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q Notices and IP Compliance
 

Legal Notices

 

In India, under the Drugs and Cosmetics Act 1940, the current edition of Indian Pharmacopoeia is a book of standards for drugs included therein and the standards as included in the Indian Pharmacopoeia would be official. Also, in several other laws of India, the Indian Pharmacopoeia is recognised as the standard book. It is expedient that enquiry be made in each case in order to ensure that the provisions of any such law are being complied with. In general, the Drugs and Cosmetics Act, 1940, the Narcotic Drugs and Psychotropic Substances Act, 1985, the Poisons Act, 1919 and the rules framed thereunder should be consulted. These statutes empower the Government agencies to enforce the law using this compendium. The monographs of the Indian Pharmacopoeia should be read subject to the restriction imposed by those laws which are applicable.

 

If considered necessary, the standards included in Indian Pharmacopoeia can be amended and the Secretary-cum-Scientific Director is authorised to issue such amendments. Whenever such amendments are issued, the Indian Pharmacopoeia would be deemed to have been amended accordingly.

 

Patents and Trade Marks

 

In the Indian Pharmacopoeia, certain drugs and preparations have been included notwithstanding the existence of actual or potential rights in any part of the world. In so far as such substances are protected by Letters Patent their inclusion in the Indian Pharmacopoeia neither conveys, nor implies, licence to manufacture without due permission, authority, or licence from the person or persons in whom such rights exist.

 

The titles given under the individual monographs are public property. These titles cannot be patented as trade marks and no person is permitted to patent any trade mark devising the root of these titles.

 

 

IP Compliance

 

·        The interpretation of a monograph must be in accordance with all the general requirements, testing methods, texts and notices pertaining to it, in the IP.

·        A product is not of standard quality unless it complies with all the requirements of the monograph.

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