The pharmaceutical industry in India is gearing up for a significant regulatory change with the introduction of the Drug Amendment Act 2022 by the Ministry of Health and Family Welfare, Government of India, on January 18, 2022.
This act mandates that pharma companies producing 300 specified drugs comply with a set of 11 criteria aimed at enhancing drug safety and traceability.
As the implementation date of August 1, 2023, approaches, it is crucial for pharmaceutical manufacturers to understand the implications of this act and take necessary measures to ensure compliance.
It is high time we delve into the critical aspects of the Drug Amendment Act 2022, understand its significance, and explore how pharmaceutical companies can comply with its requirements.
What is the Drug Amendment Act 2022?
The Drug Amendment Act 2022 introduces a series of measures to strengthen drug regulation and combat counterfeiting in India.
Under this act, Bar Code or Quick Response Code (QR Code) is required to print or affix on the primary packaging labels of drug manufacturers.
In cases where there is insufficient space on the primary package label, the code can be printed on the secondary package label.
These codes store data or information that can be easily authenticated using a software application, ensuring the traceability and authenticity of the drugs.
Why do we need the Drug Amendment Act 2022?
The Drug Amendment Act 2022 holds immense significance for the pharmaceutical industry for several compelling reasons.
Firstly, it addresses the growing concern of counterfeit drugs, ensuring that consumers receive genuine and safe medications.
By implementing serialization and track & trace technologies, the act enables efficient monitoring of the drug supply chain, from manufacturing to distribution, thus minimizing the risk of counterfeit or substandard drugs entering the market.
This, in turn, helps to safeguard public health and strengthen the reputation of the pharmaceutical sector in India.
Compliance Requirements
Pharmaceutical companies affected by the Drug Amendment Act 2022 must comply with a set of 11 criteria outlined in the act.
For detailed information about the 300 drugs and 11 criteria specified in the Drug Amendment Act 2022, please visit our detailed guide here.
These criteria encompass various aspects, including the printing of unique identification codes, maintaining an electronic record-keeping system, and establishing mechanisms for authentication and traceability.
Compliance with these requirements is essential for pharma companies to continue manufacturing and distributing the specified drugs after August 1, 2023.
Preparing for August 1, 2023
As the implementation date of the Drug Amendment Act 2022 approaches, pharmaceutical companies must prioritize their readiness for compliance.
It is crucial to assess existing processes, identify gaps, and implement suitable serialization solutions to meet the requirements outlined in the act.
The implementation of serialization and traceability solutions not only enhances drug safety and supply chain integrity but also contributes to the overall growth and development of the pharmaceutical industry in India.
Jekson’s India Serialization Solution
In the face of these regulatory changes, Jekson Vision provides a comprehensive India Serialization solution designed to assist pharmaceutical companies in meeting the requirements of the Drug Amendment Act 2022.
Our solution integrates advanced serialization technologies with state-of-the-art label printing machines, enabling the seamless implementation of serialization processes.
With the ability to generate and print unique identification codes, our solution ensures that each drug package is traceable and authenticated throughout the supply chain.
Beyond compliance, Jekson’s India Serialization solution offers several benefits to pharma companies. It streamlines the serialization process, reducing manual errors and enhancing operational efficiency.
Real-time data capture and analysis enable improved inventory management, supply chain visibility, and product authentication.
Furthermore, our solution is scalable and adaptable, catering to the diverse needs of pharmaceutical manufacturers.
The Drug Amendment Act 2022 marks a significant milestone in the Indian pharmaceutical industry, setting higher standards for drug safety and traceability.
As the enforcement date of August 1, 2023, approaches, pharma companies producing 300 specified drugs must gear up to comply with the act’s serialization and traceability requirements.
Jekson Vision’s India Serialization solution offers a robust and reliable platform to facilitate compliance while providing operational efficiencies and improved supply chain visibility.
By embracing serialization technologies, pharmaceutical manufacturers can ensure the delivery of safe and authentic medications, fostering trust among consumers and upholding the highest standards of the industry.
