MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Indian Systems of Medicine and Homoeopathy)

NOTIFICATION

New Delhi, the 31st January. 2001

G. s. R. 53(E).— T h e following draft of certain rules further to amend the Drugs and Cosmetics

Rules, 1945, which the Central Government after consultation with the Ayurvedic, Siddha and

Unani Drugs Technical Advisory Board proposes to make, in exercise of the powers conferred by

clause(a) of sub-section(l) of section 33-N read with sub-Section(l), clauses(d) and (f) of sub-

Section(2) of Section 6 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published as

required by the said section for the information of all persons likely to be affected thereby and

notice is hereby given that the said draft rules will be taken into consideration after the expiry of a

period of forty-five days from the date on which copies of the Official Gazette in which this

notification is published, are made available to the public;

Objections or suggestions, if any, may be addressed to the Secretary, Department of Indian

System of Medicine and Homoeopathy, Ministry of Health and Family Welfare, Indian Red Cross

Society Building, New Delhi - 110001;

Any objection or suggestion, which may be received from any person with respect to the said

draft rules within the period specified

above will be taken into consideration by the Central

Government.

DRAFT RULES

(i). These rules may be called the Drugs and Cosmetics (

Amendment) Rules, 2001

(ii) They shall come into force on the date of final publication in the Official Gazette;

In the Drugs and Cosmetics Rules, 1945, -

(a), after Part XVI, the following shall be inserted, namely-

THE GAZETTE OF INDIA : EXTRAORDINARY

[PART II—SEP 3(i)l

FART XVI (A)

APPROVAL OF LABORATORIES FOR CARRYING OUT TESTS OR

ANALYSIS OF AYURVEDIC SIDDHA OR UNANI, DRUGS AND RAW

-MATERIALS USED IN THEIR MANUFACTURE ON jHEHALF OF LICENSEES

FOR MANUFACTURE AND SALE OF AYURVEDIC SIDDHA OR UNANI

DRUGS.

160- A.- Application for grant of approval for testing Ayurvedic, Siddha and Unani

drugs - Application for grant or renewal of approval for carrying out tests or analysis

for identity, purity, quality and strength of Ayurvedic, Siddha or Unani drugs or the raw

materials used in the manufacture thereof on behalf of licensees for manufacture for sale

of Ayurvedic, Siddha or Unani drugs, shall be made in Form 40 to the licensing authority

appointed by the State Government for the purposes in Part XVI, XVII or XVIII of these

rules, as the case may be and referred to as the "approving authority" under this Part and

shall be accompanied by an inspection fee of Rupees six thousand

in respect of

Ayurvedic, Siddha or Unani drugs specified in First Schedule to the Act:

Provided that the applicant shall furnish to the approving authority such additional

information as may be required by him in connection with the application in Form 40:

Provided further that if the application for renewal of approval is made within six

months of such expiry, the inspection fee payable shall be rupees six thousand plus an

additional inspection fee at the rate of rupees one thousand per month in the case of

testing or analysis of Ayurvedic, Siddha or Unani drugs specified in First Schedule to the

Act.

Explanation.- For the purpose of this Part, the words "Ayurvedic, Siddha and Unani

drugs" shall also mean and include the raw materials used in the manufacture of

Ayurveda, Siddha, or Unani drugs, as the case may be.

160 -B.- Form in which approval to be granted for carrying out tests on

Ayurvedic, Siddha or Unani drugs on behalf of licensees for manufacture of

Ayurvedic, Siddha or Unani drugs and conditions for grant or renewal of such

approval. -(1) Approval for carrying out such tests or analysis of identity, purity, quality

and strength of Ayurvedic, Siddha and Unani drugs as may be required under the

provisions of these rules, on behalf of licensee for manufacture of

Ayurvedic, Siddha

and Unani drugs shall be granted in Form 41.

(2)

Before approval in Form 41 is granted or renewed, the following conditions shall

be complied with by the applicant namely:-

(i)

The premises where the tests or analysis are carried out shall be well lighted and

properly ventilated except where the nature of tests of any Ayurvedic, Siddha or Unani

drug warrants otherwise. Wherever necessary, the premises shall be air-conditioned so as

to maintain the accuracy and functioning of laboratory instruments or to enable the

performance of special tests such as sterility tests and microbiological tests

(ii) (a) The applicant shall provide adequate space having regard to the nature and

number of samples of drugs proposed to be tested:

Provided that the approving authority shall determine from time to time whether the

space provided continues to be adequate.

(b)

The applicant shall provide a list of persons who are or may be employed with

them as experts, who shall posses at least a degree from a recognized University or

equivalent

in Chemistry, Botany, Degree in Ayurved-Siddha or Unani/ Bachelor in

Pharmacy and having experience as such for at least 2 years for carrying out tests or

analysis as per the Ayurvedic, Siddha or Unani pharmacopoeias or wherever tests are

available for identity, purity, quality and strength of Ayurvedic, Siddha, or Unani drugs.

THE GAZETTE OF INDIA: EXTRAORDINARY

|PAKT II—SEC. 3(i)1

( c )

The applicant shall provide equipments essential for carrying out

tests or analysis for identity, purity and strength of Ayurvedic, Siddha, or Unani drugs.

(3)

The applicant shall provide and maintain suitable equipment having regard to the

nature and number of samples of Ayurvedic, Siddha or Unani drugs intended to be tested

or analysed which shall be adequate in the opinion of the approving authority.

(4)

The testing or analysis of Ayurvedic, Siddha and Unani drugs, as the case may be,

for identity purity quality and strength shall be carried out under the active direction of

one of the experts referred to 2(b) above who shall be the person in charge of testing and

be held responsible for the reports of test or analysis issued by the applicant.

(5)

The testing or analysis of Ayurvedic, Siddha or Unani drugs, as the case may be,

for identity, purity, quality and strength shall be carried out by persons whose

qualifications and experience of testing are adequate (not below the degree qualification)

as mentioned in 2(b) in the opinion of the approving authority.

(6)

The applicant shall provide books of standard recognised under the provisions of

the Act and the rules made thereunder and such books of reference as may be required in

connection with the testing or analysis of the products for the testing or analysis of which

approval is applied for.

(7)

The applicant shall provide list of standard Ayurveda, Siddha or Unani drugs

recognised under the provisions of the Act and rules made thereunder and such reference

samples kept in the laboratory may be required in connection with the testing or analysis

of the products of which approval is applied for.

160 - C- Duration of approval-An approval granted in Form 41 or renewed in Form 42

unless sooner suspended or withdrawn, shall be valid for a period of three years from

the date on which its is granted or renewed:

Provided that if an application for the renewal of an approval in Form 40 is made

' before its expiry or if the application is made within six months of its expiry after the

payment of the additional inspection fee, the approval shall continue to be in force until

orders to the contrary are passed on the application and the approval shall be deemed to

have expired if the application for its renewal is not made within six months of its expiry

160 -D.- Conditions of approval - An approval in Form 41 shall be subject to the

following general condition namely:-

(a)

The laboratory granted approval under this Part (hereinafter referred to as the

approved laboratory) shall provide and maintain adequate staff and adequate premises

and equipment as specified in rule 160 (B).

(b)

The approved laboratory shall provide proper facilities for storage so as to

, preserve the properties of the samples to be tested by it.

(c)

The approved laboratory shall maintain records of tests for identity, purity, quality

and strength carried out on all samples of Ayurvedic, Siddha or Unani drugs and the

results thereof together with the protocols of tests showing the readings and calculation in

such form as to be available for inspection and such records shall be retained in the case

of substances for which an expiry date is assigned for a period of two years from the

expiry of such date and in the case of other substances for a period of six years.

(d)

The approved institution shall allow the Inspector appointed under this Act to

enter with or without prior notice the premises where the testing is carried out and to

inspect the premises and the equipment used for test and the testing procedures

employed. The laboratory shall allow the Inspectors to inspect the registers and records

maintained under these rules and shall supply to such Inspectors such information as they

may require for the purpose of ascertaining whether the provisions of the Act and rules

made thereunder have been observed.

322O7j/.M>.B,__3

THE GAZETTE OF INDIA EXTRAORDINARY

|PART II—SEC. 3(i)1

(e)

The approved laboratory shall from time to time report to the approving authority

any changes in the person-in-charge of testing of Ayurvedic, Siddha or Unani drugs or

the expert staff responsible for testing, as the case may be, and any material alterations in

the premises or changes in the equipment used for the purposes of testing which have

been made since the date of last inspection made on behalf of the approving authority

before the grant of renewal of approval.

(f)

The approved laboratory shall furnish reports of the results of tests or analysis in

Form 43.

(g)

In case any sample of Ayurvedic, Siddha or Unani drug is found t>n test to be not

of standard quality, the approved institution shall furnish to the approving authority and

the licensing authority of the State where the manufacturer and/or sender of the

Ayurvedic, Siddha or Unani drugs is located, with a copy of the test report on the

sample with the protocols of tests applied

(h)

The approved laboratory shall comply with the provisions of the Act and rules

made thereunder and with such further requirements, if any, as may be specified in the

rules subsequently made under Chapter IV - A of the Act of which the approving

authority has given the approved laboratory not less than four months' notice.

(i) The approved laboratory shall maintain an inspection book to enable the Inspector to

record his impression or defects noticed.

160 - E.- Inspection before grant of approval-Before an approval in Form £1 is

granted, the approving authority shall cause the laboratory at which the testing of

Ayurvedic, Siddha or Unani drup,s, as the case may be, is proposed to be carried out to

be inrpected jointly by the Inspectors appointed by the Central Government and a State

Govt'iTini-jn' Lin lot

section 13-0 who shall examine the premises and the equipment

intended to be used for testing of drugs

and

inquire

into

the

professional

qualifications of the expert staff who are or may be employed by the laboratory.

160 - F.- Report of inspection-The Inspectors of the Department of Indian Systems of

Medicine and Homoeopathy, of the Central Government referred to in rule 160 - E shall

forward the approving authority a detailed report of the results of the inspection within

two weeks of the date of such inspection.

160 - G.- Procedure of approving authority. - (1) If the approving authority after such

further enquiry, if any, as he may consider necessary, is satisfied that the requirements

of the rules made under the Act have been complied with and that the conditions of the

approval and the rules made under the Act have been observed, he shall grant approval

in Form 41 within

four weeks of the receipt of report of the Inspectors mentioned in

rule 160-F.

(2)

If the approving authority is not so satisfied, he shall reject the application and

shall inform the applicant of the reasons for such rejection and of the conditions which

must be satisfied before approval could be granted.

160 - H .- Further application after rejection-If within a period of six months from the

rejection of an application for approval, the applicant informs the approving authority

that the conditions laid down have been satisfied and deposits inspection fee of Rupees

two thousand, the approving authority may, if, after causing a further inspection to be

made and is satisfied that the conditions for grant of approval have been complied with,

grant the approval in Form 41.

160 - I.- Renewal-On an application being made for renewal, the approving authority

may after causing an inspection to be made and if satisfied that the conditions of the

approval and the rules made under the Act have been

complied with, shall issue a

certificate of renewal in Form 42

'V-?Cahom-H

THE GAZETTE OF TNDIA EXTRAORDTNARY

[PART II—SE< 3(I)]

160-J.-

Withdrawal

and suspension of approvals. - (1) The approving

authority may, after giving the approved laboratory an opportunity to show cause why

such an order should not be passed, by an order in writing stating the reasons therefor,

withdraw an approval granted under this Part or suspend it for such period as he thinks fit

either wholly or in respect of testing or analysing of some of the categories of Ayurvcdic,

Siddha or Unani drugs to which it relates, if in his opinion the approved laboratory had

failed to comply with any of the conditions of the approval or with any provision of the

Act or the rules made thereunder

(2)

Any approved laboratory institution whose approval has been suspended or

withdrawn may within three months of the date of the order, appeal to the State

Government which shall dispose of the appeal in consultation with a panel of competent

persons appointed by the Department of Indian Systems of Medicine and Homoeopathy,

Government of India in this behalf and notified in the Official Gazette

in Schedule A, after Form 39, the following Forms shall be inserted, namely:-

FORM 40

(See rule 160-A)

Application for grant or renewal of approval for carrying out tests on Ayurvedic,

Siddha or Unani drugs or raw materials used in the manufacture thereof on behalf of

licensees for manufacture for sale of Ayurvedic, Siddha or Unani drugs

(1)

*1/We

hereby apply for the

grant/renewal of approval for carrying out tests of identity, punty, quality and strength

on the following categories of Ayurvedic, Siddha or Unani drugs or raw materials used

in the manufacture thereof on behalf of licenses for manufacture for sale of Ayurvedic,

Siddha or Unani drugs

(2)

*Categories of Ayurvedic, Siddha or Unani drugs other than those

specified in the first schedule to this Act for which testing will be carried out:

A.YURVEDA AND SIDDHA

1. Asava and Arista

2. Arka- Tinir

3. Avaleha and Paka - Ilakam

4. Kvatha Curna- Kutinir Curanam

5. Guggulu

6. Ghrta - Ney

7. Chuma - Curanam

8. Taila-Tailam

9. D ravaka - Ti ravakam

10. Lavana- Uppu

11. Ksara - Saram

12. Lepa- Pacai

13, Vati, Gutika - Kuhkai

14. Vartti -

15. Nctrabindu

16. An)ana - Kanmai

17. Sattva - Sattu

18. Kupipakva Rasayana- Kuppi Ccnturam

19. Parpati

20. Pisti

21. Bhasma - Parpam

22. Mandura - Atai Kutinir

23. Rasayoga- Ccnturam

24. Lauha

25, Ghana Sattva

26. Kvath Piavahi - Kutinir

27. Ganak (Syrup)- Manappaku

28. Tablet - Mattirai

29. Capsule

30. Ointment - Kalimapu

31. Phalvarti

32. Dhoomravarti/Doopan

33. Kshar Sutra/Kshar Varti

34. Single drugs-

la) Plant based

(b) Mineral based drugs

(d) Animal based drugs

(f) Any other A^urvcdic Siddha, Unani formulation

35 Any other form of Patent & Proprietary

•Ayurvedic, Siddha, Unani Drug

UNANI

Nabeez

Araq

Majoon , Itrifal Guland, Halwa, Lashookh,

Luboob, Jawarish, Dawa,Khamccra, Laooq,

Safoof Johshanda

Safoof

Roughan

Namak

Khaar

Zimad

Habb

Shivaf

Qutoor

Kohal, Kajal,Surma

Satt

Kushta

Joslianda

Sharbat

Qurs

Marham

Humool

Bhakhoor

Nabati

Maadani

Ajsad

Haiwani

Jauhar

(Sublimation)

Natool

(Nasal drop)

[PART II—SEC I

(3)

Names, qualifications and experience of experts employed for testing and

the person-in-charge of testing.

(4)

List of testing equipment provided.

(5)

*I/We enclose a plan of the testing premises showing the location and area

of the different sections thereof.

(6)

An inspection fee of

rupees

has been credited to

Government under the head of account

Dated

Signature

Full Address of the Applicant

Delete whichever is not applicable.

FORM 41

(See rule 160-B)

Approval for carrying out tests or analysis on Ayurvedic, Siddha or Unani drugs

or raw materials used in the manufacture thereof on behalf of licensees for manufacture

for sale of Ayurvedic Siddha or Unani drugs.

Number of approval and date of issue:

(1)

Approval is hereby granted to

for

carrying out tests for identity, purity, quality and strength on the following categories of

Ayurvedic, Siddha or Unani drugs and the raw materials used in the manufacture thereof

on the premises situated at

Categories of Ayurvedic, Siddha or Unani, drugs

(2)

Names of .experts. employed

for testing and the person-in-charge of testing

(experts) and

(person in charge)

(3)

The approval shall be in force from

(4)

The approval is subject to the conditions stated below and such other conditions

as may be specified in the rules for the time being in force under the Act.

Signature

Daie^

Designation

PIace

Seal of State Licensing Authority

Conditions of Approval

(1)

This approval and any certificate of renewal in Form 42 shall be displayed

in the approved premises and shall be produced at the request of the

Inspectors appointed under the Act

(2)

If the applicant wishes to undertake during the currency of the approval

the testing of any other category of Ayurvedic, Siddha or Unani drugs it

should apply to the approving authority for necessary endorsement as

provided in Rule 160 A

This approval will be deemed to extend to the

items so endorsed

(3)

Any change in the experts or in the person-in-charge of the testing shall be

forthwith reported to the approving authority

(4)

The applicant shall inform the approving authority in writing in the

event of any change of the constitution of the laboratory operating under

this Form Where any change in the constitution of the laboratory takes

place, the current approval shall be deemed to be valid for a maximum

period of three months from the date on which the change takes place

unless in the meantime, a fresh approval

has been taken

from the

approving authority in the name of the laboratory with the changed

constitution

FORM 42

(See rule 160 -1)

Certificate of renewal for carrying out tests or analysis on Ayurvedic, Siddha or

Unani, drugs or raw materials used in the manufacture thereof on behalf of licensees for

manufacture for sale of Ayurvedic, Siddha or Unani, drugs

(1)

Certified that approval number

granted on

the

day of

2000 for carrying out tests of identity, purity, quality

and strength on the following categories of Ayurvedic, Siddha or Unani, drugs and the

raw materials used in

the manufacture thereof

at the premises situated at

has been renewed from

Categories of Ayurvedic, Siddha or Unani, drugs

(2)

Names

experts .,

and

the

person-in-charge

testing

(experts)and

(person

in charge)

Signature

Dale

Designation

Place

Seal of State Licen sing A ttfhoi ity

FORM 43

(See rule 160 - F)

Report of test or analysis by approved Laboratory

(1)

Name of

manufacturer from whom sample

received

together with his

manufacturing

licence number

under the Act or the rules made

thereunder.

(2)

Reference number and date of the letter from the manufacturer under which

the sample was forwarded.

(3)

Date of receipt of the sample.

(4)

Name of Ayurvedic, Siddha or Unani, drug or raw material purporting to be

contained in the sample.

(5)

Details of raw material or final product (in bulk finished pack)* as obtained

from the manufacturer:

Original manufacturer's name in the case of raw materials and drugs repacked

Batch number

Batch size as represented by sample

Date of manufacture, if any

Date of expiry, if any

(6)

Results of test or analysis with protocols of test or analysis applied or as per

Ayurvedic, Siddha or Unani Pharmacopoeial standards.

(7)

Other specific tests for identity, purity quality and strength of Patent and

Proprietary drugs.

In the opinion of the undersigned, the sample referred to above is of standard

Equality/is not of standards quality as defined in the Act or the rules made thereunder

for the reasons given below

Date

(Signature of the Person-in-Charge of testing)

(F.NO

)

Place

Name & Designation

Note: Final product includes repacked material

"Delete whichever is not applicable.

INo K-11020/3/200()-DCC(ISM)]

L PRASAD. Jt Secy

Foot Note:- The Principal

Rules were published in the Official

Gazette vide

Notification

No.F.28-10/45-H(l) dated

21^s1 December, 1945 and last

amendment vide GSR No. 6(E) dated 4 1.2001. The Drugs and Cosmetics

Rules, 1945 as amended up to 1.5.1979 is contained in the publication of

the Ministry of Health and Family Welfare (Department of Health)

containing the Drugs and Cosmetics Act, 1940 (PDGHS- 61)

Printed by the Manager, Govt of India Press, Ring Road. Ma\ apun. New Delhi-110064

and Published bv the Controller of Publications, Delhi-110054