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REGISTERED No. D-(D)-72

The Gazette of India

EXTRAORDINARY

PART II—Section 3--Sub-section (i)

PUBLISHED BY AUTHORITY

No. 86] NEW DELHI, WEDNESDAY, MARCH 10, 1976/PHALGUNA 20, 1897

Separate paging is given to this Part in order that it may be filed

as a separate compilation

MINISTRY OF HEALTH AND FAMILY PLANNING

(Department of Health)

NOTIFICATION

New Delhi, the 10th March 1976

G.S.R. 117(E).—The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, which the Central Government proposes to make, after consulta- tion with the Drugs Technical Advisory Board, in exercise of the powers conferred by- sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby publish- ed, as required by the said sections, for the information of all persons likely to bo affected thereby; and notice is hereby given that the said draft rule will bo taken into consideration after the expiry of 90 days from the date on which the copies of the Official Gazette containing this notification are made available to the public;

Any objections or suggestions which may be received from any person with respect to the said draft rules before the expiry of the period so specified will be taken into consideration by the Central Government.

DRAFT RULES

1. These rules may be called the Drugs and Cosmetics (Amendment) Rules, 1976.

2. In the Drugs and Cosmetics Rules, 1945;

(1) in rule 71, in sub-rule (4), in clause (ii), after the words "approved by the licens- ing authority" the words, letters and brackets "under Part XV(A) of these rules" shall be inserted;

(589)

(2) in rule 71 A, In sub-rule (3), In clause (ii), after the words "approved by the licensing authority'' the words, letters and brackets "under Part XV(A) of these rules" shall be inserted;

(3) in rule 74, in sub-rule (c), after the words "approved by the licensing authority™ the words, letters and brackets "under Part XV(A) of these rules" shall be inserted;

(4) in rule 74A, in sub-rule (b), after the words "approved by the licensing autho- rity" the words, letters and brackets "under Part XV(A) of these rules" shall be Inserted;

(5) in rule 74B, in sub-rule (4), in clause (ii), after the words "approved by the licensing authority" the words, letters and brackets "under Part XV(A) of these rules" shall be inserted;

(6) in rule 76, in sub-rule (4), in clause (ii), after the words "approved by the licensing authority" the words, letters and brackets "under Part XV(A) of these rules" shall be inserted;

(7) in rule 78, in sub-rule (c), in clause (ii), after the words "approved by the licensing authority" the words, letters and brackets "under Part XV(A) of these rules" shall be inserted;

(8) In rule 85E, in sub-rule (3), in clause (ii), after the words "approved by the Licensing Authority" the words, letters and brackets "under Part XV(A) of these rules" shall be inserted;

(9) in rule 139, in sub-rule (4), in clause (ii), after the words "approved by the Licensing Authority" the words, letters and brackets "under Part XV(A) of these rules" shall be inserted;

(10) after Part XV, the following Part shall be inserted, namely:—

"PART XV (A)

Approval of institutions for carrying out tests on drugs/cosmetics and raw mate- rials used in their manufacture on behalf of licensees for manufacture for sale of drugs/cosmetics.

150-B. Application for grant of approval for testing drugs/cosmetics:—

(1) Application for grant or renewal of approval for carrying out tests for identity, purity, quality and strength on drugs or cosmetics or the raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs or cosmetics, shall be made in Form 36 to the Licensing Authority appointed by the State Government for the purposes of Part VII, VII(A) or XTV 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 five hundred in the case of testing of drugs specified in Schedules C and C(I) and rupees three hundred in the case of testing of drugs other than those specified in Schedules C and C(I), Homoeopathic drugs and cosmetics:

Provided that the applicant shall furnish to the approving authority such addi- tional information as may be required by him in connection with the application in Form 36:

Provided further that if the applicant applies for renewal of approval after its expiry but within six months of such expiry, the inspection fee payable shall be rupees five hundred plus an additional inspection fee at the rate of rupees four hundred per month in the case of testing of drugs speci- fied in Schedules C and C(i) and rupees three hundred plus an addi- tional inspection fee of rupees two hundred per month in the case of testing of drugs other than those specified in Schedules C and C ( I ), Homoeopathic drugs and cosmetics.

(2> A separate application shall be made for grant of approval tor carrying out tests on additional categories or drugs or items of cosmetics.

Explanation.—For the purpose of this Part, the words 'drugs' and 'cosmetics' snail also mean and include the raw materials used in the manufacture of drugs including Homoeopathic drugs or cosmetics, as the case may be.

150-C. Form in which approval to be granted for carrying out tests on drugs/ cosmetics on behalf of licensees for manufacture of drugs/cosmetics and conditions for grant or renewal of such approval.—Approval for carrying out such tests of identity, purity, quality and strength of drugs Or cos- metics as may be required under the provisions of these rules, on behalf of licensee for manufacture of drugs or cosmetics shall be granted in Form 37:

Provided that the particulars of grant or renewal of approval shall be notified by the approving authority in the Official Gazette in each case.

Before approval in Form 37 is granted or renewed, the following conditions shall be complied with by the applicant:—

(U The premises where the tests are being carried out shall be well lighted and properly ventilated, except where the nature of tests of ^iy drug or cosmetics 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, microbiological tests, etc.

\2) The applicant shall provide adequate space having regard to the, nature and number of samples of drugs or cosmetics proposed to be tested:

•Provided that the approving authority shall determine from time, to time whether the space provided continues to be adequate.

i(,'i) If it is intended to carry out tests requiring the use of animals, the appli- cant shall provide for an animal house and comply with the following requirements:—

(a) The animal house shall be adequate in area and air-conditioned.

'(c) The applicant shall provide for suitable arrangements for preparation of animal feed.

'(d) The applicant shall provide for suitable arrangement for quarantining of all animals immediately on their receipt in the institution.

(e) The animals shall be in the custody of experienced veterinary surgeon or zoologist.

>(f) The applicant shall provide for isolation of sick animals, as well as animals under test.

(g) The applicant ihall ensure compliance with the requirements of the Prevention of Cruelty to Animal Act, 1960 (59 of 1960),

(h) The applicant shall provide for an incinerator to dispose of the carcasses of animals.

<{4) The applicant shall provide and maintain suitable equipment having regard to the nature and number of samples of drugs or cosmetics intended to be tested, which shall be adequate in the opinion of the approving authority.

(5) The testing of drugs or cosmetics, as the case may be, shall be under the active direction of a person whose qualifications and experience are

considered adequate in the opinion of the approving authority and who- shall be held responsible for the reports of test or analysis issued by the applicant.

(6) The testing of drugs or cosmetics, as the case may be, for identity, purity, quality and strength shall be carried out by persons whose qualification^ and experience of testing are adequate in the opinion of the approving authority.

(7) The applicant shall provide books of standards recognised under the provi- sions 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 of which approval is applied for.

150-D. Duration of approval.—An approval granted in Form 37 or renewed in' Form 38, unless sooner suspended or withdrawn shall be valid for a period of two years from the date of issue:

Provided that if an application for the renewal of an approval in Form 37 i" made before its expiry after the payment of the additional inspection fee,. the approval shall continue to be in force until orders are passed on the application and the approval shall be deemed to have expired if the appli- cation for its renewal is not made within six months of its expiry.

150-E. Conditions of approval.—An approval in Form 37 shall be subject to the- following general conditions:—

(a) The institution granted approval under this Part (hereinafter referred to- as the approved institution) shall provide and maintain an adequate staff and adequate premises and equipment as specified in rule J50-C.

(b) The approved institution shall provide proper facilities for storage so as*

to preserve thc properties of the samples to bo tested by it.

(c) The approved institution shall maintain records of tests for identity, purity, quality and strength carried out on all samples of drugs or cosmetics and the results thereof together with the protocols of tests showing the readings and calculations in such form as to be available for inspection, and such records shall be retained in the case of substances for which: a potency date is fixed 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 officers mentioned under rule- 150-F or any Inspector to enter with or without prior notice, the pre- mises where the testing is carried on and to inspect the premises and' the equipment used for lest and the testing procedures employed. The institutions shall allow the said officers or any Inspector to inspect thc registers and records maintained under these Rules and shall supply to such officers or to such Inspector such information as they or he may require for the purpose of ascertaining whether thc provisions of the Act and rules made thereunder have been observed.

e) The approved institution shall from time to time report to the approving.- authority any changes in the person in-charge of testing of drugs or cosmetics or in the expert staff responsible for testing as the case may be and any material alterations in the premises or changes in the equip- ment used for thc purpose of testing which have been made since the- date of last inspection made on behalf of the approving authority before the grant or renewal of approval.

(f) The approved institution shall furnish reports of the results of test or analysis in Form 39.

(g) Tn case any sample of a drug or a cosmetic is found on test to be not of" standard quality, the approved institution shall furnish the approving- authority, with a copy of the test report on the sample, with the proto- cols of tests applied.

(h) The approved institution 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 of the Act, of which the approving authority has given the approved institution not less than fonr months notice.

(i) The approved institution shall maintain an Inspection Book to enable the said officers or the Inspector to record his impressions or defects noticed.

150-F. Inspection befora grant of approval,—Before an approval in Form 39 is granted, the approving authority slmll cause the institution at which the testing of drugs or cosmetics, as the case may be, is proposed to bo carried out to be inspected jointly by the officers of the Central Drugs Standard Control Organisation and the State Drugs Standard Control Organisation appointed specifically for this purpose, who shall examine all portions of the premises and the equipment intended to bo used for testing of drugs or cosmetics and inquire into the professional qualifications of the expert staff to be employed.

150-G. Report of inspection.—The officers mentioned in rule 150-F shall for- ward to the approving authority a detailed report of the results of the inspection.

J50-H. 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 will be observed, he shall grant an approval in Form 37.

•<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 bei satisfied before an approval could be granted.

il50-I. 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 fifty, the approving authority may, if after causing a further inspection to be made, he is satisfied that the conditions for grant of approval have been complied with, grant the ap- proval in Form 37.

150-J. Renewal.—On an application being made for renewal, the approving authority may cause an inspection to be made and if satisfied that the conditions of the approval and the rules made under the Act are and shall continue to be observed shall issue a certificate of renewal in Form 38.

150-K. Withdrawal and suspension of approvals.—(1) The approval authority may after giving the approved institution an opportunity to show cause why such an order should not be passed, by an order in writing stating ithe -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 some of the categories of drugs or items of cosmetics to which it relates, if in his opinion the approved institution has failed to comply with any of the conditions of the approval or with any provision of the Act or the rules made thereunder:

Trovided that such withdrawal or suspension of approval shall be notified by the approving authority in the Official Gazette.

(2) Any approved 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 it in this behalf and notified •m the Official Gazette.";

in Schedule A, after Form 35, the following Forms shall be inserted, namely:—

"FORM 36

{See Rule 150-B)

Application for grant or renewal of approval for carrying out tests on drags/cosmetics or

raw materials used in the manufacture thereof on behalf of licences for manufacture for

sale of drugs/cosmetics

(1) I/We of hereby, apply for the grant or renewal of approval for carrying out tests of identity, purity, quality and strength on> the following categories of drugs/items of cosmetics or raw materials used in the manu- facture thereof on behalf of licensees for manufacture for sale of drugs/cosmetics.

(2) *Categories of drugs, items of cosmetics:

(a) Drugs other than those specified in Schedules C and C ( l) and also excluding:

Homoeopathic Drugs:—

1. Crude vegetable drugs.

2. Mechanical contraceptives.

3. Surgical dressings.

4. Drugs requiring the use of U.V./I.R. Spectrophotometer or Chromatography.-

5. Disinfactants.

6. Other drugs,

(b) Drugs, specified in Schedule C and C ( l ) :—

1. Sera, Vaccines, Antigens, Toxins, Antitoxins, Toxoids, Bacteriophages and similar Immunological Product.

2. Antibiotics.

3. Vitamins.

4. Parenteral Preparations.

5. Sterilised surgical ligature/suture.

6. Drugs requiring tho use of animals for their test.

7. Drugs requiring microbiological tests.

8. Drugs requiring the use of U.V./I.R Spectrophotometer or Chromatography.

9 Other drugs.

(c) Homoeopathic drugs.

(d) Cosmetics.

(3) Name, qualifications and experience of expert staff employed for testing and the person-in-charge of testing.

(4) list of testing equipments provided.

(5) I/We enclose a plan of the testing premises, showing the location and area of iht different sections thereof.

(6) A fee of rupees and an inspection fee of rupees has- been credited to Government under the head of account

Date

Signature- ^_

•Delete whichever is not applicable.

FORM 37

(See rule 150-C)

Approval for carrying out tests on drugs/cosmetics and raw materials used in their

manufacture on behalf of licensees for manufacture for sale of drugs/cosmetics

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 drugs/items of cosmetics and the raw materials used in the manufacture thereof on the premises situated at

Categories of drugs/items of cosmetics.

(2) Name of approved expert staff employed for testing and the person-in-charge of tea ting.

(3) The approval shall be in force from

to

(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.

Date 1

Signature

(Designation)

CONDITIONS OF APPROVAL

(1) This approval and any certificate of renewal in Form 38 shall be kept in the approved premises and shall be produced at the request of the Inspector appointed under the Act, or an officer mentioned in rule 150-F.

(2) If the approved institution wishes to undertake during the currency of the ap- proval of the testing of any other category of drugs or items of cosmetics it should apply to the approving authority for necessary endorsement as provided in rule 150-B. This approval will be deemed to extend to the items so endorsed.

(3) Any change in the analytical staff or in the person-in-charge of the testing shall be forthwith reported to the approving authority.

FORM 38

(See rule 150J)

Certificate of renewal of approval for carrying out tests on drugs/cosmetics and raw

material used in the manufacture thereof on behalf of licensees for manufacture for salt

of drugs/cosmetics

(1) Certified that approval number granted on the for carrying out tests of identity, purity, quality and strength on the following categories of drugs/ items of cosmetics and the raw materials used in the manufacture thereof at the premises situated at has been renewed from to

Categories of drugs/items of Cosmetics.

>-"-•-.-• . . . . .. .<•-.

(2) Names of approved expert staff and person-in-charge of testing.

Signature

Date

Designation

FORM 39

[See rule 150-E(f)]

Report of test or analysis by approved institution

(1) Name of manufacturer from whom sample received together with his manufacturing licence number under the Act and under rules made thereunder.

(2) Reference number and date of the letter from the manufacturer under which tho sample was forwarded.

(3) Date of receipt of the sample.

(4) Name of drug/cosmetic/raw material purporting to be contained in the sample.

(5) Detail* of raw material/final product (in bulk)/final product (in finished pack)*, as obtained from the manufacturer:—

(a) Original manufacturer's name (in the case of raw materials and drugs repacked).

(b) Batch number.

(c) Total quantity represented by sample.

(d) Date of manufacture, if any.

(6) Results of test or analysis with protocols of test or analysis applied.

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

lis not of standard quality as defined in the Act, and the rules made thereunder for the reasons given below:—

Date

(Signature of Pcrson-hvcharge of testing) NOTE.—Final product includes repacked material.".

[No. X11013/16/75-D&MS3

SHRAVAN KUMAR, Jt. Secy.

*Dat" whichever Is not applicable.