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Exporters raise alarm over new Export NOC guidelines, seek urgent resolution
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Shardul Nautiyal, Mumbai
March 19 , 2025
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Pharmaceutical exporters have raised serious concerns over the newly introduced guidelines for the Export No Objection Certificate (NOC) for pharmaceutical products, terming them as a significant trade barrier that could hinder the growth and competitiveness of India’s pharmaceutical exports.
Exporters have sought immediate intervention from the Drugs Controller General of India (DCGI) and the Union Ministry of Health to address these pressing issues.
According to the pharma exporters, the recently implemented Export NOC system, effective from March 7, 2025, introduces stringent documentation and compliance requirements that create unnecessary bottlenecks for exporters. Expressing its dissatisfaction, an expert stated, “These new requirements pose a severe threat to the ease of doing business for pharma exporters and could severely impact the industry’s contribution to India’s export economy.”
Key concerns raised include mandatory undertaking from active pharmaceutical ingredient (API) manufacturers. The new rule mandates a legal undertaking from the API manufacturer, a requirement that is difficult to fulfil as APIs are often procured through traders.
Since manufacturers typically source APIs from multiple approved vendors, obtaining such undertakings on legal stamp paper is practically unfeasible. Exporters assert that this requirement, which was not mandatory earlier, serves no effective purpose and will disrupt the supply chain.
Another key challenge is related to the one-year validity period for export NOC. The discontinuation of quantity-specific NOCs has raised alarms among exporters, as the registration and licensing processes for pharmaceutical exports often extend beyond a year. Steps such as dossier preparation, product registration, and obtaining regulatory clearances from importing countries can take 18 to 24 months, making the one-year validity impractical. The policy change could lead to a significant drop in the export of registered products from India, pushing business towards competitor nations.
Another major issue is related to approval status from importing countries. The revised guidelines require exporters to furnish approval status from the importing country, a demand that is virtually impossible to meet.
Many countries, particularly in the Rest of the World (ROW) markets, allow special import permissions without formal product registration. Exporters warn that this requirement could drive business away from India to countries with more flexible regulations.
Under the new rules, pharmaceutical exporters will be compelled to destroy stocks with less than 60% shelf life remaining, leading to substantial financial losses.
Exporters often maintain stocks to facilitate multiple shipments, as manufacturers require minimum order quantities (MOQ) while importers demand smaller quantities. The new rule could disrupt the delicate balance between manufacturers and importers, further dampening trade prospects.
In light of these significant challenges, exporters have urged the authorities to reconsider the stringent regulations and provide a viable resolution that supports the industry’s growth. “We see this as a major trade barrier that will hamper India’s pharmaceutical export potential. A collaborative approach between exporters and regulators is needed to ensure trade efficiency while maintaining compliance,” an exporter stated.
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