Corporate Vision • Product registrations with CDSCO • Product supply to Indian distributors • Post-marketing surveillance • Handle custom clearances • Full-spectrum compliance with regulatory mandates To further detail the agent’s responsibilities: • Procure and manage the import license under Form MD-15, which can be issued only to this agent and NOT the overseas company • Ensure full product compliance under the quality and other parameters set by the Indian regulator, and if needed, handle product recall procedure. These include, but are not limited to, adhering to quality management systems, ensuring patient safety, scrutinising material and design quality of devices, and other checkpoints throughout the device lifecycles. • Provide full assistance for import compliance under relevant Acts, as also under Form MDR-17 • Provide logistical, supply chain, and inland transportation support to safely move products across the distribution and sales funnels. These include establishing inland storage infrastructure such as warehouse facilities. First-hand customer feedback available with us confirms that as an authorised agent, CliniExperts has habitually provided exceptional services across the board. What makes it a preferred choice for so many overseas companies? • Pan-India presence and coverage that offers unmatched ease of operation • Single-window feature for all registrations and regulatory compliance under one roof • Flexibility of appointing multiple sub-distributors, which prevents dependency on a single large distributor • Pharmacovigilance - CliniExperts’ elaborate market vigilance mechanism collects and collates market data and regularly shares with customers. • Information and knowledge updates - Equipped with the latest knowledge of legal amendments and regulatory updates, CliniExperts is rightly called info-savvy! The client is thus always in safe hands. This video provides insight into CliniExperts’ capabilities as an authorised agent for medical device business. Pharmaceutical Drugs portfolio Regulatory snapshot • Regulatory body: The Central Drugs Standard Control Organisation (CDSCO) • Governing laws: The Drugs and Cosmetics Act of 1940, and the Drugs and Cosmetics Rules of 1945. • Licenses required: • Registration and Import license • Form 10 for general and OTC drugs not listed in Schedule X, and Form 10-A for-prescription drugs listed in Schedule X. These licenses have to be renewed every three years. Drug and Medical Device Regulatory Dynamics in India – CliniExperts is Acing the Ace Following the firm’s win of Best Pharmaceutical & Medical Devices Regulatory Solutions Provider for 2023, we heard from CEO Dr. Ashwini Kumar. Dr. Ashwini Kumar, CEO of CliniExperts Services Pvt. Ltd. With a decentralised framework engaging both federal and state authorities, and involvement of multiple agencies in the decision-making process, India has a complex healthcare regulatory environment. The ongoing reforms also make it dynamically evolving. If companies are not continuously updated about the latest changes or amendments in the guidelines and laws, independent filings can be counterproductive. This can lead to loss of time and business. With much on the line, it is recommended that experts manage your regulatory and compliance matters while you focus on other critical aspects of marketing your products in India. In my experience and opinion, there is one entity that aces regulatory compliance in India - CliniExperts. CliniExperts - Regulatory expert trusted by over 25 global companies for India business Since 2009, CliniExperts has stood out for its capabilities in seamless, end-to-end regulatory strategy and process management. In this entity, you have a serious case to consider for your India regulatory affairs management. Especially, if you have pharmaceuticals and medical device portfolios to offer to the Indian market. That’s where CliniExperts aces the ace. CliniExperts’ deep service basket With a comprehensive and inclusive offering, CliniExperts does put all its eggs in one basket. Once a partnership with a customer sets off, the company brings to the table all the services needed to initiate and establish a successful India presence. On domain-specific offerings, here is the breakdown of CliniExperts 360-degree coverage: Medical Device portfolio Mandatory appointment of Authorised Agent Medical device exporters to India must operate through an Indian authorised agent for all inland business. This dependency on an Indian entity makes it imperative for cross-border players to have a reputed, experienced, efficient, and resourceful Indian agent who can multitask as a facilitator, provider, trouble-shooter, and more, to ensure smooth, fast, and uninterrupted operations. Obviously, this agent has to be best-in-class, someone like CliniExperts, someone who is an all-weather allrounder who gives 200% to their role and responsibilities. Role of Authorised Agent The agent is the company’s proxy operator, fulfilling these needs:
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