Drugs Rules, 1945 was published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940(23 of 1940) (thereafter referred to as the said Act) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare), number G.S.R. 999(E), dated the 5th of October, 2018, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the said Official Gazette containing the said notification were made available to the public;
- And, whereas copies of the said Gazette were made available to the public on 9th October 2018
- And, whereas objections or suggestions received from the public on the said rules were considered by the Central Government
Now (28th Dec 2023), therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act,1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board constituted under section 5 of the said Act, hereby makes the following rules further to amend the Drugs Rules, 1945, namely.
(1) These rules may be called the Drugs (….. Amendment) Rules, 2023.
(2) They shall come into force from the date of their publication in the Official Gazette.
In the Drugs Rules, 1945 (hereinafter referred to as the principal rules), in rule 74, in clause (o), for the words “Good Manufacturing Practices”, the words “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products” shall be substituted.
In the principal rules, in rule 76, in clause (8), for the words “Good Manufacturing Practices”, the words “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products” shall be substituted.
In the principal rules, in rule 78, in clause (p), for the words “Good Manufacturing Practices”, the words “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products” shall be substituted.
In the principal rules, for Schedule M, the following Schedule shall be substituted, namely: –
SCHEDULE M: Part-I: GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICAL PRODUCTS
SCHEDULE M: Part-II: SPECIFIC REQUIREMENTS FOR MANUFACTURE OF STERILE PRODUCTS, PARENTERAL PREPARATIONS (SMALL VOLUME INJECTABLES AND LARGE VOLUME PARENTERALS) AND STERILE OPHTHALMIC PREPARATIONS
SCHEDULE M: Part-III: SPECIFIC REQUIREMENTS FOR MANUFACTURING OF PHARMACEUTICAL PRODUCTS CONTAINING HAZARDOUS SUBSTANCES SUCH AS SEX HORMONES, STEROIDS (ANABOLIC, ANDROGENIC) OR CYTOTOXIC SUBSTANCES
SCHEDULE M: Part-IV: SPECIFIC REQUIREMENTS FOR MANUFACTURE OF BIOLOGICAL PRODUCTS
SCHEDULE M: Part-V: SPECIFIC REQUIREMENTS FOR RADIOPHARMACEUTICAL PRODUCTS
SCHEDULE M: Part-VI: SPECIFIC REQUIREMENTS FOR PHYTOPHARMACEUTICALS
SCHEDULE M: Part-VII: SPECIFIC REQUIREMENTS FOR THE MANUFACTURE OF INVESTIGATIONAL PHARMACEUTICAL PRODUCTS FOR CLINICAL TRIALS IN HUMANS
SCHEDULE M: Part-VIII: SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES)
SCHEDULE M: Part-IX: SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL LIQUIDS (SYRUPS, ELIXIRS, EMULSIONS AND SUSPENSIONS)
SCHEDULE M: Part-X: SPECIFIC REQUIREMENTS FOR MANUFACTURE OF TOPICAL PRODUCTS i.e., EXTERNAL PREPARATIONS (CREAMS, OINTMENTS, PASTES, MULSIONS, LOTIONS, SOLUTIONS, DUSTING POWDERS AND IDENTICAL PRODUCTS)
SCHEDULE M: Part-XI: SPECIFIC REQUIREMENTS FOR MANUFACTURE OF METERED–DOSE– INHALERS (MDI)
SCHEDULE M: Part-XII: SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ACTIVE PHARMACEUTICAL INGREDIENTS
SCHEDULE M: Part-XIII: REQUIREMENTS OF PLANT AND EQUIPMENT
Takeaway: These rules shall come into force for implementation as under:
Category of manufacturers[Based on turnover (INR)] & Timeline for implementation
Large manufacturers
(Turnover>250 crores): Six months from the date of publication of these rules
Small and Medium manufacturers
(Turnover ≤ 250 crores): Twelve months from the date of publication of these
rules
If you would like to receive notifications about drugs rules, email: info@fwqrc.com
Very useful to update our knowledge