Manufacturing

Developing Drug / Device Combination Products : Concept to Commissioning

The Current Challenges faced During the Development and Marketing of Drug / Device Combination can be summarized as below :

1. During Manufacturing of the Drug Device combination the following challenges may be encountered

• Large Scale Manufacturing
• Device Filling in Aseptic Lines with Drugs
• Replication of the Drug Impregnation / Coating process on commercial scale
• Combipack Development
• Integration of Automation
• From Production to Filling/ Coating
• Validation Protocols to be used
• Clinical Trials requirements for Novel Devices
• Packaging Requirements (Intermediate and Final)
• Filling Lines
• Sterility of Ready to Fill Systems in Aseptic Lines
• Labeling for Regulators and Users
• Choice of Sterilization Methods
• Standardization of Exchange of Data amongst Device and Drug Manufacturers

2. Affixing Responsibility

• Post Market Clinical Feedback
• Post Market Surveillance
• Vigilance and Incident Reporting
• Complaints
• Corrective and Preventive Actions

3. Classification of Drug/Device combinations in the currently prevailing law in India (Medical Device Rules 2017) states that all Medical devices incorporating medicinal products shall be assigned to Class D, if it incorporates as an integral part a substance which, — (1) if used separately, may be considered to be a medicinal product; and (2) is liable to act on a human body with an action ancillary to that of the medical device until and unless if the incorporated substance is a medicinal product exempted from the licensing requirements of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder, in which case it will be assigned to Class B,.

4. Regulatory Approvals such as EU MDR- Combination products have undergone a substantial change under the EU MDR 2017/745 and new regulatory challenges are at the horizon.

Rule 14 for device classification according to the EU MDR states that all devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from
human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the devices, are classified as class III. The main regulatory challenge is related to article 117 of EU MDR, that introduces a new concept for combination products (typically drug-device combinations).

5. Legal and Intellectual Property Right Issues amongst the parties involved in collaborative development (drug manufacturer and device manufacturer)
 

Dr. Atul Sardana (MBBS, MS, FIAGES) is a minimal access surgeon with a knack for applying technology to conventional surgical principals which benefits patients. Dr. Atul Sardana has been working in the health care sector since 1990 starting as a social worker in one of Delhi’s large government hospital. He graduated from the University of Rajasthan in 1998 and served in the rural sector in there. He then did his masters in surgery in 2002 and has since been working extensively in minimal access surgery as a consultant surgeon in various hospitals of repute including Sir Ganga Ram, Kolmet and Apollo Spectra Hospital. He has over 30 national and international clinical publication and presentations and is a honorary member of the World Association of Laparoscopic Surgeons, member of the Indian Association of Gastrointestinal and Endoscopic Surgeons and the BIS Technical Committee on Surgical Instruments (MHD01). He was also member of the steering committee for Good Clinical Practices formed by the GOI.

Dr. Atul Sardana has been invited at various forums and conferences as a key speaker on Medical Device Innovation and Medical Device Plastics and as a panelist on talk pertaining to the fund raising in the Healthcare sector with particular focus on Innovative Medical Device Companies in India. He has been on the committee for Medical Devices constituted by the Principal Scientific Advisor, GOI and also as panelist on innovation ecosystem in Gujarat organized by GSBTM. He has also been invited to deliver guest lectures at IIT-Delhi on medical applications of textiles and has conducted workshops at IIT-Delhi, IIT-Rourkee and IIT-Mumbai for FTT, TIDES and SINE incubates on Medical Device Regulations. He serves as an expert in various panels for evaluation of novel and innovative technologies for grants and funding by BIRAC, FITT IKP, BREC, C-CAMP, Bill & Melinda Gates Foundation and the Pfizer Trust. His work has been covered both press and media on several occasions. He was awarded the fellowship of Indian Association of Gastrointestinal and Endoscopic Surgeons in 2007. He was actively involved in training of surgeons in the field of Advanced Solid Organ Laparoscopic Surgery, Endo stapling Principles and Techniques, and Laparoscopic Hernia Surgery at Ethicon Institute of Surgical Education, New Delhi and is a faculty for the conduct of the fellowship of Indian Association of Gastrointestinal and Endoscopic Surgeons. He is a certified internal auditor of quality management systems for medical device manufacturing as per ISO 13485:2003 from TUV-SUD. He was the Vice Chairman of the Indian Industries Association (IIA-Delhi), a chamber of commerce and advocates policy change to encourage the development MSME sector at the Government level. He served as the head of Technical operations at Biosurge Technologies, Mumbai and later was the founder chairman at Alfa Corpuscles Private Limited where he currently serves at the Head for Research and Product Development. He has four national patents and three PCT's filed for his invention of the "Laparoscopic Trocar", "Safety Syringe", “Coated Hernia Mesh” and "Oral Vaccine Reconstitution & Delivery Device". His efforts on the safety syringe have been acknowledged by the “Wellcome Trust, UK” and the invention has been awarded the Silver Prize at the Seoul International Invention Fair 2012. He also has the distinction of being honoured twice at the Rashtrarapati Bhawan, during the display of his innovative technologies at the exhibition on "Innovations in Medical Science and Biotechnology” in 2015 and 2017.