Book Reviewed – A Commentary on Drugs and Cosmetics Act, 1940, Drugs Rules, 1945, Medical Devices Rules, 2017, New Drugs and Clinical Trials Rules, 2019, Cosmetics Rules, 2020 together with Drugs Prices Control Order, 2013 and Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 & Rules, 1955. 

Reviewed By R. W. Gudal, Former Joint Commissioner and Controlling Authority, Food and Drug Administration, Maharashtra and currently Partner of QCS LABS LLP.

Keeping with time and going ahead

For ensuring the availability of drugs of the highest quality and safe drugs, the Drug Regulation has to be updated with the emerging knowledge, new experiences and requirements. Fortunately, this is continuously being done by the Indian Drug Regulators.

The next step is the enforcement of the revised, updated regulations by Drug Enforcement Agencies and compliance by the Industry and trade. 

For this purpose, the easy availability of updated drug regulations to Industry, Trade and Enforcement Officers is absolutely necessary. This tedious and hard task is continuously being performed by S. W. Deshpande and Nilesh Gandhi since 1999, in an imaginative, creative and highly commendable way. As both of them have wide and varied experience as enforcement officers and thereafter as Consultants to Industry, they know what is exactly required and in which format it is required by the Industry, Trade, Enforcement Officers and Practicing Advocates. 

Their experience and knowledge of law, science and technology has well reflected in their comments on various Judgments delivered by various High Courts and Supreme Court. The apt comments on interpretation of various provisions of Drug legislation will be of immense help to the industry, trade, practicing advocates and regulators in better understanding and interpretation of the Statute.

Both of them are very active in the pharma field and they make use of the inputs they receive through seminars, workshops, training programs and consultations for value addition in each new edition of their book. I have seen all the editions and each edition has added value to the earlier one. The current 11 th Edition comes in two volumes with a booklet on revised Schedule M, which makes it very comfortable for handling and meets the expectations and requirements of the stakeholders. This edition has a section-wise case studies of the related judgements of various High Courts and Supreme Court with the legislative background. It also has writeup on applicability of the provisions under Code of Criminal Procedure, 1973. This edition also includes important amendments as Cosmetics Rules, 2020, NLEM 2022 as Schedule to DPCO, 2013, Amendment through Jan Vishwas (AOP) Act, 2023, Schedule H2, etc.

In addition to the Act, Rules, commentary and case laws, we can find important notifications issued from time to time, up to date list of Classification of Medical Devices as issued by DCGI from time to time, meticulously sorted, consolidated and alphabetically organized list of New Drugs

Book Reviewed – A Commentary on Drugs and Cosmetics Act, 1940, Drugs Rules, 1945, Medical Devices Rules, 2017, New Drugs and Clinical Trials Rules, 2019, Cosmetics Rules, 2020 together with Drugs Prices Control Order, 2013 and Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 & Rules, 1955. 

Reviewed By Kamal R. Chawla, Controlling Authority/ Dy. Drugs Controller, Drugs Control Department, Govt. of National Capital Territory of Delhi, Delhi.

Strict enforcement of the drug regulation is one of the tools to achieve the availability of highest quality and safe drugs. Updation of knowledge regarding the current legislation is essential for its better implementation. The book authored by S. W. Deshpande and Nilesh Gandhi, is an exhaustive commentary on Drugs legislation published by Susmit Publishers, Mumbai. In addition, it is an excellent reference book and guide for the Drug enforcement officers. The authors of this book Shri S. W. Deshpande and Shri Nilesh Gandhi have extensive experience with Food and Drug Administration of Maharashtra State. The various judgments cited in this book along with their comments reflect their knowledge of law and the experience in the field of enforcement.

I have seen all the 11 editions and each edition has added value to the previous one. The current 11 th Edition comes in two volumes with a booklet on revised Schedule M, which not only makes it very comfortable for handling but also meets the expectations and requirements of the stakeholders. This edition has a Section-wise case studies of the related judgments of various High Courts and Supreme Court with the legislative background. It also has write-up on applicability of the provisions under Code of Criminal Procedure, 1973 (now known as Bharatiya Nagarik Suraksha Sanhita, 2023). This edition also includes important amendments as Cosmetics Rules, 2020, NLEM 2022 as Schedule to DPCO, 2013, Amendment through Jan Vishwas (AOP) Act, 2023, Schedule H2, etc.

In addition to the Act, Rules, commentary and case laws, we can find important notifications issued from time to time, up to date list of Classification of Medical Devices as issued by DCGI from time to time, meticulously sorted, consolidated and alphabetically organized list of New Drugs approved / permitted by DCGI which includes FDCs, SNDs as well as Veterinary Drugs.

The apt comments on interpretation of various provisions of Drug legislation will be of immense help to the stakeholders such industry, trade, practicing advocates and regulators etc. in better understanding and interpretation of the Statute.

Dear Sir,

I have been working in the pharma industry for over 4 decades & was on the board of Sanofi besides working with Abbott exclusively as senior director Govt Affairs for their all lines of business whether pharma or medical devices. I also spent 4 years with Roche Diagnostics as Head -external affairs.  Now I am consulting companies in the field of healthcare.

In my profession, the credibility comes only when you have knowledge of law & for that you need authentic books who not only give bare act but also commentary on each section & rules besides relevant case laws. On all these fronts, my complete guide is your book esp. the 11th edition as it has also included medical devices as well as DPCO.

What I liked the most is your simple language & lucid explanation. There are not many authors who cover the Act but Deshpande & Gandhi, the authors have insights which comprehensively covers all aspects including Medical Devices Rules which are so important. Even during my stint at Roche where we are in business of IVDs the book was very useful for studying all the aspects of rules.

I would recommend this book for all fellow professional to purchase for their ready reference especially on any discussions be it with clients, be it with govt officials or be it speaking to colleagues if one works in regulatory, government affairs or public affairs function, this is your guide as one can speak with authority & authenticity when this book is in your hands.

Best wishes for 12th edition too -eagerly waiting!

Regards

Shirish Ghoge

M.COM. LLB. FCMA, ACS,

Book Reviewed – A Commentary on Drugs and Cosmetics Act, 1940, Drugs Rules, 1945,Medical Devices Rules, 2017, New Drugs and Clinical Trials Rules, 2019, Cosmetics Rules, 2020 together with Drugs Prices Control Order, 2013 and Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 & Rules, 1955.

Reviewed By Shri. Devesh Malladi, Managing Director, Embio Limited & Executive Council member, Indian Drugs Manufacturers Association (IDMA).

Pharmaceutical, Medical Device and Cosmetic industry is highly regulated, therefore compliance of regulatory requirements under various drug laws is very critical for Industry and Trade. Strict compliance of the drug regulation is the key to ensure highest quality and safe drugs. Updated knowledge regarding the current legislation is essential for better compliance. The book authored by S. W. Deshpande and Nilesh Gandhi, is an exhaustive commentary on Drugs legislation published by Susmit Publishers, Mumbai. It is an excellent reference book and guide for the Pharmaceutical, Medical Devices and Cosmetic Industry, as well as to the Drug enforcement officers. The authors of this book Shri S. W. Deshpande and Shri Nilesh Gandhi have extensive experience with Food and Drug Administration of Maharashtra State. The various judgments cited in this book along with their comments reflect their knowledge of law and the experience in the field of enforcement.

I have seen all the 11 editions and each edition has added value to the previous one. The current 11 th Edition comes in two volumes with a booklet on revised Schedule M, which not only makes it very comfortable for handling but also meets the expectations and requirements of the stakeholders. This edition has section-wise case studies of the related judgments of various High Courts and Supreme Court with the legislative background. It also has a write- up on applicability of the provisions under Code of Criminal Procedure, 1973. This edition also includes important amendments as Cosmetics Rules, 2020, NLEM 2022 as Schedule to DPCO, 2013, Amendment through Jan Vishwas (AOP) Act, 2023, Schedule H2, etc.

In addition to the Act, Rules, commentary and case laws, one can find important notifications issued from time to time, up to date list of classification of Medical Devices as issued by DCGI from time to time, meticulously sorted, consolidated and alphabetically organized list of New Drugs approved / permitted by DCGI which includes FDCs, SNDs, as well as Veterinary Drugs.

The apt comments on interpretation of various provisions of Drug legislation will be of immense help to the stakeholders such industry, trade, practicing advocates and regulators etc. in better understanding and interpretation of the Statute.