About Susmit Publishers
Susmit Publishers established on 24th October, 1995 is a proprietary concern of Dr. Smita Deshpande, M.Phil., Ph.D. in literature. Susmit Publishers published first edition of Commentary on Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 and Rules, 1955 in December, 1995 authored by Shri. S.W. Deshpande, the then Assistant Commissioner, FDA, Maharashtra. It was the first independent commentary on this Act. The three editions were published and were well accepted by the professionals in pharmaceutical industry, regulatory agencies, academics and in distribution network.
Thereafter, in 1999, Susmit Publishers published first edition of Commentary on Drugs and Cosmetics Act, 1940 and Rules, 1945 together with Drugs (Prices Control) Order, 1995 authored by Shri. S.W. Deshpande, the then Assistant Commissioner, FDA, Maharashtra and Shri. Nilesh Gandhi, the then Drugs Inspector, FDA, Maharashtra. Subsequently, the composite commentary on Drugs and Cosmetics Act, 1940 and Rules, 1945, Drugs (Prices) Control Order, 1995 Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 and Rules, 1955 was published.
The editions have been updated from time to time and 10 editions have been published from 1999 to 2023 which have been well accepted as a reference book by the professionals in pharmaceutical industry, regulatory agencies, distribution network and academics. 11th edition is recently published in two volumes and includes Medical Devices Rules, 2017, New Drugs and Clinical Trials, 2019 and Cosmetics Act, 2020. Separate handy booklet of revised Schedule M is provided for ease of reference and compliance.
11th edition also includes regular features such as fee chart, directions issued under Section 33P, applicability of CrPC, important notifications, classification of medical devices, guidelines issued under Medical Devices Rules and list of New Drugs Approved at Appendix A to G.
The unique features and strength of 11th edition are the: -
- Chart of fees applicable in the country.
- List of New drug approved by Drugs Controller General India along with list of fixed dose combination, subsequent new drugs approved up to 08.06.2023. The list is in consolidated form and made available in alphabetical manner for easy reference.
- Updated Classification of Medical Devices and In-Vitro Diagnostic Medical Devices by Drugs Controller General India under Medical Devices Rules, 2017.
- Fourteen important judgments of Supreme Court and High Court.
