The issuance of the amended Schedule M follows persistent advocacy from industry associations such as the Organization of Pharmaceutical Producers of India (OPPI). The government had previously introduced a draft Gazette Notification GSR 999 (E) in 2018. In response to concerns and opposition, the Central Drugs Standard Control Organization (CDSCO) took proactive measures by organizing regional workshops across India. These workshops aimed to sensitize manufacturers about the new requirements and facilitate a smoother implementation process.

In recent years, the quality of pharmaceutical exports from India has faced scrutiny. Recognizing the need to bolster the credibility of Indian pharmaceutical products globally, the government has strengthened sectoral export regulations. To enforce compliance, the CDSCO has conducted several raids on pharmaceutical units nationwide, revoking production licenses and sending a clear message to the industry: upgrade or face potential shutdowns.

The pharmaceutical sector plays a crucial role in India's economy, and ensuring the quality of exports is paramount for maintaining a positive global reputation. The recent regulatory actions and the revised Schedule M are steps towards achieving this objective. It is imperative for the industry to align with international best practices, standards, and inspections, including those set by WHO, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

The government's commitment to regulatory harmonization reflects a broader initiative to position India as a key player in the global pharmaceutical landscape. By adopting and implementing international standards, India aims to enhance the overall quality and credibility of its pharmaceutical products.