Drugs and Cosmetics (Draft ) Amendment Rules ,2018

Oct 09, 2018 | by Avantis RegTech Legal Research Team


Ministry of Health and Family Welfare vide notification dated October,05,2018 has published Drugs and cosmetics(Draft)  Amendment Rules,2018 further to amend the Drugs and Cosmetics Rule, 1945.

Notice is hereby given that said draft rules will be taken into consideration on or after the expiry of a period of thirty days from the date on which copies of the Official Gazette of India containing these draft rules are made available to the public.

Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi.— 110011 or e-mailed at [email protected].

Ø  These rules shall not apply to the manufacturers, who are presently licensed to manufacture drugs before the October 31,2020

Ø  In the Drugs and Cosmetics Rules, 1945 (hereinafter to be referred as said rules)- (1) In rule 74, in clause (o), for the words “Good Manufacturing Practices” the word “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products” shall be substituted

Ø  In the said rules, in rule 76, in sub-rule (8), for the words “Good Manufacturing Practices” the word “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products” shall be substituted;

Ø  In the said rules, in rule 78, in clause (p), for the words “Good Manufacturing Practices” the word “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products” shall be substituted

Ø  Substantial changes have been proposed in Schedule M.

 

Subject matter of the changes are following

 

        I.            PART I Good Manufacturing Practices for Pharmaceutical Products:

      II.            PART II Specific Requirements for Manufacture of Sterile Products, Parenteral Preparations (Small Volume Injectables and Large Volume Parenterals) and Sterile Ophthalmic Preparations

    III.            PART III Specific Requirements for Manufacturing of Pharmaceutical Products Containing Hazardous Substances Such as Sex Hormones, Steroids (Anabolic, Androgenic) or Cytotoxic Substances

    IV.            PART IV Specific Requirements for Manufacture of Biological Products

      V.            PART V Specific Requirements for Radiopharmaceutical Products

    VI.            PART VI Specific Requirements for Phytopharmaceuticals

  VII.            PART VII Specific Requirements for the Manufacture of Investigational Pharmaceutical Products for Clinical Trials in Humans

VIII.            PART VIII Specific Requirements for Manufacture of Oral Solid Dosage Forms (Tablets and Capsules)

    IX.            PART IX Specific Requirements for Manufacture of Oral liquids (Syrups, Elixirs, Emulsions and Suspensions)

      X.            PART X Specific Requirements for Manufacture of Topical Products i.e. External Preparations (Creams, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting Powders and Identical Products)

    XI.            PART XI Specific Requirements for Manufacture of MeteredDose Inhalers (MDI)

  XII.            PART XII Specific Requirements for Manufacture of Active Pharmaceutical Ingredients

XIII.            PART XIII Requirements of Plant and Equipment

 

[[F.No. X.11014/2/2017-DRS]

 

URL-http://egazette.nic.in/WriteReadData/2018/190663.pdf

 

 


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