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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. 255] NEW DELHI, FRIDAY, JULY 29, 1977/SRAVANA 7,1899

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

as a separate compilation.

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health)

NOTIFICATION

New Delhi, the 29th July 1977

G.S.R. 543(E).—The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, which the Central Government proposes to make, after consultation with the Ayurvedic and Unani Drugs Technical Adviery Board, in exercise of the powers con- ferred by section 33N of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published as required by the said section for 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 45 days from the date of publication of this notification in the Official Gazette.

Any obiections 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.

D R A FT R U L ES

1. These rules may be called the Drugs and Cosmetics (Amendment) Rules, 1977.

(1547)

2. In the Drugs and Cosmetics Rules, 1945,-—

(a) after rule 153, the following rule shall be inserted, namely —

"153-A. Loan licence.— (i) An application for the pram or renewal of a loan licence to manufacture for sale of any Ayurvedic (including SiddhaUr Unani drugs shall be made in Form 25-E to the licensing authority along with a iec of rupees thirty.

Explanation.—For the purpose of this rule, a loan licence which a licensing authrrity may issue to an applicant who does not have his own arrangements f°r manufac- ture but intends to avail himself of the manufacturing facilities owned by a licensee in Form 25-D:

Provided that in the case of renewal the applicant may apply for the renewal of the licence before its expiiy 01 within one month of tuch expiry •

Provided further that the applicant may apply lor renewal after the exiry of one mi nthv but within three months of such expiry in which case the fee payable for renwal cf such licence shall be rupees thirty plus an additional fee rf rupees fifteen.

(Jl) A fee of rupees seven and paisc fifty shall be payable ffr a duplicate copy of a licence issued under thm rule, it the originwl licence is defaced, damaged or lost",

(b) after rule 154, the following rule shall be inserted, namely —

''154-A. Form nf loan licence to manufacture for sale Ayurvedtc (including Siddha) or Unani drugs.—(i) A loan licence to manufacture fi r sale arty Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25-E.

(2) A licence under this rule shall be granted by the licensing authority after ct. 11 suit- ing such expert in Ayurvedic (including Siddha) or Unani SystemR of medicme, as the case may be, which the State Government may approve in this behalf.

(3) The licensing authority shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for testing to undertake the manufacture on behalf cf the applicant for a loan licence.";

(c) after rule 155, the following rule shall be inserted, namely :—

"155-A. Certificate of renewal of a loan licence,—The certificate if renwal of a loan licence in F rm 25-E shall be issued in Form 26-E.",

(d) after rule 156, the following rule shall be inserted, namely •—

"i;6-A, Duration of loan licence.—An original Ran licence in Furm 25-E or a renewed loan licence in Form 26-E, unless sooner suspended or cancelled, shall be valid upto the 31st December of the year following the year in which it is granted or renewed:

Provided that if the application for the renewal of a loan licence is made in accordance with rule 153-A, the Iran licence shall continue to be in force until orders arc passed on the application. The licence shall bo deemed to have expired, if application for its renewal is net made within three months cf its expiry.";

(e) after rule 158, the following rule shall be inserted, namely —

"158-A. Conditions oj loan licence.—A licence in Ft im 25-E shall be subject to the conditions stated therein and to the following lurthcr conditions, namely —

(a) The licence in Form 25-E shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 25-D whose manufacturing facilities have been availed of by the licensee is cancelled rf suspended, as the case may be, under these rules

(b) The licensee shall comply with the prw ISK HE c f the Act end c f these rules and with such futher requirements, if any, as may be specified in any rules subse- quently made under Chaptci IV-A of the Act, provided that where such further requirements ure specified in the rule, these would come into fi_rce four months after publication in the Official Gazette

(c¹) The licensee shall maintain proper records rf the details of manufacture and of the tests, if any, carried out by him, or any other person on his behalf, of the raw materials andj finished products.

1549

(d) The licensee shall allow an Inspector appi inted under the Act to inspect all registers and lccords maintained under these rulex and shall supply to the Inspector luch infoimation as he may lequire fir thy purpose of ascertaining whethot the provHiois of the Act and the rules have been observed.",

(f) for rule 167, the following rule shall be substituted, namely ••—

"167. Qualifications of Inspector.—A person who is appointed an Inspector under section 33G shall be a person who—

(a) 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

(b) has a degree in Ayurveda or Siddha or Unani System or a degree in Ayurveda Pharmacy, as the case may be, conferred by a University or a State Government or a Statutory Faculty, Council or Board ol Indian Systems ot Medicine recog- nised by the Central Government or the State Government for this purpose; or

(c) has a diploma in Ayuiveda, Siddha orUnam Systems, as the case may be, grant- ed by a Stale Government or an Institution recognised by the Central Govern- ment or a State Government for this purpose. ,

(g) in Schedule A afui 1'orm 24-D, the following Form shall be inserted, namely •—

"FORM 24-E

(See rule 154-A)

APPLICATION FOR GRANT OR RENEWAL OF A LOAN LICENCE TO MANUFACTURE FOR SALE AYURVEDIC (INCLUDING SIDDHA)

OR UNANI DRUGS

1. I/We*

off.. . . •

hereby apply for the grant/renewal of a loan licence to manufac- ture Ayurvedic (including Siddha) or Unani drugs on the premises situated at

C/o"* ,. , •

2. Nimej of drugs to be manufactured (with details).

3. The names, qualifications und experience of technical staff actually connected with the manufacture and testing of Ayurvedic (including Siddha) or Unani drugs in the manufac- turing premises.

4. I/We enclose—

(a) A true copy of a letter from me/us to the manufacturing concern whose manu- facturing concrn whose manufacturing capacity is intended to be utilised by me/us.

(b) A true copy of a letter from the manufacturing concern that they agree to lend the services of their competent technical staff, equipment and premises for manufac- ture of each item required by me/us and that they shall maintain the registers of raw materials and finished products separately in this behalf,

(c) Specimen of lcbels, cartons of the drugs proposed to be manufactured.

5. A fee of Rs

. . has been credited to Government undef the head of account and the relevant Treasury Challan is enclosed herewith

SIGNATURE

Date :

(applicant)

•Enter here the name of the propiietor, partners or Managing Director as the case may be. •("Enter here the name of the applicant firm and the address of the principal place of business.

••Enter here the name and address of the manufacturing concern where the manufacture will be actually carried out and also the Licence number under which the latter operates.".

(h) after Form 25-D, the following Form shall be inserted, namely ,—

"FORM 25-E

(See rule 154-A)

LOAhf LICENCE TO MANUFACTURE FOR SALE AYURVEDIC (lNCLUDIN G

SIDDHA) OF UNANI DRUGS

1. Number of licence 2

of ..

I* hereby granted a loan licence to manufacture for sale Ayurvedic (including Slddha) and Unani drags, on the premises situate at C/o • under the direction and supervision of the following expert technical staff

(a) Technical Staff (Names) •

(b) Name of drugs (each item to be separately specified).

3. Thehcenceshall bein forocfrom

to

e specified in the rules for (he time being in force under the Drugs and Cosmetics Act, t. The licence is subject to the conditions stated below and to audh oher conditions flfl 1940.

S i g n a t u re . .. . - <. •

D a te of issue

D e s i g n a t i on . .' 1 .. . i.

' Condition* of Licence

1. The licence and any certificate of renewal in force shall be kept on the approved pre- mises and shalj be produced at the request of an Inspector, appointed under the Drugs Bnd Cosmetics Act, 1940.

2, Any change in the technical staff named in the licence shall be reported forthwith to the licencing authority.

3. This licence shall be deemed to extent to such additional items as the licensee irray intimate to the licensing authority from time to time, and as may be endorsed by the licensing authority.

4, The licensee shall inform the licensing authority 111 writing in the evenl of any change in the constitution of the firm operating under licence Where any change in the constitu- tion of firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the dnteoi which the change takes place unless in the meantime a fresh licence has been taken from the licensing authority in the name of the firm with the changed constitution,"

(i) in Form 26-Dj after paragraph 2, the following paragraph shall be inserted, namely :—

"S. Names of drugs (each item to be separately specified)."

0) after Form 26-D, the following Form shall be inserted, namely ,—

"FORM 26-E

(See rules 155-A)

CERTIFICATE OF RENEWAL OF LOAN LICENCE TO MANUFACTURE FOR SALE OF AYURVEDIC/SIDDHA/OR UNANI DRUGS 1. Certified that loan licence No

grantedonthe . .. , . . . . . to , lorthemanufactureofAyurvedic/Siddha/Unamdrugsatthepremises situatcdat

C/o

has been renewed from to. .

2. Name of technical staff

. . ..

Date

Signature . .. Designation.

[No. X.11014/1/76-APC] AJOY BAGCHI, Jt. Secy-

t55t

X553

1&

PB1MTHD BY THE GENERAL MANAOfR, GOVERNMENT OF INDIA PRESS, MINTO ROAD,

NEW ItBLKI AND PUBLISHED BY THK CONTROLLER OF PUBLICATIONS, DILHr, 1 9 77