New Delhi, June 26: The government has invited comments and suggestions from stakeholders on the proposed framework concerning residual shelf-life requirements for imported pharmaceutical products, as part of ongoing efforts to strengthen regulatory clarity and ensure the availability of quality medicines in the country.
The consultation exercise aims to review and rationalise existing provisions governing the minimum residual shelf-life required for drugs at the time of import clearance. The objective is to ensure a balanced approach that safeguards patient safety while also improving ease of doing business for the pharmaceutical sector.
Officials said the proposed review seeks to align regulatory requirements with current global practices and supply chain realities, particularly in cases where medicines are imported to meet urgent clinical or public health needs. The initiative is also expected to reduce procedural bottlenecks and improve the efficiency of drug availability in the domestic market.
Stakeholders, including pharmaceutical manufacturers, importers, industry associations, healthcare professionals, and other concerned parties, have been requested to submit their comments and feedback within the stipulated timeframe.
The government will examine all suggestions received during the consultation process before finalising the revised guidelines on residual shelf-life requirements for imported drugs. The updated framework is expected to enhance regulatory transparency while ensuring uninterrupted access to essential medicines.
