The Central Drugs Standard Control Organization (CDSCO) has issued a circular calling upon all manufacturers to implement the revised Schedule M specified in the Drugs (Amendment) Rules, 2023. It has also urged manufacturers to comply with World Health Organization (WHO) Technical Report Series (TRS). This circular was issued on August 7, 2024.
The Indian drug industry is set to undergo significant changes as manufacturers are mandated to comply with the revised Schedule M guidelines and World Health Organization (WHO) Technical Report Series (TRS).
Recap on Revised Schedule M
The guidelines outline several key principles to be adhered to by pharmaceutical manufacturers, focusing on pharmaceutical quality systems, quality risk management, sanitation and hygiene, qualification and validation, complaints and adverse reactions, product recalls, and change control.
Manufacturers must take responsibility for ensuring pharmaceutical products’ quality, safety, and efficacy. A systematic process for assessing, controlling, communicating, and reviewing risks to the quality of medicinal products must be developed.
The guidelines emphasize on a high level of sanitation and hygiene in all aspects of drug manufacturing. Additionally, there must be rigorous review of all complaints and information concerning potentially defective products.
A formal change control system must also be implemented to evaluate all changes affecting production and product control.
What is WHO Technical Report Series (TRS) ?
The WHO Technical Report Series (TRS) is a Technical Report Series developed by the World Health Organization. IT disseminates the collective expertise of international expert groups, providing the World Health Organization with cutting-edge scientific and technical knowledge across a wide spectrum of medical and public health disciplines.
The CDSCO has also advocated for manufacturers to comply particularly with the WHO TRS 1044 Annexure 2. This covers WHO good manufacturing practices for sterile pharmaceutical products.
The circular emphasizes the need for all drug manufacturers to align their operations with the updated regulations. The revised Schedule M, which includes stringent Good Manufacturing Practices (GMP) and quality standards, aims to enhance the safety and efficacy of pharmaceutical products in India.
Drug manufacturers will now have to undertake a comprehensive gap analysis to identify areas where their facilities and processes need to be upgraded to meet the new requirements. This includes adherence to the WHO TRS guidelines, particularly those related to sterile pharmaceutical products.
The industry is expected to invest in infrastructure, technology, and training to ensure compliance with the new regulations.
