The pharmaceutical industry in the country has flagged the recent CDSCO’s norm mandating a minimum 60% shelf life for exported drugs as a significant hurdle, warning that the move could disrupt shipments, increase compliance costs and lead to higher wastage. Exporters say the blanket norm does not align with regulatory practices in several importing countries and may hurt India’s competitiveness in key overseas markets, especially for products with shorter shelf lives.
The new norm by the CDSCO will force the companies to destroy the medicine stocks to be compliant. Currently, the industry ranks third globally in volume and 14th in value, accounting for approximately 20% of the global supply of generic drugs and 60% of global vaccines.
Industry experts note that the new rule could compel companies to discard large batches of drugs that no longer meet the 60% shelf-life threshold, even if they are still safe and effective. Smaller pharmaceutical exporters, in particular, may face financial strain, as managing inventory and meeting the compliance requirements could increase operational costs and delay shipments, potentially affecting relationships with international buyers.
Saransh Chaudhary, president, global critical care, Venus Remedies and CEO, Venus Medicine Research Centre, pointed out that regulatory reforms must be carefully calibrated so that safety gains do not inadvertently create operational inefficiencies or market distortions. The recent CDSCO requirement that exported medicines retain at least 60 per cent of their shelf life has raised concerns among manufacturers, particularly for products with long supply chains or extended transit times.
In some cases, batches that fully meet buyer specifications and international regulatory standards risk being discarded purely due to timing constraints. Such outcomes underscore the importance of balancing patient safety objectives with practical realities of global pharmaceutical trade, added Chaudhary.
Dr Sunil S Chiplunkar, vice president, business development, Group Pharmaceuticals opined that the 60% shelf-life is not an issue since Indian pharma by and large ensures long shelf life dispatches. Abroad, expired products destruction is a difficulty. The point is supplied goods should be consumed and the challenge is optimal stocking.
To markets like Qatar, summer dispatch logistics is costlier; hence it is better to send long shelf life goods in non-summer dispatches. In case of OTX (over-the-counter: OTC with a prescription element) products challenge is ensuring just-right stocking and not over stocking. There may be some critical products like insulins, epinephrine and vaccines with short shelf life where this 60% shelf-life rule should be given exception, said Dr Chiplunkar.
Jatish N Sheth, president, Karnataka Drugs and Pharmaceutical Manufacturers and director Srushti Pharmaceuticals said, “If the buyer is willing to purchase the product, we do not see any necessity for CDSCO to create a road hump for the transaction and business. The fact of the matter is that companies will not be able to export without buyers’ consent.”
Now companies are looking to urge the CDSCO to reconsider or provide flexibility in the shelf-life requirement, emphasizing the need for a balance between regulatory rigor and practical trade realities. Without adjustments, industry stakeholders warn that the rule could slow India’s pharmaceutical export growth currently at US$ 30.47 billion in 2024-25 can affect supply chains, and reduce the global competitiveness of Indian pharma, said a section of companies.
Source : Pharmabiz
