This new edition provides the fully amended and updated text of the Drugs and Cosmetics Act, 1940 (as amended by Amendment Act 26 of 2008) and the Drugs and Cosmetics Rules, 1945 as amended upto the Second Amendment Rules, 2011, along with case law notes, allied Acts, Rules, Orders and Notifications. The DPCO, 1995 has been amended upto the Second Amendment Order of 2006. All systems of medicine such as Allopathic, Ayurvedic, Unani and Siddha, have been brought under the ambit of the stringent drug control law.
New materials provided in this edition:–
Schedule M-1 substituted - laying down revised Good Manufacturing Practices etc.;
New Schedule L-1 inserted laying down Good Laboratory Practices etc.;
Supplementary Guidelines for manufacturing of Ayurveda, Siddha and Unani medicines;
Date of expiry and shelf-life for Ayurveda, Siddha and Unani medicines made mandatory;
The applicable Patent Law as amended has been given;
Clinical Establishments (Registration and Regulation) Act, 2010;
List of Drugs approved upto May 2011;
List of Drugs and Combination Drugs Banned in India;
National Pharmacovigilance Program;
Circular regarding Customs Duty on Import of Cosmetics;
The new Schedule HX, as and when amended and notified would be available over the net, free of charge, to purchasers of this work.