"There have been rapid changes in the standards of drug all over the world, stakeholders felt necessary to bring out new edition of the book as it would also help keep pace with the regulatory requirements," the Union minister said while releasing the book.
The standards given in the pharmacopoeia are authoritative, legally enforceable and intended to help in the inspection and licensing of manufacturing units and distribution of drugs and pharmaceuticals.
Azad noted that the latest edition has been considerably revised and improved by introducing advanced technology and experimental methods widely adopted in India and abroad.
It prescribes the standards for drugs produced and/or marketed in India and thus contributes in the control and assurance of the quality of the medicines.
The scope of the Pharmacopoeia has been extended to include products of biotechnology, indigenous herbs and herbal products, veterinary vaccines and additional antiretroviral drugs and formulations, inclusive of commonly used fixed-dose combinations.
IP 2014 incorporates 2,548 monographs of drugs out of which 577 are new monographs consisting of APIs, excipients, dosage forms, antibiotic monographs, insulin products, and herbal products.