The Gazette of India
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 384] NEW DELHI, FRIDAY, DECEMBER 5, 1980/AGRAHAYANA 14, 1902
Separate paging is given to this Part in order that it may be filed as a separate
compilation
itMflW THE GAZEl'lt Ot INDIA : EXTRAORDINARY [Fttfcr I K - ^ i c. Stijl" And whereas the said Gazette was made available to tho public on the 19th April, 1980;MINISTRY OF HEALTH AND FAMILY WELFARE
(Deportment of Health)
NOTIFICATION
New Delhi, the 5th December, 1980
G.S.R. 681(E>.—Whereas certain draft rules further to amend the Drugs and Cosmetics Rules, 1945 were publish- ed as required by sections 21 und 33 of the Drugs and Cos- metics Act, 1940 (23 of 1940) (hereinafter referred to as the said Act), at pages 749-750 of the Gazette of India, Part II, Section 3, Sub-section (i), dated the 5th April, 1980 •under the notification of the Government of India in ihe Ministry of Health and Family Welfare (Department of Health) No. X-11013|9|79-DMS&PFA, C..S.R. 388 dated the 21st March, 1980 inviting objections and suggestions from all persons likely to be attested thereby, beJorc the expiry of a period of ninety days from the date on which the copies of the Official Oazette containing the said notifi- cation were made available to the public ;
And whereas the objections and suggestions received from the public on the said draft have been considered by the Central Government;
Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central Government, after consultation with. Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely : —
1. (i) These rules may be called the Drugs and Cosmetics (Fifth Amendment) Rules, 1980.
(ii) They shall come into force on the date of their publication In the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the said rules), in rule 64, in sub-rule (.2), after the existing proviso, the following proviso shall be in- serted, riamely :—
"Provided further that in respect of an application for the jjrant of a licence in Form 20-B or Form 21-B or both, the licensing authority shall satisfy him- self that the premises in respect of which a whole- sale licence is to be granted are :—
(i) of an area of not less than ten square meters ;
and
(H) in the charge of a competent person, who is a Registered Pharmacist or who hes passed the Matriculation Examination or its equivalent with four years experience in dealing with drugs";
3. In rules 71 and 76 of the said rules, after condition (4), the following condition shall be inserted, namely :—
"C4A) The head of the testing unit referred to in con- dition (4) shall possess a degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a University recognised for this purpose and shall have experience in the testing of drugs, which in the opinion of the licensing authority is consi- dered adequate.";
4. In rule 96 of the said rules, in sub-rule (1 ), in clnuse (iii), in sub-clause (a), in the proviso, after the words "in terms of one millilltre", the words "or fraction thereof" shall be inserted;
5. In Schedule A to the said nries, in Form 37 under the heading "Conditions of Approval", after condition (3), the following condition shall be inserted, namely :—
"(4). The approved institution shall inform the approv- ing authority in writing in the event of any change of the constitution of the institution opening under this Form. Where anv ch.inKC in the con- stitution of the institution takes place, the current approval shall be deemed to he valid for a maxi- mum period of three months from the date on which the change takes place unless in the mean- time, a fresh approval has been taken from the apnroving authority in the mmo of the institution with the changed constitution."
6. In Schedule K to the said rules, item 6 and the entries relating thereto shall be omitted.
[No. X-11013l9|79-DMS&PFA] T. V. ANTONY, Jt. Secy.