Events
Past Events
Meeting with Mr. Nitin Kumar Yadav, Joint Secretary, Department of Commerce
Members of AMCHAM’s Medical Devices and Pharmaceuticals Committees met with Mr. Nitin Kumar Yadav, Joint Secretary, Department of Commerce, Ministry of Commerce and Industry, Government of India on June 24th. The interactive session was led by Mr. Anuj Virmani, Co-Chairman – Medical Devices Committee, AMCHAM and Managing Director, Johnson & Johnson, along with Ms. Jyotsna Ghoshal, Enterprise Lead, Government Affairs & Policy India and Head India Community Impact, Johnson & Johnson Pvt. Ltd.
Key issues raised by the medical devices sector:
- Pricing Policy Reform and Trade Margin Rationalization: Members expressed the need for a transparent, predictable pricing framework, particularly for knee implants and stents.
- Policy Predictability & Quality Control Orders (QCOs): Concerns were raised over multiple QCOs issued by different ministries, leading to operational, compliance, and cost challenges. Members recommended exempting medical devices and their components, spares, and accessories from QCOs until a robust domestic component ecosystem is established.
- Refurbished Medical Equipment: Members emphasized the need to enable access to advanced medical technologies in tier-II/III cities and rural India through a clear, risk-based regulatory framework for refurbished devices that ensures patient safety and affordability.
Key issues raised by the pharmaceutical sector:
- Intellectual Property (IP) Protection: The lack of patent linkage and regulatory data protection within the current regulatory framework was highlighted as a concern. This gap results in unintentional patent infringements, effects on investor confidence and India’s global IP standing.
- Regulatory Harmonization: Industry advocated for the implementation of the 101 Rule, which promotes the adoption of globally accepted technical standards and regulatory practices. Additionally, members recommended India’s active pursuit of ICH (International Council for Harmonisation) and PIC/S (Pharmaceutical Inspection Co-operation Scheme) memberships, along with enhanced bilateral regulatory cooperation to facilitate mutual recognition and streamline regulatory approvals.
In conclusion, the Joint Secretary encouraged AMCHAM members to submit a detailed note elaborating on each issue raised during the meeting for further consideration by the Department.
From Left to Right
Ms Preety Sharma, Regulatory Head, Edwards Life Science, Mr Mehul Tyagi, Associate Director, Johnson & Johnson, Ms Shobha Mishra Ghosh, Director & Head, Govt. Affairs & Policy India & South Asia, GE Healthcare, Ms Karishma Dhar, Senior Manager- Government Affairs & Market Access, Stryker, Ms Jyotsna Ghosal, Enterprise Lead, Government Affairs & Policy, India; Global Lead, International Forums, Johnson & Johnson, Mr Anuj Virmani, Co Chairman – AMCHAMs MedTech Committee & Managing Director, Johnson & Johnson, Ms Elizabeth Jose, Director, AMCHAM, Mr Ravi Valia, Director Government Affairs, India Medtronics, Mr Sudhakar Mairpadi, Senior Director-Regulatory and Government Affairs, India /South Asia, BD India, Mr Ajay Bagga, Managing Director India & Country Head – South Asia, Mr Ajay Bijani, Country Head Baxter, Dr Vibhav Garg, Director-Health Economics & Govt Affairs India HUB & ASEAN, Boston Scientific, Mr Rohit Duhan, Market Access & Govt. Proc, Baxter, Mr Manoj Grover, Associate Director, Eli Lilly, Mr Sharad Goswami, Senior Director, Public Affairs, Pfizer.
