31 October, 2018
It gives us immense pleasure to bring forth the fourth issue of our quarterly pharmaceutical and healthcare practice newsletter- Synapse.
Cyril Amarchand Mangaldas, India’s premier full-service law firm has an industry first dedicated Pharmaceutical, Healthcare and Life Sciences practice. Our class leading practice specialists are always on top of the latest developments in the sector.
This publication is part of our thought leadership initiative and was conceptualised and created keeping in mind the need to keep our clients better informed of the latest developments in the pharmaceutical industry in a succinct format. I am happy to report that our clients have greatly appreciated this initiative at sharing and disseminating knowledge in relation to the changing landscape of the pharmaceutical and life sciences industry especially given the increase in regulatory scrutiny by the regulator in the past few years. The trust and confidence that our clients repose in us pushes us to new boundaries as we scale new industry heights.
In the current issue, we shed light on the latest notification by the Ministry of Health and Family Welfare (“MoHFW”) in relation to the Draft Rules (“Draft Rules”) amending the Drugs and Cosmetics Rules, 1945 (“D&C Rules”) in order to regulate the sale of drugs through E-Pharmacies1. Additionally, a draft bill, to regulate the collection, transmission, disclosure and usage of digital health data, was also released by the MoHFW2. In the Medical Devices sector, the National Coordination Centre-Materiovigilance Programme of India has released a Draft Guidance Document for Medical Devices3.
Moving to ban notifications, we start with the FDC ban issue, the CDSCO issued a fresh set of notifications on September 12, 2018 whereby 328 FDCs have been prohibited on grounds of safety, irrationality and lack of therapeutic justification. In addition, the Government issued notifications banning the commercial production of Oxytocin, which has been subsequently stayed by the Delhi High Court.
On the corporate side, the National Company Law Tribunal Mumbai rejected Ajanta Pharma Limited’s scheme of amalgamation and arrangement between the company and its shareholder Gabs Investments Private Limited on the grounds of General Anti Avoidance Rules. Some notable transactions have also been covered.
This and more that has happened in the industry and we have made an attempt to capture some of the major topics that may be of interest to our readers. With this in mind, we present to you Volume II Issue II of our Pharmaceutical and Life Sciences Newsletter Synapse. We hope you would enjoy reading this newsletter as much as we have enjoyed creating it. Please feel free to send your comments, feedback and suggestions to synapse@cyrilshroff.com. Your feedback enables us to better our efforts and make our publication more valuable to our readers. We also encourage you to visit our blog at https://corporate.cyrilamarchandblogs.com for more articles. Please do write to us in case we can provide additional information on any topic covered in this newsletter.
On a more personal note, as we move into the festive season, we wish you and your families a healthy, prosperous and joyous festival season and send our best wishes to all our readers.
For the full update (10 pages), please click here.
For further information, please contact:
Cyril Shroff, Managing Partner, Cyril Amarchand Mangaldas
cyril.shroff@cyrilshroff.com
