acharya, Department of Dravyaguna, IPGT&RA, Jamnagar
The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. The primary objective of the act is to ensure that the drugs and cosmestics sold in India are safe, effective and conform to state quality standards.
The related Drugs and Cosmetics Rules, 1945 contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.
This act was originally known as the Drug Act and was passed in 1940. The original act was prepared in accordance to the recommendations of the Chopra Committee formed in 1930. The related Drugs Rules was passed in 1945. Since 1940, the act has undergone several amendments and is now known as the Drugs and Cosmetics Act, 1940.
The term “drug” as defined in the act includes a wide variety of substance, diagonstic and medical devices. The act defines “cosmetic” as any product that is meant to be applied to the human body for the purpose of beautifying or cleansing. The definition however excludes soaps. In 1964, the act was amended to include Ayurveda and Unani drugs.
[Ayurvedic, Siddha or Unani] drug includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of 3 [disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulae described in, the authoritative books of 4 [Ayurvedic, Siddha and Unani Tibb systems of medicine], specified in the First Schedule;]
The D&C Act1940 has been described under five chapters (I – V) having total 39 sections. Chapter IVA gives descriptions regarding “Provisions relating to Ayurvedic Siddha and Unani drugs” under section 33 – and 19 subsections i.e B to O. there are two schedules i.e schedule first and second where schedule one enlist prescribed books Ayurveda, Siddha and Unani drugs.
The drugs and cosmetic Rules 1945 has been described under 19 parts (I to XIX) having 169 Rules. Four parts i.e Part 16 to 19 gives description about various Rules related to Ayurvedic Siddha and unani drugs, under Rules 151 to 169. There are 25 schedules(A to Y) described under this D&C Rules 1945. Under these schedules, Schedule A describes various Forms i.e. Form 1-A, 2-A, 24-D, 24-E, 25 D, 25-E, 26-D, 26-E, 26-E-I,47,48,49 are related to ASU drugs. Schedule B-1 for fees, Schedule E(1) enlist poisonous substances under ASU system of medicines and schedule T Good manufacturing practices for ASU medicines.
Provision relating to the manufacture and control of Ayurvedic. Siddha and Unani drugs has been prescribed in the Drugs and Cosmetics Act. The individual section being described here is based on the regulation as prescribed in the Drugs and Cosmetics Act 1940, for the Ayurvedic, Siddha and Unani drugs.
|I||1,2,3, 3A, 4||Introductory|
|II||5,6,7,7A,||The drugs technical advisory board, the central drugs laboratory and the drugs consultative committee|
|III||8,9,9A, 9B, 9C, 9D,10, 10A, 11,12,13,14,15,||Import of drugs and cosmetics|
|IV||16, 17, 17 A, 17 B, 17 C, 17 D, 18, 18 A, 18 B, 19—25, 26 26 A, 27, 27 A, 28, 28, 28 A, 28, 28 A, 28 B,29,30,31,31A,32, 32A,33,33A||Manufacture, sale and distribution of drugs and cosmetics|
|IV A||33 C TO O||Provisions relating to Ayurvedic Siddha and Unani drugs|
|The first Schedule||Prescribed books Ayurveda, Siddha and Unani drugs|
|The second Schedule||Standards of quality|
|DRUGS AND COSMETIC ACT, 1940
Provision relating to ASU drugs
|Ayurvedic, Siddha and Unani Drugs Technical Advisory Board(ASUDTAB)
|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, Siddha and Unani 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.
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.
|The Ayurvedic, Siddha and Unani Drugs Consultative Committee (ASUDCC)
|S.33-D.||1) To advise the Central Government, the State Governments 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 or Unani drugs.
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.
|S.33- E.||ASU drugs are deemed to be misbranded:
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
|Adulterated drugs||S.33-EE..||ASU drugs are deemed to be adulterated
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.
|Spurious drugs||S.33-EEA.||ASU drugs are deemed to be spurious
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.
|Regulation of manufacture for sale of ASU drugs.||S.33-EEB.||No person shall manufacture for sale or distribution, any ASU drug except in accordance with such standards, if any, as may be prescribed in relation to that drug.|
|Prohibition of manufacture and sale of certain ASU drugs.||S.33-EEC.||No person either by himself or by other person on this behalf
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.
|Power of Central Government to prohibit manufacture of ASU drugs in public interest.||S.33-EED.||Central govt., in the public interest if it is necessary or expedient so to do then, by notification in the official Gazette, can prohibit manufacture of ASU drugs, after satisfied on the basis of any evidence or other material available before it that the
a. Drug involve any risk to human beings or animals
b. Drug does not have the therapeutic value claimed
|Government Analysts.||S.33-F.||Central or State government or a state government may, by notification in the official Gazette, can appoint any person, with the prescribed qualification and does not have any financial interest in manufacturing and sale of ASU drugs.|
|Inspectors.||S.33-G.||Central or State govt. can appoint any person with the prescribed qualification and do not have any financial interest in manufacture or sale of ASU drugs.|
|Penalty for manufacture, sale, etc., of ASU drug in contravention of this Chapter.||S.33-I.||Manufactures for sale or for distribution of any ASU drugs deemed to be
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
|Penalty for subsequent offences.||S.33-J.|| Whoever having convicted of an offence under 33-I shall be punishable
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)
|Confiscation.||S.33K.||Any person convicted under the act, the respective stock of ASU drug can be confiscated.|
|Application of provisions to Govt. departments||S.33-L.||The provision in this chapter except 33-K shall apply in relation to manufacture for sale, sale or distribution of any ASU drugs by any department of govt. as they apply in relation to the manufacture for sale, sale or distribution of such drug by any other person.|
|Cognizance of offences.||S.33M.||a. No prosecution under this Chapter shall be instituted except by an Inspector.
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.
|Power of Central Government to make rules.||S.33N||The Central Government may –after consultation with, or on the recommendation of, the board( ASUDTAB)- and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of 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
|Power to amend First schedule||S.33-O||The central Govt. after consultation with the Board and after giving , by notification in the official gazette, not less than three months’ notice of its intention so to do , may , by a notification, add to or otherwise amend the first schedule|
|The first schedule||Sch.-I||A. Ayurveda (1 to 54 and 54 a,b & c( books and Siddha (55to 84 books) systems|
|B. Unani tibb systems 1 to 14 books|
|The second schedule||Standards of drugs|
|The Drugs and cosmetics Rules, 1945
Manufacture for sale of ASU drugs
|Manufacture on more than one set of premises||R. 151||Separate licence, for each premises, is to be obtained for manufacture of ASU drugs at more than one premises|
|Licensing authorities||R. 52||The state Govt. shall appoint licensing authorities by notification in official gazette|
|Application for licence to manufacture ASU drugs||R. 153||An application for the grant or renewal of a licence to manufacture for sale any ASU drugs shall be made in Form 24-D to the Licensing Authority along with a fee of rupees one thousand. Rupees 300 for duplicate copy|
|Application for Loan Licence.||R. 153-A.||An application for the grant or renewal of a loan licence to manufacture for sale of any ASU drugs shall be made in Form 25-E to the Licensing Authority along with a fee of rupees six hundred.|
|Form of licence to manufacture ASU drugs:||R. 154.||Subject to the conditions of rule 157 being fulfilled, a licence to manufacture for sale
any ASU drugs shall be issued in Form 25-D.
|Form of Loan licence||R. 154 -A||Subject to the conditions of rule 157 being fulfilled, a licence to manufacture for sale
any ASU drugs shall be issued in Form 25-E.
|Certificate of renewal of licence||R. 155||The certificate of renewal of a licence in Form 25-D shall be issued in Form 26 D|
|Certificate of renewal of Loan licence||R. 155 A||The certificate of renewal of a loan licence in Form 25-E shall be issued in Form 26 E|
|Certificate of award of G.M.P. of Ayurveda, Siddha and Unani Drugs.||R. 155 B||Shall be issued to licensees who comply with the requirements of GMP of ASU drugs as laid down in Schedule T.|
|Duration of Licence||R. 156||An original licence in Form 25-D or renewed licence in Form 26 –D, unless sooner suspended or cancelled, shall be valid for three years form the date of issue or renewed.|
|Duration of Loan Licence||R. 156-A||An original loan licence in Form 25-E or renewed licence in Form 26 –E, unless sooner suspended or cancelled, shall be valid for three years form the date of issue or renewed.|
|Condition for the grant or renewal of a licence in Form 25-D||R. 157||Conditions as specified in Schedule T|
|Condition of licence||R. 158||Licensee shall keep proper record, shall allow the inspector, appointed under the Act, to enter the premises, shall maintain the inspection book Form 35|
|Conditions of loan liscence||R. 158-A||-Do–|
|Cancellation and suspension of licence||R. 159||After 15 days show cause to licensee, in writing, Licensee may appeal within three months|
Approval of institutions for carrying out tests of ASU drugs and raw materials on behalf of licensees
|Identification of raw materials||R. 160||Raw materials used must be tested for genuineness and record shall be maintained.|
|Application for grant of approval for testing of ASU drugs||R. 160 -A||Applications by institutions, in Form no 47 to licensing authority appointed by state govt. for the purpose of part XVI, XVII or XVIII with fee six thousand rupees|
|Approval for testing of ASU drugs||R.160-B||For carrying out identity, purity, quality and strength of ASU drugs on behalf of licensee in Form 48|
|Duration of Approval||R. 160-C||Period of three years|
|Condition of Approval||R. 160-D||An approval in Form 48 shall subject to adequate staff, premises and equipment as specified in Rule- 160-B|
|Inspection before grant of approval||R. 160-E||Before giving approval in Form 48 the laboratory is to be jointly inspected by inspectors appointed or designated by Central and state Govt. for this purpose.|
|Report of inspection||R. 160- F||The detailed report is to be submitted to approving authority|
|Procedure of approving authority||R. 160 – G||The approving authority if satisfied shall grant approval in Form 48; if reject the application shall inform the applicant the reason of rejection and the condition which shall be satisfied|
|Application after rejection||R. R. 160- H||If within a period of six months of rejection, the applicant inform the approving authority fulfilling the conditions to be satisfied with fee of rs 2000/-|
|Renewal||160-I||The approving authority, on apply, can issue certificate of renewal, if conditions are satisfied in Form 49|
|Withdrawal and suspension of Approval||R. 160-J||Approving authority should give an opportunity to show cause, by an order in writing, stating the reasons for withdrawal or suspend.
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
|Labelling, packing and limit of alcohol||R. 161||1) True list of all the ingredients, method of preparation, as noted in the Authoritative books specified in the First schedule of the Act
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.
|Exemption in labeling and packing for export of ASU drugs||R. 161- A.||Labels and packages or containers of ASU drugs for export should be according to the law of the country for which the drug is to be exported. But the container should have cos|
Government analyst and inspector for ASU drugs
|Duties ASU drugs Inspectors||162||i. To inspect, not less than twice in a year, the premises of the licensed manufacture of 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
|Qualifications for state Drug Licensing Authority||162-A.||i. Graduate in A/S/U as per schedule II of CCIM act, 1970, B Pharma (Ayurved) of a recognized university
ii. At least 5 years experience in ASU drug manufacturing or testing /teaching/research on clinical practice
|Procedure for dispatch and receipt of sample to/ by the analyst||163||i. Registered post/by hand in sealed package with a enclosed memorandum in Form -18A to the Govt. Analyst
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
|Pharmacopoeial Laboratory for Indian Medicines|
|Functions||163-A||Pharmacopoeial Laboratory for Indian Medicines(PLIM) at Ghaziabad to function as Central Drugs laboratory for the purpose of testing or analysis of ASU drug
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
|163-B||Function of the Director of PLIM|
|Dispatch of samples for test||163-C||i. Samples of ASU drugs, for testing, with memorandum in Form –I-A, specified in Schedule A, to the Director.
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.
|Recording of condition of seals||163-D||i. The authorized person, by the Director, shall record the condition of the seal.|
|Report of analysis of test or analysis||163-E.||The result of the analysis along with to the followed protocol to carry out the tests shall be supplied to the sender in Form-2-A|
|Fees||163-F.||The fees for tests and analysis are specified in Schedule-B-I|
|Signature on the certificate||163-G||Certificate is to be signed by the Director of the officer authorized by central Government.|
|Method of tests for ASU drugs||164||As specified in respective pharmacopoeia or if not available, tests scientifically established for the ingredients maintained on the label.|
|Qualification of the Govt. Analyst||165||Analyst, if appointed under Section 33-F of the Act should possess prescribed qualification prescribed in Rule 44 or a degree ASU as the case may be. Not less than three year post graduate experience in analysis of drug in a lob. Under the control of|
|Duties of the Govt. Analyst||166||To analysie the ASU drugs send by the inspector/persons/authorities authrised by central Govt. /state govt under the provision of Chapter IV-A of the Act. And submit the results in accordance with the rule
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.
|Qualification of the inspector||167||A person appointed under Section 33-G shall be a person who-
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,
|Standards to be complied with in manufacture for sale or for distribution of ASU Drugs.||R. 168.||Single drugs: The standards for identity, purity and strength as given in editions of Ayurvedic Pharmacopoeia of India.
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.
|Permitted excipients||R. 169||Permitted excipients i.e addictives, preservatives, antioxidants, colouring agents, flavoring agents, alternate sweeteners are specified for ASU drugs under the prevention of Food Adulteration Act (PFAA), Indian pharmacopoeia(IP), British Pharmacopoeia(BP), united national formulary(UNSF) and others.|
|Schedule||A||Form 1-A, 2-A, 24-D, 24-E, 25 D, 25-E, 26-D, 26-E, 26-E-I,47,48,49 are related to ASU drugs|
|Schedule||B-1||Schedule for fees|
|Schedule||E(1)||enlist poisonous substances under ASU system of medicines|
|Schedule||T||Good manufacturing practices for ASU medicines.|
Good manufacturing practices for ASU Medicines
|GOOD MANUFACTRING PRACTICES|
|1.1(A)||Location and surroundings-|
|1.1(D)||Disposal of Waste|
|1.1(F)(C)||Finished Goods Stores|
|1.1(H)||Health, Clothing, Sanitation and Hygiene of Workers|
|1.1(J)||Machinery and Equipments|
|1.1(K)||Batch Manufacturing Records|
|1.1(M)||Record of Market Complaints|
|1.2||Requirement for Sterile Product|
|(B)||Precautions against contamination and mix:|
|A.||List of recommended machinery, equipment and minimum
Manufacturing premises required for the manufacture of
Various categories of ayurvedic, siddha system of medicines
|B||List of machinery, equipment and minimum manufacturing premises
Required for the manufacture of various categories of unani
System of medicines
|C||List of equipment recommended for in-house quality control
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