Drugs and cosmetics (I Amendment) Rules 2002 – Policies & Amendments – Express Pharma Pulse

Drugs and cosmetics (I Amendment) Rules 2002

Ministry of health & Family Welfare (department of Health)

Notification, New Delhi, the 4 April, 2002

GSR 249 (E)-Whereas draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was published, as required sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in Part-II, section 3, Sub section (i), of he gazette of India, Extraordinary, dated 9 November, 2001, vide notification of the Government of India in the ministry of Health and Family Welfare (Department of Health) number GSR 841 (E), dated 9 November, 2001, inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of a period of forty-five days from the date on which copies of the Official Gazette containing the said notification were made available to the public.

And whereas copies of the said Gazette notification were made available to the public on 10-11-2001;

And whereas the central government is of the opinion that circumstances have arisen which render it necessary to make rules without consulting Drugs Technical Advisory Board;

And whereas the Central Government proposes to consult the Drugs Technical Advisory board within six months of making these rules;

Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central government hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely:-

1. (1) These rules may be called the Drugs and Cosmetics (1st Amendment)

Rules, 2002.

(2) They shall come into force on the date of their publication in the official Gazette.

2. In the Drugs and Cosmetics Rules, 1945, in rule 3A,

(i) In sub-rule (1A), after items (b) the following items shall be inserted, namely:-

‘‘(c) The National Institute of Biologicals, Noida’’,

(ii) after sub-rule (7) the following sub-rule shall be inserted, namely:- ‘‘(8) The functions of the Laboratory in respect of Blood Grouping reagents and diagnostic kits of Human Immunodeficiency Virus, hepatitis-B surface antigen and hepatitis-C virus shall be carried out at the National Institute of Biologicals, Noida and the functions of the director in respect of the said drugs shall be exercised by the director of the said laboratory’’.

Eno X-11014/11/2001-DMS & PFA

Deepak Gupta Jt Secy

Foot Note- The principal rules were published in the official Gazette vide notification No F28-10/45-H(1), dated 21 December, 1945 and last amended vide GSR 909 (E) dated 20-12-2001

Rifampicin Bulk Drug Price revised

SO 784 (E) – In exercise of the powers, conferred by sub-paragraph (1) and (2) of paragraph 9 and paragraph 11 of the Drugs (Prices Control) Order, 1995 read with SO No 637 (E) dated 4 September, 1997 issued by the Government of India in the Ministry of Chemicals and Fertilisers and in supersession of the Order of the Government of India in the Ministry of Chemicals and Fertilisers (National Pharmaceutical Pricing Authority) No SO 754 (E) dated 6 August, 2001, in so far as it relates to Rifampicin, except as respects things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority hereby fixes the price specified in column (4) of the table given below as the maximum sale price (exclusive of excise duty and local taxes) at which the bulk drug specified in the corresponding entry in column (2) thereof shall be sold.

TABLE

Sl No Name of the bulk drug Unit Maximum Sale price (Rs)
      (Exclusive of excise duty and local taxes)
(1) (2) (3) (4)
1 Rifampicin Kg 4200.00  

2This price/ revised price shall be made effective within 15 days from the date of this order has required under sub-paragraph (1) of paragraph 14 of Drugs (Prices Control) Order, 1995. The necessary price-list should also be issued as required under sub-paragraph (3) of paragraph 14 of the Drugs (prices control) Order, 1995.

PN/59/2002/NPPA/F No F-9(26)/2001/DP/NPPA dated 5 February 2002